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Mount Vernon Cancer Network
Head & Neck NSSG
Clinical Guidelines (11-1C-103i)
Version number as approved and published
Author
Date Written
Date Reviewed
Review Date
NSSG Ratified
0.12
Dr Kate Goodchild
May 2011
February 2013 (Sarcoma pathway
added)
May 2014
1st September 2011
Agreed by:
Position: Chair of the Network Board
Name: Dr Jane Halpin
Organisation: NHS Hertfordshire
Date agreed: 1st Septmeber 2011
Position: Chair of the Head & Neck NSSG
Name: Dr Kate Goodchild
Organisation: East & North Herts NHS Trust
Date agreed: 26th August 2011
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Contents
1.
2.
3.
4.
5.
6.
Referral Guidelines
1.1 Primary Care Referrals
1.2 Non 2WW Referrals
1.3 Inappropriate referrals to the Head, Neck & Thyroid Team
1.4 Referrals to the SMDT
1.5 Identification of patients for discussion at SMDT
1.6 Internal referral guidelines between teams
1.7 Radiotherapy/Oncology referrals
1.8 Pre-treatment Assessment & Management
Cancer of the Oropharynx
2.1 Investigation and preparation
2.2 Management of primary tumour
2.3 Management of the neck
2.4 Surgery
2.5 Specific sites
2.6 Rehabilitation
2.7 Recurrent disease
2.8 Palliation
2.9 Follow-up
Cancer of the Larynx
3.1 Assessment
3.2 Investigations
3.3 Management of primary tumour
3.4 Laryngeal sub-sites
3.5 Management of the neck
3.6 Voice rehabilitation
3.7 Recurrent disease
3.8 Palliative Care
3.9 Follow-up
Cancer of the Hypopharynx
4.1 Assessment
4.2 Investigations
4.3 Management of the primary tumour
4.4 Hypopharyngeal sub-sites
4.5 Management of the neck
4.6 Rehabilitation
4.7 Recurrent disease
4.8 Palliative treatment
4.9 Follow-up
Cancer of the Nasopharynx
5.1 Assessment
5.2 Investigations
5.3 Management of the primary tumour
5.4 Management of the neck
5.5 Recurrance
5.6 Palliative care
5.7 Follow-up
Cancer of the Nose and Sinuses
6.1 Assessment
6.2 Investigations
6.3 Management of the primary tumour
6.4 Management of the neck
6.5 Recurrent disease
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6.6 Palliative treatment
6.7 Follow-up
Cancer of the Lip
7.1 Assessment
7.2 Investigations
7.3 Management of primary tumour
7.4 Recurrent disease
7.5 Palliation
7.6 Follow-up
Cancer of the Oral Cavity- Tongue
8.1 Investigations
8.2 Management
8.3 Management of the neck
8.4 Chemotherapy
8.5 Rehabilitation
8.6 Recurrent disease
8.7 Palliation
8.8 Follow-up
Cancer of the Oral Cavity- Floor of Mouth
9.1 Investigations
9.2 Management
9.3 Management of the neck
9.4 Chemotherapy
9.5 Recurrent disease
9.6 Palliation
9.7 Follow-up
Cancer of the Oral Cavity- Retromolar Trigone
10.1 Assessment and investigations
10.2 Management
10.3 Management of the neck
10.4 Rehabilitation
10.5 Recurrent disease
10.6 Palliation
10.7 Follow-up
Cancer of the Oral Cavity- Alveolar Ridge
11.1 Investigations
11.2 Management
11.3 Management of the neck
11.4 Chemotherapy
11.5 Rehabilitation
11.6 Recurrent disease
11.7 Palliation
11.8 Follow-up
Malignant tumours of the salivary glands
12.1 Major salivary glands
12.2 Submandibular gland
12.3 Minor salivary glands
Guidelines for the management of Thyroid Cancer
13.1 Screening
13.2 Diagnosis and referral
13.3 Investigations
13.4 TNM staging
13.5 Classification
Differentiated Thyroid Cancer
14.1 Principles of treatment
14.2 Standard treatment
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21.
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14.3 Procedure for 131 l ablative/therapy doses
14.4 Serum TSH measurements
14.5 Serum Thyroglobulin
14.6 Recombinant human TSH
14.7 Management of hypocalcaemia
14.8 Non standard / Low risk patients
14.9 External beam Radiotherapy
14.10 Recurrent disease
14.11 Palliative Chemotherapy
14.12 Diagnosis of thyroid cancer in pregnancy
14.13 Oxyphillic / Hurthle Cell Carcinoma
Medullary Thyroid Carcinoma (Mtc)
15.1 Investigations
15.2 Treatment
15.3 Radiotherapy and Chemotherapy
15.4 Research studies in Thyroid cancer
Thyroid Lymphoma
16.1 Investigations
16.2 Treatment
Anaplastic Carcinoma
17.1 Treatment
Lymph node resections on Thyroid cancer
Follow-up guidelines for Head & Neck Cancer
19.1 General principles
19.2 L&D and Lister Hospital
19.3 Bedford Hospital
19.4 North West Hertfordshire
Rarer Cancers
20.1 Treatments nor provided by Beds and Herts Centre
20.2 Childhood Head & Neck cancer
20.3 Management of soft tissue Sarcomas
20.4 Head & Neck Sarcomas
20.5 Rhabdomyosarcoma
20.6 Tumour involving the skull base
Acute Oncology Services
Rehabilitation
APPENDICES
Appendix 1:
Primary Care Referral Guidelines for Head & Neck Cancer for the population of
NHS Bedfordshire
Appendix 2:
Referral Proforma for patients outside the “Urgent Suspicion of Cancer”
definition
Appendix 3:
Imaging Guidelines for patients with suspected Head & Neck Cancer (including
Thyroid Cancer)
Appendix 4:
Head & Neck Cancer Team Clinical Follow-Up protocol
Appendix 5:
London and South East Sarcoma Network: Bone Sarcoma Presentation and
Diagnostic Pathway
Appendix 6:
Head & Neck- Rehabilitation & Supportive care mapping template
Appendix 7:
Head & Neck Rehabilitation Plan
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Appendix 8:
Head & Neck Cancer Rehabilitation Protocol
Appendix 9:
Supportive Care Pathway for Head & Neck Cancer Specialist Surgery to
support IOG recommendations
Appendix 10:
Mount Vernon Cancer Centre Head & Neck Radiotherapy & Chemotherapy
Treatment Protocols
Appendix 11:
Pathology Guidelines:
 Tissue pathways for head and neck pathology-- Luton and Dunstable
Hospital pathology department.
 Royal College of Pathology Datasets for Histopathology reports on Head &
Neck carcinomas and salivary neoplasms (2nd edition)
 Royal College of Pathology Tissue pathways for Head & Neck Cancer
 Royal College of Pathology Dataset for Thyroid Cancer Histopathology
Reports
 Royal College of Pathology Tissue Pathways for Endocine Pathology
Appendix 12:
Sarcoma Pathway
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5
Guidelines for the Management of Head & Neck Cancer
1. Referral Guidelines
1.1 Primary Care Referrals
(11-1A-206i)
The Head, Neck & Thyroid NSSG agreed the MVCN Head, Neck & Thyroid 2 week wait (2WW)
Urgent Cancer Referral proforma in December 2010. The agreed version is attached below.
Agreed Head, Neck
& Thyroid 2WW proforma.doc
In addition the NSSG has agreed to adopt the primary care referral guidelines for the population of
NHS Bedfordshire, and these can be found in appendix 1.
1.2 Non 2WW Referrals
(11-1A-207i)
For those patients that are outside of the 2WW “urgent suspicious of cancer” patients should be
referred via the form in appendix 2
1.3 Inappropriate referrals to the Head, Neck & Thyroid Team
Any referral received by the Head, Neck & Thyroid team that are deemed to be inappropriate, will be
returned to the referring GP with an explanation letter dictated and signed by the consultant
concerned within 24 hours of receipt by the consultant.
The SMDT will report to the PCT’s, GP’s and GDP’s annually on appropriateness and timeliness on
urgent suspect cancer referrals.
1.4 Referrals to the SMDT
All confirmed thyroid cancers are referred to the Bedfordshire & Hertfordshire SMDT before definitive
treatment is commenced but it is recognised that many are not confirmed until hemi-thyroidectomy
has been performed in one or the diagnostic centres as cytological diagnosis is often not definitive.
All thyroid lumps with Thy 4 or Thy 5 cytology are to be referred to the SMDT before surgery, surgery
will be carried out in the surgical centre (ward 21). Cases requiring neck dissection(levels I-V &/or
VII), mediastinal node dissection or extended thyroidectomy will undergo the surgery at the Luton &
Dunstable Hospital Head, Neck & Thyroid Centre.
Thy 3 lumps frequently turn out to be benign and are therefore removed by hemi-thyroidectomy at the
diagnostic centre; if definitive histology confirms cancer then they are referred to the SMDT following
staging investigations. Further surgery should be carried out at the surgical centre.
The above pathways achieve compliance with NICE guidance as each SMDT serves a population
exceeding one million. The number of surgeons carrying out definitive thyroid cancer surgery has
reduced to three for the Beds & Herts network (2011).
1.5 Identification of patients for discussion at SMDT
Clinicians wishing to refer a patient for discussion at SMDT should notify the pathway facilitator at the
L&D by no later than by the end of the working day on Tuesdays.
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1.6 Internal referral guidelines between teams
(10-1A-208i, 10-1A-209i)
Internal referral guidelines for non Head, Neck & Thyroid designated hospital clinicians;



Patient with symptoms or signs suggestive of Head, Neck & Thyroid cancer;
Cancer highly likely; urgent referral to Head, Neck & Thyroid MDT core consultant member
without biopsy or further investigation.
Cancer diagnosis uncertain and biopsy deemed necessary for initial diagnosis; urgent referral to
core Head, Neck & Thyroid MDT consultant with the result of biopsy with or without imaging as
per guidelines.
These guidelines are distributed to designated consultant clinicians and non-designated head and
neck consultant clinicians including ENT surgeons, endocrine surgeons, OMFS surgeons, oral
medicine specialists, and endocrinologists through the cancer management teams.
1.7 Radiotherapy/Oncology Referrals
Beds & Herts SMDT refers patients to Mount Vernon Cancer Centre.
1.8 Pre-treatment Assessment & Management
Careful assessment of each patient’s clinical, nutritional and psychological state must be carried out
to inform MDT decisions on treatment options. Co-morbidity, performance status, psychological
state, nutritional status and alcohol dependence should be assessed. The Clinical Nurse Specialist
should ensure that all patients and carers receive appropriate support and information, that their non
medical needs are assessed and that there is effective liaison between hospital staff, primary care
teams and other agencies as required.
Patients who are dependant on smoking, drinking or other addictive substances that increase the risk
of Head & Neck cancers should be offered interventions to help them stop.
The full range of treatment options should be discussed with the patient with supporting written
information if required. These discussions may be held over a number of meetings so that patients
have adequate time to consider the MDT’s proposals.
a) Dental Assessment
Once a treatment plan has been agreed a dental assessment should be carried out on those patients
where treatment will affect the mouth or jaws. Any necessary dental extractions should be carried out
pre-treatment with sufficient time allowed for healing. The patients should be encouraged to have
good oral hygiene and attend their general dental practitioner if appropriate. Referral to a specialist
restorative dentistry consultant should be considered in appropriate patients.
b) Speech and Language Therapist (SLT) and Nutritional Assessment
If a patient is to have treatment that will affect eating or swallowing the team should discuss the
method of feeding that will be used and inform the primary care team well in advance if tube feeding
is required so that the patient can be supported at home. The dietitian and SLT should work together
with the patient to explain swallowing and nutritional issues and make sure the patient is prepared,
before treatment begins, for any short or long term interventions that may be required.
Patients whose treatment is likely to affect the ability to communicate should be seen by the SLT
before treatment begins to explain rehabilitation strategies and how the SLT will work with the patient
to make the most of their potential for recovery of speech, voice and swallowing.
c) Anaesthetic Assessment
Patients who are to undergo surgery that will involve the airways should be assessed by the
specialist anaesthetist who works with surgeons at the MDT.
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2. Cancer of the Oropharynx
Site includes tonsil, palate, the posterior one third of tongue & the posterior wall of the pharynx.
Patients with biopsy-proven carcinoma of the oropharnyx will be fully investigated before being
considered, with the results of investigations, at the multi-disciplinary team meeting attended by all
members of the MDT. Treatment options will be discussed at the MDT and recommendations made
to the patient in the following multi-disciplinary clinic. Advice and support from the clinical nurse
specialists, speech and language therapists, dieticians and nutritional nurses and palliative care team
will also be available in the clinic.
2.1 Investigation and preparation
EUA and incisional biopsy
MRI of the head and neck
Ultrasound guided FNA of the neck
Chest x-ray
CT of the thorax for stages 2 and 3
Dental assessment
Nutritional assessment – PEG if necessary
SALT assessment
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
2.2 Management of primary tumour
T1 External beam irradiation has similar cure rates to radical surgery and produces less disability.
T2 as for T1
T3 and T4 Radical surgery and postoperative radiotherapy+/_ chemotherapy offer the best chance of
cure. However, the long-term disability following radical surgery may not intolerable so radiotherapy
with or without chemotherapy should be considered.
2.3 Management of the neck
N0 Neck irradiation or prophylactic dissection for all except localised soft palate & posterior wall
tumours.
N+ Radical neck dissection if primary treated surgically. Radical neck dissection if FNA positive after
radiotherapy of neck.
2.4 Surgery
Local resection for small tumours by a lateral pharyngotomy approach. More extensive tumours will
require mandibulotomy and floor of mouth splitting approach. Preliminary tracheostomy will be
necessary. Total or supraglottic laryngectomy may be necessary. Reconstruction will usually be by
pectoralis major or free microvasular flap, crico-pharyngeal myotomy helps prevent postoperative
dysphagia. Frozen section histology should be used to check margins.
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2.5 Specific sites
2.5.1 Tongue
T1 & 2 Surgery and radiotherapy having equivalent cure rates; elective neck dissection is essential.
T3 & 4 Most will be treated by radiotherapy initially, with or without radical neck dissection (or neck
irradiation and salvage neck dissection). For T4 tumours radical surgery offers best chance of cure
but laryngectomy may be necessary.
2.5.2 Tonsil
T1 & 2 Surgery & RT give similar results
Elective neck dissection is essential
T3 & 4 RT effective for exophytic T3 tumours
Ulcerative T3 & T4 tumours better treated by surgery & RT with
Segmental resection of mandible where necessary & neck dissection.
2.5.3 Posterior wall
T1 & 2 Surgery with local flap repair with or without RT to neck
T3 & 4 Surgery & RT & neck dissection; may require laryngopharyngectomy.
2.5.4 Soft palate
T1 & RT RT effective & effective less likely to result in nasal regurgitation.
T3 & 4 Surgery & RT with flap reconstruction of palate & neck dissection.
2.6 Rehabilitation
Rehabilitation of speech & swallowing require support from SALT & specialist nurses. Dietician will
need to advise post-operatively; many patients will need PEG feeding temporarily and some
permanently.
Management of the neck
N0 Elective neck dissection or irradiation if T3 or 4 (selective lateral neck dissection).
N1 – 3 Modified radical neck dissection + adjuvant RT.
2.7 Recurrent disease
Histological confirmation and staging to be carried out. Treatment options to be discussed by MDT.
Salvage laryngectomy often necessary and effective.
2.8 Palliation
Symptom control and nutritional support will be provided by the MDT in conjunction with specialist
pain and palliative care teams.
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
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2.9 Follow up
1st year
2nd year
3rd year
4th year
5th year
Thereafter
monthly
2 monthly
3 monthly
6 monthly
6 monthly
discharge or annual review
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3. Cancer of the Larynx
3.1 Assessment
Patients with biopsy proven laryngeal squamous carcinoma will be fully investigated before being
considered, with the results of investigations, at the multi-disciplinary team meeting attended by all
members of the MDT. Treatment options will be discussed at the MDT and recommendations made
to the patient in the following multi-disciplinary clinic. Advice and support from the clinical nurse
specialists, speech and language therapists, dieticians and nutritional nurses and palliative care team
will also be available in the clinic.
3.2 Investigations
EUA & biopsy
Chest X-ray
MRI for T3 – 4
CT chest for T3 to 4
Dental assessment if RT proposed
Nutritional assessment where necessary
SALT assessment and advice prior to treatment and during & after where necessary
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
3.3 Management of primary tumour
T1 Usually radical radiotherapy but cordectomy for verrucous carcinoma and other appropriate lesion.
T2 Usually radical radiotherapy; laser resection or vertical hemilaryngectomy may be appropriate in
some cases.
T3 Radical radiotherapy for favourable lesions. Stridor, cartilage invasion and difficulty in regular
follow-up are indications for primary laryngectomy.
T4 Laryngectomy usual treatment of choice; post-operative RT if margins close, multiple neck
metastases or extra-capsular spread.
3.4 Laryngeal sub-sites
Glottis; management as above.
Supraglottis; Supraglottic laryngectomy & RND effective for T1 – T2 N+ if patient less than 60 years
of age and good pulmonary function.
Subglottis; T1 & 2 RT
T3 & 4 Surgery & RT as appropriate.
All sites; piecemeal laser resection may be appropriate for T1 – 3, followed by neck dissection
depending on depth of invasion (Steiner W).
3.5 Management of the Neck
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Glottic –
T1 – T3 5% to 20%
Primary echelons II, III, IV
T4
25% to 40%
T1 T2 no treatment to nodes
T3 T4 irradiate or selective levels II, III, IV neck dissection
All stages comprehensive neck dissection
N0 neck
N+ neck
Supraglottic T1 5% to 25%
Primary echelons II, III
T2 30% to 70%
T3 – T4 65% to 80%
Occult metastases in 20% to 50%
N0 neck
N+ neck
All stages irradiate nodes or selective neck dissection
All stages comprehensive neck dissection
Subglottic
Cervical node involvement <20%
Para-tracheal node involvement up to 45%
treat para-tracheal nodes
T1 T2 no treatment to neck nodes
T3, T4 irradiate or selective neck dissection
All stages comprehensive neck dissection
All stages
N0 neck
N+ neck
3.6 Voice rehabilitation
Immediate tracheo-oesophageal puncture at time of surgery in most cases with posterior midline
myotomy. Rehabilitation to commence12 – 14 days post op under care of SALT and nurse specialist.
Early use of HME recommended to reduce tracheal secretions especially in asthmatic patients.
3.7 Recurrent disease
Will require appropriate histological confirmation and staging and assessment by the MDT. Salvage
will usually require surgery.
3.8 Palliative care
Palliation of symptoms including pain and nutritional support will be required.
coordinate in conjunction with specialist pain control team and palliative care team.
The MDT will
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
3.9 Follow up
1st year
2nd year
3rd year
4th year
5th year
Years 6- 10
1 monthly
3 monthly
4 monthly
6 monthly
6 monthly
discharge or annual review
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4. Cancer of the Hypopharynx
4.1 Assessment
Patients with biopsy proven hypopharyngeal squamous cell carcinoma will be fully investigated
before being considered, with the results of investigations, at the multi-disciplinary team meeting
attended by all members of the MDT. Treatment options will be discussed at the MDT and
recommendations made to the patient in the following multi-disciplinary clinic. Advice and support
from the clinical nurse specialists, speech and language therapists, dieticians and nutritional nurses
and palliative care team will also be available in the clinic.
4.2 Investigations
EUA & biopsy
Chest X-ray
MRI for T2 – 4
CT chest for T3 – 4
Dental assessment if RT proposed
Nutritional assessment where necessary
SALT assessment and advice prior to treatment and during & after where necessary.
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
4.3 Management of the primary tumour
T1; Local resection (maybe endoscopic) or radical radiotherapy.
T2; Radical radiotherapy or surgery which may be endoscopic or partial pharyngeal-laryngectomy.
T3; Usually combined treatment with pharyngo-laryngectomy followed by radiotherapy.
T4; Usually combined treatment with pharyngo-laryngectomy followed by radical radiotherapy.
4.4 Hypopharyngeal sub-sites
Posterior pharyngeal wall: small well-circumscribed tumours may be locally resected endoscopically
or via a lateral pharyngotomy. Small defects can be left to granulate but larger ones may be closed
primarily or with a free radial forearm flap.
Piriform fossa: T1 & T2 lesions may be irradiated and larger lesions will usually require total
laryngectomy and partial or total pharyngectomy with reconstruction by pectoralis major or free
jejunal flap.
Post cricoid: Smaller tumours may be treated by radical radiotherapy with, if necessary, salvage
surgery. Larger tumours may require total pharyngo-laryngectomy, at least 3cm of oesophagus
below the lesion should be removed; the extent of this resection will determine whether
reconstruction is by free jejunal flap or stomach pull up.
Endoscopic laser resection may be suitable for certain posterior pharyngeal wall and piriform sinus
tumours.
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4.5 Management of the neck
Approximately 2/3 of patients have no positive nodes at presentation and occult metastases are
found in about 40% of neck dissections for N0 staged disease, usually Levels 2, 3 and 4. Midline
tumours may spread to both sides.
N0 neck First echelon nodes should be included in the radiotherapy field if primary treatment is by
radiotherapy. If surgical treatment is used then select neck dissection of Levels 2, 3 and 4 are
recommended.
N1 – 3 neck Comprehensive neck dissection usually recommended.
4.6 Rehabilitation
SALT input is usually required for rehabilitation for both speech and swallowing.
4.7 Recurrent disease
Histological confirmation and staging to be carried out. Treatment options should be discussed by
MDT. Salvage surgery will usually include total laryngectomy. Partial laryngectomy is not
recommended as pattern of spread is unpredictable and healing may be impaired.
4.8 Palliative Treatment
Symptom control and nutritional support will be provided by the MDT in conjunction with specialist
pain and palliative care teams.
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
4.9 Follow up
1st year
2nd year
3rd year
4th year
5th year
Thereafter
monthly
3 monthly
4 monthly
6 monthly
6 monthly
discharge or annual review
14
5. Cancer of the Nasopharynx
5.1 Assessment
Tumours will be fully investigated before being considered, with the results of investigations, at the
multi-disciplinary team meeting attended by all members of the MDT. Treatment options will be
discussed at the MDT and recommendations made to the patient in the following multi-disciplinary
clinic. Advice and support from the clinical nurse specialists, speech and language therapists,
dieticians and nutritional nurses and palliative care team will also be available in the clinic.
5.2 Investigations
EUA & biopsy
Chest X-ray
EB virus - Serology (IgA anti-VCA, IgA anti-EA)
High resolution CT or MR scan of middle cranial fossa, skull base, nasopharynx, sinuses, neck and
thorax.
OPG x-ray
Bone scan if extensive nodal disease
Liver ultrasound if extensive nodal disease
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
5.3 Management of the primary tumour
Radiotherapy for primary tumour and nodes of the neck whether N0 or N positive.
chemotherapy is usually also employed.
Adjunctive
5.4 Management of the neck
Initial management of the neck is by radiotherapy, usually combined with chemotherapy. Surgery in
the form of comprehensive neck dissection is undertaken for failed radiotherapy or recurrent disease.
5.5 Recurrence
Recurrence should be biopsy-proven and staged. Treatment may be by local resection, by
fenestration of the palate or LeFort 1 osteotomy. Brachytherapy may also be employed.
5.6 Palliative care
The MDT will coordinate in conjunction with specialist pain control team and palliative care team.
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
5.7 Follow up
1st year
2nd year
3rd year
4th year
monthly
3 monthly
4 monthly
6 monthly
15
5th year
Thereafter
6 monthly
discharge or annual review
16
6. Cancer of the Nose and Sinuses
6.1 Assessment
Patients with biopsy proven tumours of the nose and sinuses will be fully investigated before being
considered, with the results of investigations, at the multi-disciplinary team meeting attended by all
members of the MDT. Treatment options will be discussed at the MDT and recommendations made
to the patient in the following multi-disciplinary clinic. Advice and support from the clinical nurse
specialists, speech and language therapists, dieticians and nutritional nurses and palliative care team
will also be available in the clinic.
6.2 Investigations
EUA & biopsy, usually endoscopic
CT of all primaries
Chest X-ray
CT or MRI neck for T3 - 4
CT of thorax T3 - 4
Dental assessment
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
6.3 Management of the primary tumour
Most tumours are managed by surgery alone or in combination with radiotherapy.
approaches include:
a)
b)
c)
d)
e)
f)
Surgical
Lateral rhinotomy for septum and lateral wall tumours including melanomas.
Mid-facial de-gloving to allow access to maxillary sinus, ethmoids, sphenoid and nasal cavity.
Maxillectomy usually for squamous cell carcinoma, particularly when involving maxillary sinus
or palate or with extension to pterygoid region. May be combined with orbital exenteration.
Cranio facial resection. Commonly carried out for adeno carcinoma, olfactory neuroblastoma,
condrosarcoma and sometimes squamous cell carcinoma. Neurosurgical expertise usually
required.
Orbital exenteration.
Endoscopic surgery suitable for benign tumours such as inverted papilloma and some
malignant melanomas.
Chemotherapy used concomitantly with radiotherapy for some tumours.
6.4 Management of the neck
N0 Expectant treatment.
N1 – 3 Comprehensive neck dissection for squamous cell carcinomas.
6.5 Recurrent disease
Recurrent disease should be biopsy-proven, staged and managed by the multi-disciplinary team.
Salvage will usually require surgery unless radiotherapy has not previously been given/
6.6 Palliative Treatment
17
The multi-disciplinary team will coordinate the management of symptoms with specialist pain control
and palliative care team.
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
6.7 Follow up
1st year
2nd year
3rd year
4th year
5th year
Thereafter
Monthly
3 monthly
4 monthly
6 monthly
6 monthly
discharge or annual review
18
7. Cancer of the Lip
7.1 Assessment
Patients with biopsy proven squamous cell carcinoma will be fully investigated before being
considered, with the results of investigations, at the multi-disciplinary team meeting attended by all
members of the MDT. Treatment options will be discussed at the MDT and recommendations made
to the patient in the following multi-disciplinary clinic. Advice and support from the clinical nurse
specialists, speech and language therapists, dieticians and nutritional nurses and palliative care team
will also be available in the clinic.
7.2 Investigations
Incisional biopsy.
Dental assessment if RT is planned.
Neck node present – FNAC, MRI H & N
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
7.3 Management of primary tumour
T1
Surgery or RT has similar cure rates. Surgery is preferable as treatment is likely to be one
stage and primary closure gives good cosmetic and functional results.
T2-4
Surgery and consider post-operative RT.
Management of the neck:
N0
Expectant policy.
N+
Modified radical neck dissection ± adjuvant RT.
If N1, RT to neck alone if the primary lesion is also treated with RT.
Primary closure has good cosmetic and functional results when the post-resection defect is up to one
third of the width of the lip. For larger defects, local flaps are adequate. Free tissue transfer is
occasionally required after surgical ablation of locally advanced disease. Decision on reconstructive
method is made jointly by the ablative surgeon and the reconstructive surgeon.
7.4 Recurrent disease
Histological confirmation, clinical and radiological staging when necessary. Appropriate treatment
options will be influenced by the extend of recurrent disease and the probability of cure, previous
treatment modalities, co-morbidity, patient’s preference and the consensus opinion of members of the
MDT. Treatments options with curative intend include surgery and /or RT.
7.5 Palliation
Pain control and nutritional support will be co-ordinated and provided by members of the MDT.
Palliative RT or chemotherapy to control symptoms will be considered by the clinical oncologist when
appropriate.
19
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
7.6 Follow-up
1st year
2nd year
3rd year
4th and 5th year
Thereafter
1 monthly
2 monthly
3 monthly
6 monthly
discharge or annual review
20
8. Cancer of the Oral Cavity - Tongue
All patients will be fully investigated before being considered, with the results of investigations, at the
multi-disciplinary team meeting attended by all members of the MDT. Treatment options will be
discussed at the MDT and recommendations made to the patient in the following multi-disciplinary
clinic. Advice and support from the clinical nurse specialists, speech and language therapists,
dieticians and nutritional nurses and palliative care team will also be available in the clinic.
8.1 Investigations
Incisional biopsy and EUA when necessary.
MRI H & N (except T1 with palpably normal neck).
Chest X-ray.
CT chest (Stage III & IV).
Dental assessment.
Pre-treatment assessment by SALT.
Haematological investigations.
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
8.2 Management
The most appropriate options of treatment will be influenced by the size of the tumour, other coexisting medical conditions and personal preference of the patient, as well as the consensus opinion
of members of the MDT.
Primary tumour:
T1 and ‘small’ T2(<3cm)
Surgery or RT alone.
Surgery with adjuvant RT.
T2(>3cm), T3 and T4
Surgery and adjuvant RT.
Reconstruction:
Small defects may be closed primarily or left to heal spontaneously (± split skin graft).
Larger defects will require pedicle flaps or preferably free tissue transfer. Decision on reconstructive
method is made jointly by the ablative surgeon and the reconstructive surgeon.
8.3 Management of the neck
This is influenced by the clinical and radiological staging of the neck, the T stage and the primary
modality of treatment chosen for the primary tumour.
N0
Watch and wait policy (T1 treated by surgery alone).
Selective neck dissection (Levels I – IV) ± adjuvant RT.
Elective irradiation.
N+
Modified or classical radical neck dissections ± adjuvant RT.
Bilateral neck dissections may be considered in large primary
tumour crossing the midline.
21
8.4 Chemotherapy
Concomitant chemo-radiation may be considered in some cases of advanced disease at the
discretion of the clinical oncologist.
8.5 Rehabilitation
Restoration of speech, swallowing and maintenance of nutrition are provided by SALT and dieticians.
Expertise in prosthodontics including dental implantology is available in selected cases.
8.6 Recurrent disease
Histological confirmation, clinical and radiological staging will be carried out. Appropriate treatment
options will be influenced by extend of recurrent disease and the probability of cure, previous
treatment modalities, co-morbidity, patient’s preference and the consensus opinion of members of the
MDT. Treatments options with curative intend include surgery and /or RT (including chemo-radiation).
8.7 Palliation
Pain control and nutritional support will be co-ordinated and provided by members of the MDT.
Palliative RT or chemotherapy to control symptoms will be considered by the clinical oncologist when
appropriate.
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
8.8 Follow-up
1st year
2nd year
3rd year
4th and 5th year
Thereafter
1 monthly
2 monthly
3 monthly
6 monthly
discharge or annual review
22
9. Cancer of the Oral Cavity - Floor of mouth
All patients will be fully investigated before being considered, with the results of investigations, at the
multi-disciplinary team meeting attended by all members of the MDT. Treatment options will be
discussed at the MDT and recommendations made to the patient in the following multi-disciplinary
clinic. Advice and support from the clinical nurse specialists, speech and language therapists,
dieticians and nutritional nurses and palliative care team will also be available in the clinic.
9.1 Investigations
Incisional biopsy and EUA when necessary.
MRI H & N (except T1 with palpably normal neck).
Chest X-ray
CT chest (Stage III & IV).
Dental assessment.
Pre-treatment assessment by SALT.
Haematological investigations.
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
9.2 Management
The most appropriate options of treatment will be influenced by the size of the tumour, other coexisting medical conditions and personal preference of the patient, as well as the consensus opinion
of members of the MDT.
Primary tumour:
T1 and ‘small’ T2(<3cm)
Surgery alone.
Surgery with post-operative RT.
RT alone is undesirable if bone is close to or involved by
tumour.
T2(>3cm), T3 and T4
Surgery and post-operative RT.
Reconstruction:
Small defects may be closed primarily or left to heal spontaneously (± split skin graft). Local flaps
may also be used in some cases. Larger defects will require free tissue transfer. When segmental
mandululectomy is required, bony reconstruction will be necessary. Decision on reconstructive
method is made jointly by the ablative surgeon and the reconstructive surgeon.
9.3 Management of the neck
This is influenced by the clinical and radiological staging of the neck, the T stage and the primary
modality of treatment chosen for the primary tumour.
N0
Watch and wait policy (T1 treated by surgery alone).
Selective neck dissection (Levels I – IV) ± adjuvant RT.
Midline lesions may require bilateral selective neck dissections.
23
Elective irradiation.
N+
Modified or classical radical neck dissections ± adjuvant RT.
Bilateral neck dissections may be considered in primary tumour crossing the midline.
9.4 Chemotherapy
Concomitant chemo-radiation may be considered in some cases of advanced disease at the
discretion of the clinical oncologist.
Rehabilitation:
Restoration of speech, swallowing and maintenance of nutrition are provided by SALT and dietitians.
Expertise in prosthodontics including dental implantology is available in selected cases.
9.5 Recurrent disease
Histological confirmation, clinical and radiological staging will be carried out. Appropriate treatment
options will be influenced by extend of recurrent disease and the probability of cure, previous
treatment modalities, co-morbidity, patient’s preference and the consensus opinion of members of the
MDT. Treatments options with curative intend include surgery and /or RT (including chemo-radiation).
9.6 Palliation
Pain control and nutritional support will be co-ordinated and provided by members of the MDT.
Palliative RT or chemotherapy to control symptoms will be considered by the clinical oncologist when
appropriate. Support from community Macmillan nurses is available and depending on patient and
carer’s view, hospice care can be introduced.
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
9.7 Follow-up
1st year
2nd year
3rd year
4th and 5th year
Thereafter
1 monthly
2 monthly
3 monthly
6 monthly
discharge or annual review
24
10. Cancer of the Oral Cavity - Retromolar Trigone
10.1 Assessment and investigations
Same as floor of mouth.
10.2 Management
The most appropriate options of treatment will be influenced by the size of the tumour, other coexisting medical conditions and personal preference of the patient, as well as the consensus opinion
of members of the MDT.
Primary tumour:
T1, T2
Surgery or RT equally effective
T3, T4
Surgery and adjuvant RT
Except in small T1 lesions, most cases require external approach with lip-splitting ± segmental or
marginal mandibulectomy.
Reconstruction:
Small soft tissue defects may be closed primarily. Lateral mandibulectomy defects do no always
require bony reconstruction. Larger soft tissue defects will need reconstruction with pedicled flap or
free tissue transfer. Decision on reconstructive method is made jointly by the ablative surgeon and
the reconstructive surgeon.
10.3 Management of the neck
This is influenced by the clinical and radiological staging of the neck, the T stage and the primary
modality of treatment chosen for the primary tumour. If an external approach via the neck is used to
gain access to resect the primary tumour, it is logical to carry out elective neck dissection in N0 neck.
N0
Expectant policy when small primary tumour was treated by surgery via intra-oral
approach.
Elective neck dissection – in continuity with resection of primary tumour.
Elective irradiation when primary tumour is treated with RT.
N+
Modified radical or classical neck dissection ± adjuvant RT.
10.4 Rehabilitation
Restoration of speech, swallowing and maintenance of nutrition are provided by SALT and dieticians.
Expertise in prosthodontics including dental implantology is available in selected cases.
10.5 Recurrent disease
Histological confirmation, clinical and radiological staging will be carried out. Appropriate treatment
options will be influenced by extend of recurrent disease and the probability of cure, previous
treatment modalities, co-morbidity, patient’s preference and the consensus opinion of members of the
MDT. Treatments options with curative intend include surgery and /or RT (including chemo-radiation).
10.6 Palliation
25
Pain control and nutritional support will be co-ordinated and provided by members of the MDT.
Palliative RT or chemotherapy to control symptoms will be considered by the clinical oncologist when
appropriate.
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
10.7 Follow-up
1st year
2nd year
3rd year
4th and 5th year
Thereafter
1 monthly
2 monthly
3 monthly
6 monthly
discharge or annual review
26
11. Cancer of the Oral Cavity - Alveolar Ridge
All patients will be fully investigated before being considered, with the results of investigations, at the
multi-disciplinary team meeting attended by all members of the MDT. Treatment options will be
discussed at the MDT and recommendations made to the patient in the following multi-disciplinary
clinic. Advice and support from the clinical nurse specialists, speech and language therapists,
dieticians and nutritional nurses and palliative care team will also be available in the clinic.
11.1 Investigations
Incisional biopsy and EUA when necessary.
MRI H & N.
Chest X-ray
CT chest (Large primary tumour).
Dental assessment.
Pre-treatment assessment by SALT.
Haematological investigations.
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
11.2 Management
Primary tumour
Most tumours have involved the bone and surgery is the mainstay of treatment. In the upper jaw,
partial maxillectomy may be required. In the mandible, marginal or segmental mandibulectomy is
required. Adjuvant radiotherapy may be required.
Reconstruction:
Small alveolar ridge defect without significant soft tissue involvement may be reconstructed with
dental prosthesis including palatal obturator. Anterior segmental mandibular defect require bony
reconstruction, preferably with composite free tissue transfer. Bony reconstruction of lateral
mandibular defect should be individualized. Decision on reconstructive method is made jointly by the
ablative surgeon and the reconstructive surgeon.
11.3 Management of the neck
N0
Expectant policy if per-oral approach is used to resect tumour.
Selective neck dissection (Levels I – IV) when the neck is used to gain access for resection or
reconstruction.
N+
Modified or classical radical neck dissection ± adjuvant RT.
11.4 Chemotherapy
Concomitant chemo-radiation may be considered in some cases of advanced disease at the
discretion of the clinical oncologist.
11.5 Rehabilitation
27
Restoration of speech, swallowing and maintenance of nutrition are provided by SALT and dietitians.
Expertise in prosthodontics including dental implantology is available in selected cases.
11.6 Recurrent disease
Histological confirmation, clinical and radiological staging will be carried out. Appropriate treatment
options will be influenced by extend of recurrent disease and the probability of cure, previous
treatment modalities, co-morbidity, patient’s preference and the consensus opinion of members of the
MDT. Treatments options with curative intend include surgery and /or RT (including chemo-radiation).
11.7 Palliation
Pain control and nutritional support will be co-ordinated and provided by members of the MDT.
Palliative RT or chemotherapy to control symptoms will be considered by the clinical oncologist when
appropriate..
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
11.8 Follow-up
1st year
2nd year
3rd year
4th and 5th year
Thereafter
1 monthly
2 monthly
3 monthly
6 monthly
discharge or annual review
28
12. Malignant tumours of the salivary glands
All patients will be fully investigated before being considered, with the results of investigations, at the
multi-disciplinary team meeting attended by all members of the MDT. Treatment options will be
discussed at the MDT and recommendations made to the patient in the following multi-disciplinary
clinic. Advice and support from the clinical nurse specialists, speech and language therapists,
dieticians and nutritional nurses and palliative care team will also be available in the clinic.
12.1 Major salivary glands
12.1.1 Investigations
FNAC.
Trucut or rarely open biopsy when FNAC equivocal.
MRI head & neck.
Chest x-ray.
Dental assessment.
Haematological tests.
Nutritional assessment and support as necessary. Patients with T1 and T2 lesions will usually
require weekly nutritional assessment and support. The need for PEG insertion should be
considered in patients with T3 and T4 lesions undergoing radical surgery and/or radiotherapy.
Psychological assessment and assessment of social circumstances may indicate the need for
psychological or social support.
12.1.2 Management
Diagnosis occasionally made after surgical removal of the salivary gland containing a lump without
clinical evidence of being malignant. The size and grade of the tumour are the most significant
prognostic indicators.
Parotid
Parotidectomy with preservation of the facial nerve unless involved preoperatively. In locally
advanced stage (T4), adjacent structures eg facial skin and mandible, will be
included in the
resection. Adjuvant RT is often necessary.
Management of the neck
N0
Expectant policy.
Selective neck dissection in high grade and /or locally advanced disease.
Adjuvant RT may be considered.
N+
Modified or classical radical neck dissection.
Adjuvant RT.
12.1.3 Reconstruction
Pedicle flaps, free tissue transfer and /or nerve grafting may be required after resection of
advancedstage tumour. Decision on reconstructive method is made
jointly by the ablative
surgeon and the reconstructive surgeon.
12.2 Submandibular gland
29
Wide submandibular clearance with selective neck dissection (Levels I – III) in N0
neck stage. Lingual and hypoglossal nerves may be sacrificed in locally advanced disease.
N+ stage will need modified or classical neck dissection. Adjuvant RT is indicated in some situation,
depending on histological results.
12.2.1 Reconstruction
This may be necessary in some locally advanced cases. Decision on reconstructive method is made
jointly by the ablative surgeon and the reconstructive surgeon.
12.3 Minor salivary glands
12.3.1 Investigations
Incisional biopsy.
MRI H & N.
Chest x-ray.
Dental assessment.
Haematological tests.
12.3.2 Management
Primary tumour:
Similar to squamous cell carcinomas. Wide local excision ± adjuvant chemotherapy, depending on
histological results.
Management of the neck:
N0
Expectant policy.
N+
Modified or classical radical neck dissection.
Adjuvant RT.
Reconstruction will depend on the extend of surgical ablation. Decision on reconstructive method is
made jointly by the ablative surgeon and the reconstructive surgeon.
12.3.3 Rehabilitation
Restoration of speech, swallowing and maintenance of nutrition are provided by SALT and dietitians.
Expertise in prosthodontics including dental implantology is available in selected cases.
12.3.4 Recurrent disease
Histological confirmation, clinical and radiological staging will be carried out. Appropriate treatment
options will be influenced by extend of recurrent disease and the probability of cure, previous
treatment modalities, co-morbidity, patient’s preference and the consensus opinion of members of the
MDT. Treatment options with curative intend include surgery and /or RT (including chemo-radiation).
12.3.5 Palliation
Pain control and nutritional support will be co-ordinated and provided by members of the MDT.
Palliative RT or chemotherapy to control symptoms will be considered by the clinical oncologist when
appropriate.
30
Support from the community Macmillan nurses and from the hospital palliative care team will usually
be available and, depending on patient’s and carer’s view, hospice care can be introduced.
12.3.6 Follow-up
1st year
2nd year
3rd year onwards
2 monthly
3 monthly
6 monthly
Follow-up as long as possible.
31
13. Guidelines for Management of Thyroid Cancer
Mount Vernon Thyroid Cancer Network manages patients according to the British Thyroid
Association guidelines (published 2007)
All patients with thyroid cancer will be managed by a Multi-disciplinary team specializing in the
management of thyroid cancer.
Management controversial
Guidelines based on large retrospective series.
Evidence available at levels II and III of AHCPR 1994.
Recommendations are grades B and C.
13.1 Screening
No screening programme for general population.
Screening is possible for familial medullary thyroid carcinoma associated with specific genomic
mutations. These cases should be referred to Royal Marsden Hospital.
13.2 Diagnosis and Referral
Usual presentation is with a lump in the neck.
Urgent referral (to see in 2 weeks) from GP if
 Thyroid lump increasing in size
 Unexplained hoarseness or voice change associated with goitre
 History of previous neck irradiation associated with a thyroid lump
 Extremes of age
 Cervical lymphadenopathy
 Presence of stridor should evoke emergency referral
13.3 Investigations
Essential






Clinical examination
Routine haematology and biochemistry
Thyroid function tests
Thyroid antibody status
Thyroid US FNA (with or without US guidance)
Vocal cord examination (prior to surgery)
Additional Investigations






Respiratory function tests (flow-volume-loop) if symptoms of upper airway obstruction
MRI neck or CT neck & chest(non-contrast enhanced)
CXR
Radionucleide imaging (99mTc or 123 I)
Incisional biopsy: should never be carried out for differentiated thyroid cancer. However an open
biopsy is necessary for suspected thyroid lymphoma
Plasma calcitonin (if medullary carcinoma of thyroid suspected)
32
13.4 TNM STAGING
T STAGE
Tx PRIMARY CANNOT BE ASSESSED
T0
No evidence of Primary tumour
T1
T2
T3
T4a
T4b
T4a*
T4b*
Tumour≤ 2cm, limited to thyroid
tumour >2cm ≤4cm,limited to thyroid
Tumour>4cm, limtited to thyroid or any tumour with minimal extrathyroid extension (eg
extension to sternothyroid muscle or perithyroid soft tissue)
Tumour extends beyond the thyroid capsule and invades any of the following:subcutaneous
soft tissues,larynx,trachea,oesophagus,recurrent laryngeal nerve
Tumour invades prevertebral fascia,mediastinal vessels or encases carotid artery
(anaplastic carcinoma only) Tumour (any size) limited to thyroid gland†
(anaplastic carcinoma only) Tumour any size extends beyond thyroid capsule‡
Multifocal tumours of all histological types should be designated (m) (the largest determines the
classification egT2(m)
*
All anaplastic/undifferentiated thyroid cancers are considered T4† Intrathyroidal anaplastic
carcinoma-considered surgically resectable
‡
Extrathyroidal anaplastic carcinoma-considered surgically unresectable
N STAGE
NX
N0
N1
Regional nodes cannot be assessed
No regional LN metastasis
Regional LN metastasis
N1a metastasis in level VI (pretracheal and paratracheal,including pre-laryngeal and
Delphian lymph nodes)
N1b metastasis in other unilateral, bilateral, or contra-lateral cervical or upper/superior
mediastinal lymph nodes
M-Distant Metastasis
MX
M0
M1
Distant metastases cannot be assessed
No distant metastases
Distant metastases
STAGE GROUPING
Papillary or Follicular
Under 45years
Stage I Any T
Any N
M0
Stage II
Any T
Any N
M1
Papillary or Follicular ≥ 45 years and Medullary
Stage I T1
Stage II
Stage III
StageIVA
Stage IVB
N0
T2
T3
T1,T2,T3
T1,T2,T3
T4b
M0
N0
N0
N1a
N1b
Any N
M0
M0
M0
M0
M0
33
Stage IVC
Any T
Any N
M1
Anaplastic?Undifferentiated (all cases are stage IV)
Stage IVA
Stage IVB
Stage IVC
T4a
T4b
Any N
Any N
Any N
M0
M0
M1
13.5 CLASSIFICATION
1.
Differentiated thyroid cancer -
2.
3.
4.
Medullary thyroid cancer
Anaplastic carcinoma
Thyroid lymphoma
Incidence
60%
17%
papillary
follicular
mixed
4%
12%
5%
34
Differentiated Thyroid Cancer
History and Clinical
Examination
Routine bloods, TFTs, Ca, CXR
FNA, CT / MRI neck and
mediastinum
Total Thyroidectomy (Diagnosis
certain) &central compartment
dissection (+selective LN dissection if
LN +ve)
Stop T3 for 14 days.
Avoid fish, addded salt,(2 days) iodine
containing medicines, X-ray contrast
examinations (6-8weeks)
Thyroid lobectomy
(diagnosis uncertain)
Completion Thyroidectomy &
central compartment dissection (+
selective neck dissection if LN +ve)
Ablation dose 3.7GBq 131I , 3 weeks post thyroidectomy . TSH
prior
Neck and body scan at 3 days. Start
T3.
OPD 6 weeks, TSH, Tg and T3.
Consider starting T4
Abnormal scan at 3 days
(suggestive of mets)
Therapeutic dose 5.5GBq iodine
4-6 months after ablation
OP 6 weeks, TSH Tg and T3, then
diagnostic scan at 4 months
Usual post ablation scan
(uptake thyroid bed
only)
Re-ablation 3.7 or 5.5GBq
Persistent uptake
thyroid bed
Whole body iodine scan,
(4-6 months after
ablation)
Abnormal
scan
Normal scan,
Known
tumour,
normal scan
EBRT
Abnormal scan,
Tg >3g/l
Annual Tg and TSH
Repeat 5.5GBq therapy dose
35
14. Differentiated Thyroid Cancer
14.1 Principles of treatment




