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GUIDELINES FOR THE MANAGEMENT OF SKIN CANCER
11-1C-110j
Agreed network-wide clinical guidelines for the management of skin cancer
Agreed: April 2015
Review: April 2017
Agreement cover sheet
The Guidelines of the Peninsula Cancer Network Skin Cancer Group have been agreed by:
Chair Peninsula Cancer Network Skin Cancer Group
Name
Organisation
Name
Karen Davies
Andrew Watts
Duncan
MacKenzie
Preshita Divekar
Chris Bower
Sheau Ng
Karen Davies
Northern Devon Healthcare NHS Trust
MDT Lead Clinicians
Organisation
Date agreed
24/04/2012
Date agreed
24/04/2012
Northern Devon Healthcare NHS Trust
Plymouth Hospitals NHS Trust
27/09/2011
Royal Cornwall Hospitals NHS Trust
Royal Devon & Exeter NHS Foundation Trust
South Devon Healthcare NHS Foundation Trust
27/04/2012
21/09/2011
22/09/2011
Date agreed
Katie Cross
Cancer Lead Clinicians
Northern Devon Healthcare NHS Trust
Sarah Pascoe
Plymouth Hospitals NHS Trust
27/09/2011
Giles Maskell
Royal Cornwall Hospitals NHS Trust
27/04/2012
John Rennison
Royal Devon & Exeter NHS Foundation Trust
27/04/2012
David Sinclair
South Devon Healthcare NHS Foundation Trust
27/04/2012
Name
Lynne Kilner
Yash Patel
Sara Wright
Emma Herd
Andy Gordon
CCG Managers for Cancer
Organisation
NHS New Devon Western Locality
NHS New Devon Eastern Locality
NHS New Devon Northern Locality
NHS South Devon and Torbay
NHS Kernow
27/04/2012
Date agreed
Table of Contents
1
Premalignant Lesions ...........................................................................................................................................7
1.1
2
3
4
Primary care referral guidelines..................................................................................................................7
Basal Cell Carcinoma .............................................................................................................................................7
2.1
Primary care referral guidelines ...................................................................................................................7
2.2
Treatment .....................................................................................................................................................9
2.3
Incomplete excisions: ...................................................................................................................................9
2.4
BCC Follow up: ............................................................................................................................................10
Squamous Cell Carcinoma ..................................................................................................................................10
3.1
Primary care referral guidelines .................................................................................................................10
3.2
Primary treatment ......................................................................................................................................10
3.3
Discussion at MDT ......................................................................................................................................11
3.4
Follow up ....................................................................................................................................................11
3.5
Clinical Imaging ...........................................................................................................................................11
Malignant Melanoma .........................................................................................................................................11
4.1
Primary care referral guidelines .................................................................................................................11
4.2
Primary Excision..........................................................................................................................................11
4.3 Dermoscopy ......................................................................................................................................................12
4.4
Wide excision:.............................................................................................................................................12
4.5
Imaging: ......................................................................................................................................................12
4.6
Sentinel Lymph Node Biopsy ......................................................................................................................12
4.7 Completion Lymphadenectomy for Positive SLNB ...........................................................................................12
4.8
Follow up ....................................................................................................................................................12
4.9
Genetic Testing of Tumours .......................................................................................................................13
4.10
Enhanced Follow-up with Imaging for patients at increased risk of metastasis: .......................................13
4.11 Vitamin D Advice ............................................................................................................................................13
4.12
5
6
Melanocytic Lesions of Uncertain Malignant Potential .............................................................................13
Skin Lymphoma` .................................................................................................................................................13
5.1
Referral .......................................................................................................................................................13
5.2
T Cell Lymphoma ........................................................................................................................................13
5.3
Photopheresis and Total Skin Electron Beam Therapy...............................................................................14
5.4
B Cell .........................................................................................................................................................14
Merkel Cell Carcinoma........................................................................................................................................14
6.1
Adequate Local Excision .............................................................................................................................14
7
8
9
6.2
Lymph Nodes ..............................................................................................................................................14
6.3
Radiotherapy ..............................................................................................................................................15
6.4
Distant Metastases .....................................................................................................................................15
6.5
Follow-Up ...................................................................................................................................................15
Skin Cancer for Specific Groups ..........................................................................................................................15
7.1
Skin Cancer of Specific Anatomical Sites ....................................................................................................15
7.2
Skin Cancers in Children & Young People ...................................................................................................16
Immunocompromised and Transplant Patients .................................................................................................16
8.1
Initial assessment .......................................................................................................................................16
8.2
Follow up ....................................................................................................................................................17
8.3
Pre-malignant lesions .................................................................................................................................17
8.4
New or fast-growing skin tumour...............................................................................................................17
8.5
Secondary prevention .............................................................................................................................17
8.6
Alteration in immunosuppression ..............................................................................................................17
Mohs Surgery......................................................................................................................................................17
10 Community Skin Cancer Services ..........................................................................................................................17
10.1 Levels of care that may be treated in the community ..................................................................................18
10.1.1 Definition of Low Risk Basal Cell Carcinoma ...........................................................................................18
10.1.2 Providers that may diagnose and treat low risk BCCs in the Community...............................................19
10.1.3 Practitioners that may perform surgery on pre-diagnosed lesions ........................................................20
10.2 A ccreditation .................................................................................................................................................20
10.2.1 Clinical accreditation ...............................................................................................................................21
10.2.2 GPs performing skin cancer treatment within the framework of the DES or LES under ........................22
GMS or PMS ........................................................................................................................................................22
10.2.3 GPs with a Special Interest................................................................................................................25
10.2.4 Model 2 Practitioners .............................................................................................................................26
10.3 Clinical Governance .......................................................................................................................................26
10.3.1 Overlap between practitioners ...............................................................................................................27
10.3.2 Process for GPs who provide care that is outside of these guidelines ...................................................27
10.4 Quality assurance...........................................................................................................................................27
10.4.1 Histopathology ........................................................................................................................................27
10.5 Data collection and audit ...............................................................................................................................28
10.6 Educational Meeting ......................................................................................................................................28
10.7 Communication..............................................................................................................................................28
10.8 Facilities .........................................................................................................................................................29
10.9 Support Services ............................................................................................................................................29
11 The Multidisciplinary Team ...................................................................................................................................29
12 Clinical Trials ........................................................................................................................................................29
Appendix 1- Primary care referral guidelines for skin cancer ....................................................................................30
Appendix 2 - Referral guidelines between Local and Specialist MDTs .......................................................................33
Appendix 3 - Extract from the South East London Cancer Network Constitution for Skin Cancer.............................34
Appendix 4 - Levels of Care ........................................................................................................................................35
Appendix 5 – Peninsula Cancer Network Urology Site Specific Group Penile Cancer Guidelines 2009.....................37
Appendix 6 - Excision of Skin Cancer in the Community Outside of the Guidelines ..................................................38
Table of Peer Review Measures
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Agreed network-wide clinical guidelines for the management of skin cancer ................. 1
Arrangements with haemato-oncology teams for lymphoma involving skin ................. 13
Agreed network referral guidelines to named supra-network T-cell lymphoma MDT for
TSEBT ........................................................................................................................ 14
Agreed network guidelines for referral for photopheresis............................................. 14
Arrangements for head and neck skin cancer ............................................................. 15
Arrangements for anal and perianal skin cancer.......................................................... 15
Arrangements for skin cancer of external female genitalia .......................................... 15
Arrangements for skin cancer of external male genitalia ............................................. 15
Arrangements with sarcoma MDTs for sarcoma involving skin .................................... 15
Network agreed referral guidelines between teams ..................................................... 15
Agreed network distribution of clinics for immunocompromised patients with skin cancer
.................................................................................................................................... 16
NSSG designated hospital practitioners for Mohs surgery and their caseload ............. 17
Policy for the provision of skin cancer services in the community ................................ 17
NSSG agreed clinical governance arrangements for community practitioners............. 17
NSSG agreed training policy for model 2 community practitioners with named
trainers/assessors ....................................................................................................... 17
named consultant dermatologist .................................................................................. 17
GPwSI training specific to skin cancer given under the supervision of a named consultant
dermatologist .............................................................................................................. 18
GPwSI accreditation group should have a lead clinician of a skin MDT who should be
involved in the accreditation and re-accreditation of community skin cancer clinicians 26
NSSG agreed training policy for model 2 community practitioners with named
trainers/assessors ....................................................................................................... 26
Agreed network primary care referral guidelines and their distribution......................... 32
Network/PCT agreed primary care referral policy and distribution of the primary care
referral guidelines........................................................................................................ 32
Network agreed referral guidelines between teams ..................................................... 33
1
Premalignant Lesions
1.1
Primary care referral guidelines
Premalignant lesions may be treated by any GP in the community
Includes actinic keratoses, Bowens disease (SCC in situ)
2
Basal Cell Carcinoma
2.1
Primary care referral guidelines
High Risk BCC
High risk of incomplete excision and
recurrence, defined as:
recurrent BCCs
BCCs on the head (face and scalp)
large BCCs > 2cm diameter unless
they are superficial BCCs (see below)
lesions that have a clinical appearance
of morphoeic, infiltrative or
basosquamous
lesions with poorly defined margins
BCCs in patients who are
immunosuppressed or have Gorlin‟s
syndrome
BCCs located over important underlying
anatomical structures (for example,
major vessels or nerves) or where
primary surgical closure may be difficult
(for example, digits or front of shin).
Extended Low Risk BCC
There is no diagnostic uncertainty that the
lesion is a primary nodular low-risk BCC and it
meets
the following criteria:
The patient with BCC is not:
aged 24 years or younger (that is, a
child or young adult)
immunosuppressed or has Gorlin‟s
syndrome
The lesion:
Is not on the nose and lips (including
nasofacial sulci and nasolabial folds),
or around the eyes (periorbital) or ears
Is less than 2 cm in diameter if below the
clavicle (unless they are superficial
BCCs see below).
Is less than 1 cm in diameter if above the
clavicle (unless they are superficial
BCCs see below).
Refer to core member of Local MDT
Suspected BCCs should usually be referred as
routine.
Consider 2 week referral if there is particular
concern that delay may have an impact because
of site or size of lesion.
Refer to either
Core member of local
MDT Or
Group 3 GPwSI in dermatology
and skin surgery
Or
Group 3a GPwSI in skin lesions
and skin surgery
Suspected BCCs should usually be referred as
routine.
Consider 2 week referral if there is particular
concern that delay may have an impact because
of site or size of lesion.
Is not morphoeic, infiltrative or
basosquamous in appearance
Does not have poorly defined margins
Is not located:
o over important underlying
anatomical structures (for
example, major vessels or nerves)
o in an area where primary
surgical closure may be difficult
(for
o
example, digits or front of shin)
in an area where excision
may lead to a poor cosmetic
result.
If any of the above exclusion criteria apply, or
there is any diagnostic doubt, the patient
should be referred to the LSMDT.
Incompletely excised BCCs should be
discussed with a member of LSMDT
Low Risk BCC
There is no diagnostic uncertainty that the
lesion is a primary nodular low-risk BCC and it
meets the following criteria:
The patient with BCC is not:
aged 24 years or younger (that is, a
child or young adult)
immunosuppressed or has Gorlin‟s
syndrome
The lesion:
is located below the clavicle (that is,
not on the head or neck)
is less than 1 cm in diameter with
clearly defined margins
is not a recurrent BCC
following incomplete excision
is not a persistent BCC that has
been incompletely excised
according to histology
is not morphoeic, infiltrative or
basosquamous in appearance
is not located
o over important underlying
anatomical structures (for
example, major vessels or nerves)
o in an area where primary
surgical closure may be difficult
(for example, digits or front of
shin)
o in an area where difficult excision
may lead to a poor cosmetic
Refer to either
Core member of local
MDT Or
Group 3 GPwSI in dermatology
and skin surgery
Or
Group 3a GPwSI in skin lesions
and skin surgery
Or
GP accredited in Skin Cancer
Suspected BCCs should usually be referred as
routine.
Consider 2 week referral if there is particular
concern that delay may have an impact because
of site or size of lesion.
o
result
at another highly visible
anatomical site (for example,
anterior chest or shoulders) where
a good cosmetic result is
important to the patient.
Incompletely excised BCCs should be
discussed with a member of the LSMDT.
BCC where there is any doubt about high or
low risk status
Refer to core member of Local MDT
Superficial BCCs – on the face
Refer to core member of Local MDT
Superficial BCCs – not on the face
If the lesion is thought to be a superficial BCC the
GP should ensure that the patient is offered the
full range of medical treatments, including
photodynamic therapy. This may require
referral to the LSMDT.
Refer to either
Core member of local
MDT Or
Group 3 GPwSI in dermatology
and skin surgery
Or
Group 3a GPwSI in skin lesions
and skin surgery
Or
GP accredited in Skin Cancer
2.2
Treatment
BCC Type
Small well-defined BCCs on trunk and limbs
Superficial BCCs
High-risk BCCs
Treatment
excision (with 3-4mm margin) or curettage &
cautery
excision, cryotherapy, imiquimod, 5-fluorouracil,
curettage or PDT: all treatment options guided
by site, size, clinician and patient preference
Surgical excision with at least 4mm margins
Monitoring rather than immediate treatment may be appropriate in cases of asymptomatic BCC in a
patient with a short life expectancy.
Consider Mohs surgery for more difficult and high risk cases such as:
Recurrent BCC
Poorly defined BCC
Aggressive histology
High risk sites
Where tissue conservation is particularly important
Radiotherapy may be useful, particularly for patients unwilling or unable to tolerate surgery.
2.3
Incomplete excisions:
Lateral margins
Deep margins
Offer re-excision or observation
Recommend immediate re-excision (and
possibly Mohs) unless patient very elderly in
which case observation may be more
appropriate, or consider radiotherapy.
2.4
BCC Follow up:
Complete excision or other definitive treatment – no follow up required, re-referral by GP if any sign of
recurrence.
Exceptions where follow-up may be appropriate:
Skin graft/flap reconstruction: review once at 3 months in selected cases to check
cosmesis/complications.
• High tumour load (ie 2 or more new BCCs per year or previous history of >10 BCCs). This decision
to be at the discretion of the treating clinician.
• Incomplete excision and opt for observation- consider follow-up 6 monthly for 1 year, then annually
for 2 years- or discuss self-observation or GP follow-up.
• Treatment with PDT/Imiquimod/Cryotherapy/C&C. Consider review once at 3 months to check on
effectiveness of treatment.
3
Squamous Cell Carcinoma
3.1
Primary care referral guidelines
Squamous Cell Carcinoma
Keratoacanthoma
3.2
2 Week Referral to core member of Local MDT
2 Week Referral to core member of Local MDT
Primary treatment
SCC Type
Treatment
Excision with ≥6 mm clinical margins (see below).
High risk SCC
High risk is defined as one or more risk factors
for recurrence or metastasis. The risk factors are
defined as:
poorly differentiated,
recurrent tumours,
tumours >2cm across,
perineural or lymphovascular
extension histologically
depth > 4mm
transplant or immunosuppressed patients
large >2cm lesions
site: ear/lip/non-sun-exposed
SCCs developing in
scars/sinuses/chronic inflammation
Low risk SCC
Excision with ≥4 mm clinical margins
Low risk is defined as not high risk.
This therefore includes:
Well differentiated tumours with no
risk factors
Moderately differentiated tumour with
no risk factors
Small well-defined and obviously well-differentiated tumours in elderly patients may be suitable for
treatment via curettage and cautery by practitioners experienced in this technique. Also in patients
with high tumour load, where patient is already having long-term follow-up.
Re-excision
If incomplete re-excise with 5mm margin.
Further treatment
Dependent upon relative risk of tumour metastasising/recurring. Adjuvant radiotherapy should
be considered for large poorly differentiated tumours and those close to excision margins.
3.3
Discussion at MDT
Completely excised, well differentiated SCCs need not be discussed at the MDT
All other SCCs (ie any incompletely excised SCCs or any moderately or poorly differentiated
SCCs) should be discussed that the MDT
3.4
Follow up
SCC Type
High risk SCC
Follow up
Consider 3 or 6 monthly follow-up for 2 years
depending on clinical situation (more need
for follow-up if more than 1 poor prognostic
factor present). Examine for local recurrence,
and lymph node draining basins. Consider
GP or patient self follow-up if
appropriate/acceptable
Low risk SCC
None required
Risk factors should be identified at the time of treatment by the dermatologist.
All patients should be made aware of the sign or symptoms that should prompt them to seek
medical advice. The Skin Cancer Service should ensure those patients who have problems
can quickly and easily be seen by the skin cancer service.
3.5
Clinical Imaging
High-risk SCC require CT for recurrent tumours
Not required for other primary SCC unless clinically indicated eg lymphadenopathy.