Ablate remaining thyroid remnant after thyroidectomy to render the patient athyrotic.
Suppression of TSH with thyroid replacement
Surveillance with whole body radio-iodine scans (WBS) and thyroglobulin measurement
Persistent or recurrent disease treated with therapy dose of radio-iodine
14.2 Standard Treatment (see flow chart)








Diagnosis certain, do near-total thyroidectomy and central compartment LN dissection. If LN
positive do selective neck dissection. 'Berry picking' no longer recommended.
Diagnosis uncertain, do thyroid lobectomy first and follow up with completion thyroidectomy
A pre-ablation scan is not routinely recommended since over 90% of patients post surgery will
require an ablative dose. If a scan is done there is a risk that exposure of the thyroid to iodine
may stun the thyroid tissue and decrease the efficiency of the ablative dose. If a scan is
considered necessary then 123I is used, which is less likely to compromise the subsequent
ablative dose of iodine.
Ablation dose (3GBq) of 131I, 3 weeks after surgery (no thyroid replacement post-op)
Whole body scan (150 - 170 MBq 131I ) 4 months later
If normal WBS, change to T4 and follow with 6 monthly TSH and thyroglobulin.
If abnormal scan, arrange therapy dose of 131I (5.5GBq). Repeat WBS 4 months later. If normal,
change to T4 as above then follow with Tg and TSH 6 monthly. If still abnormal, repeat therapy
dose of 131I until scans are normal.
Intervals between therapy doses of radio-iodine should be at least 4 months.
14.3 Procedure for 131I ablative / therapy doses









Written (information leaflet no ) and oral information given to patient
Avoid fish, added salt, iodine containing medicines for 3 weeks prior to dose and no X-ray
contrast examinations (CT) should have been done over 6-8 weeks prior to dose.
Following a diagnostic whole body scan, 4 weeks should elapse before a therapy dose is
delivered.
For ablative dose
the patient should not receive thyroid replacement post-operatively so that TSH can rise prior
to ablative dose at 3 weeks. If the ablative dose is longer than 4 weeks post-op then the
patient should be started on T3 and stopped 2 weeks prior to treatment.
For therapy dose:
- If patient of T3, stop 14 days prior to dose.
- If patient on T4, change to T3 one month prior to 131I and then stop T3 at 14 days.
Admit to room with appropriate protection and en-suite facilities (approved by radiation protection
officer)
Exclude pregnancy - if there is any doubt then pregnancy test should be done prior to dose.
Pregnancy should be avoided for12months after radio-iodine administration. Breast feeding is
contra-indicated for the same period. Pre-treatment sperm banking could be considered for
patients who are likely to have repeated treatments.
Patients who are incontinent or who have a urinary catheter/ileostomy/ colostomy should be
discussed with medical physics before admission. Patient who are unable to swallow capsules
should be discussed with Nuclear Medicine in advance as a liquid formulation may need to be
administered. Patients receiving radio-iodine also need to be self-caring, due to time restrictions
for nursing staff in the iodine room.
Check TSH, thyroglobulin, FBC and U&E's on admission
36






Encourage fluid intake after radio-iodine administration. Sodium citrate lozenges or fruit(acid)
sweets may help prevent sialadenitis and should be started on day 2.
Scans of neck and whole body at 3 days (or as advised by Nuclear Medicine)
Start thyroid replacement with T3 at 3 days. Patients should start back on replacement gradually
and increase to dose of 20 microgrammes tds. Suggest 20 microgrammes od for 2 days, 20
microgrammes bd for 2 days then 20 microgrammes tds.
Discharge after assessment by medical physics (when residual activity in thyroid bed < 800MBq)
with advice on necessary precautions. Discharge will be at least 2 days after iodine
administration.
There is no maximum cumulative dose as long as individual doses do not exceed 2 Sv total body
exposure and there is an interval of 4 - 6 months between doses. Patients receiving multiple
doses will need a FBC prior to treatment as bone marrow suppression can occur. For patients
with lung metastases pulmonary function tests are also useful.
Patients who have received a therapy dose of iodine and are thought likely to require a further
therapy dose, may be able to receive the therapy dose a week after the diagnostic scan in order
to minimise the time off thyroid replacement. This will need to be done on an individual basis and
discussed with medical physics.
14.4 Serum TSH measurements




Whilst on thyroid replacement the TSH should be undetectable (<0.05g/l).
T4 is more effective than T3 for TSH suppression
The dose of T3 should be 20g tds (bd in elderly or frail) and T4 200mg od.
The dose of T4 should be adjusted every 6 weeks by 25g until the target TSH concentration is
reached
14.5 Serum Thyroglobulin






Thyroglobulin is produced by normal and cancerous thyroid cells.
Its measurement is only useful after thyroidectomy and remnant ablation when detectable
thyroglobulin indicates residual or recurrent disease
Diagnostic sensitivity is increased when TSH raised (e.g. at time of administration of 131I)
It has a long serum half life and so should not be measured more often than 3 monthly
The presence of auto-antibody can affect the measurement of thyroglobulin
A raised serum thyroglobulin (i.e. above 3 - 5 g / l) post should be investigated initially with a
whole body scan. If the whole body scan is normal but the Tg is persistently raised the options
include further imaging with CT scan thorax, MRI / CT scan neck and PET scan. If investigations
identify site of metastasis consider treatment options of surgery / radiotherapy. If investigations
are negative consider therapeutic dose of radio-iodine in the absence of proven metastases
(raised Tg only).
14.6 Recombinant human TSH
Early trials of recombinant human TSH to avoid thyroid hormone withdrawal and hypothyroidism are
promising but it is not yet generally available. For selected patients who are unable to tolerate severe
hypothyroidism, Clinicians should apply to Dr Catherine Lemon, Lead Clinician for Thyroid Cancer
For fundind for recTSH.Current studies have shown that Tg monitoring is more sensitive after rhTSH.
14.7 Management of hypocalcaemia



Ionised calcium should be checked the day after surgery and daily until stable
If hypocalcaemia develops (ionised calcium < 1mmol/l) or the patient becomes symptomatic at a
higher calcium level, commence calcium supplements
If it does not improve or worsens then - calcidol should be started at 3g per day and adjusted
up or down according to response
37


Close monitoring is required to ensure that hypercalcaemia does not develop
After total thyroidectomy 30% of patients will need calcium supplements +/- -calcidol, by 3
months only 2% will still require calcium supplements
14.8 Non Standard / Low Risk Patients


Above protocol used for all patients with differentiated thyroid cancer except for
- young women (less than 40 years) with tumours up to 1.5cm in diameter
- any patient where the carcinoma is an incidental microscopic finding
These patients are thought to have a better prognosis and surgery with thyroid lobectomy
followed by TSH suppressive doses of thyroxine is thought to be adequate. (thyroglobulin
measurements or whole body scans cannot be done in these patients)
14.9 External Beam Radiotherapy
This is not routinely used. Indications include: Evidence at surgery of local invasion with a high suspicion of macro- or microscopic residual
disease, especially in poorer prognosis patients (men or older women). Difficulty in these
circumstances in ascertaining whether the tumour uptakes iodine. Therefore ablative iodine given
prior to external beam radiotherapy (need to calculate dose to spinal cord from ablative iodine
dose and work out cumulative cord tolerance from iodine and EBRT).
Thyroid bed alone
Technique is usually with anterior oblique wedged field (CT planned) to a total dose of 64Gy in 32
fractions over 6.5 weeks.
Thyroid bed and nodal areas
Phase I - 44 Gy using AP fields which can be extended to include the upper neck, mediastinum
(to carina) and supra-clavicular areas. The fields are usually weighted 2:1 ant:post.
Phase II - angled down lateral fields off cord for further 20Gy in 10 fractions (+/- matched
posterior neck electron fields)



For confirmed recurrent disease in the neck which is not amenable to further surgery or 131I
treatment. This should be treated to a dose of 66Gy in 33 fractions over 6.5 weeks
For palliation of metastatic disease in bone, cerebrum, spine and other areas. Consider high dose
palliation if solitary metastasis (eg 45 Gy in 20 #) or standard palliative fractionation in advanced
disease (eg 20Gy in 5 # or 8Gy single fraction)
For locally advanced tumours which are inoperable for a variety of reasons it can be used for
palliation along with TSH suppression.
14.10 Recurrent Disease

Neck recurrences - surgery is the preferred option even if complete removal not possible. This is
then combined with radio-iodine or EBRT where surgery is incomplete.

Lung or other soft tissue areas not amenable to surgery are treated with 131I if the tumour takes up
radio-iodine. Therapeutic doses of 131I are usually 5.5 MBq.

Bone metastases should be treated with a combination of EBRT,

Patients with a rising thyroglobulin in the absence of a positive radio-iodine scan can by managed
in one of two ways:
- Further imaging with MRI, CT or PET scan
- Empirical treatment with 131I followed by post treatment scan
131
I or orthopaedic intervention
38
14.11 Palliative Chemotherapy



No role in routine management
Restricted to very select cases with end-stage disease uncontrolled by surgery, radio-iodine or
EBRT for palliation..
Effective agents are doxorubicin and cisplatin (partial response rates 20-30%)
14.12 Diagnosis of thyroid cancer in pregnancy



If diagnosed early in pregnancy consider thyroidectomy during second trimester and delay
ablative dose of 131I until after delivery
Patients diagnosed later in pregnancy can be managed after delivery
Patients treated with 131I after delivery will not be able to breast feed.
14.13 Oxyphilic / Hurthle Cell Carcinoma
This is a variant of follicular thyroid carcinoma. It does produce thyroglobulin but rarely uptakes
iodine. Ablative iodine may be given in order to facilitate follow up with thyroglobulin. Prognosis is
probably worse than follicular carcinoma.
Long Term Follow up


3 monthly for the first two years, 6 monthly for 5 years, yearly thereafter.
At each visit
- Clinical examination
- Assessment of TSH suppression
- Measurement of thyroglobulin
- Measurement of serum calcium if indicated
39
15. Medullary Thyroid Carcinoma (Mtc)







Arises from C-cells (parafollicular cells) and produces calcitonin
These tumours do not uptake radio-iodine
25% are familial as part of autosomal dominant cancer syndrome known as multiple endocrine
neoplasia, type 2 (MEN - 2)
- 10% give FH
- 15% found to have familial involvement after investigation
All cases should be referred to clincal geneticist
Investigations include RET gene mutation analysis 9including exons 10,11,13,14,15,16) and
genetic screening
Even in the absence of a family history the patient may represent the herald case. Features which
suggest a familial cause in the absence of a family history include
- Early age at presentation (less than 40)
- Multi-focal disease within the thyroid
- The presence of C-cell hyperplasia on histology
Guidelines for management of the family of an isolated case without family history
- First degree relatives offered clinical and biochemical screening
- Multi-focal disease or C-cell hyperplasia in index case should initiate prompt referral for germline RET analysis
- Tumour analysed for RET gene mutation
15.1 Investigations





Baseline calcitonin and CEA
Exclude phaeochromocytoma (24 hour urinary catecholamines) and hyper-parathyroidism (serum
calcium)
Neck, thoracic and abdominal CT.
Some MTCs are positive on MIBG scanning and this can be used therapeutically
Pentavalent 99mTc DMSA has a place in detecting recurrent disease
15.2 Treatment


Total thyroidectomy and central node (level VI) dissection. This can still be done for palliative
reasons in the presence of disseminated disease
Prophylactic surgery for disease free carriers of germline RET mutations, discovered during
genetic screening. This is optimally performed as young as possible.
15.3 Radiotherapy and Chemotherapy




RT may help control local disease in cases where there is residual disease or inoperable disease.
Radiotherapy is given to a radical dose (66Gy in 33# over 6.5 weeks) using the same technique
as for differentiated thyroid carcinoma.
RT is more commonly used for MTC since potential residual disease will not uptake iodine.
Chemotherapy is ineffective
Therapeutic MIBG can be useful in selected cases
Long term follow up recommended with clinical assessment and measurement of serum calcitonin.
40
15.4 Research Studies in Thyroid Cancer
1. HiLo Study
Multicentre randomised trial of high dose versus low dose radioiodine, with or without
recombinant human thyroid stimulating hormone, for remnant ablation following surgery for
differentiated thyroid cancer
2. Phase II Studies
Patients with metastatic differentiated (non-iodine avid) or medullary carcinoma of the thyroid
should be referred to the thyroid service at the Royal Marsden Hospital for consideration of
inclusion in phase II studies of sorafenib.
41
Medullary Thyroid Carcinoma
Partial thyroidcetomy +/- lymph node biopsy
History and Clinical Examination. Review histology.
FBC, LFT, U&E, Ca, CXR, Calcitonin & CEA, CT scan neck thorax and
abdomen
Exclude
phaeochromocytoma and
hyper-parathyroidism. BP,
24hr catecholamines +/PTH
Exclude familial MCT. Family
history, blood for genetic
markers. Referral to geneticist
Completion thyroidectomy & central
compartment resection +/- modified radical
neck dissection. Neck and mediastinal RT if
disease extensive
Normal post op calitonin
Elevated post-op calcitonin
Determine site of tumour. CT
scan neck, thorax, liver. Bone
scan. DMSA whole body scan /
mIBG / octreotide
Annual clinical follow
up. Calcitonin & CEA.
Familial MCT, BP, 24hr
catecholamines, Ca +/PTH annually
Inoperable
Operable
Surgical excision + RT
Diagnostic mIBG scan
Negative
Positive
Therapeutic mIBG
Repeat after 6
months
Progressive &
symptomatic
Octreotide / interferon /
chemotherapy +/- RT
Normal calcitonin
Asymptomatic
Annual FU,
calcitonin +
CEA
FU only
42
16. Thyroid Lymphoma
16.1 Investigations




FNA suspicious for lymphoma - need open biopsy for precise diagnosis
Usually high grade NHL but low grade NHL and Hodgkin's can occur
Staging as for nodal lymphoma
- FBC, ESR, LDH, U&E, LFT, Bone profile, Serum Igs, protein electrophoresis
- CT thorax / abdomen / pelvis / neck
- Bone marrow trephine and aspirate
Consider GI investigations if symptoms since increased incidence of GI lymphoma
16.2 Treatment

Localised disease
CHOP - 3 cycles followed by RT to thyroid and involved nodal areas to dose of 35-40Gy in 20#
over 4 weeks. If still residual disease can treat to further 20Gy in 10 #.

Disseminated disease
CHOP chemotherapy - CR plus 2 cycles (minimum 6 cycles)
Cyclophosphamide
Adriamycin
Oncovin (Vincristine)
Prednisolone
750mg /m2 IV infusion d1
50mg/m2 IV bolus d1
1.4mg/m2 IV bolus d1
100mg po daily d1-5
Repeat every 21d, up to 6-8 courses
Prophylactic Allopurinol 300mg po daily week 1-4.
Radiotherapy to sites of bulk disease 40 Gy / 20# /28d.
43
17. Anaplastic Carcinoma




Very aggressive, early infiltration into surrounding tissues
Does not produce thyroglobulin or uptake iodine
Median survival 2-6 months
Histology review
17.1 Treatment



Surgical excision when possible (rare)
Tracheostomy sometimes required for tracheal compression
Radiotherapy to loco-regional tumour for local control
Options:
Radical
CHARTWEL Phase I AP opposed fields (2:1 wt A:P) 37.5 Gy / 25#
Phase II off cord
21Gy/14 #
(matched post electrons where necessary)
Total : 58.5Gy in 39 # over 2.5 weeks (3x/d)
Palliative

39 Gy in 13 # over 2.5 weeks
(Pb post cord shielding last #)
Or
20 Gy in 5# over 1 week
Systemic disease - chemotherapy
Adriamycin single agent (60 mg/m2 q = 21d)
44
Anaplastic Carcinoma
History and Clinical
Examination
Review histology. FBC, LFT, U&E, Ca, CXR,
CT scan neck thorax and upper abdomen. Bone scan
Predominantly metastatic
disease
Predominantly local disease
Surgery
Total resection if poss
Tracheostomy if
necessary
Radiotherapy
Localised
Palliative RT
Widespread progressive
symptomatic
Chemotherapy
Symptomatic care
45
18. Lymph node resections on Thyroid Cancer
(10-1C-109i)
The following surgeons are authorised to perform lymph node resection on thyroid cancers;
Mr P Kothari
Mr G Mochloulis
Ms J Panesar
46
19. Follow-up Guidelines for Head & Neck Cancer
19.1 General Principles
Following completion of primary treatment and assessment that either full remission has been
achieved or that further care will be palliative, without further anticancer therapy, then patients will be
referred back to the original referring hospital for continuing follow-up and care by the local support
team whenever possible. This decision will be taken by the treating MDT after the initial reactions to
treatment have settled and review, with or without post-treatment imaging, suggests that no further
anti-cancer treatment is required for this episode.
19.2 L & D and Lister Hospital
Patients will be followed by the MDTs at these sites. Following surgical treatment at L & D patients
referred by Lister Team will be followed up by them at Lister Hospital
19.3 Bedford Hospital
Patients will be referred to the Bedford Hospital Head & Neck Combined clinic for follow-up by MDT
members, Mr S Patel or Mr C H Chan as deemed appropriate by the MDT.
19.4 N W Hertfordshire
Patients initially referred to the L & D team will continue to be followed up by the L & D MDT in the L
& D Head & Neck clinic.
Patients initially referred to the NWPH OMFS team will be followed up by them.
47
20. Rarer Cancers
20.1 Treatments not provided by Beds & Herts Centre
Patients who are considered, following MDT discussion, to require treatments not provided at the
Centre will be referred as appropriate.
For photodynamic therapy patients will be referred to UCLH Head & Neck MDT or St Bartholomew’s
Head & Neck MDT.
For hyperbaric oxygen therapy patients will be referred to Whipp’s Cross Hospital Hyperbaric Oxygen
treatment centre.
20.2
Childhood Head and Neck Cancer
Children with head, neck & thyroid cancers (up to 16 years) are referred to a network agreed primary
treatment centre to be cared for in an age appropriate environment, with specialist nurses, youth
workers and social support, in line with the children and young persons improving outcomes
guidance. Bedfordshire patients will be referred to Addenbrooks Hospital Paediatric Oncology
service for and Hertfordshire patients to Great Ormond St Paediatric Oncology service.
20.2.1 Thyroid Tumours
Specific Investigations:
 Neck ultrasound
 Thyroid function test including TSH and Thyroglobulin
 Thyroid antoantibodies
 Serum calcitonin
 Serum calcium, Vitamin D
Treatment:
 CC:G guidelines. Tumour specific MDT
Young persons with head, Neck & thyroid neoplasms (16-24) will be referred to the network agreed
Young Persons MDT at UCLH for discussion. Place of treatment for this group will depend upon their
age. 16/17/18 year olds will be treated at the PTC, but 19-24 year olds have the choice between
being treated at the PTC or locally. This local treatment will follow the treatment plan agreed at the
PTC MDT.
20.3 Management of Soft Tissue Sarcomas– please see appendix 12 for more detail of the
pathway
As defined in the NICE Improving Outcomes Guidance for the management of Sarcoma (2008) all
sarcomas are to be discussed at a designated sarcoma centre.
MVCN does not host a sarcoma centre, nor does it have a designated clinic operating in any of the 3
acute hospital trusts. All patients must be referred to the sarcoma (supranetwork) multidisciplinary
team for discussion at the earliest suspicion of sarcoma, or when histology identifies an unexpected
sarcoma.
The MVCN designated centre is the London and South East Sarcoma Network, which is hosted by
the Royal National Orthapedic Hospital, for bone sarcomas and UCLH for soft tissue sarcomas.
The UCLH MDT is held on Fridays at 08:00, and is a joint MDT, videoconferenced with the RNOH
Bone and soft tissue sarcoma MDT.
48
The contact details are:
MDT Co-ordinator
Maria Jose
[email protected]
Telephone - 0207 691 2303 ext 4821
Fax - 020 3447 9536
UCLH Sarcoma MDT Lead Clinician
Dr Jeremy Whelan
[email protected]
0207 380 9346
Please note: cut off for referrals is the Wednesday preceding the Friday meeting.
The sarcoma MDT will review all cases of breast sarcoma. It is anticipated that surgery will be
undertaken by local breast services after discussion with the sarcoma MDT.
Management will be undertaken in accordance with guidelines agreed across the two sarcoma
MDTs.
Following discussion at the MDT:

Patients with head & neck sarcomas will be referred to the Sarcoma SMDT at UCLH.
Principle responsibility for ongoing treatment will be handed over to the receiving MDT, if appropriate,
following their discussion, until & unless it is handed back.
20.4 Head & Neck sarcomas
Head and neck sarcomas are likely to be diagnosed within the site-specific head and neck MDT.
Patients will be managed by the sarcoma oncologist, in conjunction with the head and neck MDT
for surgical management. Tumours may be of soft tissue (soft tissue sarcomas,
rhabdomyosarcoma) or bone (Ewing’s sarcoma, osteosarcoma, chondrosarcoma) origin.




20.4.1 Diagnosis and staging
Pathology review
MRI head and neck
CT thorax
Other staging (e.g. bone scan, bone marrow aspirate and trephine) as indicated.
20.4.2 Treatment of localised disease
For rhabdomyosarcoma and bone sarcomas, see tumour-specific sections above. For other
soft tissue sarcomas management is likely to include a combination of chemotherapy,
radiotherapy and surgery, which reflects the difficulty in achieving local tumour control in this
disease location. The exact ordering of treatment modalities will be determined on an
individual patient basis, following MDT discussion.
20.4.3 Treatment of metastatic disease
See tumour-specific sections above.
20.5 Rhabdomyosarcoma
Rhabdomyosarcoma (RMS) is typically a cancer of childhood, and is rare in adults. It may affect the
extremities, genitourinary system, head and neck region, trunk, or other less frequent sites.
Three main variants are recognised:
 Embryonal rhabdomyosarcoma (including botryoid variant)
 Alveolar rhabdomyosarcoma
49

Pleomorphic rhabdomyosarcoma (occurs in adults, is treated as a high grade soft tissue
sarcoma)
20.5.1 Diagnosis and staging







Biopsy, pathology review
CT/MRI of primary site
CT chest, abdomen and pelvis
Whole body bone scan or PET-CT scan
Bilateral Bone Marrow aspirate and trephine
Assessment of cerebrospinal fluid for parameningeal tumours.
Routine bloods including LDH and alkaline phoshatase.
20.5.2 Treatment of localized disease
Patients are stratified according to the risk of their disease, based on a number of prognostic factors.
The principles of treatment are:




Low Risk → surgery + chemotherapy.
Standard Risk → surgery + chemotherapy ± radiotherapy.
High Risk → chemotherapy + surgery + radiotherapy.
Very High Risk → chemotherapy +/- surgery + radiotherapy.
Local therapy (surgery and/or radiotherapy) is carried out at around week 13.
Vincristine, actinomycin D, and ifosfamide are the main chemotherapy agents.
For the very high risk patients doxorubicin may be added to the standard regimens.
Detailed guidelines for the management of all rhabdomyosarcomas including risk classification and
available clinical trials are specified in the current Unit guidelines.
20.5.3 Treatment of metastatic disease
There is no currently open clinical trial for patients with metastatic RMS.


First-line treatment → chemotherapy:
o IVADo
 Ifosfamide; Vincristine; Actinomycin D; Doxorubicin.
Local treatment → radiotherapy preceded by surgery, if feasible (at week 18)
20.5.4 Treatment of relapsed disease
Treatment will be given on an individualised basis. Regimens that can be considered include:
 Irinotecan and vincristine
20.5.5 Follow-up of rhabdomyosarcoma



Clinical evaluation of the primary site
MRI or CT scan of the primary site as clinically indicated
Chest x-ray
Recommended intervals for follow-up:
 Every 2 months in the first year.
 Every 3 months in years 2 - 3.
 Every 6 months in years 4 - 5.
50

Annually thereafter.
For the most up-to-date schedule, see current individual unit guidelines.
For the London and South East Sarcoma Network Presentation and Diagnostic Pathway for Bone
Sarcomas please see appendix 5.
20.6 Tumour involving the skull base

Patients with tumours involving the base of skull and requiring cranio-facial resection will be
referred to the Head & Neck SMDT at Charing Cross Hospital.
Principle responsibility for ongoing treatment will be handed over to the receiving MDT, if appropriate,
following their discussion, until & unless it is handed back.
51
21. Acute Oncology Services
National Chemotherapy Advisory Group, guided partly by reports from NCEPOD and NPSA and from
previous cancer peer review results, has recommended that a more systematic approach should be
taken to dealing with cancer-related emergencies. These recommendations have been embodied in
the concept of the ‘Acute Oncology Service’.
Work is now underway within the acute trusts within the Mount Vernon Cancer Network Locality to
develop a strategic approach to managing acute oncological emergencies which reflects both local
trust practice and a consistent network wide approach.
In line with this a number of policies and protocols have been developed / revised to manage acute
oncological emergencies as they present at A&E / AAU / MAU.
These have been developed by the MVCC in collaboration with the trusts and have been agreed by
the Network Acute Oncology Group.
From referral into the system the patients will be triaged to appropriate oncological input earlier within
the patient pathway. The AOS will ensure 24hr access for acute medical take and A&E doctors to
oncological assessment.
Oncological emergencies include the suspicion and diagnosis of spinal cord compression and in
these cases referral in tot the service or presentation at A&E will result in MRI, and case discussion
between MVCC and the designated spinal surgery centre to ensure earlier detection and
management of this condition.
52
22. Rehabilitation
Rehabilitation is a key component of the patient pathway. The rehabilitation specialist services
consist of:
o
o
o
o
o
Dietetics
Lymphoedema
Occupational Therapy
Physiotherapy
Speech and Language Therapy
The input from these professionals will vary depending on the patient’s diagnosis and treatment.
The Mount Vernon Cancer Network Rehabilitation Services Directory is available through the MVCN
website which identifies service availability across the network.
See Appendix 8 for detailed pathway
53
Appendix 1
Primary Care Referral Guidelines
for Head and Neck Cancer
for the population of NHS Bedfordshire
(11-1A-206i)
Version:
Draft v1.4
Date of approval:
To be entered when approved
Review date:
To be entered – 2 years from approval date
Authors:
AngCN Head and Neck NSSG
MVCN Head and Neck NSSG
Ref No:
AngCN-SSG-HN16
54
AngCN-SSG-HN16
Head and Neck Primary Care Referral Guidelines for the population of NHS Bedfordshire
CONTENTS
1
INTRODUCTION ....................................................................................................................... 56
2
STRIDOR .................................................................................................................................. 56
3
NECK LUMP ............................................................................................................................. 56
3.1
NECK LUMP - CLINICALLY NON-THYROID ................................................................................ 56
3.2
NECK LUMP – CLINICALLY THYROID ....................................................................................... 57
4. FEATURES OF UAT MALIGNANCY +/- NECK LUMP ............................................................. 58
5.
NO NECK LUMP AND NO URGENT FEATURES .................................................................... 59
6.
APPENDICES ........................................................................................................................... 60
APPENDIX 1: DOCUMENT CONTROL .................................................................................................. 60
APPENDIX 2: REFERRAL SCHEMAS ................................................................................................... 62
APPENDIX 3: REFERRAL GUIDELINES FOR SUSPECTED CANCER ......................................................... 65
Approved mmyy (enter when approved)
Insert filepath
55
AngCN-SSG-HN16
Head and Neck Primary Care Referral Guidelines for the population of NHS Bedfordshire
1. Introduction
The Anglia Cancer Network (AngCN) and Mount Vernon Cancer Network (MVCN) Head and Neck
Network Site Specific Groups (NSSG) have agreed the implementation of referral guidelines for
patients where there is a suspicion of head and neck/thyroid cancer in line with the recommendations
of the Manual for Cancer Measures and the Referral guidelines for suspected cancer from National
Institute for Health and Clinical Excellence (Appendix 3).
The primary care referring practitioner needs to decide on the basis of clinical examination and
history:

Does the patient have features suggestive of Head and Neck or Thyroid Cancer?

Does the patient have a neck lump?

Is the lump clinically a thyroid lump?

Are there other features of urgency about the lump?

Are there other urgent features which might suggest UAT or Haematological Malignancy?

Does the patient have stridor?

If there is no neck lump does the patient have features suggesting malignancy?
The numbered paragraphs deal with the actions to be taken by the referring practitioner as outlined in
the diagnostic schema in Appendix 2.
2. Stridor

If the patient has stridor then it is essential to refer immediately (same day).

Referral must be to the designated hospitals either to A&E or to the on call ENT team
3. Neck Lump
3.1 Neck Lump - Clinically Non-thyroid
Features suspicious of cancer associated with the non-thyroid neck lump itself (reference:
Department of Health Referral Guidelines for the Diagnosis of Cancer, reviewed 2005):

Where the lump persists for more than three weeks despite antibiotics, infectious mononucleosis
has been excluded and there are no non-lump features suggestive of malignancy.
If the patient has the symptoms outlined above then a 2 week wait urgent referral should be made as
shown on the following page:
Approved mmyy (enter when approved)
Insert filepath
56
AngCN-SSG-HN16
Head and Neck Primary Care Referral Guidelines for the population of NHS Bedfordshire
Neck Lump Clinic Referral (Clinically non-Thyroid)
Designated Hospital
Designated Clinician
Designated Contact
Point (2ww office)
Luton and Dunstable
Mr. Pickles
Miss Panesar
Mr. Kothari
Mr. Chan (OMFS)
Mr. Camilleri (OMFS)
Telephone Number:
01582 497247
2WW Fax Number:
01582 497910 or
497911
Bedford
Mr Patel (ENT)
Mr Chan (OMFS)
Mr Simpson (OMFS)
01234 355122
Mr Patel ext 2894
or Mr Chan ext 2071
Or Mr Simpson ext 2070
01234 792133 (Fax)
MDT Pathway
Bedfordshire and
Hertfordshire Head and
Neck SMDT
Hosted at Luton &
Dunstable Hospital
3.2 Neck Lump – Clinically Thyroid
The vast majority of thyroid nodules are benign and do not require urgent referral. Furthermore,
thyroid cancer is uncommon in patients who are not euthyroid and assessment of biochemical thyroid
status is useful in deciding on the referral pathway by the general practitioner.
Immediate (same day) referrals
Patients with stridor associated with a thyroid swelling should be referred immediately to
secondary care (depending on locally provided facilities, this may be the accident and
emergency department, head and neck or general surgical emergency services).
Urgent referrals under the 2-week rule for suspected cancer
The presence of the following symptoms or signs in association with a thyroid swelling may
indicate more aggressive or advanced disease and should be referred urgently under the 2-week
rule:
 unexplained hoarseness or voice change
 thyroid nodule/goitre in a child
 cervical lymphadenopathy associated with a thyroid lump (usually deep cervical or
supraclavicular region)
 a rapidly enlarging painless thyroid mass over a period of weeks (a rare presentation of
thyroid cancer and usually associated with anaplastic thyroid cancer or thyroid lymphoma).
Patients in whom exclusion of thyroid cancer is required should be referred to a thyroid nodule clinic,
or a surgeon, endocrinologist or nuclear medicine physician who has a special interest in thyroid
cancer and is a member of the regional thyroid cancer MDT.
Non-urgent referrals
The following patients should be referred in the normal way:
 patients with nodules who have abnormal TFTs, who should be referred to an endocrinologist
(thyroid cancer is very rare in this group)
 patients with a history of sudden onset of pain in a thyroid lump (likely to have bled into a
benign thyroid cyst) patients with a thyroid lump that is newly presenting or has been
increasing in size over months.
The above guidelines are adopted from the British Thyroid Association (BTA), 2007, p.5-6, Guidelines
for the management of thyroid cancer.
Please see below for the referral pathway and contact points.
Approved mmyy (enter when approved)
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57
AngCN-SSG-HN16
Head and Neck Primary Care Referral Guidelines for the population of NHS Bedfordshire
Neck Lump / Specialist Thyroid Clinic Referral
Designated Hospital
Designated Clinician/s
Mr M Pittam
Mr D Ravichandran
Dr R Banerjee
Luton & Dunstable
Bedford
Mr H Charfare (Thyroid)
Mr T Hoare (ENT)/
Mr Patel (ENT)
Designated Contact
Point (2ww office)
Telephone Number:
01582 497247
2WW Fax Number:
01582 497910 or
497911
MDT Pathway
Bedfordshire and
Hertfordshire Head
and Neck SMDT
Hosted at Luton &
Dunstable Hospital
01234 355122
AngCN (West)
Thyroid MDT
Mr Charfare ext 2192
Mr Hoare ext 2850
Mr Patel ext 2894
Hosted at
Addenbrookes
4. Features of UAT malignancy +/- neck lump
Features suspicious of UAT cancer (reference: Department of Health Referral Guidelines for the
Diagnosis of Cancer, revised 2005):

Hoarseness for more than 6 weeks

Oral mucosal ulcer persisting for more than 3 weeks

Oral swelling persisting for more than 3 weeks

Red or red and white patches of the oral mucosa

Dysphagia, including odynophagia, for more than 3 weeks

Unilateral nasal obstruction, especially with purulent discharge

Unexplained tooth mobility, not associated with periodontal disease

Cranial neuropathies

Orbital masses

Unilateral persistent sore throat

Unilateral otalgaia with normal otoscopy
If the patient has any of the symptoms outlined above then a 2 week wait urgent referral should be
made as shown on the table on the following page:
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58
AngCN-SSG-HN16
Head and Neck Primary Care Referral Guidelines for the population of NHS Bedfordshire
UAT Malignancy +/- Neck Lump Clinic Referral
Designated
Hospital:
Designated
Clinicians:
Designated Contact
Point (2ww office):
Mr J M Pickles
Mrs J Panesar
Mr P Kothari
Telephone Number:
01582 497247
2WW Fax Number:
01582 497910 or
497911
Mr T Hoare (ENT/
thyroid)
Mr Chan (OMFS)
Mr Simpson
(OMFS)
Mr Patel (ENT)
01234 355122
Mr Hoare’s ext 2850
Mr Chan’s ext 2071
Mr Simpson’s ext
2070
Mr Patel’s ext 2894
Luton &
Dunstable
Bedford
MDT Pathway:
Head and Neck
MDT Pathway
Bedfordshire and
Hertfordshire
Head and Neck
SMDT
Hosted at Luton
and Dunstable
Hospital
Thyroid MDT
Pathway
Bedfordshire and
Hertfordshire Head
and Neck SMDT
Hosted at Luton and
Dunstable Hospital
AngCN (West)
Thyroid MDT
Hosted at
Addenbrookes
5. No neck lump and no urgent features
The patient should be referred as a routine appointment as follows:
Hospital
Booking Contact Point
Luton & Dunstable
Routine appointments requested by letter/or by choose and book
Bedford
Routine appointments requested by letter addressed to a specific consultant/or
by choose and book
ENT – 01234 355122 ext 2894
OMFS – 01234 355122 ext 2071
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59
AngCN-SSG-HN16
6.
Head and Neck Primary Care Referral Guidelines for the population of NHS Bedfordshire
Appendices
Appendix 1: Document Control
Document ratification and history:
Approved by:
Date placed on
electronic library:
XXX
Review
period:
Authors:
XXX
2 years (or earlier in the light of new evidence)
Anglia Cancer Network and
Mount Vernon Cancer Network
Head and Neck NSSG
Version number as approved and
published:
XXX
Document Owner:
Anglia Cancer Network
Tel: 01638 608208
www.angliacancernetwork.nhs.u
k
Unique identifier no.:
AngCN-SSG-HN1
Document distribution:
Responsible for
Distribution:
To:
Sent Via:
Sent via:
Date:
Head and Neck NSSG
Network Project Manager
Anglia Cancer Network
Email
XXX
Mount Vernon Cancer
Network
Email
Anglia Cancer Network
Email
PCT Primary Care Leads
XXX
Mount Vernon Cancer
Network
Email
PCT Primary Care Leads
XXX
Anglia Cancer Network
Email
Trust Lead Cancer
Managers
XXX
Mount Vernon Cancer
Network
Email
Trust Lead Cancer
Managers
XXX
Designated consultant clinicians
Primary Care medical practices,
primary dental practices
non designated head and neck
consultant clinicians (ENT surgeons,
endocrine surgeons, oral maxillofacial surgeons, oral medicine
specialists, endocrinologists and
restorative dentistry consultants)
XXX
XXX
For comments / amendments to these guidelines, please contact:
Name
Richard Benson
Tom Roques
Hospital
Addenbrookes
NNUH
Tel. No
01223 217019
01603 287671
Email
[email protected]
[email protected]
Monitoring the effectiveness of the Process
a) Process for Monitoring compliance and Effectiveness - Review of compliance as determined by
audit. Any non compliance to be presented by QA Manager to the AngCN Business Meeting on an
annual basis – the minutes of this meeting are retained for a minimum of five years.
b) Standards/Key Performance Indicators – This process forms part of a quality system working to,
but not accredited to, International Standard BS EN ISO 9001:2008. The effectiveness of the
process will be monitored in accordance with the methods given in the quality manual, AngCN-QM
Approved mmyy (enter when approved)
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60
AngCN-SSG-HN16
Head and Neck Primary Care Referral Guidelines for the population of NHS Bedfordshire
Equality and Diversity Statement
This document complies with the Suffolk PCT Equality and Diversity statement – an EqIA
assessment is available on request to Anglia Cancer Network QA Manager, Gibson Centre, Exning
Road, Newmarket, CB8 7JG.
Disclaimer
It is your responsibility to check against the electronic library that this printed out copy is the most
recent issue of this document.
Please notify any changes required to the Anglia Cancer Network Quality Assurance Manager.
Approved mmyy (enter when approved)
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61
AngCN-SSG-HN16
Head and Neck Primary Care Referral Guidelines for the population of NHS Bedfordshire
Appendix 2: Referral schemas
Figure 1: SCHEMA – Features suspicious of cancer associated with a thyroid lump
NECK LUMP?
THYROID?
FEATURES
SUSPICIOUS OF
MALIGNANCY?
Stridor
Clinically thyroid
REFERRAL
GUIDELINE
STRIDOR?
Features
suspicious of
thyroid cancer
+/- stridor



(see section 3.2)


Neck Lump
No features
suspicious of
thyroid cancer
No Stridor


Clinically nonthyroid
Approved mmyy (enter when approved)
Insert filepath
Same day referral
Designated
clinicians or A&E
Management then
diagnosis
See Figure 2

Fast-track referral
Designated clinician
for thyroid
Thyroid / Neck
Lump Clinic
Routine
appointment
Designated
clinicians for thyroid
62
AngCN-SSG-HN16
Primary Care Referral Guidelines for Head and Neck Cancers for the population of NHS Bedfordshire
Figure 2: SCHEMA - Features suspicious of cancer associated with a non-thyroid neck lump
NECK LUMP?
FEATURES
SUSPICIOUS OF
MALIGNANCY?
THYROID?
See Figure 1
See
Clinically thyroid
 Fast-track referral
 Designated clinician for
UAT or Cons. HaemOnc.
 Neck lump clinic
 Lump persists after 3
weeks despite
antibiotics
 Info. Mono. Excluded
 No associated (nonlump) features of
malignancy
(see section 3.1)
Neck Lump
No Stridor
Clinically nonthyroid

Lump has associated
(non-lump) features
of UAT malignancy
+/- stridor
(see section 4)
Stridor

Lump has associated
(non-lump) features of
haematological
malignancy +/- stridor
No Stridor
 Lump disappears
within 3 weeks +/antibiotics or positive
for Inf. Mono.
 No associated (nonlump) features of
malignancy
Approved mmyy (insert when approved)
Insert filepath
REFERRAL
GUIDELINE
STRIDOR?
 Fast-track referral
 Designated clinician for
UAT
 Direct or at neck lump
clinic
 Same-day referral
 Designated clinician or
A&E
 Management then
diagnosis
 Fast-track referral
 Designated clinician for
UAT
 Direct or at neck lump
clinic

Not applicable
63
AngCN-SSG-HN16
Primary Care Referral Guidelines for Head and Neck Cancers for the population of NHS Bedfordshire
Figure 3: SCHEMA - No neck lump
NECK LUMP?
THYROID?
FEATURES
SUSPICIOUS OF
MALIGNANCY?
Features
suspicious of
thyroid cancer
+/- stridor
No Stridor


Stridor
Patient has nonurgent UAT
symptoms and no
lump
Insert filepath



No
Neck Lump
Approved mmyy (insert when approved)
REFERRAL
GUIDELINE
STRIDOR?