4
Malignant Melanoma
4.1
Primary care referral guidelines
Melanoma
4.2
Primary Excision
2-5mm clinical margins
2 Week Referral to core member of Local MDT
4.3 Dermoscopy
All pigmented lesions referred for assessment should be assess using dermoscopy carried out by
healthcare professional strained in this technique
4.4
Wide excision:
Dependent on staging:
Lentigo maligna
In-situ MM
Stage 1 melanoma
Stage 2 and above
melanoma
4.5
Imaging:
Stage III and above:
4.6
5mm excision clinical
margin to achieve
complete
histological excision
2-5mm margin to achieve
complete
histological
excision
1cm margin
at least 2 cm margin
Staging CT required
Sentinel Lymph Node Biopsy
Sentinel Lymph Node Biopsy may be offered to patients with melanoma more than 1mm Breslow
thickness. Patients should be offered SLNB as a staging tool and advised about advantages and
disadvantages (see NICE guideline NG14 July 2015). Patients should be advised about possible
clinical trials and allowed to make an informed choice.
4.7 Completion Lymphadenectomy for Positive SLNB
Consider completion lymphadenectomy for people whose SLNB shows micro metastases. Give the
patient verbal and written information about advantages and disadvantages as per the NICE
guidelines NG14 July 2015.
4.8
Follow up
LM or in-situ MM
Stage IA
Stage IB or above
One follow up and then discharge
3 or 6 monthly for 1 year
3 monthly for 3 years, then 6 monthly for a further 2 years
At follow up:
Examination of scar, in-transit metastases, lymph node basins, liver.
General skin check.
Discuss self-examination.
4.9
Genetic Testing of Tumours
If targeted systemic therapy is a treatment option, offer genetic testing (BRAF etc) on:
- the secondary deposit if this is possible, or
- the primary if there is no adequate sample from the secondary
4.10 Enhanced Follow-up with Imaging for patients at increased risk of metastasis:
(stage 2C with no SLNB, or stage 3) who would be eligible for systemic therapy:
Offer patients enhanced follow-up with CT scans chest/abdo/pelvis 6 monthly for 3 years. Consider
CT brain for adults. Advise MRI scanning for those under 24 years.
Advise patients of advantages and disadvantages (see NICE guideline NG14 July 2105)
4.11 Vitamin D Advice
The peninsula network has agreed there is no good evidence for routine measurement of Vitamin D
levels in patients with primary melanoma. All melanoma patients should be advised about vitamin D
supplementation if they are sun avoiding. There is a very small risk of renal stones with this
treatment.
4.12 Melanocytic Lesions of Uncertain Malignant Potential
These should be managed as melanoma
5
Skin Lymphoma`
5.1
Referral
Systemic or nodal lymphomas should be referred to the haemato-oncology MDTs.
Primary cutaneous lymphoma should be discussed at the Skin SSMDTs.
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Arrangements with haemato-oncology teams for lymphoma involving skin
5.2
T Cell Lymphoma
Patients may be referred to the Lymphoma Service in Bristol, or to St Johns Institute.
St John‟s Institute of Dermatology (Guy‟s & St Thomas‟ NHS Foundation Trust) is the Supra Network
T-cell Lymphoma MDT to which the Peninsula relates. It is part of the South East London Cancer
Network. See Appendix 3 for the relevant extract from the South East London Cancer Network Skin
NSSG Constitution.
Stage above 1b: consider/ offer referral to Lymphoma Unit,
BUT may not be appropriate or feasible in certain clinical situations eg:
single isolated tumours
very ill erythrodermic patients who are unable to travel
5.3
Photopheresis and Total Skin Electron Beam Therapy
Patients with erythrodermic cutaneous T cell lymphoma (stage 3 and 4) should be referred to
the Lymphoma Unit for consideration of photopheresis.
Patients with nodular mycosis fungoides (Stage 2b or over) should be referred to St John‟s for
consideration of Total Skin Electron Beam Therapy.
Some patients may be given Total Skin Electron Beam Therapy locally (in Plymouth) if this is
more acceptable for the patient and where the management has been planned by St John‟s.
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Agreed network referral guidelines to named supra-network T-cell lymphoma MDT for
TSEBT
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Agreed network guidelines for referral for photopheresis
5.4
B Cell
For systemic disease: refer to haematology as above.
For primary cutaneous disease:
Multiple or recurrent lesions: refer to St Johns
Local isolated disease: local skin/ haematology SSMDT
6
Merkel Cell Carcinoma
The principles of the management or Merkel cell carcinoma include:
All patients should be discussed at SSMDT
wide local excision
possible frozen section to confirm clearance
possible SLNB to assess lymph nodes
possible radiotherapy
It was agreed that there is no strong evidence base for treatment options.
It was agreed that these can be fast growing tumours and that wider excision should be timely, in line
with melanoma management.
6.1
Adequate Local Excision
Clinical local excision margins of 1-2cm
Aim for 1cm margin for tumour less than 2cm diameter.
Aim for 1- 2cm margin for tumour greater than or equal to 2cm diameter.
Consider using frozen section to confirm margins at time of operation.
If performing wider excision where original margins incomplete or close: ensure procedure is
arranged urgently (as tumours are potentially fast growing).
6.2
Lymph Nodes
Consider SLNB for patients who are clinically node negative.
For patients who are lymph node positive: Fine Needle Aspirate or Open Biopsy
If nodes positive then consider lymph node dissection (to improve loco-regional control).
If nodes positive then CT scan.
6.3
Radiotherapy
Consider for:
Large tumour >2cm
Lymph node involvement
6.4
Distant Metastases
Consider radiotherapy/ chemotherapy.
6.5
Follow-Up
As per melanoma patients ie 3 monthly for 3 years, then 6 monthly for further 2 years.
With thanks to Suyin Ong for drafting these guidelines
7
Skin Cancer for Specific Groups
7.1
Skin Cancer of Specific Anatomical Sites
The pathology for these cases should be referred to the following specified MDTs for an opinion on
management.
Anatomical Site
Head & Neck
Cancer Type
Nasal Mucosal MM
Ocular Mucosal MM
Periocular
Anal Cancer
External female
genitalia
Any
SCC
MM
BCC
Any
External male
Genitalia/Penile
Any
Rare Tumours
MDT to refer to
Head And Neck MDT
Ophthalmologists refer to oncologists
Oculoplastic/Plastic as Extended Member Of Skin
MDT
Colorectal MDT
Gynae MDT
Skin And Gynae MDT
Skin And Gynae MDT
Avon Somerset& Wilshire Supranetwork MDT
(see PCN Guidelines for Penile Cancer – Appendix
5)
Sarcoma MDT Exeter or Plymouth
Any SSMDT
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Sarcoma (see below)
Other rare tumours
(see list below)
Arrangements for head and neck skin cancer
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Arrangements for anal and perianal skin cancer
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Arrangements for skin cancer of external female genitalia
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Arrangements for skin cancer of external male genitalia
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Arrangements with sarcoma MDTs for sarcoma involving skin
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Network agreed referral guidelines between teams
Sarcoma includes all dermal and subcutaneous tumours, namely:
Dermatofibrosarcoma protuberans.
Leiomyosarcoma.
Angiosarcoma.
Kaposi‟s sarcoma.
Haemangioendothelioma.
Epithelioid sarcoma.
Primary cutaneous rhabdomyosarcoma.
Cutaneous malignant nerve sheath tumours (including cutaneous
neurofibrosarcoma and malignant Schwannoma).
Other Rare Tumours
Merkel Cell Tumours
Apocrine carcinoma.
Hidradenocarcinoma.
Eccrine porocarcinoma.
Sebaceous carcinoma.
Tumours associated with Muir–Torre syndrome
Eccrine epithelioma (syringoid carcinoma)
Microcystic adnexal carcinoma
Primary adenoid cystic carcinoma
Primary mucoepidermoid carcinoma
Primary mucinous carcinoma
Digital papillary adenocarcinoma
Malignant cylindroma
Malignant spiradenoma (spiradenocarcinoma)
Malignant pilar tumour
Malignant pilomatrixoma
Neuroendocrine carcinoma (Merkel cell tumour/trabecular carcinoma)
Atypical fibroxanthoma
7.2
Skin Cancers in Children & Young People
All children (ages 0-16) and young people (ages 16-24) with skin cancer should be discussed with the
local lead consultant for children & young people‟s cancer. This should happen as soon as is practical.
8
Immunocompromised and Transplant Patients
Clinics/allocated slots for transplant patients to be held at all 5 centres
NDH
PHT
RCH
RDE
SDH
Dr Karen Davies
Dr Cairine Wilkinson
Dr Samantha Hann
Dr Rebecca Batchelor
Dr Ng Sheau
Clinics to be held 1 – 3 monthly depending on need/ numbers
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Agreed network distribution of clinics for immunocompromised patients with skin cancer
8.1
Initial assessment
1 year post transplant: advice and information particularly sun protection and self monitoring.
Assessment for high risk factors including:
older patients
white skinned patients who have had excess sun exposure
presence of pre-malignant warty lesions or actinic keratoses
8.2
Follow up
Frequency of follow-up to be decided by clinician on basis of clinical need. This should be annual
follow-up as an ideal minimum, but then 3-6 monthly for patients with skin cancers, depending on
various factors including tumour type and presence of high risk factors (eg poorly differentiated SCC).
8.3
Pre-malignant lesions
There should be active treatment of all pre-malignant lesions.
8.4
New or fast-growing skin tumour
Patients should be given instructions on how to access service at short notice in the event of a new or
fast-growing skin tumour.
8.5
Secondary prevention
Retinoids and/or reduction of immunosuppression as below should be considered.
8.6
Alteration in immunosuppression
Transplant physicians should be contacted with regard to possible alteration in immunosuppression
particularly with:
>25 NMSCs per yr
high risk SCC
Merkel cell tumour
melanoma especially stage 11a or above
Management will vary according to type of transplant.
9
Mohs Surgery
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NSSG designated hospital practitioners for Mohs surgery and their caseload
The only practitioners authorised to carry out Mohs surgery (including 'Slow Mohs surgery') are the
following:
Dr Samantha Hann, Dr Tom Lucke (RCHT)
Dr Chris Bower, Dr Emily McGrath (RD&E)
The Mohs surgery practice is well established in Cornwall, and has started in Exeter.
10 Community Skin Cancer Services
This section covers the protocols for the accreditation, training and Governance of skin cancers
services carried out in the community.
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Policy for the provision of skin cancer services in the
community
11-1C-112j
practitioners
NSSG agreed clinical governance arrangements for community
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NSSG agreed training policy for model 2 community practitioners with named
trainers/assessors
11-6A-104j
GPwSI training specific to skin cancer given under the supervision of a
named consultant dermatologist
All healthcare professionals managing skin lesions in the community should have specialist training in
the diagnosis and management of skin lesions appropriate to their role.
All GPs who diagnose, manage and excise low-risk BCCs in the community should be fully accredited
to do so and undergo continuous professional development in the diagnosis and management of skin
lesions to maintain their accreditation. All Services for low-risk BCCs should adhere to national cancer
peer review measures.
10.1 Levels of care that may be treated in the community
The Levels of Care can be found at Appendix
4.
Level of Care
1
2 (low risk BCCs)
3
4
5
6
Practitioners who may diagnoses & treat in the community
All GPs and MDT members
See below
Community outreach from Local or Specialist MDT
Community outreach from Local or Specialist MDT
Community outreach from Specialist MDT
None
10.1.1 Definition of Low Risk Basal Cell Carcinoma
Diagnosis
Low Risk BCC
Criteria
There is no diagnostic uncertainty that the lesion is a primary nodular low-risk BCC
and it meets the following criteria:
The patient with BCC is not:
aged 24 years or younger (that is, a child or young adult)
immunosuppressed or has Gorlin‟s syndrome
The lesion:
is located below the clavicle (that is, not on the head or neck)
is less than 1 cm in diameter with clearly defined margins
is not a recurrent BCC following incomplete excision
is not a persistent BCC that has been incompletely excised according to
histology
is not morphoeic, infiltrative or basosquamous in appearance
is not located
o
o
over important underlying anatomical structures (for example,
major vessels or nerves)
in an area where primary surgical closure may be difficult
(for example, digits or front of shin)
o in an area where difficult excision may lead to a poor cosmetic result
o at another highly visible anatomical site (for example, anterior chest
or shoulders) where a good cosmetic result is important to the
patient.
See below for superficial BCCs
Extended
Low Risk BCC
Incompletely excised BCCs should be discussed with a member of the LSMDT.
There is no diagnostic uncertainty that the lesion is a primary nodular low-risk BCC
and it meets the following criteria:
The patient with BCC is not:
aged 24 years or younger (that is, a child or young adult)
immunosuppressed or has Gorlin‟s syndrome
The lesion:
Is not on the nose and lips (including nasofacial sulci and nasolabial folds),
or around the eyes (periorbital) or ears
Is less than 2 cm in diameter if below the clavicle (unless they are superficial
BCCs see
below).
Is less than 1 cm in diameter if above the clavicle (unless they are
superficial BCCs see below).
Is not morphoeic, infiltrative or basosquamous in appearance
Does not have poorly defined margins
Is not located:
o over important underlying anatomical structures (for example,
major vessels, nerves or temple)
o in an area where primary surgical closure may be difficult
(for example, digits or front of shin)
o in an area where excision may lead to a poor cosmetic result.
If any of the above exclusion criteria apply, or there is any diagnostic doubt, the
patient should be referred to the LSMDT.
Superficial
BCCs
Incompletely excised BCCs should be discussed with a member of LSMDT.
If the lesion is thought to be a superficial BCC the GP should ensure that the patient
is offered the full range of medical treatments, including photodynamic therapy. This
may require referral to the LSMDT.
All superficial BCCs on the face should be referred to the LSMDT
10.1.2 Providers that may diagnose and treat low risk BCCs in the Community
Provider
Accreditation
Community outreach from Local or
Specialist MDT (a consultant led
service that may include staff grade
and
Training is covered by conventional
specialty training in dermatology,
and practitioners are subject to the
MDT
associate specialist doctors
measures for core members in the
BCCs that
can be
treated
All
and specialist nurses.
Group 3 GPwSI in dermatology
and skin surgery
Manual for Cancer Services.
On PCT GPwSI list 1,2
Annually accredited by Local
MDT according to Error!
Reference source not found.
Group 3a GPwSI in skin lesions
and skin surgery
On PCT GPwSI list 1 (Completion of
SS1 and SS2 modules of GPwSI
training (without having completed full
GPwSI training)
Annually accredited by Local
MDT according to Error!
Reference source not found.
Annually accredited by Local
MDT according to Error!
Reference source not found.
GPs performing skin surgery within the
framework of the Directed Enhanced
Services and Local Enhanced
Services under General Medical
Services or Personal Medical
Services
Exte
nded
Low
Risk
BCCs
Exte
nded
Low
Risk
BCCs
Low
Risk
BCC
s
1
Department of Health (2007) Guidance and competencies for the provision of services using GPs with special interests
(GPwSIs): dermatology and skin surgery. Available from:
http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_074665
Department of Health (2007) Implementing care closer to home: convenient quality care for patients. Part 3: the accreditation
of GPs and pharmacists with special interests. London: Department of Health
2
Revised guidance and competences for the provision of services using GPs with Special Interests (GPwSIs)
10.1.3 Practitioners that may perform surgery on pre-diagnosed lesions
Model
2
Practitioners
A Model 2 practitioner should be one of the
following:
a medical practitioner performing skin surgery in a community setting
a suitably trained specialist nurse.
Model 2 practitioners can perform surgery on pre-diagnosed lesions including the full range of BCCs
as well as other types of skin cancer provided that
they have demonstrated surgical competence
surgery is performed after the lesions have been diagnosed by an MDT member and a
management plan identified.
10.2 A ccreditation
All community skin cancer clinicians should identify the Local Skin Cancer MDT to which they relate.
Good communication should be established to ensure the consistency and continuity of services for
patients.
The accreditation and governance arrangements are set out in the table below.
Service
Clinical
accreditation by
MDT
Placed on PCT
GPwSI list
Community outreach from Local or
Specialist MDT (a consultant led
service that may include staff grade
and
associate specialist doctors and
specialist nurses.
Model 2 Practitioners
Assumed
through
consultant led
service
No
Yes
No
Group 3 GPwSI in dermatology and skin
surgery
Yes
Yes
Group 3a GPwSI in skin lesions and
skin surgery
Yes
Yes
GPs performing skin surgery within
the framework of the DES and LES
Enhanced Services under GMS or PMS
Yes
No, but
placed on
PCT list for
GPs
performing
skin surgery
within the
framework of
the
DES and
LES
Enhanced
Services under
GMS or PMS
*Some GPs may be accredited as both a GPwSI and a Model 2 practitioner.
Employer
responsible
for clinical
governance
Acute
Trust
hosting
MDT
Acute Trust
hosting MDT
GP Practice or
GPwSI
(depending
on
contractual
arrangement
s)
GP Practice or
GPwSI
(depending
on
contractual
arrangement
s)
GP Practice
10.2.1 Clinical accreditation
Clinical accreditation will only assure competency and knowledge at the time and setting of
accreditation. It does not confer any responsibility on the MDT for the actual service. Nor does it make
any judgment on the suitability of the service model or environment in which the service is carried out.