Fast-track referral
Designated clinician
for UAT and
Thyroid
Direct
Same-day referral
Designated clinician
or A&E
Management then
diagnosis
Routine referral
Central contact
point of designated
hospital referral
proforma
64
Appendix 3: Head and Neck Referral Guidelines for suspected cancer
National Institute for Health and Clinical Excellence (NICE), Referral for Suspected Cancer (CG27),
2011, p.19.
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65
Appendix 2
Mount Vernon Head & Neck Cancer Network
…………………..Hospital
Suspected Head & Neck or Thyroid Neoplasm
General Practitioner & General Dental Practitioner Urgent Referral Form
Please see this patient with a suspected head and neck neoplasm in the urgent thyroid, neck
lump, ENT clinic or Oral & maxillofacial surgery clinic as appropriate.
The clinical features are as follows: (please circle)
1. Solitary thyroid lump
refer to thyroid lump clinic
2. Non-thyroid neck lump
refer to urgent neck lump clinic
3. Suspected neoplasm of throat or larynx nose, sinuses or ear
refer to neck lump clinic or urgent ENT clinic
4. Suspected neoplasm of oral cavity, or jaws
refer to OMFS clinic
5. Salivary Gland lump
refer to neck lump ENT or OMFS clinic
Clinical details
Past medical history
Medication
Please fax via Urgent two-week-wait fax line Tel No. 01582 497910
66
Appendix 3
Mount Vernon Cancer Network
Guidelines for imaging patients with suspected Head and Neck Cancer
(11-1C-105i)
Imaging should be arranged at the earliest possible opportunity following cytological or
histological diagnoses, or on clinical diagnosis where suspicion is string, by designated
clinicians of the diagnostic and treatment centres or members of the core team.
See also the MVCN Head & Neck Clinical Guidelines for individual Cancer sites.
Staging Investigations

MRI scan Head & Neck
All patients with biopsy proven Cancer of the Head and Neck (suprahyoid) should have an
MRI scan of the Head and Neck with the following exceptions
i)
Patients with T1NO scc glottis
ii)
Patients of very poor performance status
iii)
Patients in whom MRI is contra-indicated eg. Claustrophobia, peacemaker, metal
fragments in the Head and Neck (who should undergo a contrast enhanced CT
scan of the Head and Neck)
iv)

Patients with very superficial tumours of anterior two-thirds of tongue
CXR
All patients should have an up-to-date CXR

Contracts enhanced CT scanning of chest and upper abdomen (for those at high risk of
distant metastases)
i)
Patients with N1-3 neck disease
ii)
Patients with T3-4 primaries
iii)
Patients in whom respiratory symptoms indicate pulmonary mets or a possible
synchronous lung primary
1. Contrast enhanced CT scan of head & neck
i)
To assess presence/absence of bony invasion eg skull base, mandible, antrum,
orbit
67
ii)
To stage infrahyoid tumours and laryngeal carcinomas nut MRI is preferred for the
assessment of cartilage invasion
iii)


Patients with contra-indications to MRI Head & Neck
Ultrasound guided FNAC
i)
See unknown primary protocol
ii)
Patients with equivocal nodes on CT, MRI or PET-CT
iii)
Suspicious salivary gland enlargement
PET-CT scans
i)
Mandatory for patients with unknown primaries (pre-EUA & Biopsy) and part of
diagnostic work-up for nasopharyngeal carcinoma
ii)
Useful for imaging recurrence post-treatment
iv)
May be useful in other case scenarios but should in general be discussed in local
MDM

OPG
i)
To look for bony erosion in tumours of oral cavity
ii)
For pre-radiotherapy dental assessment
Risk of distant metastases by primary tumour site (5019)
Primary site
Incidence of distant mets (%)
Oral cavity
7.5
Faucial arch
6.7
Oropharynx
15.3
Nasopharynx
28.1
Paranasal sinuses, nasal cavity
9.1
Supraglottic larynx
15.0
Vocal cord
3.1
Hypopharynx
23.6
Total
10.9
Risk of distant metastases by stage
Stage
Risk (%)
I
2.0
II
5.7
68
III
8.5
IV
19.5
T-stage
1
5.2
2
9.6
3
12.7
4
16.1
N-stage
0
4.9
1
11.8
2
21.8
3
27.1
Risk of synchronous primary
Literature suggests of the order of 10-20%, commonest sites- bronchus, upper GI and head
and neck (clinically it appears to be lower)
69
Thyroid imaging guidelines
(11-1C-106i)
Thyroid Cancer Diagnosis/Staging :
•
US + Fnac
•
MDCT (non contrast) NECK or MRI NECK : for locally extensive tumours with extra-capsular
spread or equivocal extent evaluation on Ultrasound.
•
MDCT (non contrast) Chest : for locally extensive Tumours and/or Node positive Necks.
•
PET-CT- for patients with rising Thyroglobulin but poor Iodine uptake
Thyroid Cancer Recurrence:
US +/- Fnac and/or MDCT/ MRI (depending on local availability ) for localising and characterisation of
abnormal uptake on Nuclear Medicine study.
70
Appendix 4
Head & Neck Cancer Team Clinical Follow up Protocol
Luton & Dunstable
Hospital
Milton Keynes Hospital
Bupa
Responsible:
Maxillofacial: L&D team
Private Care
West Herts Trust (Watford,
Hemel Hempstead & St
Albans)
Responsible:
ENT: L&D Team
Maxillofacial: MVCC
Lister Hospital
Responsible:
Mr. Camilleri
QEII Hospital
Responsible:
As per Lister Hospital
Bedford Hospital
Responsible:
Maxillofacial: Mr. Chan
ENT: Mr. Patel
Agreed and signed:
Luton & Dunstable Hospital:
Lister Hospital:
Bedford Hospital:
QEII Hospital:
West Herts Hospitals Trust
71
Appendix 5
London and South East Sarcoma Network (www.lsesn.nhs.uk)
Bone Sarcoma: Presentation and Diagnostic Pathway
Referral and Presentation
Secondary Care
GP
A&E
Suspected Bone Sarcoma
- clinical presentation/signs & symptoms
- suspicious X-ray/imaging
- post-operative diagnosis
All plain films and MRI can
be carried out at referring
trusts but all biopsies to be
carried out at RNOH
Referral to The London Sarcoma Service
(Royal National Orthopaedic Hospital and University College London Hospitals)
2WW form/Tertiary referral form faxed and imaging send to MDT Coordinator;
Clare Brown, Sarcoma Unit, Muriel Sands House, RNOH, Brockley Hill, Stanmore, Middlesex HA7 4LP
Telephone: 0208 954 2300 bleep 721 Fax: 0208 909 5709 Email: [email protected]
via MDT
Coordinator
RNOH will request any further diagnostic tests required
MDT triage referrals
Patient presents to Primary/
Secondary Care with symptoms
suggestive of recurrence
Discuss at Pre-Diagnostic Meeting (RNOH)
- MDT agree diagnostic plan
Nurse-led Telephone Clinic
- explain investigations required
- send investigations leaflet
Diagnostics
via CNS
All histology
reviewed by
Specialist Sarcoma
Pathologist
via consultant
Diagnostic Investigations and additional primary
tumour imaging
If bone sarcoma suspected:
MRI, CT Chest, Bone Scan (if not had),
via CNS
Biopsy +/- GA (only to be carried out at RNOH)
Benign
‘Existing MDT’ (RNOH)
- benign patients and metastatic bone
tumours from other primaries discussed
- treatment planning as appropriate
Refer back to GP or local
Trust as appropriate
Malignant sarcoma/metastatic disease
VTC Diagnostic MDT (RNOH & UCLH)
- treatment planning
Identification of treatment centre
OPA
- patient told results and given treatment plan
- CNS present and counselling room available
CNS send diagnosis fax to GP
Palliative Care
Contact points to refer back known
patients with symptoms suspicious
of recurrence:
Patient: GP/CNS (key worker)/
MDT Coordinator (if previously
discharged)
Pre-Op Assessment Clinic
Primary/Secondary Care:
- same day as OPA if
Consultant (via secretary)
possible
72
Appendix 6
REHABILIATION - SUPPORTIVE CARE MAPPING TEMPLATE
Head and Neck
Milestones 1-3
1. Suspicion of
Cancer
2. Diagnosis
All oncology team
Holistic assessment by key
worker using PEPSI COLA aide
memoir for referral to AHP
services
Diagnostic
radiographer
Provide general radiography
service, available on demand
for outpatient clinics and for GP
referrals (if this is the practice
at the hospital), including for
example, chest X-ray, sinus Xray and
orthopantomogram (OPG)
_ Provide and arrange
appointments for specialised
imaging, for example, magnetic
resonance
imaging (MRI), computerised
tomography (CT), barium
investigations, sialogram, within
an agreed
timescale
_ Ensure that appointment
letter includes specific
explanation relating to
procedure/examination,
when and where to attend, any
preparation necessary and a
contact telephone number
_ Ensure that system is in place
to contact specific persons, for
instance, medical team, nurse
specialists, counsellors,
regarding patient queries
_ Ensure privacy and space are
available for patients to discuss
3. MDT
Referral to AHP/AHP input at
MDT where appropriate
73
1. Suspicion of
Cancer
2. Diagnosis
3. MDT
queries and concerns
_ Ensure appropriate
equipment is available during
investigations, for example, for
suctioning
_ Ensure patient undergoes
examination safely and with
minimal stress, that a clear
explanation of
procedure is given and that
patient knows when and where
to get the results
Dietitian
Assess:
– patient’s nutritional
requirements and factors
affecting nutritional status
– potential impact of treatment
on patient’s nutritional status
– patient’s circumstances and
ability to act on dietetic advice
_ Advise and discuss
importance of
maintaining/achieving optimal
nutritional status during
treatment
_ Provide practical dietary
advice, including written
information tailored to
individual’s needs,
prognosis and circumstances
_ Request that GP prescribes
sip feeds if nutritional status is
compromised
_ Draw up nutritional care plan
to achieve optimal nutritional
status
– Liaise with other health
professionals in the oncology
team
Occupational
therapist
Physiotherapist
Speech and
language therapist
See referral for criteria
See referral for criteria
Speech and language
therapist
74
1. Suspicion of
Cancer
2. Diagnosis
3. MDT
See Criteria for referral
_ Make initial contact
_ Give information regarding
role and advice
Therapeutic
radiographer
(At first appointment with
clinical oncologist)
_ Meet patient and relatives
and explain role therapeutic
radiographer will play in
patient’s
radiotherapy planning and
treatment
_ Provide specific information
about mould room,
radiotherapy planning and
treatment
_ Allow patient and relatives
time for questions
_ Discuss side effects of
treatment
_ Provide written information
and contact number
4 Pre
radiotherapy
5 Radiotherapy
6 Post
radiotherapy
All oncology team
Holistic assessment by key
worker using PEPSI COLA
aide memoir for referral to
AHP services
Holistic assessment by
key worker using PEPSI
COLA aide memoir for
referral to AHP services
Holistic assessment by key
worker using PEPSI COLA
aide memoir for referral to
AHP services
Diagnostic
radiographer
See Milestone one
_ Ensure that appointments

Provide general
Provide imaging services
as in Milestones one and
75
4 Pre
radiotherapy
Physiotherapist
5 Radiotherapy
for specialised imaging are
arranged before patient is
due to start
treatment – including if
patient has a CT/MRI scan
to use as a baseline for post
treatment
comparison
_ Ensure that relevant lymph
nodes are included in
CT/MRI scans so that
assessment of secondary
spread of disease can be
made
_ Liaise with mould room,
dental department and
treatment planning staff to
minimise the
number of journeys to
hospital, especially if
hospital transport is required
_ (Depending on hospital
practice) Arrange
appointments for treatment
planning scans/radiography
_ Carry out any required
radiological intervention
procedures for managing
nutritional problems,
for example, gastrostomy,
arranging appointments as
necessary
_ Be prepared to carry out
appropriate interventions of
the above type at any point
in any
treatment if patient is unable
to swallow
_ Discuss with referring
clinician or radiologist
changes to procedure due to
individual patient
needs, including in difficult
cases, to ensure maximum
results
radiography services on
demand for
complications, for
example, for siting of
nasogastric tube
_ Carry out radiological
procedures that may be
required if patient has
nourishment problems,
for example, gastrostomy
(see Milestone one for
procedure for arranging
appointment)
_ Liaise with staff
involved in the patient’s
care, for example,
specialist nurse
_ Co-ordinate
examinations depending
on treatment
appointments
_ Ensure previous
imaging is available at
time of current imaging
_ See Milestone two
_ Assess:
Carry out referral for
in/out-patient within one
6 Post
radiotherapy
two, with imaging
comparable in technique to
baseline scans
_ Ensure that appointments
to help monitor patient’s
response to treatment are
timed to allow
for treatment effects to
subside
_ Provide specialised
imaging within first three
months only after
discussion with the
Radiology
Department
_ Ensure previous imaging
is available at time of
current imaging
76
4 Pre
radiotherapy
– patient’s respiratory status
– patient’s general health,
mobility and function of the
neck and shoulders

5 Radiotherapy
6 Post
radiotherapy
week of commencing
radiotherapy
_ Give advice on
respiratory exercises and
care, clearance of
secretions and explain
risk of
aspiration, if appropriate
_ Explain possible side
effects of treatment, for
example, mucositis, sore
mouth, difficulty with
clearing thick, sticky
secretions, tightening of
skin over treated areas
_ Teach tracheostomy
care to patient and/or
carer if appropriate or
ensure that suitably
qualified
nurse undertakes to
teach this
_ Administer
physiotherapy to
maintain/improve range
of movements and
muscle strength over
operation and
radiotherapy sites,
including donor areas
_ Teach patient
stretching exercises to
help maintain the
elasticity of irradiated
tissues and provide
written individual exercise
sheets
_ Teach pain relief
techniques and provide
help with relief of
nausea/vomiting as
required, for
example, by
transcutaneous electrical
nerve stimulation
(TENS), relaxation,
acupuncture
_ Continue above regime
77
4 Pre
radiotherapy
5 Radiotherapy
6 Post
radiotherapy
as appropriate
throughout the course of
radiotherapy
Occupational
Therapist
See also Criteria for referral
_ Make initial contact to
explain role of occupational
therapist and to build rapport
_ Make baseline
assessment of mobility, in
conjunction with
physiotherapist, and
personal and
domestic activities of daily
living
_ Assess home situation,
including liaison with
relatives and carers, to
ascertain their concerns,
abilities and the level of
support they can provide
_ Assess where appropriate
current role with regard to
work and leisure
_ Discuss patient’s and
carers’ expectations, wishes
and concerns regarding the
short and long
term outcomes of
intervention and offer
appropriate education and
support
_ Carry out initial
assessment of psychological
coping mechanisms, for
example, altered body
image and adjustments
_ Liaise with other members
of the multidisciplinary team
as appropriate
See also Criteria for
referral
_ Assess impact of
treatment on patient’s
coping adjustment and
their quality of life
_ Assist patient’s/carer’s
psychological adjustment
to disease and treatment,
for example, altered
body image,
communication difficulties
_ Assess functional
implications of treatment
on activities of daily living
and intervene as
necessary
with aids/adaptations or
compensatory techniques
_ Assess patient’s social
situation
_ Teach appropriate
adaptation techniques,
for example:
– relaxation
– stress management
– energy conservation to
prevent fatigue
– goal setting and
problem solving
_ Liaise with members of
the multi-professional
team and other
internal/external agencies
as required
See Milestone eight
_ Assess functional ability
and equipment required to
enable maximum
functioning in home
environment
_ Provide treatment as
indicated
_ Liaise with multiprofessional team and
internal/external agencies,
for example, social services
_ Carry out home visit if
indicated and implement
recommendations
_ Ensure equipment
required to enable
independence in activities
of daily living is delivered
and
fitted for discharge
_ Discharge patient when
recommendations
implemented and goals
achieved
Speech and
language therapist
_ Prepare patient for impact
of radiotherapy on speech
and swallowing function
Establish stage in
treatment
_ Evaluate
Establish details of recent
surgical/radiotherapy
interventions
78
4 Pre
radiotherapy
Dietitian
5 Radiotherapy
6 Post
radiotherapy
_ Establish current extent of
disease and proposed form
of treatment
_ Establish details of any
previous medical/surgical
and speech therapy
interventions
_ Evaluate
oral/pharyngeal/laryngeal
mechanism, noting
presence of any surgical
voice prosthesis
_ Assess current
communication skills and
level of cognitive functioning
_ Liaise with other team
members
oral/pharyngeal/laryngeal
mechanism
_ Assess communication
and swallowing functions
_ Ensure access to
means of alternative
communication where
necessary
_ Instigate further
investigations, for
example,
nasoendoscopy,
videofluoroscopy, where
further
information is required for
effective management
_ Instruct patient in
therapeutic techniques,
for example, maintaining
range of motion in
muscles
of speech and
mastication and
compensatory strategies
such as safe swallow
_ Assist patient to
maintain speech and
swallowing functions as
radiotherapy progresses
_ Advise on good voice
care and technique
_ Maintain close liaison
with relevant members of
the team, referring to
medical colleagues
where
further opinion is needed

_ Evaluate
oral/pharyngeal/laryngeal
mechanism, noting
presence of any surgical
voice prosthesis
_ Assess communication
and swallowing functions
_ Ensure access to means
of alternative
communication where
necessary
_ Instigate further
investigations, for example,
nasoendoscopy,
videofluoroscopy, where
further
information is required for
effective management
_ Instruct in therapeutic
techniques and
compensatory strategies
_ Liaise with other team
members
_ Refer to local speech and
language therapy service,
providing details of
treatment and
management during
radiotherapy

_ See Milestone two
Also:
_ Liaise with other health
professionals in the
oncology team regarding
patient admission if
patient
is currently having out-
Assess patient’s nutritional
requirements and status
_ Assess patient’s
nutritional intake, including
via following feeding
methods/combinations:
– nasogastric, gastrostomy,
jejunostomy feeding
79
4 Pre
radiotherapy
5 Radiotherapy
patient radiotherapy and
requires administration of
nutritional support
_ Draw up and review
nutritional care plans to
achieve optimal
nutritional status
_ Provide ongoing
monitoring and support to
patient, family and carers

Therapeutic
radiographer
_ Ensure that clinical
oncologist has completed
treatment action sheet
_ Instigate treatment
preparation, either in
simulator or mould room – if
patient’s treatment is
planned initially in the
simulator (i.e. without a
treatment mask), patient can
proceed straight to
first available appointment
_ On arrival in mould room
or simulator, explain fully all
that going to happen, both at
planning
stage and treatment (mask
making procedure may be
performed by a mould room
technician)
_ Allow time for patient to
ask questions and to
discuss any worries or
concerns they may have
_ Ensure patient has had
dental assessment before
making the mask
_ Make appropriate
treatment mask according to
the treatment technique to
be used
_ Ensure patient has details
of simulator and/or CT
planning appointments
6 Post
radiotherapy
– sip feeds
– oral diet
_ Liaise with GP, nutrition
and home delivery
companies and community
based dietetic service
regarding provision of
nutritional support in the
community if required
_ Draw up nutritional care
plan for provision of
nutritional support in the
community
Escort patient into
treatment room and
explain treatment
procedures, ensuring
patient is as
relaxed as possible
before commencement of
treatment
_ Ensure patient has all
relevant details regarding
radiation treatment side
effects for head and neck
_ Check patient has
signed the consent form
_ Explain treatment
procedure
_ Ensure patient has
been given written and
verbal information
concerning:
– treatment reaction/side
effects
– review by doctor or
other professional during
course of treatment
– number of treatments
and overall duration of
treatment course
_ Refer to other
healthcare professionals
as and when necessary
during treatment
_ Assess patient carefully
at each visit throughout
80
4 Pre
radiotherapy
_ Simulate patient’s
treatments as instructed by
the clinical oncologist using
either simulator or
CT simulator
_ Arrange patient’s next
appointment for verification
of the treatment plan or
treatment
_ Produce, if necessary, a
patient contour containing
target volume and critical
structures
_ Produce, if necessary, the
optimum computer isodose
printout
_ Check that each printout
of dose distribution plans
(which may be produced by
medical
physicists) is signed by
therapeutic radiographers
who computed it and by a
planning
superintendent
radiographer, before being
passed to clinical oncologist
for prescription of
patient’s treatments
_ Check that treatment
prescription is calculated in
advance of patient’s
attendance and that this is
checked by another
therapeutic radiographer –
one of the staff involved
should be a Senior II
grade or above (see
Appendix 5)
_ Ensure that a
superintendent therapeutic
radiographer checks
prescription as appropriate
_ Check that patient has
signed consent form for
treatment
_ Verify treatment plan in
the simulator if requested by
5 Radiotherapy
6 Post
radiotherapy
course of radiotherapy to
monitor:
– any treatment
reaction/side effects
– patient’s well being
– any changes to initial
planning that may need
to be taken into
consideration/adjusted
_ Ensure patient is seen
by clinical oncologist,
treatment review
radiographer or specialist
nurse
in the weekly review
clinic or more frequently,
if required
_ Organise any
investigations/tests as
directed by clinical
oncologist, for example,
blood tests
_ Upon completion of
treatment, inform patient
about expected side
effects and give advice
about, for example, skin
care

81
4 Pre
radiotherapy
5 Radiotherapy
6 Post
radiotherapy
the clinical oncologist
_ Ensure patient has
relevant information of
treatment appointment dates
and time

7 Pre surgery/
Diagnostic
radiographer
Provide specialised imaging
services (see Milestones one
and two) to assess response
_ (Post biopsy) Allow 2 weeks
to elapse before carrying out
specialised imaging
_ Provide general on demand
radiography service, if
indicated, for example, preanaesthetic
chest X-ray
_ Liaise with ward staff if
patient is in-patient (some
patients may be treated as
outpatients after
surgery)
_ Provide specialised imaging
8 Post surgery
Provide general
radiography service on
demand for postoperative complications,
for example,
chest X-ray
_ Ensure that
appointments to help
monitor patient’s
response to treatment
are timed to allow
for treatment effects to
subside
_ Provide specialised
imaging within first six
weeks only after
discussion with the
9
Chemotherapy

Provide require specialised
imaging, as indicated, to
assess interval response
_ Ensure previous imaging
is available at time of
current imaging
82
Dietitian
Occupational
therapist
to assess feasibility of voicepreserving laryngeal surgery/
total laryngectomy (for
laryngeal tumours)
_ Ensure that scans to assess
response to treatment are
timed to allow for treatment
effects to
subside
radiology
department
_ Ensure imaging is
comparable in technique
to baseline scans
_ Ensure previous
imaging is available at
time of current imaging
Assess:
– patient’s nutritional
requirements and status
– factors affecting patient’s
nutritional status
– patient’s circumstances and
ability to act on dietetic advice
_ Discuss with patient and
provide advice on effects that
surgery may have upon
eating, nutritional
intake and nutritional status
_ Discuss effects of altered
body image on appetite and
eating
_ Discuss with patient and
provide advice on methods of
nutritional support to be
implemented
post-operatively
_ Advise patient on
importance of
maintaining/achieving optimal
nutritional status before and
after surgery
_ Liaise with other health
professionals in the oncology
team with regard to the
provision of
nutritional support
_ Provide support to patient,
family and carers
Liaise with other health
professionals in the
oncology team with
regard to the provision
of
nutritional support
_ Implement nutritional
support, which may
involve the following
modalities:
– total parenteral
nutrition – if gut is not
functional or accessible
– percutaneous
endoscopic gastrostomy
(PEG) – if long term
feeding is anticipated
(more than
21 days) or if patient is
to have post-operative
radiotherapy, and where
it is anticipated there
will be severe side
effects
– nasogastric feeding –
for short term enteral
feeding (less than 21
days)
– dietary
supplementation – e.g.
modified food textures,
high calorie diets,
nutritional supplement
drinks – where patient is
otherwise unable to
maintain nutritional
status
_ Discuss feeding
modalities with patient
_ Draw up nutritional
care plan for the
provision of postsurgical nutritional
support
_ Educate patient
regarding nutritional
support regime
_ See Milestone three
Assess effects of
surgery on baseline
assessment of mobility
Assess:
– patient’s nutritional
requirements and status
– factors affecting patient’s
nutritional status
– patient’s circumstances
and ability to act on dietetic
advice
Discuss and provide advice
on effects that
chemotherapy may have
upon eating, nutritional
intake and nutritional status
_ Discuss and provide
advice on methods of
nutritional support to be
implemented
_ Advise upon importance
of maintaining/achieving
optimal nutritional status
_ Implement nutritional
support indicated
_ Liaise with other health
professionals in the
oncology team with regard
to the provision of
nutritional support
_ Provide support to
patient, family and carers
See Criteria for referral
_ See Milestone three
83
Physiotherapist
Ensure that patient is referred
on admission to ward
and activities of daily
living
_ Discuss with patient
their ongoing concerns
and expectations
following the outcome of
surgery
and ascertain their level
of insight into their
condition and possible
prognosis
_ Liaise with relatives
regarding their
concerns, abilities and
level of short and longer
term support
available
_ In collaboration with
the patient/carers,
formulate graded
treatment plan outlining
goals that will
optimise safety, physical
and psychological
function, independence,
dignity and self worth
_ Assist the patient to
come to terms with both
physical and
psychological loss
through relearning
of old skills and/or the
acquisition of new skills
_ Support patient in
psychological
adjustment post
operatively and during
period before any
further interventions
_ Contribute to
formulating an
appropriate discharge
plan including carrying
out of a pre-discharge
home visit where
indicated
_ Liaise with other
members of the
multidisciplinary team
and other
internal/external
agencies as
required
_ Where appropriate
assess for the provision
of adaptive equipment
and/or mobility aids
(in conjunction with
physiotherapist)
Also:
_ Assess patient’s
functional ability and
equipment required to
enable maximum
functioning in
home environment
_ Provide treatment as
indicated
_ Carry out home visit if
indicated and implement
recommendations
_ Ensure equipment
required to enable
independence in activities
of daily living is delivered
and
fitted for discharge
_ Discharge patient when
recommendations
implemented and goals
achieved
_ Provide post-operative
care, starting first day
See patient as referred by
doctor
84
Speech and
language therapist
_ Assess patient’s:
– respiratory status – general
mobility and function
– circulation – social
circumstances
– head, neck, facial and
shoulder movements
_ Assess for range of
movement all joints involved
in donor graft areas
_ Assess muscle power and
function of operative and
donor sites
_ Teach patient appropriate
exercises for initial postoperative period, including
breathing,
circulatory, and mobility
exercises for operative and
donor graft sites
_ Provide any respiratory
treatment indicated
_ Explain post-operative
treatment regime to patient
and relatives and providing
advice (including
written) about:
– tracheostomy
– post operative care on
Intensive Care Unit (if
indicated)
– progression of treatment

after surgery
_ Assess patient’s
respiratory function and
plan treatment regime
indicated
_ Begin circulatory
exercises on first postoperative day
_ Assess operative and
donor graft sites daily
and begin appropriate
exercises when
indicated,
for example, mobility,
postural and
strengthening exercises
_ Explain care of any
plaster used for the
donor graft site
_ Ensure necessary
support network in place
following surgery, for
problems associated
with
altered body image
_ Commence facial
stimulation if indicated
and teach facial
exercises and massage
if appropriate
_ If patient is expected
to have a permanent
tracheostomy, teach
patient and carers
tracheostomy
care
_ Contribute to multiprofession assessment
of appropriate time for
tracheostomy
decannulation
_ Continue to re-assess
and modify and progress
treatment programme
_ Commence
mobilisation when
indicated and supply
suitable walking aids if
needed
_ If surgery is likely to
produce problems with
balance, assess static
and dynamic balance
_ If balance is impaired,
begin vestibular
rehabilitation exercises
_ Provide treatment and
support as indicated, for
example, for respiratory
problems, functional
or mobility problems,
nausea, vomiting and pain
Establish nature and extent of
surgery planned
_ Establish patient’s social
history, occupational status
and support mechanisms
Continue to consolidate
contact with patient and
carers and be available
for consultation
_ Ensure means of non-
_ See Milestone four
Also:
_ Provide
psychological/emotional
support
85
_ Evaluate
orofacial/pharyngeal/laryngeal
mechanism
_ Where appropriate, assess
suitability for surgical voice
restoration
_ Assess current
communication skills and
level of cognitive functioning
_ Explain likely post-operative
changes in communication
and swallowing and establish
an effective
communication method,
particularly for those unable
to read or write
_ Where appropriate,
introduce to the patient a
visitor who has had similar
surgery, for example,
laryngectomy
_ Provide additional
written/audio-visual material
_ Liaise with other team
members

oral communication is
established, and where
necessary provide a
communication aid
_ Confirm nature of
surgery and, where
appropriate, form of
reconstruction
_ Provide ongoing
assessment and review
of orofacial, pharyngeal
and laryngeal function
for
speech and swallowing
_ Instigate further
investigations, for
example,
nasoendoscopy,
videofluoroscopy, where
further
information is required
for effective
management
_ Instruct in
compensatory strategies
and therapy techniques
_ Liaise with other team
members, for example,
with physiotherapist if
facial stimulation
indicated
_ Continue to develop
therapeutic relationship
with client
_ Provide ongoing
information to carers
and team members
_ Plan for outpatient
speech and language
therapy or joint clinic
reviews with medical
team and
liaise with local speech
therapy service as
appropriate
86
10 Post
treatment
follow up
11 Metastatic
disease
All oncology team
Holistic assessment by key
worker using PEPSI COLA
aide memoir for referral to
AHP services
Holistic assessment by
key worker using PEPSI
COLA aide memoir for
referral to AHP services
Dietitian
See Milestone four
Also:
_ Review nutritional care
plan for the provision of
nutritional support in the
community according to:
– severity of radiotherapy
side-effects
– reconstructive surgery
conducted
– nutritional status
– nutritional intake
Occupational
therapist
Conduct follow up home
visit to assess ongoing
functional ability and any
difficulties within the
home
_ Formulate a graded
treatment plan, outlining
goals to be achieved that
will optimise safety,
physical and psychological
function, independence,
dignity and self worth,
focused on the
patient’s role within their
home environment
_ Where relevant, and
through use of graded
activity, assist in
development of new skills
or
reacquisition of previous
skills associated with
engaging in activities
necessary for successful
return to work and/or leisure
_ Offer ongoing education,
support and advice, as
necessary, for patient
undergoing further
12 Quality
assurance
87
10 Post
treatment
follow up
11 Metastatic
disease
12 Quality
assurance
surgical/therapeutic
intervention
_ Liaise with statutory and
voluntary community based
agencies as required
Physiotherapist
At discharge planning
_ Arrange for the loan of
any walking aids required
_ Liaise with district nurses
for provision of any
respiratory equipment
required for home use,
for example, portable
suction machine
_ Arrange any follow-up
out-patient treatment at
patient’s local hospital, for
example, for follow-up
of use of facial stimulator,
ongoing vestibular
rehabilitation
_ Give written and verbal
advice about exercises and
activity at home
_ Give written and verbal
advice on tracheostomy
care at home, if indicated
_ Give name and contact
number of physiotherapist,
to be used if the patient
develops problems
or questions after discharge
_ Give verbal and written
information of support
groups and their contact
numbers, if appropriate
Out-patient follow-up clinic
_ See patient at 4-6 weeks
after discharge in outpatient clinic
_ Assess range of
movement of affected joints
and power of affected
muscle groups
_ Assess functional abilities
_ If patient is continuing to
use walking aids assess
88
10 Post
treatment
follow up
11 Metastatic
disease
12 Quality
assurance
whether they are still
indicated and alter aids
accordingly
_ Ensure ongoing
assessment of any facial
stimulator
_ Assess respiratory status
and tracheostomy care
_ Arrange any further
physiotherapy treatment if
indicated
_ Refer to and liaise with
local physiotherapist if
ongoing physiotherapy
treatment is required
Arrange for supply of any
equipment required, for
example, walking aids,
nebulisers
_ Give verbal and written
advice for skin care, chest
care and general joint
mobility and physical
activity, as required by
patient
_ Give written contact name
and telephone number after
discharge
_ If patient is receiving
chemotherapy refer to local
physiotherapist if
appropriate
Speech and
language therapist
Provide assessment of
speech and swallowing
functions to identify if
patient requires ongoing
therapeutic intervention
_ Instigate further
investigations, for example,
nasoendoscopy,
videofluoroscopy, where
further
information is required prior
to goal setting
_ Start therapeutic
programme
_ Set goals of intervention
89
10 Post
treatment
follow up
11 Metastatic
disease
12 Quality
assurance
aiming to facilitate
neuromuscular recovery
and compensatory
strategies
_ Introduce and teach to
patient other means of
communication, for
example, oesophageal
speech, surgical voice
_ Instruct in management of
swallowing difficulties
_ Monitor any changes in
function that could be
indicative of structural
changes or recurrent
disease, and refer back to
medical team
Diagnostic
radiographer
Provide general
radiography service on
demand for patient
attending outpatient clinic
_ Provide specialised
imaging services as in
Milestone one
_ Ensure that imaging is
comparable in technique to
baseline scans
_ Ensure previous imaging
is available at time of
current imaging
Therapy
radiographer
Criteria for referral to occupational therapist
Occupational therapy for head and neck cancer patients can be provided on four levels:

Basic Grade – able to provide generalised occupational therapy input requiring indirect
supervision
90



Senior II – has wider occupational therapy experience and some experience of oncology and
is able to provide more wide ranging assessment and intervention
Senior I – has experience of oncology and palliative care issues and is able to work
independently, providing a specialist focused service, and is also able to act as a resource for
Senior II and Basic Grade Therapists
Head III – has wider experience of occupational therapy, oncology and palliative care issues
and is able to work independently, providing a specialist, focused service. Can adopt a
strategic role in the planning and development of oncology services.
There is a special interest group, HOPE (Occupational Therapy in HIV/AIDS, Oncology, Palliative
Care and Education) available for support and information.
Criteria for referral
 Patient is having difficulty with personal care that has the potential to affect their functional
ability to cope at home
 Patient has difficulty with mobility and transfers which may affect their safety and ability to
cope at home
 Patient is main carer at home and due to their reduced functional ability is experiencing
increasing difficulty in fulfilling this role
 Patient needs to acquire new skills or learn how to carry out new tasks in order to adapt to
changes in their daily living as a result of their current level of dysfunction
 Patient requires education and support to adapt emotionally, physically and psychologically to
any change in their role both at home and/or work
 Patient is experiencing problems as a result of reduced exercise tolerance associated with
fatigue and may require assistance/support within the home
Levels of care and criterion for referral to a speech and language therapist
Head and neck cancer patients should have access to a specialist speech and language therapist
who has received post-graduate dysphagia training and has experience and specialist training giving
competence in:





videofluoroscopy
use of instrumentation, for example, fibreoptic laryngoscopy interpretation
post-laryngectomy voice restoration and techniques
post-surgical speech rehabilitation
voice therapy techniques
Criterion for referral
 Patient is experiencing difficulties with communication and/or swallowing arising from disease
of the head and neck and its associated treatmen
Criteria for referral to a physiotherapist
On admission to hospital
 Patient is attending for radiotherapy
 Patient is admitted for surgery
 Patient develops respiratory problems
 Patient develops mobility problems
 Patient has pre-existing mobility problems which are exacerbated by surgery
 Patient is attending for chemotherapy
On discharge
 Patient has continued loss of function, which is expected to improve with further
physiotherapy treatment
91

Patient has a chronic problem which needs to be monitored, for example, long term
tracheostomy, facial palsy, requiring regular re-assessment if the patient is using the trophic
stimulator
After discharge
 Patient develops further respiratory problems
 Patient develops mobility problems due to loss of function of the operation or donor sites
Dental services
To a dental surgeon
Patient requires dental assessment and removal of any decayed teeth within the area to be treated
by radiotherapy (failure to remove decayed teeth may result in osteoradionecrosis).
There should be a delay of 10-14 days after extractions before starting radiotherapy.
Dentist should encourage long term dental care and refer to dental hygienist if necessary.
To a dental hygienist
All patients receiving head and neck cancer treatments should preferably be seen by a dental
hygienist prior to treatment, especially those whose dentition, jaw or salivary glands are to be in the
path of radiation:
1. Patients with healthy teeth require a comprehensive oral care programme to inform them in
preventative dental disease methods
2. Patients with poor dental and oral health require dental treatment prior to commencing
radiotherapy/chemotherapy
At a minimum patients should have access to appropriate information, outlining:
 side-effects of radiotherapy/chemotherapy on oral health – notably on reduction in salivary
function which frequently causes dental disease and tooth loss
 importance of frequent mechanical cleansing for oral health care, to maintain a moist, clean,
infection-free mouth
The dental hygienist is available to:
 assess, treat and advise on dental and oral health and hygiene
 refer to dentist as appropriate
 educate patient and staff in preventive measures to minimise possible side-effects of cancer
treatments
 assess and advise patient who has other medical conditions which necessitate dietary habits
that conflict with good oral health – for example, diabetes which may require the eating of
small amounts of high carbohydrate diet at regular intervals
 arrange routine follow-up after cancer treatment to monitor oral care and assess and
maximise dental prevention outcomes
Criterion for referral
 Patient must be referred by their consultant, GP or dental surgeon
 Early referral is advisable for optimum outcome.
92
Appendix 7
Head & Neck Rehabilitation Plan
Name of Keyworker…………………………..
Keyworker informed:
yes / no
Additional named contact:…………………..
Rehabilitation Need
Required ?
Please tick
Relevant to:
Referral made
to:
Team Member
(instigating
referral)
Name & Date:
Wound care/ trachy care/
Psychological
Speech/communication
Swallowing
District Nurses
Speech &
Language
Therapy
Speech &
Language
Therapy
Name & Date:
Name & Date:
Name & Date:
Nutrician
PEG support
Dietician
Nutrition Nurse
Name & Date:
Palliation
e.g. symptom control
Macmillan
Name & Date:
Specialist Psychological
support
Clinical
Psychologist
Name & Date:
Reduced mobility
Poor upper limb movement
Physiotherapy
Personal care and
financial advice
Social services
Welfare rights
Name & Date:
Name & Date:
Oral/dental care
Ongoing Support Group
Altered body image
Restorative
Dentist/Hygienist
H&N CNS
H&N Group
Buddy system
Red X
camouflage
Service
Name & Date:
Name & Date:
Name & Date:
Smoking addiction
Stop Smoking
Name & Date:
Alcohol addiction
Local AA
services
Name & Date:
Drug addiction
Local services
Lymphodeama
Macmillan unit
Activities of Daily Living
Occupational
Therapy
Name & Date:
Name & Date:
93
Appendix 8
Head & Neck Cancer Rehabilitation Protocol
Diagnoses
Palliative – nil treatment
Radical/Palliative
Radiotherapy
PDT
Brachytherapy
Chemotherapy
Other
Surgery
Rehabilitation Plan
completed by ward/MDT
Local support teams
unable to manage
specific problems,
refer patient back to
MDT
Signed
discharge
letter sent
to CNS
Appropriate referrals
made to local support
teams
Copy in patient’s
notes and copy to
key worker
Dietetics
Written and verbal handovers are given to local support teams for all PEG patients, in all areas, even
if care is continued at L&D.
94
Appendix 9
SUPPORTIVE CARE PATHWAY
FOR
HEAD & NECK CANCER SPECIALIST SURGERY
TO SUPPORT IOG RECOMMENDATIONS
Lister Hospital
DIAGNOSIS
1. Clinic
Patient informed of diagnosis. CNS to be present
 GP Fax Proforma completed and sent
 Discuss probable treatment plans and time frame if
appropriate
 Patient given CNS contact details / MVCN patient
information file
 Key worker identified
 Holistic assessment and refer to other agencies as
appropriate
 Explanation of MDT process
SMDT
2. Patient discussed at SMDT with CNS input.
 Acts as patient advocate
 Core member of MDT participates in decision making
3. Patient attends Joint Oncology Clinic/Pre Treatment - CNS present
 Appropriate written information given
 Provide patient and family with the opportunity to ask questions about treatment options
 Provide level 2 psychological support
 Ensure informed consent
 Holistic assessment and referral to other agencies as appropriate
 Complexities of treatment and adjustment to potential change, dysfunction and altered body image
introduced
 Patient consents to receive a copy of GP letter
 Discuss preparation for planned treatment, pre and post operative care
 Introduce patient / family to another patient (befriending)
 Information given on patient support groups available
 Refer to Luton & Dunstable Hospital CNS / complete transfer sheet and send copy of completed
holistic assessment
Luton
andLuton
Dunstable
Hospital
NHS
Foundation
Trust
 Patient given
and Dunstable
Hospital CNS
contact
details
95
Pre Operative Assessment (POA)
4. Luton and Dunstable Hospital CNS to meet patient and family at preop assessment appointment
 Provide further information / written and verbal if needed
 Liaise with appropriate MDT members
 Liaise with Pathway Facilitator (PF) as appropriate
 Liaise with POA staff and surgeons if necessary.
Supportive Care during Admission at Luton and Dunstable Hospital
5. Luton and Dunstable Hospital CNS
 Holistic supportive care services. Welfare / emotional / psychological
 Verbal / written information given to patient
 Co-ordination and monitoring of patients during surgical interventions
 Communication with outside agencies
 Direct referral for palliative care if appropriate
 Ensure that patient has a follow-up appointment at referring hospital
Discharge from Luton and Dunstable Hospital
6. Luton and Dunstable Hospital CNS to:
 Discuss further treatment planning options, if appropriate
 Provide psychological support Level 2
 To be present when histology results given (if it is available)
 Liaise with ward staff to ensure safe and supported discharge, refer to integrated discharge
team
 Ensure that referral to local DN and Community Macmillan Nurse, as appropriate, including
copy of holistic assessment
 Transfer of key worker / contact
Follow up / Rehabilitation
7. Lister Hospital CNS to:
 Be present when histology results are given
 Prepare for treatment planned, and give appropriate information
 Provide psychological support level 2
 Offer telephone advice
 Provide symptom / psychological management
 Signpost to support groups and rehabilitation programmes
 Provide key worker review
 Ensure pathway for patient access back into services
 Provide information on signs of recurrence and what to do
96
Appendix 10
Mount Vernon Cancer Centre
Head and Neck
Radiotherapy and Chemotherapy
Treatment Protocols
Consultant Lead:
Dr Catherine Lemon
Consultant
Dr Kate Goodchild
Consultant
Dr Russell Moule
Version
1
Valid From
June 2010
Review Date
June 2011
Signature
Date
Signature
Date
Signature
Date
97
Contents
General Principles
1.1
1.2
1.3
1.4
1.5
1.6.1
1.6.2
1.7
1.8
Incidence and Epidemiology
TNM Staging
Patient Assessment
Patient Position
Planning
Guidelines for nodal treatment
CT Planning
Post-operative radiotherapy
Palliative radiotherapy
Radiotherapy Treatment Protocols
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
2.10
Larynx
Oropharyngeal carcinoma
Hypopharynx
Nasopharynx
Oral Cavity
Parotid gland
Neck
Orbit
Ear and temporal bone
Nose and sinuses
3.
IMRT
4.
Chemotherapy Treatment Protocols
5.
Management of patients during treatment
6.
Management of patient with recurrent disease / palliative patients
7.
Research Protocols
Appendix 1Appendix 2 –
Appendix 3 –
Appendix 4 –
Appendix 5 Appendix 6 -
References
Compensation of gaps in radical radiotherapy
Anti emetic protocol
Neutropenic sepsis policy
Physics RT Protocol
Flow Charts PL-FLO-03 & 04
98
1.
GENERAL PRINCIPLES
1.1 Incidence and Epidemiology
Cancer of the head and neck is a relatively rare cancer accounting for
6% of all cancer deaths. The incidence in men is 17.2 per 100,000
and women, 5.6 per 100,000. If one takes an average of about 12 per
100,000, this means that there are about 4,700 cases in the United Kingdom.
The main aetiological factors are excessive alcohol intake and smoking.
1.2
TNM Staging (UICC 2002 sixth edition)
All patients with head and neck cancer discussed in the MDM will be staged
according to the UICC TNM classification 2002 –sixth edition
Nodal staging for all head and neck sites identical except nasopharynx (+thyroid)
Midline nodes are considered ipsilateral nodes except in thyroid
N0
N1
N2 a
N2b
N2c
N3
No neck nodes
Ipsilateral single node< 3cm
Ipsilateral single node >3-6cm
Ipsilateral multiple nodes <6cm
Bilateral,contralateral nodes <6cm
>6cm
The definitions of the M categories for all head and neck sites are the same
MX
Distant metastases cannot be assessed
M0
No distant metastases
M1
Distant metastases
The categories M1 and pM1 may be further specified according to the following
notation
Pulmonary PUL
Osseous
OSS
Hepatic
HEP
Brain
BRA
Lymph nodesLYM
Bone marrowMAR
Pleura
PLE
Peritoneum PER
Adrenals
ADR
Skin
SKI
Other
OTH
Lip, Oral Cavity
TX
T
Tis
Primary Tumour cannot be assessed
No evidence of primary tumour
Carcinoma in situ
T1
T2
Tumour≤2 cm
Tumour > 2 to 4 cm
99
T3
Tumour > 4 cm
T4a Lip:
Tumour invades adjacent structures eg through cortical bone,inferior alveolar
nerve, floor of mouth, skin (chin or nose)
T4a Oral cavity:
Tumour invades adjacent structures eg through cortical bone, into deep/
extrinsic muscle of tongue (genioglossus,hyoglossus,palatoglossus, and
styloglossus), maxillary sinus, skin of face
T4b(lip and oral cavity)
Tumour invades masticator space, pterygoid plates, or skull base, or encases
internal carotid artery
(superficial erosion of bone/tooth socket by gingival primary is not sufficient to
classify as T4 tumour)
Stage Grouping
Stage 0
Stage I
Stage II
Stage III
Stage IVA
Stage IVB
Stage IVC
Tis
T1
T2
T1,T2
T3
T1,T2,T3
T4a
Any T
T4b
Any T
N0
N0
N0
N1
N0,N1
N2
N0,N1,N2
N3
Any N
Any N
M0
M0
M0
M0
M0
M0
M0
M0
M1
Pharynx
Oropharynx
TX
T
Tis
T1
T2
T3
T4a
Primary Tumour cannot be assessed
No evidence of primary tumour
Carcinoma in situ
Tumour ≤ 2 cm
Tumour > 2 to 4 cm
Tumour > 4 cm
Tumour Invades any of the following larynx, deep/extrinsic muscles of tongue
(genioglossus,hyoglossus,palatoglossus, and styloglossus),medial pterygoid,
mandible,hard palate, T4b Tumour Invades any of the following: lateral
pterygoid muscle, pterygoid plates, lateral nasopharynx, skull base or
encases carotid artery
100
Nasopharynx
T1
Nasopharynx only
N1
Unilateral metastasis in lymph
node(s) </= 6cm, above supraclavicular fossa
T2
Soft tissue of oropharynx
and/or nasal fossa
T2a
No parapharyngeal
N3
extension
Parapharyngeal extension
Invades bony structures and/or
paranasal sinuses
Intracranial extension, involvement
of cranial nerves, infratemporal
fossa, hypopharynx, orbit or masticator space
T2b
T3
T4
N2
Bilateral metastasis in lymph
node(s)</ = 6cm, above supraclavicular
fossa
[a] > 6cm
[b] extension to supraclavicular fossa
(parapharyngeal extension denotes postero-lateral infiltration of tumour beyond
pharyngo-basilar fascia)
Hypopharynx
TX
T
Tis
T1
T2
T3
T4a
T4b
Primary Tumour cannot be assessed
No evidence of primary tumour
Carcinoma in situ
Tumour≤ 2 cm and limited to one subsite
Tumour > 2 to 4 cm or involving more than one subsite or an adjacent site
without fixation of hemilarynx
Tumour > 4 cm or with larynx fixation
Tumour invades any of the following:eg thyroid/cricoid cartilage, ,hyoid bone,
thyroid gland, oesophagus, central compartment soft tissue of
neck(prelaryngeal strap muscles &subcutaneous fat),
Tumour invades prevertebal fascia,encases carotid artery, or invades
mediastinal structures
Stage Grouping (Oro and Hypopharynx)
Stage 0
Stage I
Stage II
Stage III
Stage IVA
Stage IVB
Stage IVC
Tis
T1
T2
T1,T2
T3
T1,T2,T3
T4a
Any T
T4b
Any T
N0
N0
N0
N1
N0,N1
N2
N0,N1,N2
N3
Any N
Any N
M0
M0
M0
M0
M0
M0
M0
M0
M1
101
Stage Grouping Nasopharynx
Stage 0
Stage I
Stage IIA
Stage IIB
Stage III
Stage IVA
Stage IVB
Stage IVC
Tis
T1
T2a
T1
T2a
T2b
T1
T2a,T2b
T3
T4
Any T
Any T
N0
N0
N0
N1
N1
N0,N1
N2
N2
N0,N1,N2
N0,N1,N2
N3
Any N
M0
M0
M0
M0
M0
M0
M0
M0
M0
M0
M0
M1
Larynx
TX
T0
Tis
Primary Tumour cannot be assessed
No evidence of primary tumour
Carcinoma in situ
Supraglottis
T1
Tumour limited to one subsite, normal mobility
T2
Tumour Involving mucosa of more than one adjacent subsite of supraglottis
or glottis or region outside the supraglottis eg mucosa of BOT,vallecula,medial
wall of pyriform sinus), without fixation of larynx
T3
Tumour limited to larynx with vocal cord fixation and/ or invades any of the
following: post cricoid area,pre-epiglottic tissues,paraglottic space, and/or with
minor thyroid cartilage erosion eg inner cortex
T4a Tumour invades through thyroid cartilage, and/or extends into soft tissues of
the neck including trachea, deep/extrinsic muscles of tongue (genioglossus,
hyoglossus, palatoglossus, and styloglossus), strap muscles,thyroid,
oesophagus
T4b Tumour invades prevertebral space, mediastinal structures, or encases
carotid artery
Glottis
T1
Tumour limited to vocal cord (s) (may involve anterior or posterior
commissure) with normal mobility
T1a tumour limited to one vocal cord
T1b tumour involved both vocal cords
T2
Tumour extends to supraglottis and/or subglottis, and/or with impaired cord
mobility
T3
Tumour limited to larynx with vocal cord fixation and/or invades paraglottic
space, and/or with minor thyroid cartilage erosion eg inner cortex
T4a Tumour invades through thyroid cartilage, and/or extends into soft tissues of
the neck including trachea, deep/extrinsic muscles of tongue (genioglossus,
hyoglossus, palatoglossus, and styloglossus), strap muscles,thyroid,
oesophagus
102
T4b
Tumour invades prevertebral space, mediastinal structures, or encacarotid
artery
Subglottis
T1
Tumour limited to subglottis
T2
Tumour extends to vocal cord(s) with normal/impaired mobility
T3
Tumour limited to larynx with cord fixatiion
T4a Tumour invades through thyroid cartilage, and/or extends into soft tissues of
the neck including trachea, deep/extrinsic muscles of tongue (genioglossus,
hyoglossus, palatoglossus, and styloglossus), strap muscles,thyroid,
oesophagus
T4b Tumour invades prevertebral space, mediastinal structures, or encacarotid
artery
Stage Grouping Larynx
Stage 0
Stage I
Stage II
Stage III
Stage IVA
Stage IVB
Stage IVC
Tis
T1
T2
T1,T2
T3
T1,T2,T3
T4a
Any T
T4b
Any T
N0
N0
N0
N1
N0,N1
N2
N0,N1,N2
N3
Any N
Any N
M0
M0
M0
M0
M0
M0
M0
M0
M1
(parapharyngeal extension denotes postero-lateral infiltration of tumour beyond
pharyngo-basilar fascia)
Paranasal Sinuses
TX
T0
Tis
Primary Tumour cannot be assessed
No evidence of primary tumour
Carcinoma in situ
Maxillary Sinus
T1
Tumour limited to antral mucosa with no erosion or destruction of bone
T2
Tumour causes bone erosion/destruction, except for posterior antral
Wall and pterygoid plates, including extension into hard palate or middle nasal
meatus
T3
Tumour Invades any of the following:bone of posterior wall of maxillary sinus,
subcutaneous tissues, , floor/medial wall of orbit, pterygoid fossa, ethmoid
sinus,
T4a Tumour Invades any of the following: anterior orbital contents,skin of cheek,
pterygoid plates, infratemporal fossa, cribriform plate, sphenoid or frontal
sinuses
103
T4b
Tumour Invades any of the following:orbitl apex, dura, brain, middle cranial
fossa, cranial nerves other than maxillary division of trigeminal nerve V2,
nasopharynx, clivus
Nasal Cavity and Ethmoid Sinus
T1
Tumour restricted to one subsite of nasal cavity or ethmoid sinus, with or
without bony invasion
T2
Tumour involves two subsites in a single site or extends to involve an
adjacent site within the nasoethmoidal complex, with or without bony invasion
T3
Tumour invades medial wall or floor of orbit, maxillary sinus, palate or
cribriform plate
T4a Tumour Invades any of the following: anterior orbital contents, skin of nose or
cheek, minimal extension to anterior cranial fossa, pterygoid plates, sphenoid
or frontal sinuses
T4b Tumour Invades any of the following:orbital apex, dura, brain, middle cranial
fossa, cranial nerves other than V2, nasopharynx, clivus
Stage Grouping
Stage 0
Stage I
Stage II
Stage III
Stage IVA
Stage IVB
Stage IVC
Tis
T1
T2
T1,T2
T3
T1,T2,T3
T4a
Any T
T4b
Any T
N0
N0
N0
N1
N0,N1
N2
N0,N1,N2
N3
Any N
Any N
M0
M0
M0
M0
M0
M0
M0
M0
M1
Salivary Glands
TX
T0
Tis
Primary Tumour cannot be assessed
No evidence of primary tumour
Carcinoma in situ
T1
T2
T3
T4a
T4b
Tumour ≤ 2 cm, without extraparenchymal extension
Tumour > 2 to 4 cm, without extraparenchymal extension
Tumour having Extraparenchymal extension , and/or > 4 to 6 cm
Tumour invades skin,mandible, ear canal, seventh nerve,
Tumour invades base of skull, ptergoid plates or encases carotid artery

Extraparenchymal extension is clinical or macroscopic evidence of invasion of
soft tissues or nerves except those listed under T4a or T4b. Microscopic
evidence alone does not constitute extraparenchymal extension for
classification purposes.
Stage Grouping
Stage 0
Tis
N0
M0
104
Stage I
Stage II
Stage III
Stage IVA
Stage IVB
Stage IVC
T1
T2
T1,T2
T3
T1,T2,T3
T4a
Any T
T4b
Any T
N0
N0
N1
N0, N1
N2
N0,N1,N2
N3
Any N
Any N
1.3
M0
M0
M0
M0
M0
M0
M0
M1
Patient Assessment
All patients seen within the Head and Neck Unit will have :
Been discussed in the multi-disciplinary team meeting and seen in the combined
clinic. At this time, a decision will be made as to whether the treatment will be
palliative or radical and the modality of treatment(s) to be used. (See
management guidelines)

Patents who are planned for combined modality treatment ie surgery followed by
(chemo)radiotherapy are booked for their post-operative radiotherapy prior to
surgery so that the radiotherapy can start within 6 weeks of surgery whenever
possible. This would usually mean that planning should start approximately 3
weeks after surgery is completed to allow any swelling to settle and healing to
start.