These issues are a matter for the clinical governance of the provider and their commissioner.
10.2.2 GPs performing skin cancer treatment within the framework of the DES or LES under
GMS or PMS
There are contractual requirements for GPs and other primary care health care professionals
performing skin surgery within the framework of the DES under General or Personal Medical Services.
National guidance sets out how these contractual requirements should be assessed. These are set
out below with an indication of the method of assessment.
Contractual requirements for GPs and other primary care health care professionals
performing skin surgery within the framework of the DES under General or Personal Medical
Services
Contractual
Measures of competency and activity against these
Assessment
requirement
requirements
method
The contractor ensures
A. Has a new skin surgery practitioner demonstrated
Skin Cancer
that any health care
competency to a suitably qualified external body
Course
professional who is
using objective evidence and competency based
involved in performing
assessment tool (ie Direct Observation of
any surgical
Procedural Skills, known as DOPS)?
procedures has:
Skin Cancer
B. Has an existing practitioner demonstrated
Course
competency to perform the designated
i. any necessary
procedure(s) to a suitably qualified external body
experience,
using objective
skills and
evidence and competency based assessment
training with
tools within the preceding three years? DOPS
regard to that
assessment is appropriate
procedure
C. Does the practitioner continue to perform skin
Revalidation
to
surgery with a regular, sustained level of activity and
ii. resuscitation skills
assess that
follow a program of revalidation? 100 skin surgery
at least 20
procedures per year that leave a scar (excluding
cases of skin
cryosurgery) is recommended. If less than 100
cancer have
procedures per year are performed, it is suggested
been treated
that the practitioner demonstrate ongoing
per year
competency to perform the designated procedure(s)
by completion of further DOPS assessments at
Commission
three yearly intervals, unless the activity increases
er to asses
to the recommended amount
that
at 100
skin
surgery
procedures
per
year that
leave a scar
(excluding
cryosurgery)
are
undertaken
(accounting
for suspected
skin cancer
and
non skin
cancer
procedure
s)
The contractor:
i. obtains
written
consent for
the
surgical
procedure before
it is carried
out (where a
person consents
on a
patient‟s behalf,
that
person‟s
relationship
to the patient must
be recorded on
the consent
form), and
takes all
reasonable steps
to ensure that the
consent form is
included in the
lifelong medical
records held by
the
patient‟s general
practitioner
The contractor ensures
that all tissue removed
by surgical procedures
is sent for histological
examination, unless
there are acceptable
reasons for not doing
so
D. Has the practitioner demonstrated training and
ongoing medical education in the recognition
and
management of skin lesions appropriate to their role
(for example, a practice nurse performing skin
surgery on pre-diagnosed skin lesions will have
different skin lesion diagnostic skill requirements to
a GP diagnosing and excising lesions)?
E. Does the practitioner have evidence of
annual training in resuscitation?
F. Is the practitioner familiar with Department of Health
and General Medical Council guidance on informed
consent, particularly in relation to the Mental
Capacity Act and obtaining consent from minors,
and has best practice as detailed in these
guidance
documents been adopted?
Skin Cancer
Course
G. Does the practitioner send all skin specimens
removed to histology for analysis and provide
information about the site of excision and
provisional diagnosis on the histology request
form?
H. Does the practitioner maintain a ‟fail-safe„ log of all
procedures performed with histological outcome to
ensure that patients are informed of the final
diagnosis, and whether any further treatment
or
follow-up is required? Is this undertaken in a
timely fashion?
I. Is the practitioner aware of, and following, all
Skin Cancer
Course
Revalidation
Commission
er to assess
Skin Cancer
Course
ii.
The contractor
Revalidation
Revalidation
Commission
ensures that it has
appropriate
arrangements for
infection control
and
decontamination
in
premises where
surgical procedures
are
undertaken
The contractor
ensures that all
records relating
to all surgical
procedures are
maintained in such
a
way:
i.
that aggregated
data and details of
individual patients
are readily
accessible for
lawful purposes,
and
ii. as to facilitate
regular audit and
peer review by the
contractor of the
performance of
surgical
procedures under
the plan
relevant national guidance in relation to policies
and
procedures (for example premises,
facilities, infection control, needlestick
injuries etc)?
er to assess
J. Does the practitioner provide evidence of an annual
review of clinical compared with histological
accuracy in diagnosis to demonstrate diagnostic
competency?
K. Has a wound infection and patient experience study
Revalidation
been completed?
L. When low risk BCCs are excised, does the
practitioner demonstrate that the requirements
in
Improving Outcomes for people with skin tumours
including melanoma (update) - The management
of low-risk basal cell carcinomas (May 2010) are
met
(see Annex E).
M. Is the above considered as part of the
annual appraisal process?
Revalidation
Revalidation
Revalidation
Skin Cancer Course
Skin Cancer Courses will be run in the Peninsula to train and accredit GPs against measures A, B, D,
F & G and the following
appropriate treatment selection.
performance of local anaesthesia, punch biopsy, shave excision, curettage and elliptical
excision.
knowledge of NICE and Peninsula Skin Cancer Guidance for treatment of skin cancer.
Accreditation will involve completion of 4 satisfactory formal assessments:
2 clinical assessments (modified mini-CEX) relating to diagnosis of benign and malignant
skin lesions
2 DOPS (Directly Observed Practices) assessments relating to surgical procedures
Fulfilment of the above criteria is likely to require attendance at secondary care clinics for training,
unless the practitioner can demonstrate adequate previous experience and quality of care.
Initial Accreditation
GPs operating on Skin Cancer will need to
attend a Skin Cancer Course that fulfils the requirements set out above and be accredited as
having met the clinical requirements of the course.
Be accredited by their commissioner against measures C, E & I.
be linked to a named skin cancer MDT and be accredited by the Skin MDT Lead.
Revalidation
GPs should attend an annual Skin Cancer Review. This will be organised by the Peninsula Cancer
Network. GPs should collect and present information at this annual review sufficient to demonstrate:
Measure C specifically the treatment, using any modality, of at least 20 cases of suspected
skin cancer in the previous year.
Measure D – specifically one CPD session (a total of 4 hours) on skin lesion recognition and
the diagnosis and management of low-risk BCCs
Measure G (histology)
Measure H (fail safe log)
Measure J – specifically that at least 90% of excisions of skin cancers have a clear margin
Measure L (compliance with Guidance)
Measure M (annual appraisal)
Measure J - specifically a diagnostic accuracy of 70% (ie clinical vs. histological diagnosis) for
the low-risk BCCs they have managed.
GPs that are unable to meet these revalidation requirements will need to undergo further training and
accreditation as per initial accreditation.
Practitioners operating on Skin cancer in the Community should follow these guidelines (Section 9.5 –
9.9) regarding facilities and support services (Community skin services may only be carried out in
facilities approved by the PCT), data collection and audit, and communication.
10.2.3 GPs with a Special Interest
This accreditation applies to:
Group 3 GPwSI in dermatology and skin surgery
Group 3a GPwSI in skin lesions and skin surgery
A new „Group 3a GPwSI in skin lesions and skin surgery‟ is being developed by the Department of
Health whose role is as follows:
training and accreditation to the same standard as the „Group 3 GPwSI in dermatology and
skin surgery‟ but for skin lesions only (excluding the inflammatory skin disorders) all other
criteria, including referral pathways, link to the MDT, clinical governance arrangements and
CPD requirements, to match the Group 3 GPwSI in dermatology and skin surgery
Initial accreditation
GPwSIs performing skin surgery should follow the framework for the training and accreditation of
GPwSIs, which is defined by the Department of Health as follows:
they are accredited by the PCTs according to national guidance appropriate to their role as
GPwSIs. This will include demonstrating competency in performing local anaesthesia,
punch biopsy, shave excision, curettage and elliptical excision using the direct observation
of procedural skills (DOPS) assessment tool in the Department Health Guidance for
GPwSIs in dermatology and skin surgery.
t e GPwSI is linked to a named skin cancer MDT.
h
Revalidation
GPwSIs will need to maintain accreditation annually and should:
demonstrate adherence to the requirements for community skin cancer clinicians specified in
the dermatology and skin surgery GPwSI guidance.
Fulfil the revalidation requirements set out for GPs performing skin surgery within the
framework of the DES or LES under GMS or PMS (see above).
attend four MDT meetings per year
skin cancer clinical practice is audited annually as defined in the GPwSI guidance
GPwSIs who are unable to meet these revalidation requirements will need to undergo further training
and accreditation as per initial accreditation.
11-6A-104j
GPwSI training specific to skin cancer given under the supervision of a named
consultant dermatologist
11-6A-105j
GPwSI accreditation group should have a lead clinician of a skin MDT who should be
involved in the accreditation and re-accreditation of community skin cancer clinicians
10.2.4 Model 2 Practitioners
Initial accreditation
Model 2 practitioners should:
be trained in and have demonstrated competency in skin surgery techniques (as per SS1 and
SS2 frameworks in the GPwSI guidance)
be associated with a named MDT
perform surgery on pre-diagnosed skin cancers, receiving referrals from core MDT members
with an agreed treatment plan.
Revalidation
Practitioners will need to maintain accreditation annually and should demonstrate:
Measure C specifically the treatment, using any modality, of at least 20 cases of suspected
skin cancer in the previous year.
Measure D – specifically one CPD session (a total of 4 hours) on skin the management of lowrisk BCCs
Measure G (histology)
Measure H (fail safe log)
Measure J – specifically that at least 90% of excisions of skin cancers have a clear margin
Measure L (compliance with Guidance)
Measure M (annual appraisal)
Model 2 Practitioners who are unable to meet these revalidation requirements will need to undergo
further training and accreditation as per initial accreditation.
11-1C-113j
NSSG agreed training policy for model 2 community practitioners with named
trainers/assessors
10.3 Clinical Governance
All providers of community dermatology services that include skin cancer should ensure that:
Clinical governance arrangements are in place for all healthcare professionals providing these
services (including private providers contracted to treat NHS patients) and they are accredited to
perform skin lesion excisions.
All healthcare professionals providing these services work in accordance with the Network Skin
Cancer Guidelines (covering referral, treatment and follow-up.
Healthcare professionals managing skin lesions in the community should obtain informed
consent before any treatment is undertaken.
The clinical governance therefore sits with the employer of individual practitioners. PCTs will want to
be assured that this is in place for all providers that they commission services from.
As the Guidance states that the clinical governance for Model 2 practitioners sits with the MDT, the
MDT will want either to directly employ the Model 2 practitioner (for the relevant sessions) or formally
subcontract with the practitioner. Other, informal, relationships will compromise the ability of the MDT to
discharges its clinical governance responsibilities for which it is accountable.
10.3.1 Overlap between practitioners
An individual practitioner may be accredited in more than one group ie:
GPwSIs
Model 2 practitioner
GPs working under the DES or LES
It is the responsibility of the practitioner and their employer to ensure that there is clarity about which
role the practitioner is operating under and to ensure that the relevant guidance is followed in all cases.
10.3.2 Process for GPs who provide care that is outside of these guidelines
All GPs who perform treatment outside of these guidelines will be sent the statement “Excision of Skin Cancer in the Community Outside of the Guidelines” (Appendix 6). Each MDT
and its lead PCT will agree which party sends the statement.
All occasions of GPs operating outside of these Guidelines will be shared with the PCT.
GPs who continue to operate outside of these guidelines will be subject to the PCTs Poor
Performance Process1 Where a patient needs further treatment, a letter will be sent from the
MDT specifying the actions that should be taken by the GP.
10.4 Quality assurance
10.4.1 Histopathology
All skin lesion samples (excision, incision, punch biopsy and curettage) should be sent for histological
examination as recommended in the NICE „Referral guidelines for suspected cancer‟. This should
provide information about the site of excision and provisional diagnosis on the histology request form.
If a person has more than one lesion, samples should be sent in separate specimen pots with referral
forms. Histology request and reporting forms, and the electronic recording of these data items, should
be improved to capture the national skin cancer minimum dataset requirements2 and the Royal College
of Pathology dataset).
All healthcare professionals should have a failsafe mechanism in place to ensure that they receive
results for the skin lesion samples they send for histological assessment and act upon the results. This
means that:
all samples sent to the laboratory should be accompanied with a numerical checklist
any sample not received by the laboratory should be immediately notified to the operating GP
all results should be cross checked to ensure they have been seen and actioned.
Healthcare professionals should take appropriate action if the histology result reclassifies the lesion as a
high-risk BCC or a SCC, malignant melanoma or other rare skin tumour and refer to approved
specialists as recommended in „Improving outcomes for people with skin tumours including melanoma‟
(NICE guidance on cancer services). The following histological criteria denote high-risk BCC:
incomplete excision margins
morphoeic, infiltrative, micronodular or basosquamous
perineural invasion below the dermis.
Each PCT should commission histopathology skin cancer services that clearly identify each individual
healthcare professional. Audit data should be presented in an anonoymised fashion using individual
identifier numbers, but individual healthcare professionals and PCTs should be given data that is
identifiable.
GPs operating under DES/LES should send their low-risk BCC samples to the main histopathology
laboratory that are linked to their local MDT.
1
NHS Devon - Policy And Procedures For Managing General Practitioners, Dentists And Pharmacists In Devon
Whose Performance Gives Cause For Concern
NHS Cornwall & IOS – Cause for Concern Process
2
National Cancer Intelligence Network dataset project [in development Available from the National Cancer Intelligence
Network (NCIN): http://www.ncin.org.uk/index.shtml
10.5 Data collection and audit
Healthcare professionals managing low-risk BCCs in the community should maintain a written or
electronic record of the suspected and actual skin cancers they have managed in their individual
caseload. This will need to specify the treatments offered and carried and the rationale for choosing a
particular treatment modality.
As required by the „Manual for cancer services 2008: skin measures‟ all BCCs excised by healthcare
professionals in the community should be audited. The PCT should make these audit results available to
the multidisciplinary team (MDT), cancer network and the individual practitioner on a quarterly basis and
they should be included in the cancer network annual audit (cancer standards 08-6A-103J36).
The quarterly dataset should be a standard PCT contract monitoring item for the DES.
Individual healthcare professionals should be responsible for collating their individual audit data for
revalidation.
The MDT should source suitable patient reported outcome measures for the treatment of BCCs.
All BCCs should be registered with cancer registries to allow national, regional and local epidemiology
and health service epidemiological studies to take place.
10.6 Educational Meeting
The Skin Cancer Network Site Specific Group should run two educational meetings per year, which
should:
present the 6-monthly BCC network audit results, including a breakdown of individual
practitioner performance
include one CPD session (a total of 4 hours) on skin lesion recognition and the diagnosis and
management of low-risk BCCs
10.7 Communication
All healthcare professionals managing BCCs in the community should provide information, advice and
support for patients and their families or carers.
10.8 Facilities
Community skin services may only be carried out in facilities approved by the PCT (with guidance as
appropriate by the MDT).
Facilities should be assessed for:
Operating equipment
Lighting
Storage and use of liquid nitrogen (if being used, should be in line with Health and Safety
guidance)
Infection control and decontamination issues
10.9 Support Services
Community skin cancer services are responsible for:
The provision of information, advice and support for patients managed in primary care and
their carers
Assessment and management of risk within the service
Community skin cancer services should have their own guidelines to include:
Type of patients seen
Frequency of consultations
Range of interventions
Referral criteria
Communication pathways
Confidentiality
Community skin cancer services must be supported by:
Adequate record keeping and appropriate documentation
Close links to the Skin MDT
Clinical audit programme, including patient satisfaction survey
Complaints process and review
Incident reporting process and review, including significant event monitoring
11 The Multidisciplinary Team
The Following principles apply to the members of MDTs to ensure the correct decisions are made to
ensure best treatment.
Dermatologists who regularly treat skin cancer (and where this is a significant part of their
workload) should be a core member of their local MDT
Those who do skin cancer work as a low percentage of their overall work (eg 10% of their
workload) – and this will often apply to Plastic Surgeons - may be extended members of the
MDT ie attend 4 MDT meetings per year, but need not be core members of the MDT.
12 Clinical Trials
Participation in clinical trials is encouraged, especially those which are part of the national Cancer
Research network portfolio. In some instances the trial protocol will require diagnosis; treatment or
follow-up which is at odds with these clinical guidelines. This should not be a concern where the trial has
been through the appropriate ethical approval.
Appendix 1- Primary care referral guidelines for skin cancer
Premalignant lesions
Includes actinic keratoses, Bowens disease (SCC
in situ)
High Risk BCC
High risk of incomplete excision and
recurrence, defined as:
recurrent BCCs
BCCs on the head (face and scalp)
large BCCs > 2cm diameter (unless
they are superficial BCCs see below)
lesions that have a clinical appearance
of morphoeic, infiltrative or
basosquamous
lesions with poorly defined margins
BCCs in patients who are
immunosuppressed or have Gorlin‟s
syndrome
BCCs located over important underlying
anatomical structures (for example,
major vessels or nerves) or where
primary surgical closure may be difficult
(for example, digits or front of shin).