All patients with head and neck cancer will be treated by the head and neck team
comprising Dr Lemon , Dr Goodchild and Dr Moule.

All patients requiring radiotherapy will be discussed in the multi-disciplinary RT
planning meeting which takes place weekly on a Tuesday morning. All
consultants will be responsible for a handover of their patients to the covering
consultant whilst they are on annual leave

Any patients treated off protocol will have been discussed in the Rt planning
meeting and the reason for treating off protocol will be documented in the
patient’s notes

Adequate documentation including histology, MRI, CT and PET-CTscan reports,
EUA and operation notes should be available in the patient’s notes. Discs
containing diagnostic scans from referring hospitals should be available in the
notes for RT planning purposes.

Head and neck cancer patients should receive RT fractions according to their
prescription, gaps should be avoided wherever possible and radical patients
should be treated over bank holidays. Management of gaps should be according
to Compenstaion of gaps in Radiotherapy (see appendix 2)
105

All suitable patients should be considered for IMRT (see section 3)
Pre Radiotherapy Treatment Assessment
1.
2.
3.
4.
5.
6.
7.
Full blood count, urea and electrolytes, LFT’s
Dental assessment – patients will have an OPG and assessment by the
appropriate OMFS team.
Speech and Language Therapy assessment where appropriate
Nutritional assessment / PEG/RIG insertion. (see PEG/RIG policy)
-All patients who have chemoradiation will require enteral nutrition. Other
patients will be assessed on a case by case basis.
Consent. With appropriate information leaflets (see appendix)
Advise patients to: Stop smoking
 Reduce alcohol intake (stop spirits)
Assessment by Clinical Nurse Specialist
1.4
Patient Position
All patients should be treated in an immobilisation shell made of either Perspex or
orfit. All palliative patients and most radical patients will have orfit shells. Patients
who will need posterior neck electrons, treatment close to orbit, post laryngectomy
patients and all nasopharynx patients should be considered for Perspex shells.
At the time of booking the appropriate pathway for planning will be specified (see
flowchart). Also in planning meeting prior to simulator appointment the patients’
position and any other relevant information will be discussed:
Patient supine
Neck Position
Extent of shell
If mouthbite required
If angled down or CT coronal planning.
Patients are positioned with an appropriate head rest, the head is in the neutral
position and the spinal cord straight. The exceptions are:a)
b)
c)
d)
Nasopharynx where the head is extended but spinal cord straight
Parotid – the head is extended so that the fields come beneath the eyes
Subglottic carcinoma – if this field is to extend into the mediastinum,
then the lower cervical spine needs to be straight.
Postcricoid – for planning this tumour the cervical and thoracic spine
need to be straight and the head will probably be flexed. An inclined
head rest may be necessary.
106
Mouth gag
A mouth gag is used in patients with carcinoma of the oral cavity, nasal
septum/columella and maxillary sinuses where it may be possible to exclude either
the upper half of the mouth or the lower half of the mouth from the field.
1.5 Planning
Most patients with advanced head and neck cancer having primary radiotherapy are
treated in two phases:Phase 1
The clinical target volume (CTV44) should include the primary tumour, any involved
lymph nodes and areas of likely microscopic lymphatic spread .
Phase 2
The clinical target volume should (CTV66) encompass the primary tumour and
involved nodes
Guidelines for nodal treatment (as defined by CHART protocol)
The recommendations for specific node groups to be included in the field of
treatment are meant as a guide. The responsible clinical oncologist must make the
final decision on the individual features of the case.
In some cases eg. T1-2 N0 glottic carcinoma, the two volumes may be the same.
The following are guidelines for inclusion of lymph node areas in the phase 1
volume.
Lymph node levels are defined as follows:Level I a
Level Ib
Level II
Level III
Level IV
Level V
Level VI
Level VII
-
Submental
Submandibular
Upper deep cervical
Mid- deep cervical
Lower deep cervical
Posterior triangle
Anterior neck nodes
Paratracheal nodes
Nasopharynx
Squamous carcinoma T1 N0
Squamous carcinoma T2-4 N0 All undifferentiated carcinoma
and squamous carcinoma with
node involvement
-
no neck irradiation
Level Ib, II, III, IV, V, bilaterally
Level Ib, II, III, IV, V, bilaterally
107
Paranasal sinuses
Squamous carcinoma N0
Squamous carcinoma N+
-
Lateral pharyngeal nodes only
Levels Ib to V bilaterally
Oral Cavity
T1 / 2 N0 with well lateralised primary T2 N1 with well-lateralised primary
T2 N0 with primary approaching midline All others
Levels I to IV on same side
Levels I and V to same side
Levels I, II and IV (bilaterally)
Levels I to V (unilaterally if well lateralised or bilaterally if primary
approaching midline or significant nodal disease)
Oropharynx
T1 N0 tonsil (well-lateralised)
T2 N0 tonsil (well-lateralised)
-
-
Levels Ib to II on same side
Levels Ib to III on same side
T1/T2 N1 tonsil
T2 N0 midline tonsil
primary + other sites
-
Levels Ib to V on same side
-
Levels Ib, II and III bilaterally
All others
-
Levels Ib to V bilaterally
Larynx
T1/T2 N0 glottic
T3-4 N0 glottic
T1/T2 N0 supraglottic
All others
-
No nodal irradiation
Levels Ib, II, III and IV bilaterally
Levels Ib, II and III bilaterally
Levels Ib to V bilaterally
Hypopharynx
All
1.6.1
-
Levels Ib to V bilaterally
Conventional Planning (R1on PL-FLO-03, P1,2,3 on PL-FLO-04)
Early larynx patients (T1/2) will be planned conventionally in simulator and then CT
scanned and a plan produced. These patients who have high shoulders and where
lateral fields are difficult should be CT planned (with anterior oblique fields or coronal
technique- see R3).
Palliative patients who are treated with parallel opposed fields will usually be planned
conventionally. Palliative patients who are treated with oblique fields will be CT
planned-(see P4)
1.6.2
CT Planning(PL-FLO-03, R2 & R3 & PL-FLO-04, P4)
Most head and neck patients are planned with the help of a contrast enhanced CT
scan. The planning scan is performed with contrast. Three millimetre slices are
acquired throughout the volume from vertex to carina.(see planning protocol for use
of contrast).
108
Well lateralised tumours which are treated with lateral wedged pair fields will be CT
planned from the outset (PL-FLO-03, R3).
Other patients who require bilateral neck fields will be planned
conventionally/virtually simulated for Phase I and by CT planning for Phase II (PLFLO-03, R2). It is advised that planning target volumes be done prior to starting
treatment to confirm the phase I fields and help with definition of areas requiring
shielding (brainstem and oral cavity).
Any changes to standard protocol will be discussed in the head and neck planning
meeting.
Outlining of target volumes will be performed in the Planning department in following
the guidance in the Radiotherapy Treatment Planning Protocol (Physics) using
standard nomenclature GTV,CTV, PTV and OAR (see ICRU 50). Once the volumes
and Oar doseshave been approved by a Consultant, an RT plan will be created.
For patients who have had radical surgery the post operative field is outlined as
CTV. In standard risk patients this volume will be treated to the equivalent dose of
60Gy in 30 fractions over 6 weeks, High risk areas (with extra-capsular spread and
positive (or <1mm) margins will be treated with a boost of a further 4Gy in 2 fractions
Nodal levels are outlined according to the Gregoire defined levels (EORTC) and can
be referred to on the physics computer (physics intranet).
Outline organs at risk (OAR’s)
Specify acceptable doses to OAR
Organ
Brain stem
Hypothalamus
Normal tissue tolerance
(2Gy/#)
10Gy max no limit
40Gy max
50Gy (max point dose 55Gy
if other eye intact)
50Gy
48 Gy
(46Gy Chemoradiation)
50 Gy
50Gy
Parotid
Optic chiasm
24-27Gy (when possible)
50Gy (max point dose 55Gy)
Lens
Cornea
Retina
Optic nerve
Spinal cord
These doses should not be exceeded. If the extent of tumour risks these tolerance
doses being exceeded this should be discussed in the planning meeting and
documented in the notes and on the consent form signed by the patient and
109
consultant ( this dose not include lens and parotid doses where the dose may be
exceeded).
1.7 Post operative Radiotherapy
Fifteen factors have been identified as important -predictors of recurrence.
The first two are absolute indications for post op chemoradiation in fit patients
under the age of 70 years (see ref 1, 2).
i)
ii)
positive resection margins
extra-capsular lymph node spread
Standard dose is 60 Gy in 30 fractions with a 4 Gy boost to any areas where
one of the two high risk factors are present.
Two of the remainder suggest post-op RT should be recommended.
Concurrent chemotherapy may be considered.
iii)
iv)
v)
vi)
vii)
viii)
ix)
x)
xi)
xii)
xiii)
xiv)
xv)
close margins <5 mm
invasion of soft tissues
Two or more LN +ve
more than 1 +ve nodal group
involved node more than 3 cm in diameter
multicentre primary
peri-neural invasion
vascular invasion
poor differentiation
stage T3/4
oral cancer
CIS, dysplasia at edge of resection margin
uncertainties concerning surgical/pathological findings
High risk of recurrence associated with either (i) or (ii) alone or presence of
two or more of factors iii-ix.
Intermediate risk is associated with the presence of any one of the factors iiiix. Factors x to xiv may be of some importance in predicting recurrence and
should be borne in mind.
Treatment volume should encompass the area of surgical resection and will
include all areas considered at risk of recurrence. A margin of 10mm around
the maximal extent of surgery should be included. Where nodal involvement
has been proven, the field should be extended to include the lymphatic
drainage down to the clavicle with a boost to the small area which includes
sites at greatest risk with 10mm margin.
110
1.8
Dose Fractionation Summary
For squamous cell carcinomas,most patients are treated with a daily dose of 2Gy
per fraction daily Monday to Friday

Primary Radical Radiotherapy
Macroscopic disease should receive 66 Gy – 68 Gy/33-34 #.
Microscopic disease should receive 44 – 50 Gy/22-25#.
For small volume disease eg T1/2 N0 larynx and occasionally post op parotid
patients a 4 week fractionation schedule is used.
4 week regimen
T1 larynx
T2 larynx
Post op parotid
Cord dose
54Gy/20# (equivalent to 64Gy/32#)
55Gy/20# (equivalent to 66Gy / 33#)
50Gy/20# (equivalent to 60Gy/30#)
54Gy/20# (equivalent to 64Gy/32#)
40Gy
The cosmetic results and late toxicity of XRT given over four weeks may be poorer than
those obtained from a six week schedule.
In the past, it has been generally accepted that 50 Gy is required to sterilise
microscopic disease, but evidence from randomised controlled trial, including the
CHART trials, where a dose of 44 Gy was given to microscopic disease has
indicated that around 44 Gy may well be adequate. This is also supported by the
work of Peter Levendarg; in their group of 61 patients, 46 Gy was prescribed to the
neck and in 34 N0 patients, that is 65 necks, there were only 4 recurrences. In
addition, when attempting conformal therapy and IMRT, to avoid vital structures like
the parotid, it becomes more and more difficult to give 50 Gy to microscopic disease
and somewhere between 44 and 46 is becoming more acceptable.
Some patients will be treated in a single phase. For more complex treatments a two
phase technique is used:Phase I
44 Gy intersection dose in 22#, 2 Gy per fraction over 30-34 days(including cord
if necessary)
Phase II.
22– 24 Gy intersection dose, 11-12# over 12-16 days
External Beam Therapy Plus Implant
111
Implants are rarely used. If indicated the patient should be discussed with Professor
Hoskin. The dose used is:Conventional radiotherapy, 44 – 50Gy, 22 – 25 fractions once daily plus 20 – 25Gy
at 0.5 cm (dose rate 35-45Gy per hour) with implant.
Gaps
Patients should not miss treatments during a course of radiotherapy. Arrangements
are made for patients to be treated on a different treatment machine if their usual
treatment machine is being serviced.
If patients are too unwell to travel for radiotherapy as an outpatient then they should
be admitted to the ward.
If any patient miss any treatments these missed treatments are compensated for
using the flow chart (see appendix 2)
Altered Fractionated Schedules
CHART schedule - Continuous Hyperfractionated Accelerated Radiotherapy has
recently been evaluated in a UK wide study. This intensive regime is costly to
deliver. It shows a local control benefit for larynx patients but has yet to show overall
survival advantage in head and neck cancer.
Accelerated regimes show
improvement in local control rates similar to the improvement seen by adding
chemotherapy to conventional radiotherapy. Adding chemotherapy to accelerated
regimes is only used in a trial setting. This schedule is also used omitting the
weekends for convenience and is known as CHARTWEL (Continuous
Hyperfractionated Accelerated Radiotherapy Weekend Less).
CHART / CHARTWEL schedules are currently being used for treatment of rapidly
growing tumours such as columella and anaplastic thyroid patients. These schedules
are also used for selected patients who may require radiotherapy as an inpatient to
reduce the overall treatment time.
DAHANCA schedule - There is evidence from the meta-analysis that a modest
acceleration of radiotherapy maintaining the dose at 66Gy is advantageous

Post op Radiotherapy
Post op should receive 60Gy/30#
Post op high risk areas (ECS and/ or positive margins) should receive 64Gy/32#

PALLIATIVE RADIOTHERAPY]
Dose schedules for palliation include:27 Gy in 6#, followed by a boost (off spinal cord) of 4.5 Gy
2#/week
27 Gy in 6 #(if spinal cord within irradiated volume)
weeks
37-39 Gy in 13# (2.84-3 Gy/#) treating daily Monday to Friday
}
} over 3
112

OTHER TUMOUR TYPES
LYMPHOMAS
These patients should receive a total dose of 40Gy in 20 fractions (high grade) and
30Gy in 15 fractions (low grade).
These patients are treated by the lymphoma team.
Plasmacytomas
These patients should receive a total dose of 50Gy in 25 fractions.
113
2.
RADIOTHERAPY TREATMENT PROTOCOLS
2.1 LARYNX
GLOTTIC TUMOURS
Position
Supine
Cervical spine straight
T1
Centred on vocal cord (1cm below thyroid promontory)
CTV to include the whole larynx. Extends from the hyoid superiorly
encompassing the cricoid inferiorly and covering the width of the
thyroid cartilage. Anterior bolus 5mm thick and 2cm wide will be used
over the shell if there is anterior commissure involvement.
No prophylatic nodal radiotherapy
T2
CTV should include the whole larynx andwill be expanded
based on the supraglottic and/or subglottic extension.
Usually no prophylactic nodal irradiation but if large tumour
immediate lymph nodes (field anterior to cord) may be
irradiated.
The para-oesophageal and paratracheal lymph nodes are included for
extensive subglottic extension
T3
CTV to include include the whole larynx and pre-epiglottic space.
Extends from above the hyoid to 1cm below the cricoid (lower if
subglottic spread). If there is a trachostomy then this must be also
included.
Nodal fields: level 1, 2, 3 and 4 bilateral
T4
Primary surgery with or without neck dissection combined with postoperative radiotherapy is the treatment of choice. Synchronous
chemotherapy and radiation offer an alternative in those patients who
are medically unfit.
Technique
Parallel opposed pair
Wedged fields (under wedge if anterior commissure involved)
Anterior oblique fields if short neck
Dose
< 42cm2 or 6cm or less in length 55Gy/20 (5#/week)
> 42cm2
64-66 Gy/32-33# (5#/week)
SUPRAGLOTTIC TUMOURS
114
T1/2/3 N0
These tumours are associated with a high incidence of occult positive nodes
Position
Supine
Cervical spine neutral
Phase I
CTV includes the whole larynx and extends upwards to include the preepiglottic space. T2/3 treat nodes level 1, 2, 3, bilateral.
Phase II
To encompass the primary tumour only.
Technique
Parallel opposed wedged fields.
N+ Supraglottic Tumours
Position
Supine
Cervical spine neutral
Technique
Parallel opposed wedged fields
Anterior neck split
Phase I
CTV Includes the whole larynx , level 1 – 5 nodes bilaterally
Lower anterior neck split field to treat the lower cervical nodes and
supraclavicular nodes
Parallel opposed photon beams
Phase II
Ctv includes the whole larynx and involved regional nodes
Anterior neck
Parallel opposed photon beams
Posterior neck
Electron fields
SUBGLOTTIC TUMOURS
T1/T2/T3/T4
Position
Supine
Cervical spine neutral
Technique
CTV Includes the whole larynx with expansion to cover subglottic
extension
Anterior oblique field arrangements usually used. The inferior extent
may necessitate a coronal technique.
115
POST-OPERATIVE RADIOTHERAPY
N0 disease
Can be treated with one phase as the fields do not extend
over the spinal cord
N+
Phase 1 Parallel opposed with anterior neck split
Phase 2 Tumour only –photons for ant neck
Electrons for post neck
2.2 OROPHARYNGEAL CARCINOMA
TONSILLAR TUMOURS
T1/T2/N0
Position
Supine
Cervical spine straight
Clinical Target Volume
Tonsillar fossa, Ipsilateral level 1 to III nodes
Technique
Anterior and posterior wedged pair
(+/- matched low ipsilateral neck)
T1/T2/N+
Position
Supine
Cervical spine straight
Technique.
Phase I
bilaterally.
CTV to include Tonsillar fossa, level 1-5 nodes
Parallel opposed fields
Anterior split neck field, shield centrally
116
Phase II
nodes
CTV to include tonsillar fossa and involved neck
Anterior Upper neck – parallel opposed photon
fields
Posterior upper neck – electron fields
Matched ipsilateral neck
Or
Oblique parallel pair upper neck and matched low
ipsilateral neck
T3/T4 NO or N+
Position
Technique
Phase I
Phase II
Supine
Cervical spine straight
tonsillar fossa and level I-5 nodes bilaterally
Parallel opposed fields
Anterior neck split
CTV to include tonsillar fossa and involved neck nodes
anterior upper neck - Parallel opposed photon fields
Posterior upper neck - Electron fields
Matched low neck as appropriate
POSTERIOR THIRD OF TONGUE
T1-4 N0-1
Position
Supine
Cervical spine straight
TECHNIQUE
Phase I
bilaterally
CTV to include Base of tongue, level 1-5 nodes
Parallel opposed fields
Ant neck split
117
Phase II
nodes
CTV to include primary tuour and involved regional
Upper
anterior neck – parallel opposed photon
fields
Posterior upper neck (if required) – electron fields
N+ (>2cm, N2, N3) Technique as for N+ tonsil
SOFT PALATE
N0 DISEASE
Position
Supine
Cervical spine straight
Technique
Phase I
CTv to include Soft Palate primary, level 1 2 3 nodes
bilaterally
Parallel opposed fields
Phase II
Ctv to include primary only
Upper
anterior neck – parallel opposed photon
fields
N+ Disease
As for N+ tonsil
HYPOPHARYNX
PYRIFORM FOSSA
N0- (any T)
Position
Supine
Cervical spine straight
118
Phase I
CTv to include Primary site, level 1-5 nodes bilaterally
Include skull base and mastoid
Phase II
Ctv to include Primary site only
Technique
Phase 1 parallel opposed & ant neck split
Phase II anterior neck parallel opposed
N+ (any T)
Technique as for N+ tonsil
POSTERIOR PHARYNGEAL WALL
N0 (any T)
Position
Supine
Cervical spine straight
Phase I
CTV to include whole hypopharynx, level 1-5 nodes bilaterally
Phase II
CTV to include primary site only
Technique
Lateral parallel opposed fields, angled down if necessary.
N+ (any T)
Technique as for N+ tonsil
POST CRICOID CARCINOMA
N0 (any T)
Position
Supine
Cervico-thoracic spine straight
Technique
CTV to include Primary tumour including the hypopharynx and if
possible 3-4cm of cervical oesophagus below the known tumour
extent. If there is nodal involvement, radiotherapy may have to be
palliative as the full dose cannot be given to all the tumour without
compromising the cord dose. Consider IMRT in this situation.
.
3 field arrangement, 2 anterior oblique fields and an anterior field with
a sup-inf. wedge
2.4 NASOPHARYNX
Lymph node positive disease
Position:
Supine
119
Neck extended
Chin up as far as possible
Patients will be CT planned for Phase II and III and may be CT planned for
Phase I.
Phase I
Large parallel opposed fields extending from the skull base to the low
neck then match lower anterior neck avoiding junction over nodes
Clinical target volume includes:
Base of skull (middle temporal fossa)
Posterior half of the orbit
Posterior half of the nasal fossa
Para-pharyngeal space
Lateral pharyngeal, posterior and upper deep cervical nodes
Dose
30Gy/15#
Phase II
The volume is split into two parts:
Primary area:
Parallel opposed pair to the nasopharynx, parapharyngeal space, base of
sphenoid and posterior orbit – ensuring that there is sufficient cover of
disease extension
The neck is treated by a matched ant post neck with central shielding to spinal
cord.
Dose
20Gy/10#
Phase III
Primary
The volume is reduced further to avoid the retina, optic nerve and optic chiasm
using a 2 or 3 field plan
Undifferentiated NPC
Dose 16 -18Gy/8 - 9#
Differentiated NPC
Dose 16 -18Gy/8 - 9#
Involved nodes are treated to a further dose of 16 – 18 Gy using shortened AP
fields or electrons.
LYMPH NODE NEGATIVE (Well–differentiated NPC)
Phase I
Dose
As the phase II technique described above or as Phase I but with higher
junction
50Gy/25#
Phase II
Two or Three field technique as described above.
Dose
16 -18Gy/8 -9#
120
2.5 ORAL CAVITY
ANTERIOR 2/3 TONGUE
T1/smaller T2 Lesions
These patients are usually treated with surgery. Brachytherapy can be considered
but is rarely used the majority of these patients will be treated with external beam
irradiation only.
Small T1 tumours
Brachytherapy only dose 65Gy,
T2
Phase 1 - 44 – 50Gy external beam in 22 – 25 fractions once daily
plus 20 – 25Gy at 0.5 cm (dose rate 35-45Gy per hour) with implant.
External Beam (Ipsilateral treatment only – T1,2 well lateralised, N0 or 1)
Radiotherapy Position
Supine
Cervical spine straight
Mouth bite
Technique
CTv to include primary site and regional lymph nodes
(as previously defined)
Lateral Wedged field arrangement
Pterygoid fossa is included in RMT tumours
External Beam (Bilateral treatment – T1,2 midline, all T3,4 all N2, 3)
Radiotherapy Position
Supine
Cervical spine straight
Mouth bite
121
Technique.
Phase I
CTV to include oral cavity tumour, level 1-5
nodes bilaterally.
Parallel opposed fields
Anterior split neck field, shield centrally
Phase II
fields
Anterior Upper neck – parallel opposed photon
Posterior upper neck – electron fields
Matched ipsilateral neck
Or
Oblique parallel pair upper neck and matched low
ipsilateral neck
FOM / Buccal Mucosa
As above with FOM counted as a midline tumour. Buccal mucosa tumours are
generally well lateralised and so treatment may be limited to ipsilateral treatment as
described for ant 2/3 tongue.
2.6 PAROTID GLAND
INDICATIONS FOR POSTOPERATIVE RADIOTHERAPY
Pleomorphic adenoma
Incomplete removal
Recurrence post-surgical excision combined with surgery to remove bulk
disease
Large adenoma of the deep lobe (consider)
Recurrence rate reduced from 30% to 5%
Risk of 2nd malignancy 0.7%
Low Grade Malignancy
If there is any doubt about resection margins anatomically or histologically,
consider radiotherapy to the parotid bed
122
High Grade Malignancy
Post-operative radiotherapy for mucoepidermoid, adenocarcinoma, adenoid
cystic and squamous cell carcinoma
Consider elective neck irradiation in squamous, adenocarcinoma, high grade
mucoepidermoid and anaplastic.
Position
Supine
Head extended
Mandible perpendicular to couch top
CT Plan
Entire parotid bed must be included
Include the parotid duct, parapharyngeal space and scar (if at high risk)
Adenoid cystic carcinomas spread along nerves and therefore this
should be considered in planning
Outline contralateral parotid and lens
Technique
Anterior and posterior wedged fields
Dose
Pleomorphic adenoma
Post – op high grade
50Gy/25#
60-64Gy/30-32#
2.7 NECK
NECK ONLY – POST-OPERATIVE OR UNKNOWN PRIMARY
Position
Supine
Cervical spine straight
Chin up as high as possible
CTV
To include levels 1-5 nodes (see Gregoire paper)
Technique
Anterior/posterior parallel opposed fields
Asymmetric diaphragm for midline
Separation at vocal cords < 14cm – 10MV anterior only
Separation at vocal cords >14cm – Parallel opposed 6MV
Patients who present with neck nodes and an unknown primary site will be
investigated according to the unknown primary pathway (see network management
guidelines)).
123
If following investigation there is no likely primary site then patients can be treated
either with radiotherapy to the neck only( ipsilateral irradiation only) as above or to
include possible mucosal primary sites (bilateral irradiation). Concurrent
chemotherapy may also be given to certain individuals following MDM discussion
If it seems highly likely that the primary tumour lay in oro-pharynx, hypo-pharynx, or
nasopharynx then radiotherapy is given as for these sites.
These possible primary sites will usually be treated to a dose of 50Gy in 25 fractions
unless the PET scan suggests macroscopic disease where a full radical dose will be
used to these areas (total 66Gy in 33 fractions).
2.8 ORBIT
All orbital tumours treated with radical radiotherapy will be CT planned. Sarcomas
and lymphomas will be referred to the appropriate teams.
EXTRACONAL TUMOURS – EYE INTACT
Includes lacrimal gland tumours
Position
Supine
Neck straight
Technique Direct anterior and angled or asymmetric lateral field
Weighted anteriorly
Pencil lead to shield the lens, eyeball and intraconal space*
(*must be certain that no tumour lies within the shielded area)
If the tumour extends superiorly or inferiorly the anterior field can
be angled superiorly or inferiorly to ensure that the corneal
shadow falls outside the PTV
INTRACONAL TUMOURS/GROSS PROPTOSIS/LATERAL GLOBE
DISPLACEMENT
The technique for extraconal tumours is unsuitable if there is intraconal
disease, proptosis or tumour both inside and outside the muscle cone.
Position
Supine
Neck straight
Technique Superior and inferior anterior fields
Eye open during treatment to spare cornea
124
POSTERIOR ORBIT
Position
Supine
Neck straight
Technique thyroid eye disease
Single lateral field where low doses are used
Anterior margin 0.25cm in front of the lateral bony margin of the
orbit
Asymmetric technique or gantry angle of 85 to avoid the opposite
lens
20-40Gy depending upon whether intent is palliative or radical.
Thyroid eye disease dose 20Gy/10#
POST-OPERATIVE
Position
Supine
Neck straight
CT Plan
Outline CTV
Outline contralateral eye, lens, pituitary fossa and brainstem
Technique Anterior and antero-lateral wedged pair
60-64Gy in 30-32#
2.9 EAR AND TEMPORAL BONE
Tumours included
• All cutaneous tumours of the pinna and ear canal
• All tumours of the middle ear
• Tumours of the parotid invading the facial nerve and temporal bone
PINNA
Modality:
Technique:
electrons or photons
For electrons:
GTV outlined. PTV = CTV + 1cm margin, a wax backed Pb shield is
placed behind the area to be treated, wax / wet tissue build up is
applied
to ensure that the surface dose is 100%, a Pb cut out may be required
125
Dose:
55Gy in 20#
66-68Gy in 33-34#
EXTERNAL AUDITORY MEATUS (not penetrating the middle ear)
Position:
Technique:
Supine, neck extended so that exit beam avoids lens.
Anterior and posterior wedged fields
MIDDLE EAR
Position
Supine
Neck extended (to avoid exit of posterior field through the eyes).
CT Planning
The CTV includes the GTV plus the pre and post-auricular
lymph nodes.
Outline brainstem and both eyes
Technique
Anterior and posterior wedged fields
2.10 NOSE AND SINUSES
MAXILLARY ANTRUM
Position
Supine
Cervical spine straight
Mouthbite
CT Plan
Clinical target volume will include the maxilla, pterygoid fossa, ethmoid
sinus, nasal fossa and lateral pharyngeal node
Care should be taken to shield the brain stem, optic pathways, eyeball,
lacrimal gland and orbit wherever possible.
Field Arrangement
Anterior and one or 2 lateral fields (angled behind the eyes or using
asymmetric jaw centred behind the outer canthus to avoid exit through
contralateral eye), fields weighted anteriorly.
ETHMOID SINUS
126
Position
Supine
Cervical spine straight
Mouthbite
CT Plan
Clinical target volume will include the medial half of the maxilla on the
involved side, pterygoid fossa, both ethmoid sinuses and nasal fossa.
Care should be taken to shield the brain stem, optic pathways, eyeball,
lacrimal gland and orbit wherever possible.
Field Arrangement
Field arrangements will depend on the dose to OAR within the PTV eg:
optic chiasm and eye.
Anterior and one or 2 lateral fields (angled behind the eyes or using
asymmetric jaw centred behind the outer canthus to avoid exit through
contralateral eye), fields weighted anteriorly.
NASAL VESTIBULE, COLUMELLA AND SEPTUM
Position
Supine
Cervical spine straight
CT Plan
CT assessment is needed as the posterior margins of columella lesions
may be difficult to assess.
Field Arrangement
Anterior wedged pair of photon fields or an anterior electron field can
be used in conjunction with a wax block.
In many cases, the whole of the nasal cavity has to be included.
Anterior wedge fields are then employed with lead to shield the lenses
and optic chiasm.
127
3. INTENSITY MODULATED RADIATION THERAPY
IMRT was introduced at MVCC in June 2009. This treatment
technique allows the treatment of complex target volumes. The
planning target volume and organs at risk are defined on a CT planning
scan. Varying the intensity of dose across the beam and using multiple
beams with multi-leaf collimation allows the radiation beam to be
shaped to fit the PTV as closely as possible. This allows normal
tissues to be spared and dose escalation to the PTV to be facilitated.
The PARSPORT study has shown that the incidence of xerostomia can
be significantly reduced in patients undergoing IMRT for orophayngeal
and hypopharyngeal cancer without loss of local tumour control and
survival (see appendix). Therefore all eligible patients with
oropharyngeal and hypopharyngeal cancers will be considered for
IMRT. Eligible patients with T1-4,N0-3,M0 will be identified in the head
and neck MDMs.
All patients with parotid cancers who require post-operative
radiotherapy will be considered for the COSTAR study.
Any patient with nasopharyngeal carcinoma can be considered for
IMRT.
All patients with differentiated thyroid cancer who require post –
operative radiotherapy by virtue of heavy node involvement (with extranodal spread or incomplete resection) or who are iodine-resistant can
be considered for post-operative IMRT.
All treatment will be CT planned, with scans taken at intervals through
the primary tumour site (2) and cervical lymph nodes (2mm). Clinical
target volumes for macroscopic disease and areas at risk of harbouring
microscopic disease will be outlined on each CT slice, as will critical
structures. MRI scans, clinical information and EUA findings may be
used to assist the definition of target volumes. The parotid glands,
submandibular glands, spinal cord, brain stem, mandible and oral
cavity will be outlined. Elective nodal irradiation volumes will be
outlined as in the guidelines of Nowak et al 1999, Wijers et al 1999 and
Gregoire et al 2000.
CTV 1 includes the primary tumour and involved nodes. The CTV
around the primary tumour will be the gross tumour volume plus first
station nodes (i.e. ipsilateral II) with a 1cm margin to account for
microscopic tumour spread. The margins can be reduced at the
borders of an uninvolved anatomic space.
CTV 2 includes the lymph node groups at risk of harbouring metastatic
disease. This volume will vary depending on the site and stage of the
128
primary tumour. For oropharyngeal tumours it should include ipsilateral
Ib, bilateral levels II-V, and retropharyngeal nodes in all cases. For
tumours that cross the midline, contra-lateral level Ib is target. Level Ia
is only target for tumours that involve the floor of mouth or if level Ib is
involved. For tonsil tumours the upper deep jugular (above the digastric
muscle) may be omitted on the contra-lateral side to allow contralateral parotid gland sparing.
A margin not less than 3mm in all directions will be added to the CTV to
produce the PTV.
IMRT planning
A 5-9 field technique will be used. Goals for treatment planning will be
to deliver 65Gy in 30 fractions to the PTV. The method of treatment
planning will be inverse planning using the Eclipse planning system
with dynamic MLCs. Dose distributions should be calculated corrected
for in-homogeneities and deliverable beams.
Dose and fractionation
Primary radiotherapy: A total dose of 65 Gy in 30 daily fractions over 6
weeks (radiobiologically equivalent to 70Gy, 2Gy/ fraction; five times
per week) will be delivered to macroscopic primary tumour and
involved/high risk lymph nodes (PTV1).
Clinically uninvolved lymph node areas (PTV2) in patients will be
treated to the radiobiologically equivalent dose of 54Gy in 30 fractions.
Dose prescription
Prescription of IMRT plans.
For IMRT plans, the prescription will be to the median dose point on the
DVH such that the prescription dose (65Gy) is received by 50% of the
PTV1. The minimum and maximum doses to the PTV should be within
90 –110% of the prescription dose (see table below). Less than 5% of
the volume outside the PTV should receive >110% of the prescription
dose.
Acceptable under- and over-dose for the PTV
% PTV
2%
5%
7%
2%
% Dose
<90%
<95%
>107%
>110%
Dose limits for Organs at Risk (OARs)
The dose limits for radiosensitive organs are given below and
should be assessed from dose-volume histograms of 3D volumes:
Contra-lateral parotid gland
Mean dose <24Gy
129
Spinal cord
with chemotherapy)
Brain stem
Maximum dose 48Gy (46Gy
Maximum dose 60Gy
Verification of dose delivery
This will be done by measurement of the delivered dose using ion
chambers.
Quality assurance
QA of the delivered dose will be co-ordinated by Physics.
130
4. CHEMOTHERAPY PROTOCOLS FOR HEAD AND NECK CANCER
Patients <70 years, of good performance status, with node postive head and
neck cancer or T3/T4 primary tumours shoud be considered for concurrent
chemoradiation using cisplatin.
Pre treatment assessment
1. Baseline FBC
2. Baseline biochemical profile inc. U+E, LFT’s, bone profile
3. Assessment of GFR with EDTA (preferable) or Cockcroft – Gault
calculation:
Women:
Creatinine clearance in ml/min = 0.85 x (140-age (yr) x body wt (kg)
72 x serum creatinine (mol/l)
Men:
Creatinine clearance in ml/min = 1 x (140-age (yr) x body wt (kg)
72 x serum creatinine (mol/l)
Chemotherapy should not be administered if the GFR is <40ml/min. If
the GFR is <60ml/min then carboplatin should be used AUC =5.
4. Informed consent
5. When receiving cisplatin chemotherapy, all patients should receive pre
and post hydration and anti-emetics (usually 5HT antagonist and
dexamethasone as highly emetogenic) according to protocol.
6. All patients should be considered for an audiogram
7. Men should be offered sperm banking and women with child bearing
potential should be counselled about the risks of infertility. Patients can
be referred to UCLH for further assessment.
Concomitant chemotherapy
Cisplatin 80 - 100mg/m2 IV or carboplatin (AUC 4 or 5) day 1, 22 and 43 of
radiotherapy
Weekly FBC and U&E will be monitored carefully during treatment.
Scheduling of Concurrent Chemotherapy and Radiotherapy
131
Radiotherapy should be delivered after the chemotherapy. This requires
the chemotherapy to be commenced early in the morning to allow RT to be
given before 5pm.
Standard timings are for patient to be admitted to the ward at 2pm on the day
before chemotherapy is due. If blood tests can be done a day or two prior to
this admission it is easier. Otherwise a blood test is done urgently on
admission. The chemotherapy is taken off hold by 4pm that afternoon.
Pre-hydration starts at 12 midnight so that the cisplatin chemotherapy can run
from 6 – 10 am. Radiotherapy is administered between 10am and 2pm and the
post hydration schedule will generally finish by around 4pm allowing the
patient to be discharged. Patients on hospital transport will usually stay in
two nights in total.
Standard anti-emetic protocol used (see appendix 3).
Neutropenic sepsis is treated according to Mount Vernon Hospital neutropenic
sepsis policy (see appendix 4).
Neo-adjuvant chemotherapy
Cisplatin
80-100mg/m2 IV day 1
5FU
1g/m2 infused IV days 1 to 4 repeat day 22, 43 etc.
This is used rarely for symptom relief while patients are being planned for their
radiotherapy.
Induction with a taxane based regimen (TPF) can be considered for patients
with advanced disease who have a WHO performance status of 0/1.
Taxotere 75mg/m2 d1
Cisplatin 75 mg/m2 d1
5-fluoro-uracil 750 mg/m2 d1-5
Schedule repeated every 21 days for 2 – 3 cycles
Concurrent cetuximab with radiotherapy
A Phase III study has demonstrated a local control, disease-free and overall
survival benefit for patients with locally advanced head and neck cancer who
receive cetuximab and radiacal radiotherapy versus radiotherapy alone(ref 3,
see appendix 1)
No benefit was seen for patients with a Karnofsky Performance Status  80
who were 65 years of age or older.
In June 2008 NICE approved the use of concurrent cetuximab with radical
radiotherapy for patients with locally advanced head and neck cancer
receiving radical radiotherapy who had a Karnofsky performance status > 90%
and in whom cisplatin based chemotherapy was contra-indicated.
A cetuximab radiotherapy initiation form is completed and sent with the C form
to pharmacy.
132
.
Cetuximab is administered once a week concomitantly with radiation therapy.
A loading dose of 400mg/m2 over 120 minutes should be administered
intravenously one week before radiotherapy begins and should be continued
weekly at a dose of 250 mg/m2 over 60 minutes iv until the end of the radiation
period. Prior to each infusion, the patient should be pre-medicated with an
antihistamine eg chlorpheniramine 10 mg iv. Patients should be monitored for
an allergic reaction for at least 60 minutes after administration.
Weekly monitoring of FBC, U&Es, LFTs is not required but these tests should
be performed prior to the commencement of treatment (and should be normal
before preceeding with treatment) and on at least one occasion during
treatment.
Patients may experience an infusion related reaction which is rare and
dyspnoea. Skin reactions are common which should be treated with
appropriate antibiotics eg tetracyclines. Severe skin reactions ( grade 3: NCICTC) require cessation of cetuximab therapy until skin reaction has resolved
to grade 2. (see appendix )
133
5.
MANAGEMENT OF PATIENTS ON TREATMENT
Patients are reviewed weekly whilst on treatment by the team.
The patient will have the radiotherapy head and neck radiotherapy nurse
specialist as their key worker during treatment. Patients will have her contact
details if there are any problems during treatment. Any problems during the
week between the hours of 9am and 5pm are dealt with initially by the head
and neck nurse and then the team are involved as appropriate. After 5pm and
at weekends patients will contact either the ward or the senior nurse on call at
Mount Vernon Hospital.
The patients’ regular medication is assessed by the team and converted to
soluble / liquid preparations when appropriate.
Patients are instructed to shave using an electric razor if they shave during
treatment.
Aqueous cream is supplied and patients are instructed to apply regularly (at
least twice a day) to the irradiated area. This should not be applied
immediately prior to their radiotherapy treatment.
Telodont mouthwash tablets are used to ensure oral hygiene during treatment
and small soft toothbrushes are also available.
Patients undergoing chemoradiation will have a weekly FBC and U&Es,
creatinine
Nutritional assessment
Weekly weight measurement and assessment by the dietitiion if using
PEG/RIG tube or diet compromised in any way.
Analgesia assessment / Mucositis management
Analgesia used according to a typical analgesic ladder.
Initial – mild mucositis
Aspirin mouthwash 300-600mg tds
Paracetamol (soluble)1g qds
Moderate mucositis
Cocodamol (disp) 30/500 two qds
Voltarol (disp) 50mg tds (if no history of peptic
ulceration / indigestion)
Severe mucositis
Oramorph (10mg/5ml) 5 ml prn initially
If required on a regular basis, stop cocodamol and
start fentanyl 25mcg patches (changed every 3 days)
with oramorph for breakthough pain. Voltarol can be
continued.
134
A regular laxative such as 1-2 movicol sachets daily should be started
when opiate analgesia commenced.
Patients intolerant to opioids will be treated with oxycodone (5mg/5ml) 5
mg 4 hourly
The palliative care team will be involved for difficult pain control issues.
Management of excessive mucus production
Saline nebulisers are available for patients to borrow to help with
excessive mucus.
Management of Skin Reaction
Erythema and dry desquamation is managed with regular application of
aqueous cream. Moist desquamation is best managed by application of
paraffin gauze dressings up to 3 times a day. The head and neck radiotherapy
nurse will supervise this and instruct patient / carers appropriately.
Speech and Language therapy Assessment
Patient with speech or swallowing difficulties will be assessed weekly when
appropriate in the clinic.
Follow up
On completion of treatment patients will continue to be seen weekly /
fortnightly in the ‘on treatment clinic’ until the radiotherapy reactions are
settled. Patients will usually return to the joint head and neck clinic 6-8 weeks
after completing treatment. Patients who have had treatment with primary
(chemo)radiotherapy will be scanned at 6-8 weeks prior to returning for
discussion at the MDM and the patient attending the joint clinic. Persistent
mucositis may delay this assessment but should be performed by 16 weeks
after the end of radiotherapy. Patients who have received radiotherapy post
operatively may have a baseline assessment scan at this time especially if it is
felt that the normal anatomy is significantly changed by the treatment.
Further follow up schedule as Network Protocol.
135
6. MANAGEMENT OF RECURRENT DISEASE AND PALLIATIVE
PATIENTS
Management of recurrence.
Patients who are suspected of having recurrence should be assessed
clinically. Recurrence should be histologically proven where possible.
Patients should be re-staged with an MRI of the head and neck, CT chest/upper
abdomen. Other investigations eg bone scan or PET-CT may be required.
Patients with recurrence should be discussed in the head and neck MDM
where a management plan can be formulated. Treatment options will depend
on previous treatment received, current symptoms, co-morbidities,
performance status and patient choice. Patients should be referred to their
local palliative care team with their consent. Close links should be maintained
between the hospital based team and the community team.
Management of Palliative Head and Neck Patients
The decision to recommend palliative treatment will have been discussed in
the MDM and thn communicated to the patient and their family or carer. This
decision is based on the TMN stage, performance status, co-morbidities and
social circumstances of the individual.
The pros and cons of palliative chemotherapy and/ or radiotherapy in the
management of the patient should be discussed with the patient and the
family/carer. Written information leaflets will be provided as listed in section.
Radiotherapy schedules (see PL-FLO-04, P1-4)
Palliative treatment requires high doses, and short fractionation regimes are associated with
marked acute toxicity. Regimens that can be considered on an individual basis include:
27Gy in 6# , 4.5 Gy/# treating twice a week for 3 weeks
37Gy in 13# ,2.85 Gy/#, treating daily (if spinal cord in field)
39Gy in 13#, 3Gy/# (if spinal cord NOT in field)
Patients treated with palliative intent do not usually require a dental
assessment.
Palliative chemotherapy schedules
Cisplatin
5FU
75mg/m2 IV day 1 or carboplatin (AUC4 or 5)
1g/m2 infused IV days 1 to 4 repeat (q=21d)
Patients will be assessed for response after 2-3 cycles (clinically or with
MRI/CT) and will receive 4-6 cycles if there is evidence of clinical response
Patients should be considered for entry into appropriate clinical trials.
136
Patients who are treated with palliative intent, should, with their consent be
referred to the Community Palliative Care Team and close liaison between the
hospital based team and community team should be maintained at all times.
Cetuximab may be combined with first line platinum and 5FU (4-6 cycles)
through individual application to the Cancer Drugs Fund. Cetuximab is
continued weekly until progression. The criteria for cetuximab need to be
satisfied for approval: histological or cytoloigcall proven SCC of the Head and
Neck, stage III/IV metastatic or recurrent disease, not previoulsly treated with
chemotherapy except in multi-modality treatment completed > 6 months
previously, and Karnofsky performance status of >70%. Once approved the
Cancer Drugs Fund requires a record of treatment and outcome monitoring
every 3 months or until progression.
Second line chemotherapy schedules
All patients who progress on first line chemotherapy and remain fit should be
considered for the DORA study (contact Prof Chris Boshoff at UCLH)
Taxotere 75 mg/m2 (q=21 days) iv
Patients require a pre-medication with anti-histamines and steroids (see
protocol, appendix ). Patients will be assessed for response after 2-3 cycles
(clinically or with MRI/CT) and will receive 4-6 cycles if there is evidence of
clinical response
137
7. HEAD AND NECK CANCER RESEARCH PROTOCOLS
All patients discussed in the network MDM will be considered for inclusion in
trial protocols.
The following studies are open for patients with locally advanced disease
1. COSTAR – Phase III randomized study of post operative IMRT vs conventional
radiotherapy in patients receiving surgery for parotid carcinoma
NCRN adopted
2. ARIX- A phase III randomized study assessing whether acupuncture can
alleviate xerostomia in patients who have received radical radiotherapy for head and
neck cancer.
NCRN adopted
3. EGF 105998 – Phase III study of lapatanib with chemoradioation in post op
setting.
A randomized, double blind, placebo controlled multi-centre phase III study
of post-operative adjuvant lapatinib or placebo and concurrent chemoradiotherapy followed by maintenance lapitinib or placebo monotherapy in
high risk subjects with rescted squamous cell carcinoma of the head and
neck (EGF 105998) sponsored by GSK and NCRN adopted
PET NECK trial
A PET-CT guided watch and wait policy versus planned neck
dissection for locally advanced (N2/N3) nodal metastases in stage III
and IV patients with head and neck squamous cell carcinoma treated
with radical chemoradiation sponsored by the NCRN. Has MVCC
R&D approval.
The following study closed in 2009
A Phase III randomized trial or chemotherapy with or without panitumumab
in patients with metastatic and/or recurrent squamous cell carcinoma of the
head and neck (AMG 954, panitumumab 20050251) sponsored by AMGEN
and NCRN adopted
The following study closed in 2008
EGF 105884 – Phase II Lapatanib study with primary chemoradiation
A randomized, double blind, placebo-controlled,multicentre, phase II study
of lapatinib in combination with concurrent radiotherapy and cisplatin
versus radiotherapy and cisplatin alone, in subjects with stage III and IVA,B
138
squamous cell carcinoma of the head and neck (EGF 105884) sponsored by
GSK and NCRN adopted
A Phase 1b study of cetuximab and combretastatin (C4A-P) in
combination with radical radiotherapy in patients with locally
advanced head and neck cancer
The following studies closed in 2007
Phase 1 pilot study of serial PET scans during RT
This study evaluating serial FDG –PET-CT images acquired during
conventionally fractionated radiotherapy or chemoradiotherapy for
squamous cell carcinoma of the head and neck
Target accrual 20 patients
Accrual completed
Palifermin Study
A Phase III, randomized, double-blind, placebo-controlled study to evaluate the
efficacy and safety of weekly doses of palifermin (recombinant Human
Keratinocyte Growth Factor, rHuKGF) for the reduction of oral mucositis in
subjects with advanced head and neck cancer receiving adjuvant radiotherapy
and chemotherapy (RT/CT)
Target accrual 5 patients
Actual accrual 3 patients
139
Appendix 1
References
1. Cooper J, Pajak TF, Forastiere A, et al. Postoperative concurrent radiotherapy
and chemotherapy for high-risk squamous-cell carcinoma of the head and
neck. New England Journal of Medicine 2004;350:1937–1944.
2. Bernier J, Domenge C, Ozsahin M, et al. Postoperative irradiation with or
without concomitant chemotherapy for locally advanced head and neck
cancer. New England Journal of Medicine 2004;350:1945–1952.
3. Bonner J,Harari P, Giralt J, Azarnia N, Shin D, Cohen R, Jones C, Sur R,
Raben D, Jassem J, Ove R, Kies M, Baselga J, Hagop Y, Amellal N,
Rowinsky E and Ang K. Radiotherapy plus Cetuximab for Squamous-Cell
Carcinoma of the Head and Neck. New England Journal of Medicine 2004;
354:567-578
4. First results of a phase III multicenter randomized controlled trial of intensity
modulated (IMRT) versus conventional radiotherapy (RT) in head and neck
cancer. Nutting et al. Proc ASCO JCO 2009;27(2):799s
140
APPENDIX 2-Compensation for Gaps in Radiotherapy Treatment
141
Are there enough days before the planned treatment end date to
accelerate the remaining fractions by treating twice daily or using weekends?
Yes
Accelerate the remainder of the treatment using weekends
or twice daily treatments, keeping dose per fraction, total dose and
fraction number the same, completing treatment on the same end date.
Must allow 6 hour gap between treatments
Weekend treatments are preferable to BD treatments
Increased fractional dose
If there has been a single missed day in a 2 Gy per fraction treatment with
no critical normal tissue in the field (eg skin cancer)
Deliver a 3.22 Gy dose on the day after the gap and then proceed with the
original dose and fractionation.
This should not be performed more than 3 times in a treatment course.
No
A radiobiological calculation is required
Should only be used if there is insufficient
time to allow acceleration.
Equivalent dose calculation
This can only be used if a treatment gap is predicted before the start of the
treatment course. Or for an early gap where acceleration is not possible
1) Calculate the BED for the proposed
treatment (for both tumour and
late-reacting normal tissue) using the formula:
BED = nd[1 + d/(α/β)]
2) Then calculate the dose per fraction
for the reduced number of fractions
(E.g. For a standard 30# treatment, if 2 days are to be lost, re-calculate for
28 fractions, i.e. 30 x 2 Gy ~ 28 x 2.1 Gy)
Increased Total Dose
1) Calculate the tumour and normal tissue BED using the formula: BED = nd [1+d(α/β)]-K(T-Tdelay)
Where n = number of fractions, d = dose per fraction, T = overall treatment time,
K = biological dose per day required to compensate for repopulation (~ 0.9 for tumour, = 0 for late-responding normal tissue)
T delay = delay time (from beginning of treatment) before the onset of accelerated repopulation ≈ 28 days.
2) Determine overall time until start of the unscheduled gap and the respective BEDs prior to the gap
3) Determine a treatment option which will give the minimum extension of treatment time
4) Calculate dose per fraction to achieve this and now re-calculate tumour and normal tissue BEDs
5) May need to ‘fine-tune’ the compensation to maximise tumour BED whilst minimising normal tissue BED
142
Are there enough days before the planned treatment end date to accelerate the
remaining fractions by treating twice daily or using weekends?
Yes
Accelerate the remainder of the treatment using weekends or
twice daily treatments, keeping dose per fraction, total dose
and fraction number the same, completing treatment on the
same end date.
Must allow 6 hour gap between treatments
Weekend treatments are preferable to BD treatments
Increased fractional dose
If there has been a single missed day in a 2 Gy per fraction treatment
with no critical normal tissue in the field (eg skin cancer)
Deliver a 3.22 Gy dose on the day after the gap and then proceed with the
original dose and fractionation. This should not be performed more than 3
times in a treatment course.
No
A radiobiological calculation is required
Should only be used if there is
insufficient time to allow acceleration.
Equivalent dose calculation
This can only be used if a treatment gap is predicted before
the start of the treatment course. Or for an early gap where
acceleration is not possible
1) Calculate the BED for the proposed treatment (for both
tumour and late-reacting normal tissue) using the formula:
BED = nd[1 + d/(α/β)]
2) Then calculate the dose per fraction for the reduced
number of fractions
(E.g. For a standard 30# treatment, if 2 days are to be lost,
re-calculate for 28 fractions, i.e. 30 x 2 Gy ~ 28 x 2.1 Gy)
Increased Total Dose
1) Calculate the tumour and normal tissue BED using the formula: BED = nd [1+d(α/β)]-K(T-Tdelay)
Where n = number of fractions, d = dose per fraction, T = overall treatment time,
K = biological dose per day required to compensate for repopulation (~ 0.9 for tumour, = 0 for late-responding normal tissue)
T delay = delay time (from beginning of treatment) before the onset of accelerated repopulation ≈ 28 days.
2) Determine overall time until start of the unscheduled gap and the respective BEDs prior to the gap
3) Determine a treatment option which will give the minimum extension of treatment time
4) Calculate dose per fraction to achieve this and now re-calculate tumour and normal tissue BEDs
5) May need to ‘fine-tune’ the compensation to maximise tumour BED whilst minimising normal tissue BED
143
APPENDIX 3 – Anti-emetic protocol
GUIDELINES FOR THE MANAGEMENT OF NAUSEA AND VOMITING IN ADULT PATIENTS
RECEIVING CHEMOTHERAPY AND/OR RADIOTHERAPY
SCOPE
The following guidelines have been designed for use within Mount Vernon Cancer
Network for adult oncology and haemato-oncology patients receiving chemotherapy
and/or radiotherapy.


AIM
To ensure appropriate prescription and administration of antiemetics for patients receiving chemotherapy
and/or radiotherapy.
To reduce the risk of emesis and minimise the side effects and complications of antiemetic drugs.
RISK FACTORS
Certain risk factors exist which predict those patients likely to be more susceptible to the
emetogenic effects of chemotherapy or radiotherapy:

Female gender

Young (<30 years old)

History of nausea and vomiting (e.g. sickness in pregnancy, motion sickness)

Poor control of emesis with prior chemotherapy or radiotherapy

Anxiety
There should be a low threshold for increasing the level of antiemetic cover for patients with more than two of any
of these risk factors.
CHEMOTHERAPY
Section 1: Notes on Use of Guidelines
1.1 Choice of antiemetics






Consult section 2 for the antiemetic category of the relevant individual cytotoxic drugs or specific
oncology/haemato-oncology chemotherapy regimen being prescribed. The categories represent minimal
(category A), low (category B), moderate (category C) or high (category D) levels of emetogenicity.
Choose and prescribe the appropriate pre and post chemotherapy antiemetic regimen from the relevant
category listed in section 3.
For combination chemotherapy regimens not specifically listed in section 2, choose the appropriate
antiemetic regimen for the most emetogenic drug in the regimen.
For multiple day chemotherapy regimens, prescribe the appropriate pre chemotherapy antiemetics for each
day of the highest emetogenic drug and prescribe post chemotherapy antiemetics from the day after the final
dose of the highest emetogenic drug.
Many chemotherapy regimens for haemato-oncology patients incorporate corticosteroid treatment
(commonly with prednisolone or dexamethasone). These patients should NOT receive dexamethasone as part
of their antiemetic regimen even if the chemotherapy regimen falls into Category B, C or D in section 2.
Generally no patient with acute leukaemia should receive dexamethasone as an antiemetic even if the
drug/regimen falls into category B, C or D (although some of these regimen may include a corticosteroid as
part of the anti-cancer treatment).
Note: A chemotherapy regimen named in section 2 does not imply approval to prescribe, if that regimen
contains a non-NICE approved high cost drug.
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144
1.2 Antiemetic failure


If prolonged/distressing nausea occurs or 2 or more episodes of vomiting in 24 hours occurs after a course of
chemotherapy, move onto suggested antiemetic regimens for the next category level of emetogenicity.
Ensure patient has taken post chemotherapy antiemetic drugs regularly as prescribed.
1.3 Anticipatory nausea and vomiting

Prescribe lorazepam 1-2mg orally/sublingually at least 1 hour prior to chemotherapy, in addition to standard
antiemetics. If severe, consider 1mg night before chemotherapy and 1mg on the morning of chemotherapy.
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145
Section 2: Categorisation of Individual Chemotherapy Drugs and Specific Chemotherapy
Regimens
Notes:
(a) This list is in alphabetical order based on the name of the drug or regimen.
(b) Check comments column for any special instructions related to the antiemetic or chemotherapy regimen.
(c) In the “tumour site” column, “various” denotes that the drug or regimen is used in more than two tumour sites.
Drug / Regimen
ABCM
Tumour Site
Antiemetic
Category
(refer to
section 3)
Haemato-onc
Comments or special
instructions
AB week only
C
ABCM
ABVD
AC
ACE
ADE (AML 15)
Haemato-onc
Haemato-onc
Breast
Germ cell
Haemato-onc
A
D
C
D
C
Alemtuzumab
Amsacrine
Asparaginase
BCG intravesical
BEP
Bevacizumab
Bleomycin
Haemato-onc
Haemato-onc
Haemato-onc
Urology
Germ cell
Lower GI
Various
A
A
A
A
D
A
A
Bortezomib
Capecitabine
Carboplatin
Haemato-onc
Lower GI
Germ cell /
gynaecology
Lung
Head & neck
Haemato-onc /
CNS
Lung
Haemato-onc
Lower GI
Haemato-onc
Haemato-onc
Haemato-onc
B
A
C
Carboplatin / Etoposide
Carboplatin / 5-FU
Carmustine
CAV
CDT
Cetuximab
Chlorambucil
ChlVPP
CHOP
C
A
B
A
A
C
Various
Gynaecology
Gynaecology
D
D
D
Various
Haemato-onc
Haemato-onc
D
A
B
CMF
C-VAMP
Breast
Haemato-onc
B
C
CVP
Haemato-onc
C
Various
Various
A
C
Drug / Regimen
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Tumour Site
October 2008
No dexamethasone as
antiemetic
Dexamethasone 8mg PO premedication to prevent reactions
C
C
C
Cisplatin
Cisplatin / Doxorubicin
Cisplatin weekly/oral
etoposide (Van Der Burg
regimen)
Cisplatin / 5-FU
Cladribine
CMD
Cyclophosphamide
Cyclophosphamide
CM week only
Antiemetic
No Dexamethasone as
antiemetic.
All regimens
2-CDA
No Dexamethasone as
antiemetic.
No Dexamethasone as
antiemetic.
No Dexamethasone as
antiemetic.
Oral only
IV doses <1500mg/m2
Comments or special
146
Category
(refer to
section 3)
Cyclophosphamide
Cytarabine
Haemato-onc
Haemato-onc
D
B
Cytarabine
Haemato-onc
C
C-Z-DEX
Haemato-onc
C
DA (AML 15/16)
Haemato-onc
C
Dacarbazine
Daunorubicin / Clofarabine
(AML 16)
Daunorubicin
De Gramont
(standard/modified)
Deoxycoformycin
Docetaxel
Melanoma
Haemato-onc
D
C
Haemato-onc
Lower GI
C
A
Haemato-onc
Breast
A
B
Urology
(prostate)
B
Docetaxel / Capecitabine
Breast
B
Docetaxel / Carboplatin
Lung /
gynaecology
C
Lung
D
Various
Breast
Upper GI
Upper GI
C
C
D
D
Docetaxel
Docetaxel / Cisplatin
Doxorubicin
EC
ECF
ECX
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October 2008
instructions
IV doses >1500mg/m2
IV doses <1000mg/m2 (No
dexamethasone as antiemetic if
AML)
IV doses >1000mg/m2 (No
dexamethasone as antiemetic if
AML)
No Dexamethasone as
antiemetic.
No dexamethasone as
antiemetic
No dexamethasone as
antiemetic
Pentostatin
Dexamethasone 8mg PO
BD for 3 days starting day
before docetaxel + post
chemo metoclopramide as
per section 3.
Given the concurrent use
of prednisolone, the
recommended
premedication regimen is
oral dexamethasone 8 mg,
12 hours, 3 hours and 1
hour before the docetaxel
+ metoclopramide as per
section 3
Dexamethasone 8mg PO
BD for 3 days starting day
before docetaxel +
metoclopramide as per
section 3
Dexamethasone 8mg PO
BD for 3 days starting day
before docetaxel +
ondansetron /
metoclopramide as per
section 3
Dexamethasone 8mg PO
BD for 3 days starting day
before docetaxel +
ondansetron /
metoclopramide as per
section 3
147
EP
Epi-CMF
Epi-CMF
Epirubicin
Erlotinib
ESHAP
Germ cell / lung
Breast
Breast
Breast
Lung
Haemato-onc
D
C
B
C
A
D
Etoposide
Etoposide
Various
Various
A
B
Drug / Regimen
Etoposide
Tumour Site
Antiemetic
Category
(refer to
section 3)
Germ cell
C
EV
FAD
Lung
Haemato-onc
B
C
FC (Fludarabine /
Cyclophosphamide)
FEC
FLAG-Ida (AML 15)
Haemato-onc
C
Breast
Haemato-onc
C
C
Fludarabine
5-Fluorouracil
Haemato-onc
Various
A
A
FMD
Haemato-onc
B
GCP
Germ cell
C
Gefitinib
Gemcitabine
Gemcitabine / Carboplatin
Gemcitabine / Cisplatin
Gem-TIP
Lung
Various
Lung
Lung / Urology
Germ cell
A
A
C
D
D
Gemtuzumab Ozogamicin
Hydroxycarbamide
Hyper-CVAD + Rituxumab
Haemato-onc
Haemato-onc
Haemato-onc
A
A
C
Idarubicin
Haemato-onc
C
Ifosfamide
Ifosfamide / Doxorubicin
Imatinib
Various
Sarcoma
GIST /
Haemato-onc
Renal
Lower GI
Lower GI
C
C
A
Upper GI
Haemato-onc
Gynaecology
CNS
Haemato-onc
C
C
B
A
B
Interferon alfa
Irinotecan
Irinotecan / De Gramont
(FOLFIRI)
Irinotecan / Mitomycin C
IVE
Liposomal Doxorubicin
Lomustine
MACE (AML 15)
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October 2008
Epirubicin only
CMF only
No Dexamethasone as
antiemetic.
Oral only
IV only (except high dose
etoposide for germ cell)
Comments or special
instructions
High dose 1.6gm/m2 etoposide
for germ cell
No Dexamethasone as
antiemetic.
All epirubicin doses
No dexamethasone as
antiemetic
Oral and IV
Includes continuous infusional
5-FU and 5-FU + RT regimens.
No Dexamethasone as
antiemetic.
Dexamethasone 20mg IV pre 3
weekly paclitaxel (instead of
8mg) plus other antiemetics as
per section 3.
Dexamethasone 20mg IV pre 3
weekly paclitaxel (instead of
8mg) plus other antiemetics as
per section 3.
Hydroxyurea
No Dexamethasone as
antiemetic.
No dexamethasone as
antiemetic if AML
A
C
C
No dexamethasone as
antiemetic
148
Melphalan
Haemato-onc
A
Mercaptopurine
Haemato-onc
A
Various
A
Methotrexate
Drug / Regimen
Tumour Site
Antiemetic
Category
(refer to
section 3)
Methotrexate
Haemato-onc
C
MidAC (AML 15)
Haemato-onc
C
MiniBEAM
MiniBEAM
Mitomycin C
Mitomycin C / Capecitabine
Mitomycin C / 5-FU
Haemato-onc
Haemato-onc
Urology
Lower GI
Lower GI
C
B
A
B
B
Mitoxantrone
MM
MMM
MVC
MVP
OMB
Oral C-weekly
Oxaliplatin
Oxaliplatin / Capecitabine
(XELOX)
Oxaliplatin / De Gramont
(FOLFOX)
Paclitaxel
Various
Breast
Breast
Urology
Mesothelioma
Germ cell
Haemato-onc
Lower GI
Lower GI
B
B
B
D
D
C
A
C
C
Lower GI
C
Various
B
Paclitaxel / Carboplatin
Gynaecology /
lung
C
PCV
Pemetrexed
CNS
Lung /
mesothelioma
A
B
PMB
PMitCEBO
Gynaecology
Haemato-onc
D
C
PMitCEBO
POMB
Procarbazine
Raltitrexed
R-CHOP
Haemato-onc
Germ cell
Haemato-onc
Lower GI
Haemato-onc
A
D
A
B
C
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October 2008
Including PO melphalan +
prednisolone; IV melphalan +
dexamethasone.
No dexamethasone as
antiemetic if ALL
Oral and IV doses <300mg/m2
only.
Comments or special
instructions
IV doses > 300mg/m2 (No
dexamethasone as antiemetic if
ALL)
No dexamethasone as
antiemetic
Day 1 & 6 only
Day 2 – 5 only
Intravesical only
For Mitomycin C weeks only
All regimens. For Mitomycin C
weeks only
Dexamethasone 20mg IV pre
three weekly paclitaxel or 8mg
IV pre weekly paclitaxel plus
other antiemetics as per section
3.
Dexamethasone 20mg IV pre
three weekly paclitaxel or 8mg
IV pre weekly paclitaxel plus
other antiemetics as per section
3.
Dexamethasone 4mg PO
BD for 3 days starting day
before pemetrexed + other
antiemetics as per section
3.
MitCE week only. No
Dexamethasone as antiemetic.
BO week only.
No Dexamethasone as
antiemetic.
149
R-CVP
Haemato-onc
C
R-ESHAP
Haemato-onc
D
R-FC
Rituximab
R-IVE
R-MiniBEAM
R-MiniBEAM
Haemato-onc
Haemato-onc
Haemato-onc
Haemato-onc
Haemato-onc
C
A
C
C
B
Drug / Regimen
Tumour Site
Antiemetic
Category
(refer to
section 3)
R-PMitCEBO
Haemato-onc
C
R-PMitCEBO
Sorafenib
Stanford V
Haemato-onc
Renal
Haemato-onc
A
A
C
Stanford V
Haemato-onc
A
Sunitinib
Temozolamide
Thalidomide
Tioguanine
TIP
Renal
CNS
Haemato-onc
Haemato-onc
Germ cell
A
A
A
A
D
Topotecan
Trastuzumab
Trastuzumab / Docetaxel
Gynaecology
Breast
Breast
B
A
B
Trastuzumab / Paclitaxel
Breast
B
Trastuzumab / Vinorelbine
UK ALL XI Induction Phase
1
UK ALL XI Induction Phase
2 Day 1, 15, 29
UK ALL XI Induction Phase
2 Day 8, 22
UK ALL XI Intensification –
high dose MTX
UK ALL XI Consolidation
Cycle 1, 2, 4
UK ALL XI Consolidation
Cycle 3 Day 1, 8, 15, 22, 29
VAD
Breast
Haemato-onc
A
C
Haemato-onc
C
Haemato-onc
B
Haemato-onc
C
Haemato-onc
B
Haemato-onc
C
Haemato-onc
C
VAMP
Haemato-onc
C
VAPEC-B
Haemato-onc
C
VAPEC-B
Vinblastine
Haemato-onc
Various
A
A
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No Dexamethasone as
antiemetic.
No Dexamethasone as
antiemetic.
Day 1 & 6 only
Day 2 – 5 only
Comments or special
instructions
MitCE week only. No
Dexamethasone as antiemetic.
BO week only.
Week 1, 3, 5, 7, 9, 11 only. No
Dexamethasone as antiemetic.
Week 2, 4, 6, 8, 10, 12 only.
Thioguanine
Dexamethasone 20mg IV pre 3
weekly paclitaxel (instead of
8mg) plus other antiemetics as
per section 3.
Dexamethasone 8mg PO
BD for 3 days starting day
before docetaxel +
metoclopramide as per
section 3.
Dexamethasone 20mg IV pre 3
weekly paclitaxel (instead of
8mg) plus other antiemetics as
per section 3.
No dexamethasone as
antiemetic
No dexamethasone as
antiemetic
No dexamethasone as
antiemetic
No dexamethasone as
antiemetic
No dexamethasone as
antiemetic
No dexamethasone as
antiemetic
No dexamethasone as
antiemetic
No dexamethasone as
antiemetic
Week 1 & 3 only. No
Dexamethasone as antiemetic.
Week 2 & 4 only
150
Vincristine
Vinorelbine
Vinorelbine / Carboplatin
Vinorelbine / Cisplatin
VIP
Z-DEX
Various
Breast / lung
Lung
Lung
Germ cell
Haemato-onc
A
A
C
D
D
C
No dexamethasone as
antiemetic
Section 3: Antiemetic Regimen Categories (grouped according to emetogenic potential)
Category A: MINIMAL EMETOGENIC POTENTIAL
PRE CHEMOTHERAPY
POST CHEMOTHERAPY
No routine antiemetic indicated
DOMPERIDONE
20mg PO TDS prn
Category B: LOW EMETOGENIC POTENTIAL
PRE CHEMOTHERAPY
POST CHEMOTHERAPY
DEXAMETHASONE 8mg PO
(IV only if nausea / vomiting
/ dysphagia)
and
DOMPERIDONE 20mg
PO
(Metoclopramide 20mg IV
only if nausea / vomiting /
dysphagia)
DEXAMETHASONE
4mg PO BD regularly x 3 days
and
DOMPERIDONE
20mg PO TDS x 3 days, then
prn
ANTIEMETIC FAILURE (see
definition – section 1)
 Recommend Domperidone postchemotherapy to be taken regularly.
 Commence on first line antiemetics
for breakthrough nausea and vomiting
(Section 4).
 Treat on subsequent courses of
chemotherapy as for low emetogenic
(Category B).
ANTIEMETIC FAILURE (see
definition – section 1)
 Ensure took antiemetics regularly post
chemotherapy (as prescribed).
 Commence on first line antiemetics for
breakthrough nausea and vomiting
(Section 4) or subsequent line if had
before with no benefit.
 Treat on subsequent courses of
chemotherapy as for moderate
emetogenic (Category C).
Category C: MODERATE EMETOGENIC CHEMOTHERAPY
PRE CHEMOTHERAPY
POST CHEMOTHERAPY
ONDANSETRON
8mg PO (8mg IV if
nausea/vomiting/dysphagia)
DEXAMETHASONE
4mg PO BD regularly x 3 days
and
and
DEXAMETHASONE 8mg PO
(IV only if nausea / vomiting /
dysphagia)
DOMPERIDONE
20mg PO TDS x 3 days, then
prn
ANTIEMETIC FAILURE (see
definition – section 1)
 Ensure took antiemetics regularly post
chemotherapy (as prescribed).
 Commence on first line antiemetics
for breakthrough nausea and vomiting
(Section 4) or subsequent line if had
before with no benefit.
 Treat on subsequent courses of
chemotherapy as for high emetogenic
(Category D).
Category D: HIGH EMETOGENIC CHEMOTHERAPY
PRE CHEMOTHERAPY
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ANTIEMETIC FAILURE (see
definition – section 1)
151
ONDANSETRON
8mg PO (8mg IV if
nausea/vomiting/dysphagia)
and
DEXAMETHASONE 8mg PO
(IV only if nausea / vomiting
/ dysphagia)
ONDANSETRON
8mg PO BD x 1 day
and
DEXAMETHASONE
4mg PO BD x 3 days
and
DOMPERIDONE
20mg PO TDS x 3 days, then
prn
Cisplatin >70mg / m2
Cisplatin >70mg / m2
As above but also:
As above but also:
APREPITANT 125mg PO
(Fosaprepitant 115mg IV only if
nausea / vomiting / dysphagia)
APREPITANT 80mg PO OD
on days 2&3 post chemo
 Ensure took antiemetics regularly post
chemotherapy (as prescribed) and
used suppositories if vomiting.
 Commence on first line antiemetics
for breakthrough nausea and vomiting
(Section 4) or subsequent line if had
before with no benefit.
 Consider treating on subsequent
courses with:
Ondansetron 8mg PO BD for up to 5
days maximum
and/or
Regular antiemetic from
Section 4 in addition to the post
chemotherapy antiemetic regimen.
 Consider aprepitant for patients with
grade 3 / 4 N&V if they are not already
receiving it
Note: TTA’s – For category D drugs/regimens, prescribe DOMPERIDONE suppositories 30mg PR QDS
prn if vomiting)
Section 4: Breakthrough nausea and vomiting
DRUG AND SCHEDULE
1st
Line
Cyclizine
50mg PO TDS
2nd Line
COMMENTS
 Prescribe regularly in addition to
recommended post chemotherapy
antiemetics

Prochlorperazine – replaces
Metoclopramide as post chemotherapy
antiemetic

Metoclopramide – replaces
Domperidone as post chemotherapy
antiemetic

Prescribe regularly in addition to
recommended post chemotherapy
antiemetics.
Consider adding first line if anxiety
component/anticipatory nausea
Prochlorperazine
5-10mg PO TDS or 25mg
PR TDS
or
Metoclopramide
10-20mg PO QDS or 30mg
PR QDS
3rd Line
Lorazepam
1mg PO/SL upto TDS
(2mg in patients > 100kg)

4th Line
Methotrimeprazine
12.5mg PO nocte – BD
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antiemetic
152
or

Consider instituting S/C infusion of
Cyclizine 1st or 2nd line if severe
vomiting occurs in inpatients.

Only in patients who have failed the
category D antiemetic regimen and
have CTC grade 3 / 4 Nausea and
Vomiting.
Cyclizine
100-150mg continuous
subcutaneous infusion
over 24 hours
or
Nabilone
1mg PO TDS
5th Line
Aprepitant
125mg PO prior to
chemotherapy, followed by
80mg od for 2 days after
chemotherapy
Radiotherapy guidelines for PATIENTS AT mount vernon cancer centre
Notes on Use of Guidelines
Major determinants of emetic risk include treatment field, dose of radiotherapy administered per fraction,
pattern of fractionation and previous chemotherapy.
RISK
Low
Moderate
AREA RECEIVING
RT
ANTIEMETIC REGIMEN
Breast
Head and Neck
Extremities
Pelvis
Thorax
No routine antiemetics – treat symptomatically
with
Upper abdominal
Abdominal – pelvic
Mantle
Cranium
Craniospinal
Before each fraction:
Dexamethasone 4-8mg PO
and either:
Metoclopramide 20mg PO
or
Ondansetron 4-8mg PO (or 4-8mg IV)
Metoclopramide 10mg PO QDS prn
(and Metoclopramide 10mg PO QDS prn after
radiotherapy)
High
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Dexamethasone 8mg PO/IV
and
153
Ondansetron 8mg PO (or 8mg IV)
(and 8mg PO BD for one day after)

Antiemetic failure: If patients suffer breakthrough nausea and vomiting while receiving the above
recommended antiemetics, additional therapy should be commenced in accordance with the
guidelines for breakthrough nausea and vomiting for adult chemotherapy patients in Section 4.

Chemoradiation: Treat according to the highest emetogenic risk based on radiotherapy treatment
field or cytotoxic drug(s)/regime.
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APPENDIX 4 - Neutropenic sepsis protocol
GUIDELINES FOR THE USE OF GRANULOCYTECOLONY STIMULATING
FACTOR (G-CSF) IN ADULT ONCOLOGY AND
HAEMATOLOGY PATIENTS
Signature
Produced by:
Michael Powell, Network Lead
Pharmacist
Ratified by:
MVCN Chemotherapy Steering Group
Kay Bell, Chair
Date:
Date for
review:
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July 2009
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Mount Vernon Cancer Network
GUIDELINES FOR THE USE OF GRANULOCYTE-COLONY STIMULATING FACTOR (GCSF) IN ADULT ONCOLOGY AND HAEMATOLOGY PATIENTS
Section 1: Background
Chemotherapy-induced febrile neutropenia is a serious side effect of cancer treatment and is
not only a major risk factor for infection-related morbidity and mortality, but is also a significant
dose-limiting toxicity. Patients developing severe (grade 3/4) or febrile neutropenia (FN) during
chemotherapy frequently receive dose reductions and/or delays to their chemotherapy
schedule. This may impact on the success of treatment, particularly when treatment intent is
either curative or to prolong survival (1). One method of reducing the incidence of severe or FN
is through the prophylactic use of G-CSF – those commercially available at the current time are
filgrastim, lenograstim and pegfilgrastim. G-CSF may also be used to increase neutrophils in
those patients experiencing severe prolonged neutropenic episodes after chemotherapy
treatment or in those patients requiring mobilisation of peripheral blood stem cells for
harvesting.
The aim of this guideline is to provide evidence-based guidance to clinicians and other health
professionals on the rational prescribing and safe administration of G-CSF and to promote
harmonisation of prescribing practice across Mount Vernon Cancer Network. (Please note:
these guidelines do not apply to acute leukaemia patients – follow guidelines stated within the
relevant trial protocol).
Section 2: Indications
G-CSF may be prescribed for the following indications, according to the criteria for G-CSF
prescribing outlined in section 4:
a. Chemotherapy support for regimens with curative/radical intent (primary/secondary
prophylaxis).
b. Supportive therapy for severe neutropenic sepsis.
c. Peripheral blood stem cell mobilisation.
d. Clinical trials where appropriate and stated within the trial protocol.
Note: Patients receiving palliative chemotherapy should not generally receive prophylactic GCSF for chemotherapy support – manipulations to minimise neutropenic episodes and sepsis
must initially include dose delay and/or dose reduction (refer to individual chemotherapy
protocols for guidance) as there is no evidence that dose maintenance or escalation improves
clinically important outcomes. The use of G-CSF in this setting must be approved on an
individual patient basis by the appropriate directorate manager or lead clinician.
Section 3: Approval to Prescribe
For all indications except in peripheral blood stem cell mobilisation:
A consultant oncologist/haematologist or specialist registrar must initiate G-CSF treatment for
these indications (except in exceptional cases within the network where patients are admitted
under a general physician for management of neutropenic complications, in which case a
general medical physician may prescribe but must do so according to these guidelines). Senior
house officers, pre-registration house officers or staff grade doctors may only initiate treatment
for these indications under instruction from a consultant oncologist/haematologist or specialist
registrar and this instruction must be documented in the patient’s medical notes.
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Peripheral blood stem cell mobilisation:
Any member of the oncology or haematology medical team may prescribe G-CSF according to
the appropriate protocol for the particular patient.
Section 4: Criteria for G-CSF Prescribing (1)(2)(3)
The following criteria must be adhered to prior to prescribing G-CSF:
Criteria 1a: Chemotherapy support for regimens with curative/radical intent:
Primary Prophylaxis (first and subsequent cycle use)
Recommendation:
Chemotherapy patients should not routinely be prescribed prophylactic G-CSF after their
first cycle of chemotherapy.
Primary prophylaxis may only be considered for patients with a high overall risk (> 20%) of
febrile neutropenia as defined below:
 Patients receiving myelotoxic chemotherapy with curative or radical intent (including
adjuvant/neoadjuvant chemotherapy) and which has a documented incidence rate of FN of
> 20% (refer to Appendix 1 for list of relevant network chemotherapy regimens)
Or

Patients receiving myelotoxic chemotherapy with curative/radical intent (including
adjuvant/neoadjuvant chemotherapy) and which has a documented incidence rate of FN of
10 – 20% (refer to Appendix 2 for list of relevant network chemotherapy regimens)
And any one or more of the following pre-disposing patient risk factors:
 Pre-existing neutropenia due to disease infiltration of bone marrow or other aetiology
 Age > 65 years
 Advanced disease stage
 Poor performance status
 Previous episodes of febrile neutropenia whilst receiving earlier chemotherapy of a similar or
less dose intensity
 Extensive prior chemotherapy
 Previous irradiation to large volume of bone marrow
 Poor nutritional status
 Active infections or increased risk of infections (e.g. presence of open wounds)
 Serious co-morbidities
Refer to section 5 for GCSF dosage and administration guidelines in the prophylactic setting.
Criteria 1b: Chemotherapy support for regimens with curative/radical intent:
Secondary Prophylaxis (prophylactic use for subsequent cycles after initial
episode(s) of severe and/or febrile neutropenia)
Recommendation:
Secondary prophylaxis should only be considered in patients:
 Receiving myelotoxic chemotherapy with curative or radical intent
And in any one of the following circumstances:
 Where two or more dose reductions have occurred due to neutropenia or febrile
neutropenia after a chemotherapy cycle
 Where chemotherapy treatment is delayed on two or more occasions due to
neutropenia or febrile neutropenia
Note: Dose modifications will be a reasonable alternative in many clinical situations.
Secondary prophylaxis may only be considered after one delay in chemotherapy treatment or
one dose reduction due to an episode of neutropenia or febrile neutropenia for the following
patient groups:
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