Extended Low Risk BCC
There is no diagnostic uncertainty that the
lesion is a primary nodular low-risk BCC and it
meets the following criteria:
The patient with BCC is not:
aged 24 years or younger (that is, a
child or young adult)
immunosuppressed or has Gorlin‟s
syndrom
e
The lesion:
Is not on the nose and lips (including
nasofacial sulci and nasolabial folds),
or around the eyes (periorbital) or ears
Is less than 2 cm in diameter if below the
clavicle (unless they are superficial
BCCs see below).
Is less than 1 cm in diameter if above the
clavicle (unless they are superficial
BCCs see below).
Is not morphoeic, infiltrative
or basosquamous in
appearance
Does not have poorly defined margins
Is not located:
o over important underlying
anatomical structures (for
example, major vessels or nerves)
o in an area where primary surgical
May be treated by any GP in the community
Refer to core member of Local MDT
Suspected BCCs should usually be referred as
routine.
Consider 2 week referral if there is particular
concern that delay may have an impact because
of site or size of lesion.
Refer to either
Core member of local
MDT Or
Group 3 GPwSI in dermatology
and skin surgery
Or
Group 3a GPwSI in skin lesions
and skin surgery
Suspected BCCs should usually be referred as
routine.
Consider 2 week referral if there is particular
concern that delay may have an impact because
of site or size of lesion.
o
closure may be difficult (for
example, digits or front of
shin)
in an area where excision
may lead to a poor cosmetic
result.
If any of the above exclusion criteria apply, or
there is any diagnostic doubt, the patient
should be referred to the LSMDT.
Incompletely excised BCCs should be
discussed with a member of LSMDT
Low Risk BCC
There is no diagnostic uncertainty that the
lesion is a primary nodular low-risk BCC and it
meets the following criteria:
The patient with BCC is not:
aged 24 years or younger (that is, a
child or young adult)
immunosuppressed or has Gorlin‟s
syndrom
e
The lesion:
is located below the clavicle (that is,
not on the head or neck)
is less than 1 cm in diameter with
clearly defined margins
is not a recurrent BCC
following incomplete excision
is not a persistent BCC that has
been incompletely excised
according to histology
is not morphoeic, infiltrative
or basosquamous in
appearance
is not located
o over important underlying
anatomical structures (for
example, major vessels or nerves)
o in an area where primary
surgical closure may be difficult
(for example, digits or front of
shin)
o in an area where difficult excision
may lead to a poor cosmetic
result
o at another highly visible
anatomical site (for example,
anterior chest or shoulders) where
a good cosmetic result is
important to the patient.
Refer to either
Core member of local
MDT Or
Group 3 GPwSI in dermatology
and skin surgery
Or
Group 3a GPwSI in skin lesions
and skin surgery
Or
GP accredited in Skin Cancer
Suspected BCCs should usually be referred as
routine.
Consider 2 week referral if there is particular
concern that delay may have an impact because
of site or size of lesion.
Incompletely excised BCCs should be
discussed with a member of the LSMDT.
BCC where there is any doubt about high
or low risk status
Refer to core member of Local MDT
Superficial BCCs – on the face
Refer to core member of Local MDT
Superficial BCCs – not on the face
If the lesion is thought to be a superficial BCC the
GP should ensure that the patient is offered the
full range of medical treatments, including
photodynamic therapy. This may require
referral to the LSMDT.
Refer to either
Core member of local
MDT Or
Group 3 GPwSI in dermatology
and skin surgery
Or
Group 3a GPwSI in skin lesions
and skin surgery
Or
GP accredited in Skin Cancer
Suspected BCCs should usually be referred as
routine.
Consider 2 week referral if there is particular
concern that delay may have an impact because
of site or size of lesion.
Squamous Cell Carcinoma
Keratoacanthoma
Melanoma
2 Week Referral to core member of Local MDT
2 Week Referral to core member of Local MDT
2 Week Referral to core member of Local MDT
It is recognised that some skin cancers will be excised accidentally by GPs where the diagnosis was
not apparent. These guidelines assume that GPs will not knowingly treat patients beyond their remit.
See Section 9 for the Governance of skin cancer services in the community.
11-1C-110j
Agreed network primary care referral guidelines and their
distribution
11-6A-101j
Network/PCT agreed primary care referral policy and distribution of the primary care
referral guidelines
Appendix 2 - Referral guidelines between Local and Specialist MDTs
Local MDT
Plymouth Hospital
North Devon Hospital
Royal Devon and Exeter Hospital
South Devon Hospital
Royal Cornwall Hospital
Specialist MDT
Plymouth Hospital
Royal Devon and Exeter Hospital
Royal Cornwall Hospital
Patients requiring care level 5 and above should be referred from the Local to the Specialist MDT,
including:
Metastatic SCC
Radiotherapy
Other adjuvant therapy
Mohs‟ surgery
Selected SCCs and BCCs
Skin lymphoma
Sarcoma
Other rare tumours
Patients with genetic syndromes including Gorlin‟s (these patients may be reviewed regularly
by the LSMDT team, with input as necessary from the SSMDT).
Malignant melanomas stage 11b or above
All malignant melanomas for patients under 19yrs (whose management plan need to be
agreed with the principal Treatment Centre for Children‟s Cancer in Bristol)
Metastatic Malignant melanomas
See Section 5 for referral guidance for Skin Lymphomas
See Section 6 fore referral for Kaposi‟s sarcoma and other rare skin cancers
11-1A-207j
Network agreed referral guidelines between teams
Appendix 3 - Extract from the South East London Cancer Network Constitution
for Skin Cancer
9. T-Cell Lymphoma MDT Supra Network for Total Surface Electron Beam Therapy (TSBET).
See also supporting document TSEB Guidelines May 2009
The St John‟s Institute of Dermatology, Guys‟ and St Thomas‟ NHS Foundation Trust will provide
supra Network specialist services and the supra Network MDTs for SE London and wider populations
to be determined in conjunction with the Specialist Commissioning Group. St John‟s operates as a
supraregional centre for skin cancers and in the three years to 2006 received more than 600 referrals
for primary cutaneous T-cell and B-cell lymphoma, of which three quarters came from outside SE
London. It will continue to offer supra regional services for skin cancers referred from across the
country
Patient Pathway
Joint Skin Tumour Unit Out Patients St Johns
Institute, St Thomas‟ Hospital
Consultant Clinical Oncologist makes decision to
offer TSEBT
Patient Consent and Information given
Patient Planning Appointment
Patient Treatment
Patient Follow up
2 weeks prior to start date
Boost treatment
Positions planned
Shielding planned
Patch treatment planned
Radiotherapy Prescribed
Weekly medical review
Daily radiographer review
See in Clinical Oncology Outpatients at weeks
1-3 if toxicity and ongoing care needed
ST Johns joint Clinic 1 month post
Audit and Outcome Monitoring
10. Referral for Photopheresis See also supporting document TSEB Guidelines May 2009.
There is a photopheresis facility available at St John‟s Institute of Dermatology, Guy‟s & St Thomas
Hospital.
Cutaneous tumour Stage T3 N0-1 M0 (IIB)
Complete responses with TSEBT are lower with stage T3 tumours in the region 36 – 54% 4,6,12. This is
however much superior to skin directed superficial radiotherapy and topical Nitrogen Mustard which
has complete response rates of 8%. Therefore patients with stage IIB disease are offered TSEBT as first
line treatment for its superior response rate and rapid palliative effect. It is combined with adjuvant
treatment such as PUVA which improves the 5 year relapse free survival from 30% with TSEBT alone to
55% with TSEBT and adjuvant PUVA.
Erythroderma stage T4N0-1M0 (III)
TSEBT can produce rapid and sustained responses in erthrodermic MF ameleriorating the severe
cutaneous symptoms experienced by such patients. The reported complete response to TSEBT for
stage III MF ranges from 60-100% with 5 year progression free survival of 69%. The complete response
rate and progression free survival is less in patients with blood or visceral involvement. These patients
may benefit from adjuvant photophoresis. TSEBT is an appropriate first line therapy for these patients.
We currently use it as second line therapy following treatment with PUVA, A-interferon, photopheresis
or methotrexate.