Lymphoma patients (non-hodgkins lymphoma or hodgkins disease)
Germ cell tumours (non-seminomatous germ cell tumours, seminomas or other germ cell
derived tumour)
 Patients receiving the sequential FEC100-Docetaxel regimen for adjuvant treatment of early
breast cancer
 Radical chemoradiation (where delay or omission of chemotherapy treatment during
concurrent therapy may have a negative impact on disease control)
Refer to section 5 for GCSF dosage and administration guidelines in the prophylactic setting.
Criteria 2: Supportive therapy for severe neutropenic sepsis
Recommendation:
G-CSF must not be routinely prescribed for the treatment of patients with uncomplicated
febrile neutropenia or afebrile neutropenia.
G-CSF may only be prescribed for the supportive treatment of patients with severe
febrile neutropenia in scenarios as defined below:
 Profound febrile neutropenia: defined as absolute neutrophil count (ANC) < 0.1 x
109/L and patient febrile
And any one of the following prognostic factors that are predictive of poor clinical
outcome:
 Clinically unwell with signs such as hypotension, organ dysfunction etc indicating
potential risk of septic shock
 Expected prolonged duration of neutropenia (> 10 days)
 Persistent pyrexia despite appropriate antibiotics/antifungals
 Uncontrolled primary disease
 Pneumonia
 Proven or suspected invasive fungal infection
Patients who have already received pegfilgrastim as primary or secondary prophylaxis should
not receive further daily G-CSF as supportive therapy for severe neutropenic sepsis unless
more than 14 days since pegfilgrastim administration.
Refer to section 5 for GCSF dosage and administration guidelines in the neutropenic sepsis
setting.
Criteria 3: Peripheral blood stem cell mobilisation
Recommendation:
G-CSF should be prescribed to all patients undergoing harvesting of peripheral blood
stem cells in conjunction with priming cytotoxic chemotherapy.
Refer to section 5 for GCSF dosage and administration guidelines in the stem cell harvesting
setting.
Criteria 4: Clinical trials where appropriate and stated within the trial protocol
Recommendation:
G-CSF may be prescribed to patients receiving chemotherapy with radical or curative
intent who are being treated within a clinical trial and where G-CSF is recommended or
allocated as part of the trial protocol.
Refer to section 5 for GCSF dosage and administration guidelines in the clinical trial setting.
Section 5: Choice of G-CSF and Dosage and Administration Guidelines
The following G-CSF products may be used in the relevant criteria settings:
Criteria 1a/1b: Chemotherapy support for regimens with curative/radical intent
Table 1: G-CSF Dosage and Administration Guidelines for patients fulfilling criteria 1a/1b
Days to prescribe (see note 1)
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Drug
Patient
weight
Dosage
Route
Frequency
Pegfilgrastim
(see note 2
below)
Filgrastim
All
6mg
S/C
Once only
< 85 kg
300mcg
S/C
daily
Filgrastim
> 85 kg
480mcg
S/C
daily
Lenograstim
All
263mcg
S/C
daily
Weekly
chemo
cycle
2 weekly
chemo
cycle
3 weekly
chemo
cycle
4 weekly
chemo
cycle
At least 24 hours after completion of
chemotherapy
Day 3 - 7 Day 5 –
11
Day 3 - 7 Day 5 –
11
Day 3 - 7 Day 5 –
11
Day 5 –
11
Day 5 –
11
Day 5 –
11
Day 5 –
11
Day 5 –
11
Day 5 –
11
Note 1: The optimal timing and duration of G-CSF administration in the prophylactic
setting has not been defined however the recommendations above should be considered
as a guide.
Note 2: Pegfilgrastim may only be used in those hospitals in the network that are
receiving a discount from the pharmaceutical company, otherwise conventional G-CSF
should be prescribed.
Note 3: G-CSF should not normally be prescribed for prophylactic use after the final
chemotherapy cycle unless the patient is at high risk of severe febrile neutropenia and hospital
admission.
Criteria 2: Supportive therapy for severe neutropenic sepsis
Table 2: G-CSF Dosage and Administration Guidelines for patients fulfilling criteria 2
Drug
Dosage
Route
Frequency
Filgrastim
Patient
Weight or
BSA
< 85 kg
300mcg
S/C
daily
Filgrastim
> 85 kg
480mcg
S/C
daily
Lenograstim
< 2m2
263mcg
S/C
daily
Lenograstim
> 2m2
526mcg
S/C
daily
Criteria for
stopping
treatment
Stop G-CSF
once ANC >
0.5 x 109/L for
at least two
consecutive
days
Note: Pegfilgrastim is not approved for use in this setting.
Criteria 3: Peripheral blood stem cell mobilisation (4)
Commence G-CSF at day + 1 after priming chemotherapy and generally
continue until stem cell harvesting complete.
GCSF - 5mcg/kg/day (plus priming chemotherapy)
Patient
weight
< 85kg
>85kg
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<48kg
48-60kg
61-96kg
>96kg
Filgrastim 5mcg/kg S/C daily
Filgrastim 300mcg S/C daily
Filgrastim 480mcg S/C daily
Filgrastim 780mcg S/C daily
GCSF alone or with chemotherapy
Filgrastim 10mcg/kg/day for 5-7 days
Weight
<30
30-39
40-49
50-60
61-78
79-90
>90
Dose/route
300mcg S/C
300mcg S/C
480mcg S/C
600mcg S/C
780mcg S/C
900mcg S/C
960mcg S/C
Vials used
1 x 300 mcg
1 x 300 mcg
1 x 480 mcg
2 x 300 mcg
1 x 300 mcg + 1 x 480 mcg
3 x 300 mcg
2 x 480 mcg
Lenograstim 10mcg/kg/day for 5-7 days
Weight
<30
30-39
40-54
55-64
65-79
80-84
>85
Dose/route
263 mcg S/C
368 mcg S/C
526 mcg S/C
631 mcg S/C
789 mcg S/C
894 mcg S/C
1052 mcg S/C
Vials used
1 x 263 mcg
1 x 263 mcg + 1 x 105 mcg
2 x 263 mcg
2 x 263 mcg + 1 x 105 mcg
3 x 263 mcg
3 x 263 mcg + 1 x 105 mcg
4 x 263 mcg
Note: Pegfilgrastim is not approved for use in this setting.
Criteria 4: Clinical trials where appropriate and stated within the trial protocol
The G-CSF brand, dosage and administration schedule used within a clinical trial should be that
recommended within the trial protocol.
Section 6: G-CSF Side Effects and Management
For those patients who suffer from musculo-skeletal side effects due to G-CSF administration
(e.g bone pain/aches, other musculo-skeletal pains):
 Treat with simple analgesics (e.g. paracetamol)
 If severe or intolerable, consider reducing frequency of administration of non-pegylated
G-CSF products to alternate days. If patient receiving pegfilgrastim, consider changing to
alternate daily non-pegylated G-CSF.
For full information about each G-CSF product including other side effects, refer to the individual G-CSF
Summaries of Product Characteristics.
References:
(1) Aapro et al. Position paper: EORTC Guidelines for the Use of Granulocyte-Colony
Stimulating Factor to reduce the Incidence of chemotherapy-induced febrile neutropenia in adult
patients with lymphomas and solid tumours. Eur J Cancer 42 (2006): 2433 – 2453.
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(2) Smith et al. 2006 Update of Recommendations for the Use of White Blood Cell Growth
Factors: An Evidence-Based Clinical Practice Guideline. J Clin Oncol July 1 2006; 24 (19): 3187
– 3205.
(3) National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology
(2007). Myeloid Growth Factors.
(4) North London Cancer Network (2004): D Blake and N.Saini. Guidelines for the use of
Haematopoietic Colony-Stimulating Factors in Adult Oncology and Haematology Patients.
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APPENDIX 5- Cetuximab protocol
MOUNT VERNON CANCER CENTRE
PROTOCOL GUIDELINES
NAME OF PROTOCOL
Single Agent Cetuximab + Radiotherapy
INDICATION
Locally advanced squamous cell cancer of the head and neck
(patients with Karnofsky PS > 90% and where platinum based
chemo/radiotherapy is contraindicated)(1)
DOSAGE(2)
Cetuximab 400mg/m2 (loading dose) IV infusion over 2 hours Week
1 then 250mg/m2 IV infusion over 1 hour every week thereafter for
total of 7-8 weeks (i.e. until last week of radiotherapy). Start
cetuximab one week prior to radiotherapy treatment.
FREQUENCY OF REGIMEN(2)
Weekly
DURATION OF REGIMEN
7 – 8 weeks total (depending on duration of radiotherapy)
SUPPORTIVE TREATMENTS
Pre-medication:
Antihistamine should be administered prior to each weekly dose of cetuximab – Chlorphenamine 10mg
IV bolus.
ANTIEMETICS
Refer to Cancer Network Antiemetic Guidelines(3). No routine antiemetics should be necessary.
PRE-TREATMENT INVESTIGATIONS
FBC, U&E’s including creatinine, serum magnesium and LFT’s must be performed prior to
commencement of treatment and at 4 and 8 weeks during therapy. Normal hepatic, renal and
haematological function should be confirmed prior to treatment commencement in week 1. The results of
these investigations are not required prior to drug administration in week 4 and 8.
DOSE MODIFICATIONS
1. Haematological toxicity
Not applicable
2. Hepatic impairment(2)
Cetuximab has not been investigated in patients with hepatic impairment. Only patients with adequate
hepatic function have been investigated to date (transaminases < 5 times and bilirubin < 1.5 times the
upper limit of normal).
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3. Renal impairment(2)
Cetuximab has not been investigated in patients with renal impairment. Only patients with adequate
renal function have been investigated to date (serum creatinine < 1.5 times the upper limit of normal).
POTENTIAL TOXICITIES AND MANAGEMENT
1. Pulmonary toxicity(2)
Dyspnoea has been reported in up to 25% of patients. In elderly patients and in patients
with reduced performance status or pre-existing cardiac or pulmonary disorders, an
increased incidence of dyspnoea, sometimes severe, was observed. It may occur in
close temporal relationship to the cetuximab infusion as part of an infusion-related
reaction, but has also been reported after several weeks of therapy, possibly related to
an underlying disorder. If patients develop dyspnoea during the course of cetuximab
treatment, it is recommended to investigate them for signs of progressive pulmonary
disorders as appropriate.
Individual cases of interstitial lung disorders of unknown causal relationship to cetuximab have been
reported. If interstitial lung disease is diagnosed, cetuximab must be discontinued and the patient be
treated appropriately.
2. Cardiotoxicity(2)
No significant incidence of cardiotoxicity has been reported. However, a rare
manifestation of the cetuximab-induced infusion related reaction (see section 5) may
include angina pectoris, myocardial infarction or cardiac arrest.
3. Gastro-intestinal toxicity(2)
(a) Nausea and Vomiting
The incidence of nausea and vomiting is low with cetuximab and radiotherapy. Patients
should be managed with standard antiemetics as required.
(b) Mucositis
In combination with local radiotherapy, additional undesirable effects observed were
those typical of radiation therapy to the head and neck area including mucositis and
dysphagia. Symptomatic management should include the use of appropriate topical
mouthwashes and analgesics as required.
(c) Diarrhoea
Not applicable
4. Neurologic toxicity
Not applicable
5. Hypersensitivity reactions(2)
Mild or moderate infusion-related reactions comprising symptoms such as fever, chills, nausea,
vomiting, headache, dizziness, or dyspnoea often occur in a close temporal relationship mainly to the
first cetuximab infusion.
Severe infusion-related reactions may occur, in rare cases with fatal outcome. They
usually develop during or within 1 hour of the initial cetuximab infusion (but may occur
after several hours or with subsequent infusions) and may include symptoms such as
rapid onset of airway obstruction (bronchospasm, stridor, hoarseness, difficulty in
speaking), urticaria, hypotension, or loss of consciousness; in rare cases, angina
pectoris, myocardial infarction or cardiac arrest have been observed. It is recommended
to warn patients of the possibility of such a late onset of symptoms and to instruct them
to contact the hospital if symptoms of an infusion-related reaction occur. Although the
underlying mechanism has not been identified, some of these reactions may be
anaphylactoid / anaphylactic in nature.
If the patient experiences a mild or moderate infusion-related reaction, the infusion rate may be
decreased. It is recommended to maintain this lower infusion rate in all subsequent infusions.
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Occurrence of a severe infusion-related reaction requires immediate and permanent discontinuation of
cetuximab therapy and may necessitate emergency treatment.
6. Other toxicities(2)
Dermatological toxicity - In the Bonner study(4), the incidence of severe acute radiation dermatitis was
slightly higher in patients receiving radiation therapy in combination with cetuximab than in those
receiving radiation therapy alone.
Cetuximab-induced skin reactions may develop in more than 80% of patients and mainly present
as acne-like rash and/or, less frequently, as pruritus, dry skin, desquamation, hypertrichosis, or
nail disorders (e.g. paronychia). Approximately 15% of the skin reactions are severe, including
single cases of skin necrosis. The majority of skin reactions develop within the first three weeks
of therapy. They generally resolve, without sequelae, over time following cessation of treatment
if the recommended adjustments in dose regimen are followed (see below). According to NCICTC, grade 2 skin reactions are characterised by rash up to 50% of body surface area, while
grade 3 reactions affect equal or more than 50% of body surface area.
If a patient experiences a severe skin reaction ( grade 3; US National Cancer Institute - Common
Toxicity Criteria, NCI-CTC), cetuximab therapy must be interrupted. Treatment may only be resumed, if
the reaction has resolved to grade 2.
If the severe skin reaction occurred for the first time, treatment may be resumed without any change in
dose level.
With the second and third occurrences of severe skin reactions, cetuximab therapy must again
be interrupted. Treatment may only be resumed at a lower dose level (200 mg/m² body surface
area after the second occurrence and 150 mg/m² after the third occurrence), if the reaction has
resolved to grade 2.
If severe skin reactions occur a fourth time or do not resolve to grade 2 during interruption of treatment,
cetuximab treatment should be permanently discontinued.
For > grade 1 acne-like rash, treatment with systemic antibiotics should also be considered (e.g.
Doxycycline 100mg PO daily).
Skin lesions induced by cetuximab may predispose patients to superinfections (e.g. with S.
aureus), which may lead to subsequent complications, e.g. cellulitis, erysipelas, or, potentially
with fatal outcome, staphylococcal scalded skin syndrome or sepsis.
Electrolyte disturbances – Progressively decreasing serum magnesium levels have been observed
leading to severe hypomagnesaemia in some patients. Hypomagnesaemia is reversible following
discontinuation of cetuximab. Depending on severity, other electrolyte disturbances, mainly
hypocalcaemia or hypokalaemia, have also been observed.
Determination of serum electrolyte levels is recommended prior to and periodically during cetuximab
treatment. Electrolyte repletion is recommended, as appropriate.
Ocular disorders – Conjunctivitis may be expected in approximately 5% of patients.
Hepatotoxicity - Mild to moderate increase in liver enzyme levels (AST, ALT, ALP) have been reported
commonly.
PRECAUTIONS(2)
Hypersensitivity – due to the risk of cetuximab-induced infusion related reactions, all patients
should be pre-medicated with anti-histamine IV prior to each week’s treatment (see “Supportive
Treatments”). Close monitoring of the patient is also required during the infusion and for at least
1 hour after the end of the infusion, with each dose of drug.
COMMON DRUG INTERACTIONS(2)
There are no known significant drug interactions with cetuximab. No formal interaction studies with
cetuximab have been performed in humans.
REFERENCES
(1) National Institute for Health and Clinical Excellence. Cetuximab for the treatment of locally
advanced squamous cell cancer of the head and neck. Technology Appraisal Guidance 145
(June 2008). Available at www.nice.org.uk.
(2) Summary of Product Characteristics – Cetuximab (Merck Serono). Accessed from the eMC
20/8/08.
582727853
October 2008
164
(3) Mount Vernon Cancer Network – Guidelines for the Management of Nausea and Vomiting in
Adult Patients receiving Chemotherapy and/or Radiotherapy. November 2006.
(4) Bonner et al. Radiotherapy plus Cetuximab for Squamous-Cell Carcinoma of the Head and
Neck. N Engl J Med 2006; 354:567-78.
Protocol written by:
Signature:
Michael Powell, Senior Oncology Pharmacist
Protocol approved by:
Dr Kate Goodchild, Consultant Oncologist
Date produced:
October 2008
October 2010
Signature:
Review date:
Mount Vernon Cancer Centre
CHEMOTHERAPY PROTOCOL SUMMARY
Consultant:
(place in Patient Notes)
Ht (cm):
Wt (kg):
BSA (m2):
Intent: Radical
Patient label
Protocol: Cetuximab with Radiotherapy
Diagnosis: Locally advanced head and neck
cancer
REGIMEN: Cetuximab 400mg/m2 (loading dose) IV infusion over 2 hours Week 1 then
250mg/m2 IV infusion over 1 hour every week thereafter for total of 7-8 weeks (i.e. until last
week of radiotherapy). Start cetuximab one week prior to radiotherapy treatment.
Supportive medication:
Pre-medication: antihistamine should be administered prior to each weekly dose of cetuximab – Chlorphenamine 10mg IV bolus.
Total No. of cycles intended: 7 – 8 weeks
DATE
Week No.
1
Haemoglobin
(g/dL)
WBC (x109/L)
Neutrophils
(x109/L)
Platelets (x109/L)
Intravenous
Dose
Cytotoxic
582727853
2
Dose
Review every _______ weeks
3
Dose
October 2008
4
Dose
5
Dose
6
Dose
7
Dose
8
Dose
165
Cetuximab IV
infusion (over 2
hours week 1,
over 1 hour
subsequent
weeks)
Pre-medication
Dose
Dose
Dose
Dose
Dose
Dose
Dose
10mg IV
10mg IV
10mg IV
10mg IV
10mg IV
10mg IV
10mg IV
Dose
Chlorphenamine
10mg IV
Ordered by:
Prescribed by:
Given by:
PRESCRIPTION SHEET
DOCTORS NOTES
DOSE MODIFICATIONS:
582727853
October 2008
166
Mount Vernon Cancer Centre
INPATIENT CHEMOTHERAPY PRESCRIPTION SHEET
Regimen: Cetuximab with Radiotherapy
Patient label
Cycle No.:
Date
BSA:
DRUG
DOSE
Chlorphenamine
Cetuximab
ROUTE
DILUENT
VOLUME
INFUSION
DURATION
10mg
IV
-
-
Bolus
____mg
IV
Sodium Chloride
0.9%
250ml
JOB/BATCH
NO.
____hours*
NURSES
SIGNATURE
TIME
STARTED
PHARMACY
1
2
1
2
* Infuse cetuximab over 2 hours Week 1 and over 1 hour in subsequent weeks.
Signature of doctor authorising chemotherapy administration: __________________________
Full Blood Count results (only if applicable)
Hb
WBC
Neutrophils
Platelets
167
Appendix 11
MVCN Pathology Guidelines
Reporting of pathology specimens for Head & Neck UAT and thyroid cancer specimens will follow the
appropriate Royal College of Pathologists guidelines (see below).
Additional local guidelines for major specimens are as follows.
Tissue pathways for head and neck pathology-- Luton and Dunstable Hospital pathology
department.
Staffing and workload.
All of pathologist in this unit are competent in the reporting of specimen from the head and neck. However
two pathologists take the lead and deputy lead role.
Lead pathologists in future will participate in a specialist head and neck EQA scheme.
All are newly diagnosed malignancies are doubled reported.
All cases discussed at the MDT are reviewed by the MDT pathologist prior to the meeting.
The department uses the guidelines for staffing and workload in cellular pathology generated by the Royal
College. Time for MDT work is allocated in accordance with the college recommendation.
Laboratory facilities
A full range of routine laboratory facilities are available including access to immunocytochemistry, frozen
section facility .
A dedicated FNA service is available.
Protocols for decalcification, immunocytochemistry and specimen dissection and reporting are provided ,
thus maintaining Uniformity.
Specimen submission and dissection.
All specimens are those seen in the laboratory in formalin. Complex specimens are received with
orientation and the macroscopical the features are usually discussed with the surgeon before blocks are
taken. Photograph facilities are available.
Mucosal biopsies
Specimens where appropriate are inked for marginal assessment. The sections are taken according to the
individual sample and mostly are sampled across the short axis for closest excision margin assessment.
Major salivary glands
Blocks are taken to sufficiently sample adequacy of surgical margins, adjacent mucosa and normal salivary
glands, one block per centimetre diameter of tumour, proximal and distal aspect of nerves if identifiable and
any intra glandular or adjacent lymph nodes.
Immunocytochemistry and special mucin stains are regularly used for assessment.
168
Larynx , pharynx and tonsil
The specimens are orientated usually with the help of the surgeon. Relevant margins are inked.
Measurement is usually three-dimensional. Weight is noted where relevant.
Complex specimens are dealt according to college guidelines.
Associated lymph nodes , thyroid , salivary gland, blood vessels, nerves adipose tissue art examined and
relevant blocks taken.
In addition to free text Royal College protocol is used for reporting.
The report content records the type of tumour, tumour interface, relationship the major vessels and nerves
and nearest surgical margin.
References.
Tissue Pathways for Head & Neck Pathology. September 2008.
Royal College of Pathologists (Appendix 1)
Standards and datasets for reporting cancers
Dataset for thyroid cancer histopathology reports April 2010
Royal College of Pathologists (Appendix 2)
169
The Royal College of Pathologists
Pathology: the science behind the cure
Standards and Datasets for Reporting Cancers
Datasets for histopathology reports on head and neck carcinomas
and salivary neoplasms
(2nd edition)
June 2005
This dataset was commissioned by The Royal College of Pathologists' Working Group on Cancer
Services. It replaces the first edition published in 1998.
According to the College’s pre-publication policy, this document was placed on the College website for consultation from 16 November to
12 December 2004. Five pieces of feedback were received, which were forwarded to the lead author and considered in this final version.
Professor John A Lee
Director of Publications
Acknowledgement
The Royal College of Pathologists’ Working Group on Cancer Services acknowledges the use of the
Appraisal Instrument for Clinical Guidelines (Cluzeau F, Littlejohns P, Grimshaw J, Feder G. London: St
George’s Hospital Medical School, May 1997) in the preparation of this publication.
The Royal College of Pathologists
2 Carlton House Terrace
London
SW1Y 5AF
Website: www.rcpath.org
Registered Charity No. 261035
© 2005 Royal College of Pathologists
170
CONTENTS
General introduction to the Standards and Datasets for Reporting Cancers
Recommendations
Feedback
The Royal College of Pathologists’ Working Group on Cancer Services
References
1
1
1
1
1
Dataset for histopathology reports on head and neck carcinomas and salivary neoplasms
General overview
2
Section A
Mucosal malignancies of the head and neck region
Specimen request form
Preparation of the specimen before dissection
Notes on site-specific considerations and block selection
Core data items to be included in the histopathology report
1. Clinical data (provided by the surgeon or oncologist)
2. Pathological data
3. Diagnostic coding of primary carcinomas
4. Reporting criteria for small biopsy specimens
5. Use of frozen section diagnosis
3
3
3
4
4
4
4
7
7
7
Section B
Salivary gland neoplasms
Specimen handling and block selection
1. Pathological data
2. Diagnostic coding
3. Grading of salivary malignancies
8
8
8
9
9
Section C
Neck dissection specimens
Specimen request form
Preparation of the specimen before dissection
Notes on dissection and block selection
Core data items to be included in the histopathology report
1. Clinical data (provided by the surgeon)
2. Pathological data
3. Diagnostic coding of metastases
4. Sentinel node biopsy
11
11
12
12
13
13
13
14
14
References
15
Appendix A
TNM classification of malignant tumours
General principles
Site-specific ‘T’ codes
18
18
19
Appendix B
SNOMED ‘T’ codes
21
Appendix C
SNOMED ‘M’ codes
23
Appendix D
Request forms for primary mucosal carcinomas and node dissections
24
Appendix E
Reporting proformas
Head and neck carcinoma dataset
Salivary carcinoma dataset
26
26
27
171
General introduction to the Standards and Datasets for Reporting Cancers
All these documents are evidence-based and define the minimum standards for reporting each group of tumours.
They conform to a standard format and include a proforma that is intended to function as an aide memoire when
reporting specific tumours. Although the data in the proforma may be presented as or supplemented by free text,
the use of proformas in histopathological reporting is recommended; published audits have shown that they are
very effective in ensuring that all necessary data are provided.1,2
Copies of the reporting forms are available at the end of this booklet and can also be downloaded from
the College website (www.rcpath.org/publications).
Recommendations
The Royal College of Pathologists’ Working Group on Cancer Services recommends that:
•
•
•
•
•
•
the datasets for reporting tumours are used in the system of standard setting, data collection,
audit and feedback for those involved in caring for these patients
histopathology laboratories nominate a lead pathologist for each of the main cancers with
responsibility for liaising with relevant local committees and clinicians and ensuring that the
relevant cancers are examined, sampled and reported appropriately and in a consistent
fashion
histopathologists should be members of multidisciplinary teams dedicated to the diagnosis and
management of patients with specific cancers (and be involved in auditing the service)
the SNOMED coding system is used to achieve as much uniformity as possible from centre to centre
and to facilitate reliable cancer registration. Either the 1979 or 1993 version of SNOMED can be
used, as currently there is no clear consensus for using one or the other
histopathologists reporting cancers should participate in appropriate external quality assessment (EQA)
schemes
Cancer Centres and Units should be supported only by laboratories accredited with CPA (UK)
Ltd
and staffed in accordance with the recommendations of The Royal College of Pathologists and the
Association of Clinical Pathologists.
Feedback
Anyone wishing to make specific or general comments on any of the documents should contact Dr Timothy
Helliwell, Department of Pathology, University of Liverpool, Duncan Building, Daulby Street, Liverpool, L69
3GA. Email: [email protected]
This document will be reviewed if new evidence emerges.
Members of The Royal College of Pathologists’ Working Group on Cancer Services
Dr Tim Helliwell (Chair)
Dr Derek Allen
Dr Ian Ansell
Dr Mark Ashton
Dr Clair du Boulay
Dr Gill Lawrence
Dr Nicholas Mapstone
References
1.
Cross SS, Angel CA. Five audit cycles of the informational content of histopathological reports of
bladder carcinoma. J Pathol 1997;181:7A.
2.
Cross SS, Feeley KM, Angel CA. The effect of four interventions on the informational content of
histopathology reports of resected colorectal carcinomas. J Clin Pathol 1998; 51:481–482.
172
Datasets for histopathology reports on
head and neck carcinomas and salivary neoplasms (2nd edition)
Coordinators: Dr TR Helliwell and Dr JA Woolgar, University of Liverpool
GENERAL OVERVIEW
These guidelines present the core data that should be provided in histopathology reports of specimens of
squamous carcinomas originating in the mouth, nose, pharynx and larynx, malignant neoplasms arising in the
major salivary glands, and neck dissection specimens for metastatic disease. The datasets for squamous
carcinoma and neck dissections are unchanged since the first edition of this publication, but the guidelines have
be n revised in the light of a national audit in 2001 and more recent evidence supporting the inclusion of specific
data items. The appendices list current systems of classification and staging for these malignancies, as well as
illustrative histopathology request forms and proforma reports.
The guidelines should be implemented for the following reasons.
1.
Certain features of invasive mucosal carcinomas (type, size and grade of the primary carcinoma, the
pattern of invasion and proximity of carcinoma to resection margins, lymph
node status and the
presence of extranodal spread) have been shown to be related to clinical outcome.1–8 Similar
principles apply to salivary malignancies.9–11 These features may therefore be important in:
a)
deciding on the most appropriate treatment for particular patients, including the extent
of surgery and the use and choice of adjuvant radiotherapy or chemotherapy
b)
monitoring changing patterns of disease, particularly by cancer registries.
2.
These features provide sufficiently accurate pathological information that can be used,
clinical data, for the patient to be given a prognosis.
together with
3.
To allow the accurate and equitable comparison of surgeons in different surgical units, to identify good
surgical practice and the comparison of patients in clinical trials.
The criteria have been widely discussed by pathologists and surgeons, and formal approval was sought from the
British Society of Oral and Maxillofacial Pathology, the British Association of Head and Neck Oncologists, the
British Association of Oral and Maxillofacial Surgeons, the British Association of Otolaryngology – Head and
Neck Surgeons, the UK Association of Cancer Registries. Comments from specialist and general
histopathologists on the draft version of this document, which was published for consultation on the College
website in 2004, have been considered as part of this dataset.
On the request forms, we are grateful to Professor DG McDonald, University of Glasgow, for permission to use
the diagrams of the oral cavity and jaws, and to the International Union Against Cancer (UICC) and SpringerVerlag to use the diagrams of the larynx and neck that are adapted from the TNM Atlas (3rd edition), 1989
173
Section A
Mucosal malignancies of the head and neck region
This section applies to the reporting of squamous carcinomas of the upper aerodigestive tract, i.e. those arising
in the nose and paranasal sinuses, mouth (including the tongue), pharynx (including nasopharynx, hypopharynx,
oropharynx and tonsillar area) and larynx. Squamous carcinoma accounts for 95% of malignant neoplasms
arising at these sites, but similar principles may be applied to the reporting of other mucosal malignancies
arising in this anatomical area including adenocarcinomas, undifferentiated nasopharyngeal carcinomas,
malignant melanoma, and to neuroendocrine epithelial neoplasms including carcinoid tumour, small cell
carcinoma and olfactory neuroblastoma, that are important considerations in the differential diagnosis but are
not described in detail.
Optimal reporting of specimens from the head and neck area requires a partnership between the pathologist and
surgeon/oncologist. The surgeon can help the pathologist to provide the information necessary for patient
management by the appropriate handling and labelling of the specimen in the operating theatre. Regular
discussion of cases at clinicopathological meetings and correlation with pre-operative imaging studies are
important in maintaining and developing this partnership. 12
The guidelines are presented as a proforma that lists the core data items that may be applied across the head and
neck region. The proforma may be used as the main reporting format or may be combined with free text as
required. Individual centres may wish to expand the detail in some sections, e.g. for sites and subsites, to
facilitate the recording of data for particular tumour types. A detailed dissection protocol is beyond the scope of
these guidelines, but a brief summary of dissection methods and block selection is included to facilitate
recording of the core data items.
SPECIMEN REQUEST FORM
The request form should include patient demographic data, the duration of symptoms, whether surgery is
palliative or curative, details of previous histology or pathology reports and the core clinical data items (see
below). Clinical TNM stage is useful as the final pathological T coding at some sites, e.g. the larynx, will be
determined by clinical features such as vocal cord mobility.13 A history of previous radiotherapy or
chemotherapy should be included, as this may influence the interpretation of the histological changes and should
prompt a comment on the extent of any response to treatment. The request form should provide the opportunity
for surgeons to provide annotated diagrams of specimens either as free-hand drawings or on standard diagrams
(see Appendix D). Copies of reports that are sent to the Cancer Registries should include the patient’s address if
possible.
PREPARATION OF THE SPECIMEN BEFORE DISSECTION
Resection specimens should be orientated by the surgeon and pinned or sutured to cork or polystyrene
blocks. The surgeon should indicate surgically critical margins using metal tags or sutures. Fixation is in a
formaldehyde-based solution for 24–48 hours in a container of adequate size (the volume of fixative should be
ten times that of the tissue). Photography and radiography of the specimen may be used to record the nature of
the disease and the sites from which tissue blocks are selected. Surgical margins should be painted with Indian
ink or an appropriate dye to facilitate the later recording of the proximity of carcinoma to the margin.
174
NOTES ON SITE-SPECIFIC CONSIDERATIONS AND BLOCK SELECTION
Oral cavity and oropharynx
In general, these specimens may be assessed by cutting the specimen with a large knife into 5 mm slices to
demonstrate both the relationship of the tumour to mucosal resection margins and the maximum depth of
invasion by the tumour. Specimens from the central and lateral parts of the mouth should be cut in the coronal
plane, while specimens from the anterior mouth should be sliced in the sagittal plane. If the tumour is close to
bone, the specimen should be decalcified with soft tissue in situ.
Larynx and hypopharynx
5 mm thick horizontal slices provide optimal demonstration of the relationship between the tumour and the
laryngeal cartilages. For supraglottic carcinomas, blocks should include the relationship between the carcinoma
and the anterior (submucosal) resection margin at the base of the tongue; blocks taken in the sagittal plane are
more appropriate to demonstrate this feature. The description should include the subsite of origin of carcinoma,
and the extent of involvement of laryngeal cartilages and extra-laryngeal tissues.14
Paranasal sinuses and maxillectomy specimens
These are complex specimens that require careful orientation and labelling by the surgeon if the pathologist is to
provide accurate information. When appropriate, the surgeon should assist the pathologist in the dissection of
the intact specimen to ensure that critical margins are oriented and submitted for histological examination. For
partly disrupted specimens, it may sometimes be necessary for surgically critical margins to be sent as separate
specimens to the laboratory.
Selection of blocks for histology
•
•
•
•
•
•
•
Tumour – at least one block per 10 mm diameter of tumour, including one selected to demonstrate the
maximum depth of invasion; whole tumour if less than 10 mm.
Blocks of defined mucosal and soft tissue margins.
Non-neoplastic mucosa.
Bone surgical margins (if applicable).
Bone or cartilage (larynx, nose), if grossly involved by tumour.
Thyroid if present in laryngectomy.
Tracheostomy site.
CORE DATA ITEMS TO BE INCLUDED IN THE HISTOPATHOLOGY REPORT
1 Clinical data (provided by the surgeon or oncologist)
1.1
Site(s) and side(s) of the carcinoma(s). For carcinomas that involve more than one site, the principal
site of involvement should be recorded and coded; this may not be the site of origin. If required, the
involvement of associated sites can be noted to help in later data analysis. Sites and subsites should be
recorded according to the International Union Against Cancer (UICC) nomenclature (see Appendix
A).
1.2
Type of resection specimen, e.g. total or partial glossectomy, laryngectomy.
2
Pathological data
2.1
Maximum diameter of tumour (in millimetres). The macroscopic diameter should be used (Figure 1)
unless the histological extent is greater than macroscopically apparent, in which case the microscopic
dimension is used. As for other tissues, e.g. breast, measurements are madepragmatically,
acknowledging distortion of tissues by fixation and processing
2.2
Maximum depth of invasion (millimetres) below the luminal aspect of surface; if the tumour has
ulcerated then the reconstructed surface should be used (Figure 1). The aim should be to provide a
best estimate of tumour depth; for large carcinomas this may be an approximation. A more detailed
comment on the nature of the tissues invaded (mucosa, muscle, etc.) should occur in the ‘Comments’
sections. Tumour thickness is significantly related to nodal metastasis, although the optimal cut-off
point for prognostic purposes is uncertain, with 3 mm and 5 mm being suggested by different studies of
lingual carcinomas.15, 16
175
Figure 1 Descriptors of the size of the primary carcinoma. (A) for a nodular carcinoma and (B) for an
ulcerated carcinoma. Note that depth of invasion refers to the depth of greatest spread in
presumed continuity below the top of the adjacent mucosa. For both nodular and ulcerated
tumours, the line of the original mucosal surface is reconstructed to determine the true
thickness.
2.3
Histological type of carcinoma. These guidelines specifically apply to conventional squamous
carcinomas. Subtypes of squamous carcinoma, such as papillary, verrucous, basaloid, adenosquamous
and spindle cell carcinomas, should be recognised 17 and listed in the core dataset and potential
prognostic implications noted in the ‘Comments’ sections.
2.4
Degree of differentiation. Grading is based on the degree of resemblance of the carcinoma to the
normal epithelium and follows the descriptions in the World Health Organization (WHO)
classification.17 The most aggressive area (medium magnification field) is graded as well differentiated,
moderately differentiated or poorly differentiated. This system is widely used and prognostically
useful, even though it suffers from inter-observer variability and sampling problems.5,18 While most
squamous carcinomas will be moderately differentiated, it is important for prognostication to separate
well differentiated and poorly differentiated tumours.
2.5
Invasive front of the carcinoma. The pattern of invasion by the carcinoma at its deep margin is of
proven prognostic value for oral carcinomas.4,19,20 The few published studies of tumours at other sites
suggest that a similar approach may be of value.3
Scoring systems for histopathological features of squamous carcinomas include features relatedto
differentiation and to the tumour/stromal interaction. 1–3 While these have the potential to improve the
consistency of reporting, they are not in widespread use and for these guidelines it is suggested that the
recording of differentiation and invasive pattern is made separately.
It should be recognised that the pattern of tissue invasion by carcinoma is a continuous spectrum of
changes. For prognostic purposes, two groups can be recognised: carcinomas
composed of broad
cohesive sheets of cells or strands of cells (more than 15 cells across), and carcinomas composed of
narrow strands, non-cohesive small groups or single cells (see Figure 2).4
176
Figure 2
Patterns of invasion by squamous carcinoma.
a, b, c are examples of cohesive patterns.
d, e, f are examples of non-cohesive or infiltrating patterns.
2.6
Distance from invasive carcinoma to surgical margins (in millimetres). Measure the distance
histologically for both mucosal and deep margins. From a surgical point of view, >5 mm is ‘clear’,1–5
mm is ‘close’ and <1 mm is ‘involved’. Incomplete resection or the presence of dysplasia at themargin
is associated with a significantly increased risk of local recurrence.21 In the ‘Comments’section, it may
be noted that if the tumour has an infiltrating pattern of invasive front (or vascular or perineural spread
ahead of the invasive front) and a close margin, this may be associated with a high risk of local
recurrence. Note that comment on the deep resection margin of a laryngectomy specimen may be
inappropriate unless the tumour extends close to the base of tongue or into the soft tissues of the neck.
2.7
Vascular invasion. The presence or absence of vascular invasion should be mentioned if it is an
obvious feature on medium magnification examination of the tumour. The presence of carcinoma cells
within an endothelial-lined space is the essential criterion. It is not necessary to distinguish between
small lymphatics and venous channels.
2.8
Nerve invasion. The presence or absence of invasion of the perineural space ahead of the invasive front
of the carcinoma should be recorded. This is especially important for carcinomas of the lip where
this feature predicts local recurrence. Intra-tumoural perineural invasion is of doubtful prognostic
significance.
2.9
one invasion or cartilage invasion. The involvement of bone may be by non-invasive erosion of the
cortex, or diffuse infiltration of medullary intertrabecular and perineural tissues. 13 These should be
distinguished in the ‘Comments’ section. If bone margins can be identified, the resence or absence of
carcinoma at the margins should be described in the ‘Comments’ section.
2.10
Severe dysplasia/in situ carcinoma. Epithelial dysplasia forms a continuous spectrum of appearances
from mild to severe dysplasia/carcinoma in situ. Detailed discussion of the criteria and reproducibility
of grading systems is not part of these guidelines and consensus has not been reached on the most
clinically appropriate and reproducible grading system. The options include the standard WHO
system,17 the system based on grades of squamous intraepithelial neoplasia22 and the Ljubliana
classification for laryngeal lesions.23 Severe dysplasia and carcinoma in situ are generally regarded as
synonymous and are associated with a high risk of progression to carcinoma. The presence of severe
dysplasia/carcinoma in situ adjacent to the primary carcinoma and at the resection margins (where it
may predict local recurrence) should be recorded. 24,25
177
Other features form part of a complete description, but are not core data items
These features should be included as part of a comprehensive description of a carcinoma and the surrounding
tissues. Some are preferences of individual centres, but are considered to be of uncertain prognostic significance
at most sites in the head and neck region and therefore are not part of the dataset at present.
•
•
•
•
Type and intensity of inflammatory infiltrate and desmoplastic stromal response.
Involvement of a tracheostomy (if present).
Response to previous therapy (if applicable).
Results of other investigations, e.g. flow cytometry, molecular and immunohistochemical
studies.
Molecular markers including measures of cell proliferation and nuclear DNA content, the expression of
involucrin, blood group antigens, cell adhesion molecules and oncogenes, and the intensity of neoangiogenesis
have been investigated as potential prognostic factors. These features generally correlate with cellular
differentiation but do not provide any consistent independent prognostic information. 6,26,27 While molecular
markers predictive of tumour behaviour or response to therapy may be required pathological data in the future,
current surgical practice does not demand their inclusion in the dataset .8,21
Immunocytochemical studies may help to resolve differential diagnostic problems. Most antibodies lack a
precise tissue or neoplastic specificity, so that a combination of appropriate results is required to make a
diagnosis. These results should always be consistent with the haematoxylin and eosin appearances.
3
Diagnostic coding of primary carcinomas
3.1
pT status should be recorded according to the UICC guidelines (see Appendix A).13
3.2
SNOMED ‘T’ code(s) should be recorded for primary site(s). A list of ‘T’ codes against site and
subsite is provided in Appendix B.
4 Reporting criteria for small biopsy specimens
4.1
The data that can be obtained from small biopsy specimens will be determined, in part, by their size.
The type of carcinoma and its grade are the minimum data required to determine treatment. It is
recognised that, in large tumours, the grade in superficial biopsy material may not be representative
of the most aggressive part of the invasive front. If severe dysplasia/in situ carcinoma is present, this
should be recorded as it may influence the position of excision margins. For larger diagnostic biopsies,
as may be obtained from oral neoplasms, the pattern of invasion can be determined. It is not realistic
to assess reliably the tumour thickness or presence of vascular invasion in small biopsies.
5 Use of frozen section diagnosis
5.1
The initial diagnosis of carcinoma will usually be made before definitive surgery is performed. On
occasions, intra-operative frozen section diagnosis of the nature of a neoplasm will be required. While
it will usually be possible to identify the presence of neoplastic tissue, the nature of a poorly
differentiated neoplasm may be impossible to determine on frozen sections.
5.2
The assessment of the presence or absence of carcinoma at surgical resection margins is the
most common indication for intra-operative frozen section diagnosis. The surgeon should
select the tissue for frozen section diagnosis with care, bearing in mind that it is not usually
possible to section material more than 10 mm in diameter.
5.3
The report on the frozen section specimen should form part of the final diagnostic report on the case.
178
Section B Salivary gland neoplasms
Malignant tumours of the salivary glands are usually removed by partial excision of the gland including the
tumour mass, or by total excision of the gland. Parotid tumours may require an extended radical procedure with
resection of the subcutis and skin of the pre/infra-auricular region and upper neck. Resection margins around
salivary tumours will be either salivary tissue and/or soft tissue. The most important prognostic features are the
histological tumour type, the clinical/pathological stage and the adequacy of the excision. 11,28
The dataset does not cover benign salivary neoplasms, although pathology reports on these neoplasms would be
expected to include an overall description of the specimen and the tumour, the histological type (WHO
classification) and the proximity of the neoplasm to the resection margins. The parotid gland is richly supplied
with two networks of lymphatic vessels, paraglandular and intraglandular, which may or may not
intercommunicate. Each gland contains 20–30 lymph nodes that may be the site of metastases from salivary
tumours and other malignancies, particularly those arising in the head and neck region. The efferent lymphatics
from the parotid drain primarily to the superior deep cervical nodes (level II). The submandibular gland does not
contain intraglandular lymph nodes and the parenchyma drains to the 2–5 submandibular nodes that lie close to
the gland, and then to nodes at level II. The sublingual gland drains to the submandibular, submental and level II
nodes.29
SPECIMEN HANDLING AND BLOCK SELECTION
The exposed margin of the excised tissue should be marked with Indian ink or a suitable pigment before the
tissue is serially sliced. If a major nerve has been resected, the proximal and distal margins should be indicated
by the surgeon, thus facilitating accurate assessment of any peri- or intra-neural invasion.
Blocks to be taken
•
•
•
Representative blocks of tumour (at least one per 10 mm of tissue diameter) to include
tissue and the relationship between tumour and the nearest resection margin.
Lymph nodes within the gland or in peri-glandular soft tissue.
Blocks from designated resection margins of nerves.
normal
Neck dissection specimens associated with salivary neoplasms are handled as described in Section C.
1 PATHOLOGICAL DATA
1.1 Macroscopic features
Core data items for a salivary tumour are:
•
•
•
•
•
•
•
the maximum diameter of the tumour (in millimetres)
the distance from the tumour to the nearest resection margin (the macroscopic measurements should be
confirmed histologically and, if there is a discrepancy, then the histological distance should be stated in
the dataset)
macroscopic extraglandular extension to involve adjacent structures
the histological type of neoplasm (according to the WHO classification)
the grade of malignancy (see below)
the presence or absence of perineural or vascular invasion
the presence or absence of lymph node involvement.
179
1.2 Other macroscopic features form part of a complete description, but are not core
data items:
•
•
•
•
•
•
•
•
the type of specimen (superficial or total parotidectomy, extent of any neck dissection
the overall size of the specimen with regard to anatomical features
the length of the excretory duct, if obvious
the size of the tumour in three dimensions
a note of the presence and size of lymph nodes around or within the gland
the nature of the tumour: solitary or multifocal; solid or cystic, etc.
the nature of the edge of the tumour: discrete (well defined) or poorly defined
the appearance and texture of the cut surface: translucent or cartilaginous, brown or
haemorrhagic, cystic, necrotic, etc.
1.3 Other microscopic features form part of a complete description, but are not core
data items:
•
•
•
•
•
mitotic index
microscopic encapsulation or invasion of normal tissues
changes in the macroscopically normal salivary tissue
immunocytochemical labelling may help to characterise some types of neoplasm that contain
myoepithelial cells (e.g. caldesmon, calponin, p63, S-100 protein), luminal cell cytokeratins
(CK 8, 18, 19) or mitochondria, but diagnosis should be based primarily on morphological
criteria
molecular markers such as MIB-1, bcl-2, p53, HER-2 may have prognostic value,11, 30 but are not
routinely performed.
2
DIAGNOSTIC CODING
2.1
pTNM stage according to standard criteria (see Appendix A). The TNM staging according to the UICC
classification applies to tumours of the major salivary glands.13 Salivary-type neoplasms of minor
glands should be staged according to the criteria for mucosal squamous carcinomas.
2.2
SNOMED ‘T’ and ‘N’ codes (see Appendix B).
3
GRADING OF SALIVARY MALIGNANCIES
3.1
Mucoepidermoid carcinoma
Grading of mucoepidermoid carcinomas is related to metastatic potential and survival, whichever system is
used.9,31–33 In general, low-grade (cytologically benign) tumours with abundant mucous cells and mucin
production are less aggressive and rarely metastasise. Tumours that are predominantly solid and have a
preponderance of epidermoid cells have the greatest metastatic potential. There has been considerable debate
around grading criteria and the relative merits of 2 and 3 grade systems. A modification of the American Forces
Institute of Pathology (AFIP) grading system31 has the merit of simplicity and appears to allow good
discrimination between tumours with good and poor prognosis. This system scores a range of histological
features but, in essence the presence of two or more poor prognostic features indicates a high grade tumour (see
Table 1).
180
Table 1 Prognostic features for mucoepidermoid carcinoma
31
Grade 1
Predominant goblet cell component. Lack of aggressive features.
Grade 2
Predominant intermediate cell component. Aggressive invasion pattern but
lacks other features of grade 3.
Grade 3
Predominant squamous cell component. Aggressive invasion pattern plus one
or more of the following features:
• necrosis
• >4 mitoses per 10 high power fields
• high-grade nuclear pleomorphism
• perineural invasion
• vascular invasion
•bony invasion
3.2 Acinic cell carcinoma
Acinic cell carcinomas are usually circumscribed but incompletely encapsulated. Cytologically lowgrade
tumours show several configurations (solid, papillary, follicular, clear-cell) but neither the configuration nor the
cytological grade are generally accepted as useful indicators of behaviour ,10,34
and hence do not form part of a core dataset.
3.3 Adenoid cystic carcinoma
The histological type of adenoid cystic carcinoma is related to metastatic potential, with 0–4% of cribriform,
hyaline and tubular carcinomas, and 33% of solid (basaloid) carcinomas metastasising to local lymph nodes .9,35
Distant metastasis is more common in solid tumours.10,30
3.4 Carcinoma in pleomorphic adenoma
Carcinomas arising in pleomorphic adenomas may be of any histological type, but are thought to be particularly
aggressive and the prognosis of the carcinomatous component is poorer than that of comparable carcinomas
developing de novo.9,10,36 Evidence for a pre-existing adenoma (remnants of myxochondroid stroma, focal
scarring, hyalinised nodular ‘ghost’) should be sought in all carcinomas, particularly those showing multiple
histological types and a varied histological appearance. The extent of invasion should be measured for these
tumours as it is prognostically useful, although precise criteria are not defined. Invasion more than 5–6 mm from
the capsule of the residual adenoma is associated with a high risk of local recurrence and distant metastasis. 37,38
181
Section C Neck dissection specimens
SPECIMEN REQUEST FORM
The type of neck dissection and node levels present should be specified by the surgeon using standard
terminology.39 It may be appropriate to use a request form that encourages the annotation of a schematic
diagram to indicate the extent of the dissection. As the terminology applied to modified operations is potentially
confusing, dissections should be described by specifying which node groups and non-lymphatic structures the
surgeon has dissected and the relevant non-lymphatic structures that have been preserved or removed.
Three main types of neck dissection may be received:
•
comprehensive neck dissection, which includes both radical and modified radical (functional)
dissections. A radical neck dissection includes removal of cervical lymph nodes (levelsI–V),
sternomastoid muscle, internal jugular vein, spinal accessory nerve and the submandibular salivary
gland, while in a functional dissection, the sternomastoid muscle, internal jugular vein, or the spinal
accessory nerve may not be removed
•
selective neck dissection involves removal of the nodal group(s) considered to be the most
likely site for metastasis, preserving one or more nodal groups that are routinely removed in a
radical dissection
•
extended neck dissection when additional lymph node groups or non-lymphatic structures are
removed.
Terminology of node groups
Six major anatomical groups (levels) of lymph nodes are described (see Figure 3).
•
Level I: nodes of the submandibular and submental triangles.
•
Levels II, III and IV: nodes of the upper, middle, and lower jugular chain. These nodes lie deep to the
upper, middle and lower thirds of the sternocleidomastoid muscle respectively. The point at which the
omohyoid muscle crosses deep to the sternocleidomastoid muscle is a useful landmark separating
levels III and IV. Level IV extends from the omohyoid muscle to the clavicle.
•
Level V: nodes of the posterior triangle, behind the posterior border of the sternocleidomastoid muscle.
•
Level VI: nodes of the anterior compartment,
around the midline visceral structures of the
neck from the hyoid bone to the suprasternal
notch.
Imaging studies may subclassify node levels II
and V.40 It is not suggested that this should be part
of routine pathological practice but if separate
groups are submitted, e.g. IAA and IIB, this
should be noted in the pathology report.
Figure 3 Diagrammatic representation of lymph node levels in the neck
182
PREPARATION OF THE SPECIMEN BEFORE DISSECTION
•
•
•
•
•
•
Resection specimens should be orientated by the surgeon and pinned or sutured to cork or
polystyrene blocks.
The surgeon should indicate surgically critical margins and identify the general territories of
node groups by placing markers such as metal tags or sutures at the centre of each anatomical group.
A practical alternative for selective dissections is for the surgeon to separate the node groups,
mark the superior margin of each group with a suture, and place each group in a separately l
abelled container.
Nodes in addition to the main groups, e.g. parapharyngeal nodes, should be sent as separate
specimens.
Fixation is in a formaldehyde-based solution for 24–48 hours in a container of adequate size (the
volume of fixative should be ten times that of the tissue).
Photography of the specimen may be used to record the nature of the disease and the sites from which
tissue blocks are selected. Surgically important margins may be marked with Indian ink or an
appropriate dye.
NOTES ON DISSECTION AND BLOCK SELECTION
1.
Identify the component structures. From the outer aspect: the submandibular salivary gland; the
sternocleidomastoid muscle; the omohyoid muscle; the external jugular vein; the spinal accessory
nerve; the tail of the parotid gland. Some dissections may include skin or other structures such as the
stylohyoid and digastric muscles. From the deep aspect, identify the internal jugular vein.
2.
Lymph nodes are identified by inspection and palpation around the vein, and around the submandibular
gland and adipose tissue of the anterior and posterior triangles, and assigned to the appropriate
anatomical level (this should be indicated by surgical markers). Each discrete node is dissected out
with attached pericapsular adipose tissue. Larger nodes should be bisected or sliced. If there is obvious
metastatic tumour, the half/slice with the more extensive tumour should be processed, together with the
perinodal tissues to show the extent of extracapsular spread. If the node appears negative, all slices
should be processed. Small or flat nodes should be processed whole, and several nodes (from the same
anatomical level) can be processed in the same cassette. One H&E stained section from each block is
usually sufficient for routine assessment.
3.
An alternative method, that may be particularly useful for selective dissections is to serially slice the
fixed specimen and to embed all of the tissue.41 Care should be taken not to double-count larger nodes
that are present in more than one block. Note that large nodes containing obvious metastatic carcinoma
only need to be sampled to identify any extracapsular spread.
4.
A radical neck dissection may yield an average of 20 nodes (range 10–30), in the absence of previous
chemotherapy or irradiation, although on occasions 50–100 nodes may be identified. This examination
would be expected to include, as a minimum, all palpable nodes greater than 3 mm in diameter.
5.
Other blocks for histology: submandibular gland, jugular vein and sternomastoid if involved
tumour.
by
183
CORE DATA ITEMS TO BE INCLUDED IN THE HISTOPATHOLOGY REPORT
1
Clinical data (provided by the surgeon)
1.1
Nature of neck dissection (comprehensive or selective).
1.2
Node levels present.
2
Pathological data
2.1
At each anatomical level, record the total number of nodes identified and number of nodes involved by
carcinoma. For practical purposes, the critical factor is involvement of levels IV or V. Including level
III provides some leeway when describing spread so one is not forced into only saying upper or lower
nodes are involved.
2.2
Size of largest metastatic deposit. Note that this is not the same as the size of the largest node. The
size of the largest metastasis is a determinant in the TNM staging.13
2.3
Presence or absence of extra-capsular rupture and the node level(s) showing this feature. Extracapsular
spread should be recorded as present or not identified. Any spread through the full thickness of the
node capsule is recorded, and the previous separation into
macroscopic and microscopic spread is
now considered not to be necessary.42 Involvement of adjacent anatomical structures should be
recorded separately in the ‘comments’ section. If histological evidence of extracapsular spread is
uncertain, it should be recorded as ‘present’. This should prompt the use of adjuvant radiotherapy.
Extracapsular spread is a manifestation of the aggressiveness of a carcinoma and is associated with a
poor prognosis.6,42–45
2.4
The prognostic significance of micrometastases (<2 mm diameter) is not certain,46,47 their
presence should be included in the number of involved nodes and TNM coded as pN1(mi) or
pN2(mi).
2.5
The 6th edition of the TNM classification13 has introduced a category of pN0(i+) for nodes that contain
clumps of isolated tumour cells (<0.2 mm) that are usually only detected by immunocytochemistry but
may be seen on H&E stained sections. The prognostic significance of isolated tumour cells is not
known for head and neck cancer, but studies of sentinel nodes may provide such data. At present, it is
suggested that dissection and sectioning protocols are not modified, and that nodes containing isolated
clumps of tumour cells are classified as pN0(i+) with the comment that “previously such cases would
have been classified as pN+”.
2.6
Involvement of lymphatic channels in neck is a poor prognostic factor, and may be mentioned
the text of the report.
2.7
If there is obvious metastatic disease with fusion (matting) of lymph nodes, record:
a)
the level(s) of nodes involved by the mass
b)
the maximum dimension
c)
an estimate of the number of nodes that might be involved in the mass.
2.8
Isolated nodules of tumour in the connective tissue may represent discontinuous extensions of the
primary tumour, soft tissue metastases or nodal metastases that have destroyed the node. Absolute
distinction between these possibilities is not always possible and, while the 6th edition of the TNM
classification13 recommends regarding all deposits that do not have the contour of a node as
discontinuous tumour extension, there does not appear to be any evidence for this approach in the head
and neck. A practical approach is to regard any tumour nodule in the region of the lymphatic drainage
as a nodal metastasis, and to only diagnose discontinuous extension of a carcinoma within 10 mm of
the primary carcinoma and where there is no evidence of residual lymphoid tissue. 14
in
184
Other features form part of a complete description, but are not core data items
These features should be included as part of a comprehensive description of a neck dissection specimen but are
of uncertain prognostic significance:
•
presence of other pathology in cervical nodes
•
presence of evidence of response of tumour, e.g. keratin debris, to previous therapy.
2
Diagnostic coding of metastases
pN status should be recorded according to the UICC guidelines13 (see Appendix A), apart
from the designation of isolated nodules of tumour cell (see Section 2.8).
3
Sentinel node biopsy
Sentinel lymph node biopsy has been suggested as a method to reduce the morbidity associated with cervical
node dissections. This is currently an experimental technique for head and neck cancer patients and not part of
standard patient care.48,49 A standard dissection and sectioning protocol has yet to be defined, although current
research studies use the following:48
•
bisect or serially slice the node into 2.5 mm slices
•
if node is negative on initial H&E sections, then:
–
step serial section at 150 μm intervals
–
one section from each level is stained with H&E
–
if these sections are negative, then immunocytochemical labelling with AE1/3 is
performed; only morphologically viable labelled cells are counted as positive.
Cytological imprints and frozen section analysis are not part of the current research protocols.
185
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a
188
Appendix A TNM classification of malignant tumours 13
GENERAL PRINCIPLES
PT Primary tumour
pTX
Primary tumour cannot be assessed.
pT0
No evidence of primary tumour.
pTis
Carcinoma in situ.
pT1, pT2, pT3, pT4: increasing size and/or local extent of the primary tumour (see specific sites).
pN
Regional lymph nodes (for all primary sites, except nasopharynx)
pNX Nodes cannot be assessed.
pN0
No nodal metastasis.
pN0(i+) Isolated tumour cells only (<0.2 mm).
pN1(mi) Micrometastasis (2mm or less) only, in single node
pN1
Metastasis in single ipsilateral node 30 mm or less in diameter
pN2(mi) Micrometastasis (2 mm or less) only, in multiple or bilateral nodes
pN2a
Metastasis in single ipsilateral node 31–60 mm diameter
pN2b
Metastasis in multiple ipsilateral nodes <61 mm diameter
pN2c
Metastasis in bilateral or contralateral lymph nodes, none more than 60 mm in greatest
pN3
Metastasis in lymph node more than 60 mm diameter.
dimension.
Notes
(i)
For nasopharyngeal primary carcinomas:
pN1 – unilateral metastasis <61 mm above supraclavicular fossa
pN2 – bilateral metastases <61 mm above supraclavicular fossa
pN3 – metastasis in nodes >60 mm or in supraclavicular fossa.
(ii)
Direct extension of a primary into a node is classified as nodal metastasis.
(iii)
A tumour nodule >3 mm in the connective tissue without residual node is classified as a nodal
metastasis. A nodule <3 mm is classified in pT as discontinuous extension.
(iv)
When size is a criterion for pN classification, measure the size of the metastasis, and not that
the entire node.
(v)
Midline nodes are considered ipsilateral.
M
Distant metastasis
MX
Distant metastasis cannot be assessed.
M0
No distant metastasis.
M1
Distant metastasis (may be subgrouped by site of metastasis).
of
189
SITE-SPECIFIC ‘T’ CODES
Lip, oral cavity and oropharynx
T1
Tumour 20 mm or less in greatest dimension.
T2
Tumour 21–40 mm in greatest dimension.
T3
Tumour >40 mm in greatest dimension.
T4
Tumour invades adjacent structures.
Nasopharynx
T1
Tumour confined to nasopharynx.
T2
Tumour extends to soft tissue of oropharynx and/or nasal fossa.
T3
Tumour invades bone and/or paranasal sinuses.
T4
Tumour with intracranial extension and/or involvement of cranial nerves, infratemporal fossa,
hypopharynx or orbit.
Hypopharynx
T1
Tumour limited to one subsite and 20 mm or less in greatest dimension.
T2
Tumour involves more than one subsite or measures 21–40 mm in size.
T3
Tumour >40 mm in size or with fixation of hemilarynx.
T4
Tumour invades adjacent structures.
Larynx, supraglottis
T1
Tumour limited to one subsite with normal vocal cord mobility.
T2
Tumour invades more than one adjacent subsite without fixation of larynx.
T3
Tumour limited to larynx with vocal cord fixation, and/or invades postcricoid area, pre- epiglottic
tissues or deep base of tongue.
T4
Tumour invades through thyroid or cricoid cartilage and/or invades tissues beyond the larynx,
soft tissues of neck, thyroid or into oesophagus.
e.g.
Larynx, glottis
T1
Tumour limited to vocal cords with normal mobility.
T2
Tumour extends to supraglottis and/or subglottis, and/or with impaired vocal cord mobility.
T3
Tumour limited to larynx with vocal cord fixation and/or invades the paraglottic space and/or
invasion of inner cortex of thyroid cartilage.
with
T4
Tumour invades through thyroid or cricoid cartilage and/or invades tissues beyond the larynx,
soft tissues of neck, thyroid or into oesophagus.
e.g.
190
Larynx, subglottis
T1
Tumour limited to subglottis.
T2
Tumour extends to vocal cords with normal or impaired mobility.
T3
Tumour limited to larynx with vocal cord fixation.
T4
Tumour invades through thyroid or cricoid cartilage and/or invades tissues beyond the larynx,
soft tissues of neck, thyroid or into oesophagus.
e.g.
Maxillary sinus
T1
Tumour limited to antral mucosa with no bone involvement.
T2
Tumour causing bone erosion or destruction, except for posterior wall.
T3
Tumour invades posterior wall of sinus, subcutaneous tissues, floor or medial wall of orbit,
infratemporal fossa, pterygoid plate, ethmoid sinuses.
T4
Tumour invades skin of cheek, orbital contents beyond floor and medial wall, base of skull,
nasopharynx, sphenoid sinus or frontal sinus.
Nasal cavity and ethmoid sinus
T1
Tumour restricted to one subsite in the nasal cavity or ethmoid sinus, with or without bone
erosion.
T2
Tumour involves two subsites** within one site or extends to involve an adjacent site within the
nasoethmoidal complex, with or without bone erosion.
T3
Tumour extends to involve the medial wall or floor of the orbit, maxillary sinus, palate or
cribriform plate.
T4
Tumour with intracranial extension, anterior orbital extension, or involves sphenoid or frontal sinuses
and/or skin of nose. ** Sites for classification are the individual maxillary and ethmoidal sinuses and
the nasal cavity. The nasal cavity is divided in the following subsites: septum, floor, lateral floor and
vestibule.
Major salivary glands
Tx
Primary tumour cannot be assessed.
T0
No evidence of primary tumour.
T1
Tumour 20 mm or less in greatest dimension without extraparenchymal extension.
T2
Tumour more than 20 mm but not more than 40 mm in greatest dimension without
extraparenchymal extension.
T3
Tumour more than 40 mm and/or tumour with extraparenchymal extension.
T4a
Tumour invades skin, mandible, ear canal or facial nerve.
T4b
Tumour invades base of skull, pterygoid plates or encases carotid artery.
Note:
Extraparenchymal extension is clinical or macroscopic evidence of invasion of soft tissues or
nerve except those listed under T4a or b. Microscopic evidence alone does not constitute
extraparenchymal extension for classification purposes.
191
Appendix B SNOMED ‘T’ codes
SNOMED ‘T’ code
Sites and subsites
T-52000
T-52230
T-52240
T-52003
Lip
External upper lip (vermilion border)
External lower lip (vermilion border)
Commisures
T-51000
T-51300
T-52250
T-51030
T-51600
T-51010
T-54920
T-54930
T-51110
T-53000
T-53120
T-53123
T-51200
Oral cavity
Buccal mucosa
Mucosa of upper and lower lips
Cheek mucosa
Retromolar areas
Bucco-alveolar sulci
Upper alveolus and gingiva (upper gum)
Lower alveolus and gingiva (lower gum)
Hard palate
Tongue
Dorsum and lateral borders of anterior 2/3
Inferior (ventral) surface
Floor of mouth
T-60200
T-53122
T-53130
T-60230
T-60220
T-61100
T-61240
T-61150
T-60210
T-51120
T-51130
Oropharynx
Anterior wall (glosso-epiglottic area)
Base of tongue
Vallecula
Lateral wall
Tonsil
Tonsillar fossa and pillars
Tonsillar pillars
Posterior wall
Superior wall
Inferior surface of soft palate
Uvula
T-23000
T-23001
T-23002
T-51122
Nasopharynx
Postero-superior wall
Lateral wall (includes fossa of Rosenmuller)
Inferior wall (superior surface of soft palate)
192
SNOMED ‘T’ code
Sites and subsites
T-60300
T-24080
T-60320
T-60350
Hypopharynx
Pharyngo-oesophageal junction (post-cricoid area)
Piriform sinus
Posterior pharyngeal wall
T-24100
T-24010
T-24310
T-24320
T-24440
T-24400
T-24470
T-24450
Larynx
Epiglottis
Aryepiglottic fold, laryngeal aspect
Ventricular bands (false cords)
Glottis
Vocal cords
Commissures
Subglottis
T-21000
T-21030
T-21320
T-21340
T-21360
Nose
T-22000
T-22100
T-22200
T-22300
T-22400
Paranasal sinuses
Maxillary sinus
Frontal sinus
Ethmoid sinus
Sphenoid sinus
T-55000
T-55100
T-55200
T-55300
T-55400
Salivary glands
Parotid gland
Submandibular gland
Sublingual gland
Minor salivary gland
Olfactory region of nose
Nasal vestibule
Nasal septum
Nasal turbinate
193
Appendix C SNOMED ‘M’ codes
Note: This is not a comprehensive list of all malignancies and other codes should be used as
necessary.
Squamous carcinoma and variants
M-80702
Squamous carcinoma in situ
M-80703
Squamous carcinoma
M-80705
Microinvasive squamous carcinoma
M-80713
Keratinising squamous carcinoma
M-80723
Non-keratinising squamous carcinoma
M-80743
Spindle cell squamous carcinoma
M-80753
Adenoid squamous carcinoma
M-85603
Adenosquamous carcinoma
Salivary malignancies
M-85503
Acinic cell carcinoma
M-84303
Mucoepidermoid carcinoma
M-82003
Adenoid cystic carcinoma
M-82003
Polymorphous low grade adenocarcinoma
(terminal duct adenocarcinoma)
M-85623
Epithelial-myoepithelial carcinoma
M-81473
Basal cell adenocarcinoma
M-84103
Sebaceous carcinoma
M-84503
Papillary cystadenocarcinoma
M-84803
Mucinous adenocarcinoma
M-82903
Oncocytic carcinoma
M-85003
Salivary duct carcinoma
M-81403
Adenocarcinoma
M-89823
Malignant myoepithelioma (myoepithelial carcinoma)
M-89413
Carcinoma in pleomorphic adenoma (malignant mixed tumour)
M-80703
Squamous cell carcinoma
M-80413
Small cell carcinoma
M-80203
Undifferentiated carcinoma
194
Appendix D
Draft request forms for primary mucosal carcinomas and
node dissections
Surname:
Consultant:
Forename:
Location:
Date of Birth:
Sex:
Hospital Number:
NHS No:
Relevant medical or dental history:
Clinical diagnosis:
Site of lesion
Previous reports (laboratory number if known)
Duration of symptoms:
Predisposing factors:
Other information:
Date of operation:
Signature:
Right
Left
Left
Right
195
Right
Left
Left
Right
Right
Left
196
Appendix E
Reporting proformas
HEAD AND NECK CARCINOMA DATASET
Surname ……………………….…..Forenames ……………..….. Date of birth …...… … Sex …......
Hospital …………………………… Hospital no ………………... NHS no …....……..………….…….
Date of receipt …………….……… Date of report …………..…. Report no ……..…….…….….…....
Pathologist ……………………………..……….. Surgeon ………...….…...…………..……………..…
Clinical TNM stage ……………………… Previous radiotherapy Yes �
No �
Unknown �
T…… N…… M……
No �
Unknown �
Previous chemotherapy Yes �
Primary tumour
Site ……………………………………….
Maximum diameter ………………. (mm)
Subsite(s) …………………………….…..
Maximum depth of invasion …….. (mm)
Right � Left � Midline �
Distance from invasive tumour to
Type of resection ………………………..
mucosal margin ……….………. (mm)
Histological type: Squamous carcinoma � deep margin …………...…….… (mm)
Other/subtype……………..
Vascular invasion
Yes � No �
Differentiation Well �
Nerve invasion
Yes � No �
Moderate �
Bone/cartilage invasion
Yes � No �
Poor �
Severe dysplasia present Yes � No �
Invasive front Cohesive � Non-cohesive � Severe dysplasia at margin
Yes � No �
Right neck dissection : Yes � No �
Left neck dissection:
Yes � No �
Comprehensive � Selective �
Comprehensive �
Selective �
Node levels present: I II III IV V VI Other �
Node levels present: I II III IV V VI Other �
Total number of nodes………………
Total number of nodes………………
Number positive nodes……………...
Number positive nodes……………...
Levels with metastases: I II III IV V VI Other �
Levels with metastases: I II III IV V VI Other �
Largest metastasis …..……….. (mm)
Largest metastasis …..……….. (mm)
Extracapsular spread Yes � No �
Extracapsular spread Yes � No �
Levels with ECS………………………
Levels with ECS………………………
Summary of pathological data:
Tumour site………………………….………
pTNM stage pT.….. pN……. pM…..…
SNOMED codes
New primary � Recurrence � Not known � T……………… M……………….
Tumour type………………………………
T……………… M……………….
Resection of pri
Signed:
Date:
197
SALIVARY CARCINOMA DATASET
Surname ……………………….….. Forenames ……………..….. Date of birth ……...…... Sex …......
Hospital …………………………… Hospital no ………………... NHS no …....……..………….…….
Date of receipt …………….……… Date of report …………..…. Report no ……..…….…….….…....
Pathologist ……………………………..……….. Surgeon ………...….…...…………..……………..…
Primary tumour
Site: Parotid � Submandibular � Sublingual � Left / Right
Other � Please specify ………………………………………………..……
Histological type ………………………………………..
Histological grade (if appropriate) ……………………
Maximum dimension …………………………… (mm)
Macroscopic extraglandular extension: Yes / No
Minimum excision margin …………………...… (mm)
Right neck dissection : Yes � No �
Left neck dissection: Yes � No �
Comprehensive � Selective �
Comprehensive � Selective �
Node levels present: I II III IV V VI Other �
Node levels present: I II III IV V VI Other �
Total number of nodes………………
Total number of nodes……………
Number positive nodes……………...
Number positive nodes……………...
Levels with metastases: I II III IV V VI Other �
Levels with metastases: I II III IV V VI Other �
Largest metastasis …..……….. (mm)
Largest metastasis …..……….. (mm)
Levels with metastases: I II III IV V VI Other �
Levels with metastases: I II III IV V VI Other �
Largest metastasis…….(mm)
Largest metastasis…….(mm)
Extracapsular spread Yes � No �
Extracapsular spread Yes � No �
Levels with ECS………………………
Levels with ECS………………….
Comments/additional information:
Summary of pathological data:
pTNM stage pT.….. pN……. pM…..…
Tumour site………………………….………
SNOMED codes
New primary � Recurrence � Not known � T……………… M……………….
Tumour type………………………………
T……………… M……………….
Resection of primary tumour clear � close � involved �
Signed:
date:
198
The Royal College of Pathologists
Pathology: the science behind the cure
TISSUE PATHWAYS FOR HEAD AND NECK PATHOLOGY
September
2008
Unique document number
G077
Document name
Tissue pathways for head and neck pathology
Version number
1
Produced by
Professor Paul Speight, University of Sheffield (Writing
Group Lead), Dr Adam Jones, University of Sheffield, Dr
Séamus Napier, Royal Group of Hospitals, Belfast Dr Tim
Helliwell, University of Liverpool on behalf of the College’s
Cancer Services Working Group
Date active
April 2008
Date for review
April 2011
Comments
In accordance with the College’s pre-publications
policy, this document was put on The Royal
College of
Pathologists’ website for consultation from 1 April –
2
May 2008. Fifteen pieces of feedback were
received, and the authors considered them and
amended the document accordingly.
Please email [email protected] if you
wish to see the responses and comments.
Professor Carrock Sewell
Communications
The Royal College of Pathologists
Director of
2 Carlton House Terrace
London,
SW1Y 5AF
Tel: 020
7451 6700
Fax: 020 7451 6701
Web: www.rcpath.org
Registered charity in England and Wales, no. 261035
© 2008, The Royal College of Pathologists
199
CONTENTS
General introduction
Section A
Mucosal biopsies
Section B
Teeth
Section C Cysts: odontogenic and non-odontogenic
Section D
Minor salivary glands
Section E
Major salivary glands
Section F
Jaw lesions
Section G
Nasal cavity and paranasal sinuses
Section H
Larynx, pharynx and tonsil
Section I
Neck lesions
Section J
References
GENERAL INTRODUCTION
1. Staffing and workload
Preferably at least two or more pathologists in a unit should be competent in the reporting of
specimens from the head and neck. If one of these is not an Oral and Maxillofacial
Pathologist with expertise in oral mucosal biopsies and of the special tooth-related and
odontogenic pathology of the jaws, then access to this expertise should be ensured.
Pathologists reporting head and neck specimens should participate in an appropriate EQA
scheme. Lead pathologists should participate in a specialist Head and Neck EQA scheme.
There are no clear maximum workloads for a full time head and neck pathologist. The Royal
College of Pathologists Guidelines for Staffing and Workload in Histopathology and
Cytopathology Departments1 are a guide. Workload may vary considerably according to the
nature of the specimens received. Pathologists undertaking a significant amount of oncology
work will be able to report fewer requests per year than a pathologist dealing primarily with
non-neoplastic specimens.
2. Laboratory facilities
The full range of routine laboratory facilities is needed, including access to immunocy to
chemistry and electron microscopy, which may be off site. Facilities for sectioning of hard
tissue are required, including an appropriate saw (band saw or diamond- coated saw) for
dissection of bone resections of the jaws, expertise in decalcification and preparation of
specimens of bones and teeth. Fixation in formalin for 24-48 hours after slicing bone,
and before decalcification, may improve morphology. Facilities and expertise for the
preparation of ground sections of teeth are also sometimes necessary (or should be
available off site).
Detailed protocols for decalcification are beyond the scope of this document (see Bancroft
and Gamble5) and an appropriate balance needs to be reached between slower decalcification
for optimal morphology and more rapid decalcification to facilitate patient management.
Some decalcifying protocols may interfere with immunocytochemistry and excessive
200
decalcification affects the morphology. In general, strong acids e.g. nitric acid, are best
avoided as decalcification is rapid and difficult to control. For most purposes, 5% formic acid
is an appropriate decalcifying agent, with the end point confirmed by palpation and/or
ammonium hydroxide5. Unless the tissue is likely to fragment or otherwise be distorted, it is
recommended that bone is trimmed to block size (approximately) before decalcification. This
should allow decalcification to be completed in 1-10 days, although very dense bone may take
longer.
3. Specimen submission and dissection
Most specimens are received in the laboratory in formalin as routine diagnostic or
therapeutic specimens according to standard procedures. For most specimens no special
facilities are required for specimen dissection and preparation apart from bone and teeth
as mentioned above. It is good practice to photograph large specimens so that a
permanent record of the macroscopic appearance and location of blocks can be recorded
and filed in the patient records. Specimen dimensions are measured in mm.
Fresh tissue specimens are occasionally required primarily for the diagnosis of
vesiculobullous lesions using direct immunofluorescence. In these cases a mucosal biopsy
is submitted fresh to the laboratory, either immediately wrapped in damp gauze, or in a
suitable transport medium.
The guidelines for the handling of head and neck specimens may vary according to the
type of specimen2.
SECTION A. TISSUE PATHWAY: MUCOSAL BIOPSIES
1. Specimen dissection
Most of these specimens are small. The specimen is measured in three dimensions.
Identify and describe the colour and texture of the mucosa as well as any identifiable lesion
e.g. polyp, ulceration. Incisional biopsies of sufficient size are bisected through the long
axis, and may be inked to indicate orientation for embedding purposes. For excision
specimens the closest excision margins are often best sampled by sectioning across the short
axis (transversely).
2. Sectioning
Routinely a single section is usually sufficient for diagnostic purposes.Lesions where
dysplasia is suspected or needs to be excluded, or from high risk sites (e.g. floor of mouth,
non-homogeneous leukoplakia) should have three levels cut at 100µm intervals.
3. Staining
Haematoxylin and eosin (H&E) stained sections are required for all cases. White lesions
and dysplastic lesions, which are often infected with Candida species, may be stained using
PAS with prior diastase digestion.
4. Further investigations
These are occasionally needed to confirm a diagnosis and are requested as necessary.
Examples include stains for amyloid, immunocytochemistry for suspect lymphomas or
melanomas.
Immunofluorescence
Fresh samples submitted for vesiculobullous disorders are stained for IgG, IgA, IgM and
C3.
201
5. Report content
The report specifically refers to the overlying epithelium, lamina propria and other
identified tissues including an indication of the depth of the biopsy (e.g. by reference to
muscle on the deep aspect). Any infective agents or dysplastic features (graded according
to the WHO guidelines) are highlighted within the report. For excision specimens of oral
leukoplakia, the presence and degree of dysplasia at surgical margins is noted (this is not
relevant for small, diagnostic mucosal biopsies).
SECTION B. TISSUE PATHWAY: TEETH
1. Specimen dissection
Teeth are received in formalin usually with odontogenic cysts or as part of a resection
specimen and may require histological examination to determine the vitality of the pulp.
This can inform the pathogenesis of a periapical lesion.
Occasionally a clinical diagnosis of a tooth disorder requires histological confirmation for example for idiopathic resorption, or developmental disorders.
Tooth notation, site, morphology, presence of caries, and filling material are recorded.
Assess enamel and dentine structure including colour, transparency, banding, erosion,
abrasion and relative hardness. Root number, morphology and presence of resorption are
identified.
Teeth are usually decalcified before dissection and sectioning. However for diagnosis of
enamel defects a ground section is required. In this case the tooth is bisected in a band
saw and a ground section taken from one half and the other half submitted to decalcification.
2. Sectioning
Incisors, canines and premolar teeth are sectioned in the bucco-lingual plane. Molar teeth are
sectioned mesio-distally.
3. Staining
Ground sections are viewed using Canada Balsalm as an embedding agent as this has a
similar refractive index to normal enamel.
Decalcified sections are stained using H&E.
4. Further investigations
Accurate clinical information including family history, extent of teeth affected, presence of
metabolic bone disorders and examination of radiographs is required for accurate diagnosis of
developmental disorders.
Disorders of tooth structure require the availability of polarised light microscopy.
5. Report content
The report refers to the enamel including thickness, structure, presence of enamel matrix and
appearance of amelodentinal junction, and to the dentine including the appearance and
presence of mantle zone, pre-dentine, primary, secondary, tertiary and inter-globular dentine.
Specifically the appearance and presence of dentine tubules including relative width and
orientation as well as the location of dysplastic dentine.
Pulp examination includes assessment of the root apex, vitality, inflammation, relative size
and location.
202
SECTION C. TISSUE
ODONTOGENIC
PATHWAY:
CYSTS–ODONTOGENIC
AND
NON
1. Specimen dissection
Most of these specimens are small, soft and fragmentary in nature. Record the number of
pieces and dimensions of the largest piece. Small hard tissue fragments are common and
decalcification overnight is often sufficient. Large fragments of bone and identifiable teeth or
tooth fragments are described, decalcified and blocked separately. The relationship to the
tooth such as attachment to the cement-enamel junction or root apex is recorded. Tooth
notation, caries status and the presence of restorations are documented.
Large cysts require a description of the wall and the presence of mural thickening or nodules.
Examination of the cyst lumen and its contents may reveal the presence of keratin squames,
cholesterol or intraluminal nodules.
Small fragmented lesions are embedded in their entirety. Small intact cysts can be bisected.
For large cysts, representative transverse slices are best. Care is taken to sample any nodules
or mural thickenings.
2. Sectioning
A single section is usually sufficient for diagnostic purposes.
3. Staining
H&E stains are required for all cases.
4. Further investigations
Clinical information and preferably examination of radiographs is required for accurate
diagnosis since it is often important to know the relationship to the teeth.
Unusual findings require three levels at 100μm as well as further representative samples.
Stains for PAS, alcian blue or mucicarmine may be useful in the diagnosis of glandular
odontogenic cysts.
5. Report content
The report specifically describes the cyst lining and the type and nature of the epithelium e.g.
the presence of keratinisation or basal palisading, mucous metaplasia, hyaline (Rushton)
bodies, or atypical features. The capsule is described, particularly the presence or absence of
inflammation and features such as daughter cysts, calcifications, odontogenic rests or foreign
material.
SECTION D. TISSUE PATHWAY: MINOR SALIVARY GLANDS
1. Specimen dissection
Most of these specimens are relatively small and less than 15mm.
Mucoceles are usually fluctuant and may be covered by mucosa. The presence of minor
salivary gland tissue is identified.
The specimen is measured in three dimensions and may be bisected in the longitudinal plane.
For excision specimens, dissection is in planes appropriate to sample the closest excision
margins. If multiple lobules of minor salivary gland tissue are received then the collective
area is measured. Certain sites such as the upper lip are at an increased risk of tumour
development even though these may clinically and macroscopically appear to be mucoceles.
Resection specimens are orientated as indicated by the surgeon on the request form. Deep
203
and peripheral excision margins are inked. Care is taken to examine the capsule and record
any areas where it is incomplete or ruptured. Where a tumour is suspected, describe its
location, consistency (i.e. solid, cystic, gelatinous), capsule and circumscription.
Blocks required include:
• One block per 10mm diameter of tumour for larger specimens; most specimens will
be blocked in their entirety.
• Sufficient sampling to determine adequacy of surgical margins
• Adjacent mucosa and normal salivary glands.
2. Sectioning
A single section from each block is usually sufficient for diagnostic purposes in cystic and
inflammatory conditions.
3. Staining
H&E stains are required for all cases.
4. Further investigations
Stains for PAS, alcian blue or mucicarmine are useful for identifying subtle extravasation of
mucin and in the diagnosis of benign salivary gland tumours.
Immunohistochemistry is occasionally useful for the diagnosis of salivary gland
tumours.
5. Report content
Cysts
• Nature of cyst and lining i.e. epithelium or connective tissue
• Type of inflammatory infiltrate. Presence of atrophy, mucous extravasation, ductal
ectasia and minor salivary gland tissue.
Benign tumours
• Type of tumour as based on WHO guidelines3
• Distance of tumour from the nearest peripheral margin
• Distance of tumour from the deep margin
• Presence of a capsule and any breach.
Any unsuspected malignancy is reported according to the RCPath Head and Neck Cancer
Dataset4.
SECTION E. TISSUE PATHWAY: MAJOR SALIVARY GLANDS
1. Specimen dissection
Submandibular and sublingual glands are usually removed entirely as a result of sialolithiasis.
Radiographs may be used to identify a sialolith.
Parotid gland specimens most often comprise a superficial parotidectomy of the lower pole of
the superficial lobe. Total parotidectomies are rare for benign disease but may be performed
204
for deep lobe tumours.
The superficial and deep lobes may be provided separately.
Specimens should be orientated by the surgeon and in cases of doubt the surgeon must be
consulted.
Superficial parotidectomy specimens resemble a triangle, with the smooth surface
representing the superficial surface and the shortest profile the superior margin.
Deep lobes of the parotid and sublingual glands are difficult to orientate and are best done
surgically by the operating clinician.
The submandibular gland can be orientated by the indentation produced by mylohyoid on the
deep margin and by the duct at the anterior aspect.
Required measurements include:
• Dimensions and weight (g) of the specimen
• Dimension and number of cysts
• Dimensions of any identifiable tumour
• Distance to the nearest margins
• Presence of a capsule and whether or not this is intact.
Describe the location of any tumour, its consistency (i.e. solid, cystic, gelatinous), capsule and
circumscription.
Blocks required include:
• One block per cm diameter of tumour
• Sufficient sampling to determine the adequacy of surgical margins
• Adjacent mucosa and normal salivary glands
• Proximal and distal aspect of nerves if identifiable
• Any intra-glandular or adjacent lymph nodes.
2. Sectioning
Routinely a single section of each block is sufficient for diagnostic purposes in cystic,
infective and inflammatory conditions.
3. Staining
H&E stains are required for all cases.
4. Further investigations
Mucin stains, e.g. PAS, alcian blue or mucicarmine are helpful in the diagnosis of benign
salivary gland tumours.
Immunohistochemistry is occasionally useful for the diagnosis of salivary gland tumours and
for the differential diagnosis of benign lymphoepithelial lesions from extranodal marginal
zone (MALT) lymphoma. This can be supplemented by molecular analysis for light and
heavy chain restriction.
5. Report content
Cysts
• Nature of cyst and lining i.e. epithelium or connective tissue
205
• Type of inflammatory infiltrate
• Presence of atrophy, mucous extravasation and ductal ectasia
• Presence of salivary gland tissue. Benign tumours
• Type of tumour as based on WHO guidelines3
• Distance of tumour from the nearest peripheral margin
• Distance of tumour from the deep margin
• Presence of a capsule and any breach. Any malignancy is reported accordingly4.
SECTION F. TISSUE PATHWAY: JAW LESIONS
1. Specimen dissection
This category includes a number of benign lesions which necessitate major resective surgery.
This includes ameloblastomas and fibro-osseous lesions among other conditions.
The presentation of jaw specimens is variable and includes enucleated specimens composed
of fragmented pieces of soft tissue or bone as well as bone resections.
If multiple fragments are included the number of pieces, total dimensions and dimensions of
the largest piece are recorded. It is important to determine the relationship between resection
specimens and separate fragments, especially with regard to excision margins. This is
particularly relevant to maxillectomy specimens which may become fragmented during
removal.
If small, all samples are processed, otherwise representative sections are usually sufficient.
Some odontogenic tumours and hamartomas are cystic in nature. If associated with teeth,
the relationship is documented. In addition, examination of the cyst lumen can reveal the
presence of mural or luminal nodules in unicystic ameloblastomas.
For larger specimens identification of operation type and orientation is required. Photographs
are used and carefully labelled to indicate orientation and the origin of blocks. Radiographs
are useful in assessing the extent of the lesion, tooth resorption and the presence of
calcification.
Required measurements include:
• Antero-posterior diameter along the alveolar ridge
• Maximum bone height i.e. ramus
• Dimensions of tumour
• Distance and location of the nearest margin.
Surgical margins e.g. mucosal, deep, superior limit of ramus etc. may be inked.
Small specimens can be decalcified in their entirety before sampling or blocking out. For
large resections, especially of the mandible, it is often helpful to takes slices of 5-8mm on a
band saw. It may also be possible to slice maxillary specimens. Sometimes these are very
fragile and decalcification of the entire specimen helps sampling and to preserve orientation.
As most lesions are intraosseous, dissection of soft tissue from bone is usually not necessary.
However, evidence of cortical perforation requires close soft tissue examination and handling
as for those resections in malignant disease4.
2. Sectioning
206
A single section of each block is usually sufficient for diagnostic purposes.
3. Staining
H&E stains are required for all cases.
4. Further investigations
Accurate clinical information is required for accurate diagnosis. In general, hard tissue lesions
are not reported without examination of radiographs and/or CT images.
Congo red, alizarin red or thioflavine T are useful for the detection of amyloid proteins in
adenomatoid and calcifying epithelial odontogenic tumours.
Van Gieson stains are useful in identifying dentinoid material e.g. in calcifying cystic
odontogenic tumours.
Immunohistochemistry is rarely required.
5. Report content
An accurate description of any epithelium, including any reference to the formation of duct–
like structures as well as the presence of atypical features such as mitotic figures. Atypical
features such as pleomorphism are common in some odontogenic tumours including the
calcifying epithelial odontogenic tumour. If no odontogenic epithelium is identified this is
stated.
The appearance of the stroma is described including the presence of enamel, dentine, bone or
other calcified material.
The presence of amyloid is confirmed with special stains.
Comment is made upon the relationship to normal structures, e.g. teeth, bone. The presence
of a capsule and nature of the surgical margins are recorded.
Any malignant tumour is reported accordingly4.
SECTION G. TISSUE PATHWAY: NASAL CAVITY AND PARANASAL SINUSES
1. Specimen dissection
Most of these specimens are small and fragmentary in nature. Specimens should be measured
in three dimensions. Identify and describe the colour and texture of the mucosa as well as
any identifiable lesion e.g. polyp, ulceration. Small specimens are measured and usually
embedded whole. Specimens of sufficient size are best bisected through the long axis. Larger
samples and sinonasal polyps should have representative samples taken. Unilateral nasal
polyps are usually blocked in their entirety because unilateral lesions have a slightly
higher risk of being neoplastic than bilateral lesions. Small hard tissue fragments are
common and decalcification overnight is often sufficient. Large fragments of bone should
be described, decalcified and blocked separately
2. Sectioning
A single section of each block is usually sufficient for diagnostic purposes. Three levels at
100µm intervals may be indicated for more detailed examination of papillomas where
dysplasia or invasive malignancy is suspected.
3. Staining
H&E stains are required for all cases.
207
4. Further investigations
PAS, Grocott’s and Gram stains are useful for detecting fungal and bacterial infections.
Mycobacterial stains are required in granulomatous conditions. If Wegener’s granulomatosis
is suspected, an elastic van Gieson stain may be helpful in identifying damaged vessels and
further clinical information on the presence of positive c-ANCA tests and ESR is useful.
Immunohistochemistry is usually not necessary in the diagnosis of benign nasal lesions.
However, rare soft tissue tumours such as extrapleural solitary fibrous tumour, pituitary gland
neoplasm and meningioma may occur.
Minor salivary gland tumours and fibro-osseous lesions are reported as indicated in the
relevant sections.
5. Report content
The report may refer to the overlying epithelium, lamina propria and other identified tissues.
Note the type of inflammatory infiltrate. Any infective agents or dysplastic features (graded
according to the WHO guidelines) are highlighted. The presence and degree of dysplasia at
surgical margins is noted for excision specimens, but this is usually not possible in
fragmented samples..
Specific diagnoses are provided for any polypoid lesion i.e. allergic / inflammatory type,
inverted papilloma, in view of the potential risk of malignant transformation in the latter.
SECTION H. TISSUE PATHWAY: LARYNX, PHARYNX AND TONSIL
1. Specimen dissection
Most of these specimens are small or fragmentary in nature. Identify and describe the colour
and texture of the mucosa as well as any identifiable lesion, e.g. polyp, ulcer. Measure in
three dimensions. Specimens of sufficient size are bisected through the long axis or sliced
serially. Piecemeal resection specimens of the pharynx are embedded in their entirety.
Resection specimens are orientated as indicated by the surgeon on the request form. Deep
and peripheral excision margins are inked. Care is taken to examine the capsule and record
any areas where it is incomplete or ruptured. Describe the location of the tumour, consistency
(i.e. solid, cystic, gelatinous), capsule and circumscription. Dissection should be in planes
appropriate to sample the closest excision margins
Laryngectomy specimens and major resections for benign disease are treated as for laryngeal
malignancy4.
Tonsillectomy specimens :
• Are orientated (if possible) and the deep margins inked
• Are measured in three dimensions and may be weighed.
• Are examined grossly and cut into 4-5mm transverse slices
• Should have any abnormality measured and described
• Should have representative blocks taken. If there is no macroscopic abnormality, then
2 blocks are sufficient.
Note: the ipsilateral tonsil is often the source of metastatic squamous cell carcinoma in the
neck, particularly cystic metastases that can mimic branchial cysts. The primary lesion may
be microscopic. In cases of tonsillectomy for patients who have proven or suspected
metastasis in neck nodes and where tumour is not clearly identified within the tonsil at
macroscopic examination, the tonsillectomy specimen is blocked serially and submitted in
208
total to exclude a microscopic primary in the tonsil itself.
2. Sectioning
A single section from each block is usually sufficient for diagnostic purposes.
Lesions from high risk sites i.e. non-homogeneous leukoplakia from the vocal cords have
three levels at 100µm intervals.
Retention of unstained sections is preferable, if resources permit.
3. Staining
H&E stains are required for all cases. Lesions suspicious of Candida infection are stained
with PAS and diastase pre-treatment .
4. Further investigations
Immunohistochemistry is usually not required, although this may be beneficial for some
rare diagnoses.
5. Report content
The report specifically refers to the overlying epithelium, lamina propria and other
identified tissues.
Any infective agents or dysplastic features (graded according to the WHO guidelines)
are highlighted within the report. The presence and degree of dysplasia at surgical
margins is noted.
Salivary and other benign tumours are reported as discussed in the relevant
sections.
SECTION I. TISSUE PATHWAY: NECK LESIONS
1. Specimen dissection
Swellings of the neck can be associated with any closely related structures such as lymph
nodes, thyroid, salivary glands, blood vessels, nerves or fat. A wide variety of disease may
present but most relate to cervical lymph node enlargement.
For benign disease, most neck specimens are small excisional biopsies. Neck dissection is
handled as for malignant disease4.
Lymph nodes – small nodes (up to 4 mm in maximum dimension) are embedded whole.
Nodes up to 10 mm around the equator (around the girth) are bisected longitudinally through
the hilum (or “bivalved”) and embedded in total. Nodes larger than 10 mm in the equatorial
plane are sliced serially at approximately 4mm intervals and have 2 or 3 representative slices
embedded.
Cysts - measure in three dimensions. Thyroglossal cysts usually present as a strip of fibrous
tissue surrounded by fat and muscle.
Branchial cysts are typically submitted intact. Sufficient sampling of branchial cysts is
required to rule out the possibility of a cystic metastatic carcinoma. Examine the cyst
lumen for nodules and record the nature of contents and thickness of the cyst wall. Small
specimens are bisected or embedded intact, while larger specimens are serially sliced and
representative blocks (2-4) taken.
Soft tissue tumours and carotid body paragangliomas - these are not usually orientated and
may be fragmented. Ink the external surfaces and measure:
209
• Dimensions of the specimen
• Dimensions of the tumour (if different from those of the specimen)
• Distance from tumour to the nearest surgical margin or to marked vessels and nerves.
Describe the tumour including the colour, whether encapsulated or infiltrative, and
the presence of haemorrhage and necrosis. Serially slice the tumours into 4-5mm
sections. Representative blocks include one block per cm of tumour. Record the
presence of necrotic and haemorrhagic areas.
2. Sectioning
A single section per block is usually sufficient for diagnostic purposes.
Lymph nodes – usually one section per block (see also lymph node Tissue Pathway)..
3. Staining
H&E stains are required for all cases.
4. Further investigations
Immunohistochemistry may be useful for a range of neck lesions including for micrometastases, to exclude lymphomas, and in the diagnosis of soft tissue tumours.
5. Report content
For cysts the report should record:
• Cyst lining i.e. keratinisation, presence of atypical features and mitotic figures
• nature of the capsule such as fibrous, fibro-myxoid and the degree of inflammation
• Presence of foreign body reaction to ruptured cysts.
For tumours the report should record:
• Type
• Tumour – tissue interface i.e. infiltrative or encapsulated
• Relationship to major vessels and nerves
• Nearest surgical margin.
REFERENCES
1. Guidelines on Staffing and Workload for Histopathology and Cytopathology
Departments. 2 edition. RCPath. June. 2005.
http://www.rcpath.org/resources/pdf/GuideHistoCytoWorkload0605.pdf
nd
2. Allen DC, Cameron RI. Histopathology Specimens: Clinical, Pathological and Laboratory
Aspects. Springer-Verlag. London. 2004.
3. Barnes L, Eveson JW, Reichart P, Sidransky D. World Health Organization
Classification of Tumours: Pathology and Genetics of Head and Neck Tumours. IARC
Press. Lyon. 2005.
4. Helliwell TR, Woolgar JA. Standards and Datasets for Reporting Cancers: Datasets for
histopathology reports on head and neck carcinomas and salivary neoplasms. 2nd
edition. Royal College of Pathologists. 2005.
210
http://www.rcpath.org/resources/pdf/HeadNeckDatasetJun05.pdf
5. Bancroft JD, Gamble M. Theory and practice of histological techniques. Fifth edition.
Churchill Livingstone, London, 2002, pages 274-279.
211
Standards and datasets for reporting cancers
Dataset for thyroid cancer histopathology reports
April 2010
Coordinators:
Professor Timothy J Stephenson, Sheffield Teaching Hospitals
NHS Foundation Trust
Dr Sarah J Johnson, Royal Victoria Infirmary, Newcastle upon Tyne
Unique document number
Document name
Version number
Produced by
Date active
Date for review
Comments
G098
Dataset for thyroid cancer histopathology reports
2
Professor Timothy J Stephenson, Sheffield Teaching
Hospitals NHS Foundation Trust
Dr Sarah J Johnson, Royal Victoria Infirmary,
Newcastle upon Tyne
April 2010
April 2012
In accordance with the College’s pre-publications
policy, this document was on The Royal College of
Pathologists’ website for consultation from 22
February to 22 March
2010. 40 items of feedback were received and the
authors considered them and amended the
document if
deemed appropriate. Please email
[email protected] if you wish to see the
responses and comments.
Dr Peter Cowling
Director of Communications
The Royal College of Pathologists
2 Carlton House Terrace, London, SW 1Y 5AF
Tel: 020 7451 6700
Fax: 020 7451 6701
Web: www.rcpath.org
Registered charity in England and W ales, no. 261035
© 2010, The Royal College of Pathologists
PUB
190410
1
V1
Final
212
Contents
Foreword ............................................................................................................................3
1. Introduction ...................................................................................................................3
2. Clinical information required on the specimen request form .........................................4
3. Specimen handling, description and block selection.....................................................5
4. Microscopic report.........................................................................................................6
5. Core data items.............................................................................................................7
6. Non-core data items....................................................................................................10
7. Recommendation: TNM pathological staging (seventh edition, UICC)........................10
8. SNOMED coding.........................................................................................................11
9. Audit criteria ................................................................................................................11
10. References ................................................................................................................12
Appendix A TNM staging (seventh edition, UICC).............................................................16
Appendix B SNOMED codes ............................................................................................18
Appendix C Dataset for thyroid cancer histopathology ......................................................19
Appendix D Thyroid carcinoma dataset monitoring sheet (AGREE standards) .................21
213
Foreword
The Cancer Datasets published by the Royal College of Pathologists are guidelines that
should assist pathologists in providing a high standard of care for patients. Guidelines are
systematically developed statements to assist the decisions of practitioners and patients
about appropriate health care for specific clinical circumstances and are based on the
best available evidence at the time the dataset was prepared. It may be necessary or
even desirable to depart from the guidelines in the interests of specific patients and
special circumstances. Just as adherence to the guidelines may not constitute defence
against a claim of negligence, so deviation from them should not necessarily be
deemed negligent.
The dataset has been reviewed by the Cancer Services Working Group and was placed
on the College website for consultation with the membership from 22 February to 22
March 2010. All comments received from the Working Group and membership have
been addressed by the authors to the satisfaction of the Chair of the Working Group
and the Director of the Professional Standards Unit.
No major organisational changes have been identified that would hinder the
implementation of the dataset.
Each year, the College will ask the authors of the dataset, in conjunction with the
relevant sub-specialty adviser to the College, to consider whether or not the dataset needs
to be revised.
This dataset was developed without external funding to the writing group. The College
requires the authors of datasets to provide a list of potential conflicts of interest; there are
none.
1.
Introduction
1.1.
Endocrine cancer datasets
The management of endocrine tumours is the responsibility of an appropriately experienced
multidisciplinary team (MDT). Since these tumours bridge various anatomical divides, they
are dealt with by a number of specialist teams. Because several mimics of thyroid
carcinomas exist,1,2 the pathologist reporting them should ideally have a special interest in
endocrine pathology. Alternatively, he/she should have an interest in endocrine tumours in
his/her area of systematic pathology or, if a general pathologist, should participate in a
network with the opportunity for specialist pathology review since observer variation is well
documented in thyroid tumours3,4 and the range of prognostic features5 can require
experience in their recognition. The reporting pathologist should either be a core member of
the Thyroid Cancer MDT or have access to a pathologist who is a core member, for review
purposes.
Each group of tumours is dealt with in a separate section. Although the guidelines of The
Royal College of Pathologists (RCPath) are primarily aimed at collecting core data in the
reporting of cancers, we suggest that the endocrine guidelines also provide a useful
template for the reporting of benign endocrine tumours and for hyperplastic conditions. We
have therefore included some of these options in the dataset proforma (see Appendix C,
section on adjacent thyroid).
1.2.
Thyroid cancer dataset
214
The proper handling and reporting of the thyroid tumour specimen is important as gross
and histological features contribute to the staging of the tumour, and this has implications
for prognosis and therapy. There are several systems for staging thyroid tumours. The
Royal College of Physicians (RCP) and the British Thyroid Association’s recent guidelines6
recommended the use of the TNM system of staging, using both its pathological component
and the suggested conversion to clinical staging. Our recommendation is to adopt the
seventh edition,7 as it reinstates a therapeutically important feature of the fifth edition which
was deleted in the sixth edition. We have restricted our recommended data to the