Appendix 4 - Levels of Care
Care
Leve
l
1
2
3
4
5
Case mix or Procedures
Benign lesions
Actinic Keratoses
Precancerous – SCC, in situ/Bowen‟s
Low risk BCC – defined as not high risk (see Level 3)
High risk BCC other than categories
below
High Risk BCC - defined as
recurrent BCCs
BCCs on the head (face and scalp)
large BCCs > 2cm diameter unless they are superficial BCCs that can
be managed non-surgically
lesions that have a clinical appearance of morphoeic, infiltrative
or basosquamous
lesions with poorly defined margins
BCCs in patients who are immunosuppressed or have Gorlin‟s syndrome
BCCs located over important underlying anatomical structures (for example,
major vessels or nerves) or where primary surgical closure may be difficult (for
example, digits or front of shin).
SCC other than categories below
High risk BCC Recurrent or with +ve excision
SCC Recurrent or with +ve excision
Malignant Melanoma (MM) – new, single primary, adult, non-metastatic, not for
approved trial entry, up to and including stage II a (must fulfil all these criteria)
Radiotherapy if attendance by clinical oncologist at LSMDT
Lesion where diagnosis is uncertain but may be malignant
Incompatible clinical and histological findings
Selected BCCs and SCCs needing plastic/reconstructive surgery by SSMDT core
member (as per Network clinical guidelines) • Radiotherapy (as per Network clinical
guidelines). If not discussed and treated by LSMDT clinical oncology core team
member
Metastatic SCC on presentation or newly metastatic
MM – stage IIb or more, or < 19 years or metastatic on presentation or newly
metastatic or recurrent or for approved trial entry Any cases for approved trial entry
Any cases for adjuvant therapy (as per Network clinical guidelines)
Histology opinion from SSMDT core pathology team member
Mohs surgery
Skin Cancer in immunocompromised patients including organ transplant recipients
Skin Cancer in genetically predisposed patients including Gorlin‟s Syndrome.
Cases to be dealt with by only one agreed SSMDT per Network, if more than one in
the Network:
Cutaneous lymphoma
Kaposi‟s sarcoma
Cutaneous sarcoma above superficial fascia. (Below fascia, refer to sarcoma
MDT) in
cancers
Other rare skin cancers (see appendix 1 in the Skin Cancer IOG pg 128/129.
6
Notes:
Where a network chooses to have a MMDT all cases of MM for level 5 care from
the MMDT’s catchment area should be referred to the MMDT.
There should be agreed working arrangements with certain site specialised MDT’s
(see topic 08-1A).
T-cell Cutaneous Lymphoma: Total Body Surface Electron Beam Therapy
Appendix 5 – Peninsula Cancer Network Urology Site Specific Group Penile
Cancer Guidelines 2009
The NSSG has adopted the Guidelines of the Avon, Somerset and Wiltshire Network as the Supra
Network for penile cancer. These local guidelines are designed to explain the presentation and
assessment which will be carried out within the PCN before referral to the penile cancer team, as well as
the treatments which may be conducted locally after discussion at the Supra Network MDT meeting.
They are not intended to be exhaustive list of different presentations, findings and assessments that
apply to every single patient.
PRIMARY CARE SETTING
Presentation will usually be with an ulceration or mass on the penis. The presence of phimosis may
make assessment difficult. Patients should be referred under the 2 week wait system if there is
suspicion of cancer.
SECONDARY CARE SETTING
Patients will be assessed clinically at the out-patient department, specifically penile examination and
assessment of inguinal lymph nodes. Biopsy of suspicious penile lesions may be carried out by the
local team, and also aspiration cytology of any suspicious inguinal lymph nodes.
Following histological confirmation, CT or MR scanning of the thorax, abdomen and pelvis is performed
for further staging and referral made directly to Mr D Dickerson, Southmead Hospital for discussion at the
Supranetwork MDT meeting, with a view to seeing the patient to discuss further management. In some
unfit patients referral may be made back to the local hospital for simple partial penectomy. More
complex surgery will either be performed by the core penile team at Southmead Hospital, or by Mr J
Palmer, Plastic Surgeon, Royal Devon and Exeter Hospital, or Mr R Pearcy, Derriford Hospital, who are
members of the extended penile cancer team. Discussion of further staging, surgery or adjuvant
treatment is detailed in the ASW supranetwork guidelines, and under their direction.
Follow-up may be delegated back to the local team after an appropriate period, as decided by the core
team
Appendix 6 - Excision of Skin Cancer in the Community Outside of the
Guidelines
In response to NICE Guidance, the Peninsula Cancer Network has agreed guidelines on the
management of skin cancer in the community. [PCT Name] is committed to ensuring all services are
carried out in accordance with this guidance, in collaboration with the Skin Cancer Multidisciplinary
Team at [hospital name].
NHS [xxx] will be using information from the local Skin Cancer Multidisciplinary Team (MDT)
Departments to review adherence to this guidance.
A
Skin Cancers that SHOULD NOT be managed in primary care
GPs, including GPwSIs, should not knowingly treat the following skin cancers
Malignant melanoma
Squamous cell carcinoma
High risk basal cell carcinoma (BCC)
The following definition of high-risk BCC should be used for clinical triage in primary care:
recurrent BCCs
BCCs on the nose and lips (including nasofacial sulci and nasolabial folds), or around the
eyes (periorbital) or ears
BCCs greater that 2 cm in diameter if below the clavicle (unless they are superficial BCCs
that can be managed non-surgically).
BCCs greater that 1 cm in diameter if above the clavicle (unless they are superficial BCCs
that can be managed non-surgically).
lesions that have a clinical appearance of morphoeic, infiltrative or basosquamous
lesions with poorly defined margins
BCCs in patients who are immunosuppressed or have Gorlin‟s syndrome
BCCs located
over important underlying anatomical structures (for example, major vessels or nerves)
in an area where primary surgical closure may be difficult (for example, digits or front of
shin)
in an area where excision may lead to a poor cosmetic result.
Patients where there is diagnostic uncertainty
Patients aged 24 years or younger
BCCs that have been incompletely excised according to histology
Superficial BCCs on the face
B
Skin Cancers that MAY be managed by an accredited GPwSI
Extended Low Risk BCC
There is no diagnostic uncertainty that the lesion is a primary nodular low-risk BCC or superficial
BCC and it meets the following criteria:
The patient with BCC is not:
aged 24 years or younger (that is, a child or young adult)
immunosuppressed or has Gorlin‟s syndrome
The lesion:
Is not on the nose and lips (including nasofacial sulci and nasolabial folds), or around the
eyes (periorbital) or ears
Is less than 2 cm in diameter if below the clavicle (unless they are superficial BCCs that can be
managed non-surgically).
Is less than 1 cm in diameter if above the clavicle (unless they are superficial BCCs that can be
managed non-surgically).
Is not morphoeic, infiltrative or basosquamous in appearance
Does not have poorly defined margins
Is not located:
o over important underlying anatomical structures (for example, major vessels or nerves)
o in an area where primary surgical closure may be difficult (for example, digits or front of
shin)
o in an area where excision may lead to a poor cosmetic result.
Incompletely excised BCCs should be discussed with a member of Skin Cancer MDT
C
Skin Cancers that MAY be managed by an accredited GP primary care
Low Risk BCC
The patient with BCC is not:
aged 24 years or younger (that is, a child or young adult)
immunosuppressed or has Gorlin‟s syndrome
The lesion:
is located below the clavicle (that is, not on the head or neck)
is less than 1 cm in diameter with clearly defined margins
is not a recurrent BCC following incomplete excision
is not a persistent BCC that has been incompletely excised according to histology
is not morphoeic, infiltrative or basosquamous in appearance
is not located
o over important underlying anatomical structures (for example, major vessels or nerves)
o in an area where primary surgical closure may be difficult (for example, digits or front of
shin)
o in an area where difficult excision may lead to a poor cosmetic result
o at another highly visible anatomical site (for example, anterior chest or shoulders)
where a good cosmetic result is important to the patient.
Incompletely excised BCCs should be discussed with a member of the LSMDT.
D
Superficial Basal Cell Carcinomas
Patients with superficial BCCs (not usually classified as high risk) should be appropriately
referred in order that they can be offered a full range of medical treatments, including
photodynamic therapy. This may require referral to the Skin Cancer Multidisciplinary Team.
Healthcare professionals managing superficial BCC in the community should have experience
and knowledge of this condition. All superficial BCCs on the face should be referred to the Skin
Cancer MDT.
Histological Specimens
ALL skin specimens removed should be sent to histology for analysis. GPs should provide
information about the site of excision and provisional diagnosis on the histology request form. 4
2. Topical and ablative therapies (ie cryotherapy) should only be used if the diagnosis is certain.
1.