pathological component of TNM; the seventh edition7 may be consulted for detail of how
to map this to the recommended clinical stage if desired locally.
These proposals for the reporting of thyroid cancers should be implemented for the
following reasons:
1. Pathological staging is important in deciding the correct clinical management of these
tumours.
2. Outcome has been shown to be related to particular features (e.g. variants of papillary
carcinoma; minimal or wide invasion in follicular carcinoma, and since publication of the
previous thyroid cancer dataset, number of foci of capsular and/or vascular invasion in
encapsulated follicular variant papillary carcinoma, number of foci of vascular invasion in
both minimally invasive and widely invasive follicular carcinoma8,9 and the proper
definition of poorly differentiated thyroid cancer).10,11 These features should therefore be
included in histopathology reports to:
a) provide prognostic information to the surgeon/physician treating the patient;
b) provide accurate data for cancer registration and national datasets.
This document has been devised to include the data required for a careful assessment of a
thyroid cancer specimen. Where possible, it is evidence based. It has been widely
discussed and approved by the UK Endocrine Pathology Society (www.ukeps.net), the
British Thyroid Association (www.british-thyroid-association.org), the British Association of
Endocrine and Thyroid Surgeons (www.baes.info) and the British Association of Head and
Neck Oncologists (www.bahno.org.uk). Panels of specialist and general histopathologists
acting on behalf of the College have also reviewed it.
The following text outlines the approach to be taken in handling specimens. Aspects of best
practice in handling thyroid specimens have been reviewed12 and there are descriptions of
the clinically-oriented pathology of the thyroid.13 A synoptic reporting proforma has been
provided as an aide memoire for the core data on these neoplasms. This may be
supplemented by a more detailed written report.
It is beyond the scope of this document to discuss the details of fine needle aspiration
(FNA) cytology of thyroid, but most lesions should have had FNA before surgery, so a
differential diagnosis may be available. The cytopathologist should be a member of the
MDT or have access to a pathologist who is. The descriptive cytology report will inform the
clinical d e c i s i o n s o n management. We r e c o m m e n d a d d i t i o n a l u s e o f t h e n u m e r i c a l
categories Thy1−5 as proposed in the guidelines of the RCP/British Thyroid Association,6
recently updated by the RCPath in consultation with the British Society for Clinical Cytology
and other interested parties.14
Intraoperative frozen section is occasionally used to confirm the diagnosis of papillary
carcinoma, medullary or anaplastic carcinoma, or to identify lymph node involvement. It
should not be used to differentiate follicular carcinoma from adenoma. This is because
follicular carcinoma is an architectural diagnosis, based on the finding of capsular or
vascular invasion which can be very focal. Incision of an unfixed specimen can,
215
additionally, disrupt the capsule rendering subsequent assessment of the fixed tissue
difficult. Even with papillary carcinoma, which can be diagnosed on frozen sections, extra
care needs to be taken as the characteristic nuclei with their clearing are an artefact of
formalin fixation/paraffin processing and they may not be fully developed in frozen
sections15,16
2.
Clinical information required on the specimen request form
This should include full patient details, clinical presentation, results of previous cytology
and biopsies, and of imaging investigations. The patient’s thyroid hormonal status should
be given where relevant, together with details of any hormonal or drug therapy and any
familial cancer or endocrine tumour syndromes. If the operation has resulted in multiple
specimens or parts thereof, then these should be catalogued explicitly. Any specimens
which may bedifficult to orientate should have orientation markers attached and
these should be described on the specimen request form, with diagrams where words
alone will not suffice.
3.
Specimen handling, description and block selection
3.1.
Gross examination
The specimen will usually be described as total (or near-total) thyroidectomy; right or left
hemithyroidectomy (+/- isthmus) or isthmusectomy. It should be noted whether the thyroid
capsule appears intact on receipt (excluding the intrathyroidal margin on lobectomy
specimens).
The specimen should be weighed, measured and described grossly, particularly if there are
any unusual features. In thyroidectomy specimens, measurements of each lobe
and isthmus (plus pyramidal lobe if present) should be noted where possible. The
surface should be inked. The specimen should then be sliced (usually transversely) at
intervals no thicker than a tissue block, and the cut surfaces of all the slices should be
inspected.
The appearance and location(s) of the lesion(s) should be noted. The inclusion of a
diagram or photograph in the records with annotation of block selection is best practice. It
is important to record the greatest dimension of the lesion (or of the largest lesion, if
multiple) as this defines the pT status. If this is < 20 mm, the macroscopic size should be
confirmed or adjusted by the microscopic measurement of size. The presence of
macroscopically- apparent direct extension beyond the thyroid, which is prognostic,17
should be recorded, including which anatomical structures are invaded, to inform the
pT3/4 staging. Clearances from the thyroid capsule and relevant resection margins
should be measured and noted. The site of any possible parathyroid glands should be
noted and they should be sampled if present.
The number and site of lymph nodes submitted or identified in the main specimen should
be recorded, and all the nodes should be sampled. Sampling of formal neck dissections
should follow protocols published with the guidelines for tumours of the head and neck
(http://www.rcpath.org/index.asp?PageID=1158). Central/level VI lymph nodes are often
submitted with known papillary carcinoma specimens.
3.2.
Block selection
The number of blocks taken will vary according to the tumour type. Tumour type may be
known or suspected from any preoperative cytology, enabling appropriate block taking
when the specimen is initially dissected. Alternatively, the specimen may require extra
blocks to be taken after the initial histological diagnosis has been made. The use of mega
216
blocks may be considered to show resection margin relationships to large lesions and they
may show the entire circumference of capsule of such lesions in one section.
3.2.1. Papillary carcinoma (PTC)
For papillary carcinoma, there are few published studies regarding sampling. Some
recommend that the whole gland is processed.18 However, a more practical approach is to
block the whole tumour if the lesion is ≤ 20 mm in diameter; if larger, it should be sampled
widely enough (as a compromise we suggest at least two blocks per cm diameter of
tumour) to permit diagnosis and to assess whether the tumour is of uniform type. Blocks of
the tumour edge and of the thyroid margin closest to the tumour should be taken to assess
completeness of excision. Any surgical excision margin within the thyroid (e.g. isthmic
margin in a lobectomy specimen) should be processed. Any apparent extrathyroidal
extension should be sampled. Apparently normal tissue from the ipsilateral lobe and the
contralateral lobe (where present) should be examined carefully for evidence of tumour.
Any suspicious areas, such as nodules or pale scarred-looking areas, should be sampled.
Even when no other lesions are identified by naked-eye examination, two blocks of normallooking tissue should be taken from each lobe. This is to assess whether the lesion is single
or multifocal, as multifocal lesions have a poorer outcome,19 and to look for other
background conditions. The presence of multifocal disease is reflected in the staging;
therefore, if one papillary microcarcinoma (equivalent to stage pT1a)7 is found, the rest of
the specimen should be examined carefully for multifocality.
3.2.2. Follicular neoplasms
Follicular lesions that are not grossly invasive should be widely sampled at the interface
between the tumour capsule and normal gland,15 to detect capsular and/or vascular
invasion. Some suggest that the total interface is examined histologically in all cases.20 A
more practical approach is to process small lesions (≤ 30 mm in diameter) in their entirety
and to take at least 10 blocks from larger lesions.21,22 Where there are multiple nodules, the
largest should be processed as described. Any others showing obvious encapsulation
should also be sampled, as should those with unusual features, such as solid areas or a
pale colour. Follicular lesions that are grossly invasive should be sampled widely enough to
allow identification of any poorly differentiated carcinoma,10 documentation of foci of
vascular invasion,8,9 measurement of distance to resection margins, and recognition of
spread beyond the thyroid capsule with documentation of the tissues found to be invaded.
3.2.3. Medullary carcinoma
In cases of intrathyroidal medullary carcinoma, the specimen should be blocked adequately
to confirm the diagnosis, recognise the relationship to the thyroid capsule and detect any
extrathyroidal extension with definition of which tissues are invaded.18 The non-involved
gland may be examined for evidence of C-cell hyperplasia in an attempt to identify familial
cases. C cells are usually found in the central parts of the middle and upper thirds of the
lobes so these areas must be sampled. See section 5.3 regarding genetic testing for
familial mutations which should be discussed at the MDTM and is tending to replace
detailed histology for indentification of C cell hyperplasia.
4.
Microscopic report
There are a number of features that should be documented in all tumours, and specific
features relating to the individual tumour types. Differentiated tumours may contain a
minority component of more poorly differentiated tumour. Reports should specifically state
whether or not any foci of poorly differentiated carcinoma have been found, as they may
confer a worse prognosis.10,23 Such poorly differentiated components may be recognised by
tumour necrosis and elevated mitotic count,11 as well as by growth pattern. Only when
poorly differentiated carcinoma constitutes the majority (> 50%) of the tumour should the
217
overall classification change. However, where there is any focus of anaplastic change, the
tumour should be classified overall as undifferentiated/anaplastic (further, all anaplastic
carcinomas are defined as stage pT4).7
4.1.
Core data items for all malignant thyroid tumours
• Type of malignancy.
•
Whether a carcinoma is a single lesion or multifocal.
•
Maximum dimension of carcinoma (largest if multifocal).
•
Closest distance to surgical resection margin.
•
Extension into extrathyroidal tissues, which should be identified, and whether
the extension is macroscopic or microscopic.
•
Number of foci of any lymphatic/vascular invasion.
•
Site and number of lymph nodes sampled and number of those involved.
•
SNOMED codes, in a version approved by the local cancer registry.
4.2.
Non-core data items
•
•
Detailed tumour subtypes, beyond the core data, may be recorded.
Incidental microscopic conditions in the background thyroid should be
recorded:
1. to account for macroscopically described lesions that have prompted block taking;
2. when they may have affected the clinical impression of tumour extent (e.g. benign,
background nodules); and
3. when they may have clinical implications for the aftercare of the patient (e.g.
hyroiditis).
5.
Core data items
5.1.
Papillary carcinoma
There are a number of variants which have to be defined as they are prognostically
important.
Papillary microcarcinoma
A single classical papillary microcarcinoma (≤ 10 mm in diameter) discovered incidentally in
the examination of a hemithyroidectomy/thyroidectomy performed for another disease is not
thought to have a significant risk of recurrence or metastasis. These should be defined
separately.2,6,24 When such a microcarcinoma is identified, any residual thyroid tissue
should be examined carefully for multifocal disease. The report must state clearly whether
there is unifocal or multifocal carcinoma as the recommended treatment differs.5,25−28
Clinical papillary carcinoma
These tumours present clinically as thyroid masses or with lymph node metastases. A
number of variants of papillary carcinoma have been defined including the follicular variant,
the encapsulated variant and the solid variant, all of which are thought to have a similar
prognosis to the typical papillary carcinoma. It is important to differentiate the tall cell and
columnar variants, as there is some evidence that these may show more aggressive
behaviour.29,30 The outcome of the diffuse sclerosing variant is a matter of debate.31,32 As
with follicular tumours, an oncocytic variant is also recognised but this should only be
diagnosed when the characteristic nuclear features of papillary carcinoma are present.
Papillary architecture in a follicular oncocytic tumour should not be misinterpreted.33,34
Follicular variant of papillary carcinoma (FVPTC)
Evidence is emerging that FVPTC should be divided into two entities: a non-encapsulated
218
invasive type which has a metastatic potential like classical papillary carcinoma, and
encapsulated type which has behaviour that is partially similar to follicular carcinoma.11,35 In
particular, encapsulated FVPTC has very low metastatic potential if no capsular or vascular
invasion is found, leading some authors to recommend use of the term (which we have not
adopted): “well differentiated tumors of uncertain malignant potential (WDT-UMP)”.36 This
metastatic potential increases significantly if four or more foci of capsular or vascular
invasion are found in total, and even more if ten or more invasive foci are identified.11 Some
thyroid nodules have small, non-contiguous foci individually qualifying as FVPTC within
them, posing a dilemma as to whether to regard these as multifocal microcarcinomas or as
unifocal and equivalent to the maximum diameter of the whole nodule. The latter approach
is recommended on the basis of molecular biological evidence that the entire extent of
these lesions tends to have features of FVPTC.37 The FVPTC may also show oncocytic
change. As with the usual PTC, these are differentiated from oncocytic follicular tumours on
the basis of nuclear features.
FVPTC is subject to observer variability in its diagnosis,3,4 which relies upon identification of
the defining nuclear features for papillary carcinoma: optically clear, enlarged, oval nuclei
which have frequent nuclear grooves, some intranuclear cytoplasmic inclusions and may
overlap each other.3,4 The threshold for referring lesions thought to be FVPTC to an expert
thyroid pathologist should be low. In the hands of such pathologists, and in laboratories
regularly performing immunohistochemistry on such tumours, the expression of recognised
markers of papillary carcinoma, including its variants, can be useful in the identification of
FVPC. The markers found to be useful include cytokeratin 19, high molecular weight
cytokeratins and HBME1. 38,3 9
The adverse histological subtypes of the rare tall cell and the even rarer columnar cell PTC
variants, defined by their cell height to width ratio and their detailed nuclear features, should
be specifically mentioned if present in other than occasional small foci.20 To prevent overdiagnosis of the variant, we suggest a stringent approach to diagnosis of the tall cell variant,
whereby a height to width ratio of 3x is required in the majority (> 50%) of the tumour. At
present, grading of such tumour has not been included in the reporting proforma, although
there is emerging evidence that grade, especially presence of the poorly differentiated
grade (however defined), is important in prognosis.11, 40, 41
5.2.
Follicular neoplasms
A follicular neoplasm is defined as carcinoma on the basis of capsular and/or vascular
invasion. Capsular invasion is characterised by complete penetration of the capsule, often
with capsular blunt-ended breaks. Care should be taken in assessing this, as the invading
tongue of tumour may stimulate the formation of a neocapsule.1,4 Entrapment of groups of
cells or follicles in the capsule is not defined as invasion. Distinction between this
entrapment and true invasion may need levels to be cut and/or the taking of further blocks.
Pseudoinvasive changes may be seen following FNA.42, 43 These are usually accompanied
by inflammation, haemosiderin deposition and/or new fibrosis.43
Vascular invasion is defined as invasion of large calibre vessels within or beyond the
tumour capsule. The tumour cells should normally project into the vessel lumen, attach to
the luminal aspect of the vessel wall and be covered by endothelium.21
Minimally invasive tumours show only focal microscopic vascular and/or capsular invasion.
It is important to indicate whether there is only capsular invasion or whether the tumour is
angioinvasive, and to define the frequency of vascular invasion. Tumours showing only
capsular invasion have a minimal risk of metastasis. However, those with vascular invasion
have a higher risk, and this increases with the frequency of vascular involvement, being
demonstrably worse if four or more foci of vascular invasion are documented.9,11
219
The tumour is defined as widely invasive when it shows obvious gross invasion or extensive
microscopic infiltration of thyroid parenchyma, capsular or extratumoural vessels, or
extrathyroidal tissues. In most cases, these are not difficult to recognise. However, where
the diagnosis is made on the basis of histology, there are no absolute published criteria for
defining the threshold. Some would put otherwise minimally invasive tumours with high
incidences (e.g. 10 or more) of demonstrable vascular invasion into this category, although
we recommend leaving these in the minimally invasive category and communicating the
adverse prognosis through recording in the dataset the number of foci of vascular invasion
found. Widely invasive tumours have a worse prognosis than the minimally invasive lesions11
and the prognosis worsens still further in proportion to the number of foci of vascular
invasion found.9
For diagnostic purposes, oncocytic (Hürthle cell) follicular tumours are regarded as a
variant of follicular tumours and the criteria for the assessment of malignancy are the same.
This category should be restricted to tumours comprising at least 75% oncocytic cells.18,33,34
More focal oncocytic change can be found in ordinary follicular lesions. The distinction from
oncocytic follicular variant of papillary carcinoma is made on the nuclear features, as
outlined above. Other variants of follicular carcinoma including clear cell and signet ring cell
tumours are described, but there is no evidence that their behaviour is significantly
different.18
For thyroid carcinoma, including the follicular category, there is emerging evidence there
may be higher grade variants of tumour that confer a worse prognosis. In particular, the
finding of a trabecular or solid growth pattern and/or a mitotic count of 1−4 per 10 hpf is
thought to be associated with an adverse prognosis,7 although we have not extended the
dataset specifically to include this in the current revision.
5.3.
Medullary carcinoma
In best practice, the diagnosis should be confirmed by calcitonin immunoreactivity. In the
written histology report, it is usual to describe the cellular pattern, but this has no prognostic
significance,45 so is omitted from the dataset. The presence of amyloid, confirmed by
appropriate histochemical stains, is thought to confer a better prognosis, but does not
influence treatment, so again this is omitted from the dataset. Tumour desmoplasia is
thought to be an adverse prognostic indicator,46 but has been omitted from the dataset until
there is further confirmation. In less well-differentiated tumours, where
calcitonin
immunoreactivity is lost, positivity for carcinoembryonic antigen (CEA) may serve as a
surrogate marker.47 Loss of calcitonin immunoreactivity is now considered not to be of
adverse prognostic significance.44
In the syndromes of multiple endocrine neoplasia (MEN) Type 2 and familial medullary
thyroid carcinoma (FMTC), medullary carcinoma is often multifocal and
preceded/accompanied by C-cell hyperplasia.48 However, the histological evaluation of Ccell hyperplasia can be difficult, as the normal range is not properly defined.49 In addition,
extension of the tumour within the gland may produce nodules in the near vicinity. Finally,
the presence of C-cell hyperplasia may not necessarily correlate with familial disease as
there are data to suggest that mild degrees can be found around other tumours and in a
variety of other pathological conditions.45 We suggest, therefore, that this diagnosis is only
made when nodules of C cells, confirmed by calcitonin immunoreactivity, are found in
blocks that do not contain the main tumour. Diagnosing C-cell hyperplasia histologically is
optional as clinical guidelines recommend that all newly diagnosed patients with medullary
carcinoma have genetic testing for RET mutations to detect familial syndromes.50
5.4.
Poorly differentiated carcinoma
220
This group includes follicular cell-derived tumours with necrosis and/or with mitotic counts
of 5 or more per 10 hpf.11 Their growth patterns may be insular (the cells arranged in welldefined nests resembling pancreatic endocrine tumours),10 trabecular or solid.51 Before the
tumour is placed in this category, the ‘majority (> 50%)’7 or ‘predominant’11 component
should have this appearance. We have, however, included mention of minority components
of poorly differentiated carcinoma in the dataset as there is a report that even the presence
of a minor component of poorly differentiated carcinoma significantly worsens the
prognosis.52 It is also important to note that if the nuclei have the characteristic features of
papillary carcinoma and the tumour has a solid growth pattern, then it should not be
diagnosed as poorly differentiated carcinoma but as the solid variant of papillary cancer,
which has a rather better prognosis than poorly differentiated carcinoma.51
It is important to recognise poorly differentiated carcinomas as they have a worse prognosis
than differentiated carcinoma, although in the few instances where the poorly differentiated
carcinoma only shows minimal invasion or is encapsulated, the prognosis is worsened to
the same degree.11 Poorly differentiated carcinoma usually expresses thyroglobulin, may or
may not respond to radio-iodine treatment and is generally thought to represent part of the
spectrum between differentiated and anaplastic tumours.53 Where there is concern that a
poorly differentiated appearing tumour may be C-cell derived (i.e. medullary carcinoma), the
immunohistochemistry should include CEA and calcitonin antibodies as the term poorly
differentiated carcinoma is reserved for follicular cell-derived tumours. Medullary carcinoma
is classified as such irrespective of the growth pattern.
5.5.
Undifferentiated/anaplastic carcinoma
Where a follicular or papillary carcinoma shows even a minor undifferentiated (anaplastic)
component, the diagnosis is that of undifferentiated/anaplastic carcinoma.7
Most undifferentiated tumours will not have a surgical resection, but will be diagnosed by
FNA or occasionally by open biopsy. Where a resection is performed, multiple blocks
should be taken and immunostaining for thyroglobulin, TTF1 and calcitonin may be
performed to attempt to identify a differentiated component. These stains are almost always
negative in the anaplastic areas. Immunocytochemistry for cytokeratins (testing for a wide
range is recommended) may confirm the epithelial nature.34,39 Often, however, the
diagnosis is one of exclusion, and the most important differential diagnosis to exclude is
lymphoma,54, 55 as this has a radically different prognosis and treatment.
5.6
Mixed/combination tumours
When one or multiple foci recognisable as papillary carcinoma are present within what
would otherwise be an encapsulated follicular adenoma, it is accepted convention to stage
the tumour as a unifocal follicular variant papillary carcinoma equivalent to the full size of
the encapsulated lesion.37
Other rare tumours include mixed follicular/medullary and mixed papillary/medullary
carcinomas.56 These may show immunohistochemical features of both components.
6.
Non-core data items
Tumourgrade
We do not advocate use of tumour grading systems beyond the grades and types in the
core data since only the latter have consistently proven to be of clinical significance.
Histological subtypes beyond the core data
These may be included to facilitate teaching and research, and to demonstrate to any
221
reviewing pathologist that they have been recognised, but their clinical significance has
been proven to be low, compared with the core data.
Parathyrois
Where possible parathyroid glands should be identified macroscopically, and processed to
confirm their nature and the presence or absence of any pathology. The presence of any
parathyroid tissue or glands should be stated in the report, to provide correlation with any
clinical concerns over calcium status.
Adjacent thyroid
It is recommended that pathological evidence of autoimmune thyroid disease (AITD) is
recorded in the dataset. This may help elucidate the relationship between AITD and the
pathogenesis of thyroid tumours and is good practice in correlating with clinical status.
Incidental neoplasia may be found, such as incidental papillary microcarcinoma, prompting
a search for multifocal disease or rendering an already-diagnosed papillary carcinoma
multifocal.
7.
TNM pathological staging (seventh edition, UICC)
The recommendation to use the seventh edition7 (see Appendix A) is based on the fact that
the pT1a cut-off is ≤ 10 mm, allowing the identification of papillary microcarcinomas as a
separate group. This is important as they generally have a benign biological behaviour and
may be treated by lobectomy and thyroid stimulating hormone suppression rather than total
thyroidectomy and radioactive iodine therapy.2,6 In the sixth edition, these were grouped
together with tumours up to 2 cm. The latter have a different prognosis and treatment,
which led many groups at that time to recommend continued use of the fifth edition.
Resection (R) stage is deemed R0 when there is no microscopic evidence of true resection
margin (RM) involvement. (No definition exists of a tumour distance from the RM that
indicates RM involvement.) Microscopic RM involvement defines the stage as R1 while
macroscopic RM involvement defines it as R2. For R2, the surgeon will typically infer that
resection has been incomplete.
8.
SNOMED coding
See Appendix B.
9.
Audit criteria
The following standards are suggested as some of criteria that might be used in periodic
reviews of the thyroid pathology service.
•
•
•
•
Completeness of histopathology reports expressed as average proportion
of the core data items recorded, or as proportion of the reports that
successfully include
100% of the items – the standard is that all contain 100% of the items;
Size distribution of tumour maximum diameters as a graph – the standard is
that the distribution should be smooth and continuous with no obvious
rounding of measurements, e.g. to nearest 0 or 5 figure;
Number of lymph nodes found in specific specimen types;
Inter- and intra-observer studies in classification of tumours.
222
10.
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226
Appendix A Pathological TNM staging (UICC edition 7)7
pTX
pT0
pT1a
pT1b
pT2
pT3
Primary tumour cannot be assessed
No evidence of primary tumour
≤ 10 mm, limited to thyroid
≤ 20 mm but > 10 mm, limited to thyroid
> 20 mm, ≤ 40 mm, limited to thyroid
> 40 mm, limited to thyroid or any tumour with minimal extrathyroidal extension,
e.g. extension to sternothyroid muscles or perithyroid soft tissues
pT4a Tumour invades beyond thyroid capsule and invades any of: subcutaneous soft
tissues, larynx, trachea, oesophagus, recurrent laryngeal nerve
pT4b Tumour invades prevertebral fascia, mediastinal vessels, or encases carotid artery
All anaplastic carcinomas are considered pT4 tumours
pT4a Anaplastic carcinoma limited to thyroid
pT4b Anaplastic carcinoma extends beyond thyroid capsule
Multifocal tumours (≥ 2 foci) of all histological types should be designated (m), the
largest focus determining the classification, e.g. pT2(m)
pNX Cannot assess regional lymph nodes
pN0 No regional nodes involved
pN1a Metastasis in level VI (pretracheal, paratracheal and prelaryngeal/Delphian)
lymph nodes
pN1b Metastasis in other unilateral, bilateral or contralateral cervical (levels I, II, III, IV or
V) or retropharyngeal or superior mediastinal lymph nodes
M1
RX
R0
R1
R2
Distant metastases proven histologically (MX is not used in TNM v7 which
considers that proof of M0 cannot be arrived at by surgical pathology alone)
Cannot assess presence of residual primary tumour
No residual primary tumour
Microscopic residual primary tumour
Macroscopic residual primary tumour
227
Clinical staging
This is mentioned for ease of reference as it may be mentioned in MDT discussion and in
relation to clinical trials, but we recommend that pathology reports include only the
pathological TNM staging. The translation of the pathological data into staging differs with
the tumour type.6
In papillary and follicular carcinoma, there is evidence that prognosis is poorer in older
patients and therefore different criteria are applied to patients under 45 years from those
to patients aged 45 years and older. In medullary carcinoma, no age stratification applies.
All undifferentiated/anaplastic tumours are regarded as categories within
stage IV.
Papillary or follicular under 45
years
Stage I
Stage II
Any T
Any T
Any N
Any N
M0
M1
N0
N0
N0
N1a
N1b
N0, N1
Any N
Any N
M0
M0
M0
M0
M0
M0
M0
M1
Papillary or follicular 45 years or over
Stage I
Stage II
Stage III
Stage IVA
Stage IVB
Stage IVC
T1a, T1b
T2
T3
T1, T2, T3
T1, T2, T3
T4a
T4b
Any T
Medullary carcinoma
Stage I
Stage II
Stage III
Stage IVA
T1a, T1b
T2, T3
T1, T2, T3
T1, T2, T3
T4a
T4b
Any T
N0
N0
N1a
N1b
Any
Stage IVB
N
Stage IVC
Any
Any N
N
Anaplastic/undifferentiated carcinoma
M0
M0
M0
M0
M0
M0
M1
All are considered stage IV
Stage IVA
Stage IVB
Stage IVC
T4a
T4b
Any T
Any N
Any N
Any N
M0
M0
M1
228
Appendix B SNOMED codes
The codes for the more common types are:
Thyroid
used
TB6000 or T96000, depending on SNOMED edition
Papillary carcinoma*
Follicular carcinoma*
Poorly differentiated carcinoma
Anaplastic carcinoma
Medullary carcinoma
C-cell hyperplasia
M80503
M83303
M80213
M80203
M85103
T96050 + M72000
*When Hürthle (oncocytic) differentiation present, add M82903
229
Appendix C Dataset for thyroid cancer histopathology
Surname………………………
Forenames………………….…
Date of birth…………
Hospital………….……………
Hospital no……………….…...
NHS no……………....
Date of receipt………….…….
Date of reporting………..….....
Report no…………….
Pathologist……….…………...
Surgeon………………….……
Sex….
Specimen type
Tick the least number of boxes that fully accounts for everything received
Thyroidectomy
Total
Near total
Not stated
Hemithyroidectomy
Right
Left
Not stated
Total
Near total
Isthmus
Biopsy of thyroid
Biopsy/resection of metastasis (define site)…………………………………
Gross description of thyroid specimen
Location of carcinoma(s)
Right lobe
Left lobe
Isthmus
Unknown
Microscopic report
Papillary carcinoma
Single incidental microcarcinoma
Multiple incidental microcarcinoma
Variant: Encapsulated FVPTC
Non-encapsulated FVPTC
Classical PTC
Other type (specify) ………………
For encapsulated FVPTC, no. of foci of capsular invasion ........ and number of foci of vascular invasion ….....
Follicular carcinoma Not Hürthle cell type or Hürthle cell (oncocytic) follicular carcinoma
Minimally invasive (capsule only)
Minimally invasive (angioinvasion)
Select both types of
invasion if both are seen
Widely invasive
Number of foci of angioinvasion found for the follicular carcinoma
Medullary carcinoma
Definite background C-cell hyperplasia
For all above types
Minority poorly differentiated (not anaplastic) component
Poorly differentiated carcinoma
……………..
Absent
Present
(Majority (> 50%) of tumour is poorly differentiated)
Undifferentiated/anaplastic carcinoma
Differentiated component identified (specify)………………………….
Mixed follicular/papillary and medullary carcinoma
230
Surname………………………
Forenames………………….…
Date of birth…………
Hospital no……………….…...
For all tumour types
Confined to thyroid
Unifocal
Multifocal
Size ………………………………… mm
Minimal extension beyond thyroid capsule into sternothyroid or perithyroidal soft tissues only, pT3
Microscopic extension beyond thyroid capsule into subcutaneous soft tissues, larynx, trachea,
oesophagus or recurrent laryngeal nerve, pT4a
Microscopic extension beyond thyroid capsule into prevertebral fascia, mediastinal vessels
or encasement of carotid artery, pT4b
Any macroscopic extension beyond thyroid capsule, pT4b
Lymphatic/vascular invasion
Yes
Total number of lymph nodes ………
Number of foci found ……..
Uncertain
No
Number of lymph nodes positive ……………..
Site of lymph nodes involved ……………………………………………………………
Unilateral Level VI
Excision margins
Any other group
Unable to assess
Free of tumour
Minimum distance ……mm
Tumour present on microscopy
Tumour present macroscopically
Adjacent thyroid
Normal
Mild thyroiditis
Severe thyroiditis
C-cell hyperplasia (medullary carcinoma only) Yes
Other (define)………………..
Nodular goitre
No
Uncertain
Comments……………………………………………………………………………………..
Parathyroids identified
Stage pT ……….
Number ……..
pN ……….
M1?
Site(s) …… Pathology …………..……………………..
R ……….
Signature …………………… Date……………… SNOMED code TB6 M…………….
231
Appendix D Thyroid carcinoma dataset monitoring sheet
The Cancer Datasets of the Royal College of Pathologists comply with the AGREE
standards for good quality clinical guidelines (www.agreecollaboration.org). The
sections of this dataset that indicate compliance with each of the AGREE
standards are indicated in the table.
AGREE Standard
SCOPE AND PURPOSE
1. The overall objective(s) of the guideline is (are) specifically described
2. The clinical question(s) covered by the guidelines is (are)
specifically described
3. The patients to whom the guideline is meant to apply are
specifically described
STAKEHOLDER INVOLVEMENT
4. The guideline development group includes individuals from all the
relevant
professional
groups
5. The patients’
views and preferences have been sought
6. The target users of the guideline are clearly defined
7. The guideline has been piloted among target users
RIGOR OF DEVELOPMENT
8. Systematic methods were used to search for evidence
9. The criteria for selecting the evidence are clearly described
10. The methods used for formulating the recommendations are
clearly described
11. The health benefits, side effects and risks have been
considered in formulating the recommendations
12. There is an explicit link between the recommendations and the
supporting evidence
13. The guideline has been externally reviewed by experts prior
to its publication
14. A procedure for updating the guideline is provided
CLARITY OF PRESENTATION
15. The recommendations are specific and unambiguous
16. The different options for management of the condition are
clearly presented
17. Key recommendations are easily identifiable
18. The guideline is supported with tools for application
APPLICABILITY
19. The potential organisational barriers in applying the
recommendations have been discussed
20. The potential cost implications of applying the recommendations
have been considered
21. The guideline presents key review criteria for monitoring and/or
audit purposes
EDITORIAL INDEPENDENCE
22. The guideline is editorially independent from the funding body
23. Conflicts of interest of guideline development members have
been recorded
Section
of
dataset
1
1
1
1
N/A
1
Feedback
follows use
of a previous
edition
1
1
1
1
3-5, 10
1
Foreword
3-5
3-5
3-5
Appendix C
1,3
N/A
3-7
1
1
232
Tissue pathways for endocrine pathology
July 2008
Unique document number
G078
Document name
Tissue pathways for endocrine pathology
Version number
1
Produced by
Dr Anne Marie McNicol (Writing Group Lead), Dr Tim
Stephenson, Dr Sarah Johnson, Dr David Poller, Dr
Debra Milne and Dr Catriona Anderson, on behalf of
the College’s Specialty Advisory Committee on
Histopathology and the Cancer Services Working
Date active
July 2008
Group
July 2010
Date for review
Comments
In accordance with the College’s pre-publications policy,
this document was put on The Royal College of
Pathologists’ website for consultation from 21 May – 20
June 2008. Four pieces of feedback were received,
none of which suggested any changes.
Professor Carrock Sewell
Director of Publications
The Royal College of Pathologists
2 Carlton House Terrace
London, SW1Y
5AF Tel: 020 7451
6700
Fax: 020 7451 6701
Web: www.rcpath.org
Registered charity in England and Wales, no. 261035
© 2008, The Royal College of Pathologists
233
Contents
A
Adrenalectomy specimens ................................................................................. 2
References .................................................................................................................... 3
B
Parathyroidectomy specimens............................................................................5
References .......................................................................................................................6
C
Thyroidectomy and thyroid lobectomy specimens ...........................................7
References .......................................................................................................................8
234
A
Adrenalectomy specimens
1
Indications
Bilateral adrenalectomy as treatment for Cushing’s disease, where pituitary surgery is
not possible or has failed.
Bilateral adrenalectomy as treatment for ectopic adrenocorticotrophic hormone
(ACTH) syndrome, where the source of ACTH has not been identified or surgical
removal of the tumour secreting ACTH is not possible or is incomplete.
Bilateral adrenalectomy as treatment for Cushing’s syndrome in primary pigmented
nodular dysplasia (PPND, part of Carney’s complex).1
Bilateral adrenalectomy in Cushing’s syndrome associated with nodular hyperplasia
and suppressed ACTH.
Occasionally, unilateral adrenalectomy in Cushing’s syndrome or Conn’s syndrome
with unilateral nodular hyperplasia.
Bilateral adrenalectomy at the stage of medullary hyperplasia in multiple endocrine
neoplasia type 2 (MEN2).
Adrenalectomy for other indication (e.g. adrenal mass on imaging, diagnosis unclear).
2
Staffing and workload
Ideally, there should be two consultant pathologists with a special interest or experience
in endocrine pathology. It is recognised that this may be difficult in small departments. If
there is only one, there should be a network for referral/review. There is currently no EQA
scheme.
3
Specimen submission
Usually received in formalin, which should be of adequate volume. If received fresh,
formalin is added.
4
Specimen dissection
Where there is an apparently single nodule, the specimen is dealt with according to
The Royal College of Pathologists’ guidelines for reporting of adrenal cortical
carcinoma and malignant phaeochromocytoma.2
The specimen will usually comprise the adrenal gland and surrounding fat. The total
weight and dimensions are noted. Specimens removed by laparoscopic procedure may be
disrupted; if present, this is noted in the description. Where possible, the fat is stripped
and the dimensions and weight of the gland noted. The head, body and tail of the
gland are identified. The gland is sliced from head to tail. The appearance of the cortex
is described, including the presence or absence of nodules (including maximum
dimension of large nodules). The distribution of the medulla is recorded as extension
into the tail indicates hyperplasia.3 In most cases, one block is taken from each of the
head, the body and the tail. However, additional blocks are taken if there are focal
abnormalities. In some cases it can be useful to have photographs of the gross and
dissected specimen for orientation and discussion.
235
5
Sectioning and staining
A single haematoxylin and eosin (H&E) stained section per bloc is adequate for
examination, provided the sections cover the full face of the blocks. If there is
tangential sectioning, deeper levels may be necessary.
6
Further investigations
None is usually required.
7
Report content4
i.
Cushing’s syndrome
The pattern of zonation of the cortex is described and the presence of nodules where
appropriate. If nodular, the appearance of the intervening cortex is noted. In pituitarydependent Cushing’s syndrome, the whole cortex is hyperplastic. Nodular hyperplasia is
not common in ectopic ACTH syndrome. In the rare cases of primary pigmented nodular
dysplasia, the intervening cortex is usually atrophic. The distribution of the medulla is
described.
ii.
Adrenal medullary hyperplasia
The distribution of medullary tissue is described and note made as to whether the
hyperplasia is nodular or diffuse. An arbitrary limit of 10 mm is the cut-off between
nodular hyperplasia and phaeochromocytoma. The pattern of zonation of the cortex is
described and the presence of nodules noted.
8
References
1.
Shenoy BV, Carpenter PC, Carney JA. Bilateral primary pigmented nodular
adrenocortical disease. Rare cause of the Cushing syndrome. Am J Surg Pathol
1984;8:335–344.
2.
The Royal College of Pathologists. Dataset for histopathology reporting in adrenal
cortical carcinoma and malignant phaeochromocytoma/paraganglioma. The Royal
College of Pathologists, 2006. www.rcpath.org/publications
3.
DeLellis RA, Wolfe HJ, Gagel RF, Feldman ZT, Miller HH, Gang DL et al. Adrenal
medullary hyperplasia. A morphometric analysis in patients with familial medullary
thyroid carcinoma. Am J Pathol 1976;83:177–196.
4.
Lloyd RV, Douglas BR, Young WF. Endocrine Diseases. Atlas of Tumor Pathology.
Washington DC: Armed Forces Institute of Pathology, 2002.
236
B
Parathyroidectomy specimens
1
Indications
Removal of hyperfunctioning parathyroid tissue in primary, secondary or tertiary
hyperparathyroidism.
The surgeon may request intra-operative confirmation of tissue type by frozen section.
2
Staffing and workload
Confirmation of the nature of the tissue at frozen section can be performed by any
consultant pathologist.
For reporting of paraffin histology, there should ideally be two consultant pathologists with a
special interest or experience in endocrine pathology. It is recognised that this may be
difficult in small departments and, if there is only one, there should be a network
for referral/review. There is currently no EQA scheme.
3
Specimen submission
These are often received fresh for intra-operative frozen sections. After frozen sectioning
has been completed, the whole gland is placed in formalin.
If no intra-operative consultation is required, the gland is received in formalin, which
should be of adequate volume.
4
Specimen dissection
For each parathyroid gland, the site, weight, dimensions, colour and consistency are noted.
Small glands are bisected. Larger glands are cut into parallel slices, cutting through the
vascular pole where possible. Glands should have margins inked prior to frozen section if
the diagnosis of carcinoma is being considered. This would be more usual in large glands
with a thick capsule or where the surgeon has indicated difficulty in removing the gland.
For frozen section, one representative block is taken. All tissue is processed to paraffin
blocks after the frozen section. Where no frozen section is required, all tissue is embedded.
Some parathyroid glands are intrathyroidal. If a thyroid lobectomyor partial lobectomy
specimen is received, it is weighed and measured. The specimen is sliced and any
nodule(s) embedded. If no nodules are identified, all slices are embedded.
5
Sectioning and staining
A single H&E stained section per block is adequate for examination, provided the blocks
taken are fully represented on the slide. If there is tangential sectioning, deeper levels
may be necessary.
6
Further investigations
None is usually required.
7
Report content
For each parathyroid gland it is noted whether or not the gland is enlarged, has a diffuse
or nodular pattern or is encapsulated. The presence or absence of fat is noted. The cell
types are documented.
Other specimens may be submitted as parathyroid glands (e.g. thyroid or lymph node).
The tissue type present and any abnormality are reported.
The report indicates whether the histological appearances favour adenoma or hyperplasia.
It is also useful to identify whether there is single gland or multigland parathyroid disease.
This is usually easy in secondary or tertiary hyperparathyroidism. However, with the current
trend for targeted removal of a single gland in primary hyperparathyroidism without the
surgeon viewing the others, it is difficult to be certain.1
Where intra-operative frozen section has been performed, the report should document who
gave the result to whom and should specify the date and time.
More detailed instructions on handling can be found in the following references.1,2
8
References
1.
Johnson SJ, Sheffield EA, McNicol AM. Best practice no 183. Examination of
parathyroid gland specimens. J Clin Pathol 2005;58:338–342.
2.
The Royal College of Pathologists. Dataset for parathyroid cancer histopathology
reports. The Royal College of Pathologists, 2006. www.rcpath.org/publications
C
Thyroidectomy and thyroid lobectomy specimens
1
Indications
To relieve compressive symptoms or for cosmetic reasons in multinodular goitre or
Hashimoto’s thyroiditis.
As treatment, where medical therapy has been unsuccessful in Graves’ disease.
2
Staffing and workload
Ideally, there should be two consultant pathologists with a special interest or experience in
endocrine pathology. It is recognised that this may be difficult in small departments and,
if there is only one, there should be a network for referral/review. There is currently no
dedicated EQA scheme, although thyroid cases may be included in general EQA
schemes and the specialist head and neck pathology EQA scheme.
3
Specimen submission
Usually received in formalin, which should be of adequate volume. If received fresh,
formalin is added.
4
Specimen dissection
The nature of the specimen and side (in lobectomy specimens) are noted. If possible, the
specimen is orientated. A search is made for parathyroid glands. The thyroid capsule is
examined to assess whether it appears intact. The resection margins are inked. The
specimen is weighed and the dimensions of each lobe noted. The specimen is cut into 5
mm slices i n the horizontal plane. Any parathyroid glands or lymph nodes identified are
processed. In some cases, it can be useful to have photographs of the gross and
dissected specimen for orientation and discussion.
a)
Multinodular disease
Submit one block from representative nodules, up to a maximum of five from each lobe.
Any encapsulated nodule should be treated as a potential follicular tumour and sampled
according to The Royal College of Pathologists’ guidelines for thyroid tumours.1 Any
unusual foci are also processed.
b)
Inflammatory disease
Submit three representative blocks from each lobe and one from the isthmus, if
present. Any unusual foci are also processed.
5
Sectioning and staining
A single H&E stained section is adequate for examination provided the sections represent
the full face of the blocks. If there is tangential sectioning, deeper levels may be necessary.
6
Further investigations
None is usually required. However, if the histological features in a case of Hashimoto’s
thyroiditis raise the possibility of lymphoma, appropriate immunohistochemical and
molecular analyses are performed.
7
Report content2,3
The report summarises the gross and histological features and includes a diagnosis.
8
References
1.
The Royal College of Pathologists. Dataset for thyroid cancer histopathology reports.
The Royal College of Pathologists 2006. www.rcpath.org/publications
2.
Lloyd RV, Douglas BR, Young WF. Endocrine diseases. Atlas of Nontumor Pathology.
Washington, DC: Armed Forces Institute of Pathology, 2002.
3.
Rosai J, Carcangiu ML, DeLellis RA. Tumors of the Thyroid Gland. Atlas of Tumor
Pathology, Third Series, Fascicle 5. Washington DC: Armed Forces Institute of
Pathology, 1992.
London and South East
Sarcoma Network
London and South East Sarcoma Network
Shared Care Pathway for Soft Tissue Sarcomas Presenting to Site Specialised
MDTs
Head and Neck sarcomas
Background
This guidance is to provide direction for the management of patients with sarcomas that may present through
Head and Neck cancer services and to define the relationship that should exist with the specialist sarcoma
MDT. This guidance refers to the care of patients in the London and South East Sarcoma Network and
therefore recognises that specialist services for soft tissue sarcomas are provided by the Sarcoma Unit at The
London Sarcoma Service provided through joint working of UCLH and RNOH. All bone sarcomas are managed
by the London Sarcoma Service.
The local control rate for intermediate and high grade soft tissue sarcoma of the head and neck is markedly
inferior to that of sarcoma of the limbs. This is largely related to the extent and nature of the excisions possible.
The surgical factors associated with higher control rate in the limb are (i) primary, en bloc, rather than
piecemeal, resection and (ii) resection with negative margins. These goals are difficult to achieve in the head
and neck. Furthermore, although post operative radiotherapy reduces the local relapse rate, this still remains
high when surgical margins are positive. For surgery to be sufficient local treatment alone, margins must be
wide. Where radiotherapy is used with surgery the width of the margin is less important provided that the
margins are negative.
The first aim of this pathway is to ensure early discussion with a specialist head and neck sarcoma MDT so that
the chances of the first surgical intervention resulting in negative margins are maximised. Where possible the
surgery should be en bloc. Surgery alone may be sufficient when sarcomas are small (2 cm or less) and can
be excised en bloc with a wide margin (minimum 0.5 cm of uninvolved tissue or across an intact fascial plane).
In all other cases combined modality treatment with surgery and radiotherapy is indicated. For high grade
sarcomas, adjuvant chemotherapy will also be considered in all cases. The sequence has usually been surgery
followed by radiotherapy but increasingly pre-operative radiotherapy +/- chemotherapy may be preferred. The
major rationale for neoadjuvant chemotherapy is that in overview studies of adjuvant chemotherapy in STS as a
whole, use of chemotherapy is associated with a reduction in local recurrence. While this may be insignificant in
sarcomas of the limb, where the local relapse rate is 10-15% with surgery and radiotherapy, the impact of
chemotherapy may be greater where the expected local relapse rate is of the order of 25-50%. Therefore, for
patients without contraindications to both chemotherapy and pre–operative radiotherapy (where it will not
significantly compromise long term morbidity) both modalities are considered before surgery.
The rarity of head and neck sarcomas, their clinical diversity, the poor outcomes referred to above and the
important differences compared with squamous carcinomas of the head and neck argue for close co-operation
between head and neck and sarcoma MDTs and for centralisation of care. Where patients are receiving
combined modality treatment, especially with pre-operative chemotherapy and/or radiotherapy, receiving all
treatments at a single institution has many advantages for patients and treating teams. Regular multidisciplinary
clinical review when patients are on treatment and co-ordination between surgeon and oncologist is essential.
Principals
This guidance is being developed in accordance with the relevant measures in the Manual for Cancer Services:
Sarcoma Measures and the Manual for Cancer Services: Head and Neck Measures. They are also written in
accordance with the LSESN referral guidelines (see www.lsesn.nhs.uk) and the LSESN Patient Management
Policy.
1) Notification
All sarcoma patients presenting to a specialist Head and Neck MDT should be notified to the sarcoma MDT
nominated in the local network Head and Neck cancer operational policy.
2) Review by Sarcoma MDT
a) Pathology
All sarcomas arising in the head and neck will have pathology review undertaken by the nominated
specialist sarcoma pathology service (for details see MDT operational policies).
b) Management
Management of all new soft tissue sarcomas sarcomas will be discussed with the sarcoma MDT. Early
referral from the time of suspicion or biopsy is recommended. All new bone sarcomas will be referred at
time of suspicion to UCLH Sarcoma Unit.
3) Site of Definitive Treatment
Discussion between MDT’s will take place to determine the appropriate hospital for definitive excision. In
general, primary surgical excision at the sarcoma centre is preferred. All patients undergoing pre-operative
chemotherapy or radiotherapy will be managed at the sarcoma centre.
All craniofacial bone sarcomas will be managed at UCLH.
Chemotherapy and radiotherapy will be undertaken by designated practitioners as agreed by the SAG.
4) Recurrence
All recurrent head and neck sarcomas will be discussed and reviewed by the sarcoma MDT.
Presentation
Diagnosis
Treatment
Follow up
Role and Responsibility
Specialist Head and Neck
Sarcoma MDT/Clinic
MDT/Clinic
Assess new cases of suspected head
and neck cancer
Notify Sarcoma MDT of all new cases
of head and neck sarcoma
Refer all cases of head and neck
Review pathology of all new cases
sarcoma for pathology review.
of head and neck sarcoma
Refer all new cases of head and neck Clinical review of all new cases
sarcoma for review by sarcoma MDT
Excision when agreed by head and
Consider definitive excision of all
neck and sarcoma MDT’s
head and neck sarcomas; need for
adjuvant chemotherapy and/or
radiotherapy; re-excision of all
incompletely excised or recurrent
sarcomas.
All radical chemotherapy and
radical radiotherapy except agreed
by sarcoma and head and neck
MDT’s that individual factors
determine otherwise
Follow up according to agreed
Follow up in accordance with
guidelines of selected patients agreed sarcoma follow up guidelines of all
by MDT’s
patients treated by the sarcoma
MDT
Pathway Summary:
Suspected head and neck sarcoma
Specialist Head & Neck MDT

Assess new cases of suspected head & neck cancer
Notify sarcoma MDT of all new cases of head & neck sarcoma

Suspected/biopsy-proven
soft tissue sarcoma
LSS MDT Coordinator Contact details:
Ucl-tr.LondonSarcomaService:nhs.net
Tel: 020 3447 4821
suspected bone sarcoma
Sarcoma MDT



UCLH
All histology
reviewed by
Specialist
Sarcoma
Pathologist
Register patient
Review diagnosis
Plan management
Patients under 24 will also
be referred to the teenage
and young adult or
paediatric MDTs as
appropriate


Treatment
Follow-Up
Pre-operative
chemo and/or
radiotherapy
e.g < 2cm; low
grade
at sarcoma
centre*
Definitive Excision
Discussion between MDTs to determine
appropriate hospital for definitive
excision*
Excision or palliation by local team
by local team
Follow Up
Follow Up according to agreed head & neck MDT
guidelines and LSESN sarcoma follow-up guidelines (for
those patients treated by sarcoma MDT)
Recurrence
Follow Up