Download Docetaxel for locally advanced or metastatic non

Regimen: Docetaxel for locally advanced or metastatic non-small cell lung cancer
ICD10 Codes
Codes Pre-fixed with C34.
Indication
NICE approved for second-line treatment of locally advanced or metastatic NSCLC
cancer who have relapsed after previous chemotherapy. (NICE CG121)
Day
Drug
Dose
Route
1
Docetaxel
75mg/m2
IV
Docetaxel is administered in a 250ml PVC-free sodium chloride 0.9% bag over 60
minutes.
Regimen detail
Administration
Doses >190mg should be diluted in 500ml (maximum concentration 0.74mg/ml).
Patients should be observed closely for hypersensitivity reactions, particularly during
the first and second infusions.
Hypersensitivity reactions may occur within a few minutes following the initiation of
the infusion of docetaxel and therefore facilities for the treatment of hypotension and
bronchospasm must be available.
Frequency
Extravasation
Premedication
Emetogenicity
Additional
recommended
supportive
medication
Pre- treatment
evaluation
Regular
investigation
If hypersensitivity reactions occur, minor symptoms such as flushing or localised
cutaneous reactions do not require discontinuation of therapy. The infusion may be
temporarily interrupted and when symptoms improve re-started at a slower infusion
rate. Severe reactions, such as hypotension, bronchospasm or generalised
rash/erythema require immediate discontinuation of docetaxel and appropriate
therapy. Patients who have developed severe hypersensitivity reactions should not
be re-challenged with docetaxel.
Every 21 days for 4 – 6 cycles, depending on response.
Docetaxel is an exfoliant (Group 4)
Dexamethasone 8mg bd PO for 3 days, starting the morning of the day prior to
chemotherapy. Patient should receive 3 doses prior to treatment.
In the case where 3 doses have not been taken, dexamethasone 16 -20mg IV
should be administered 30-60 minutes prior to chemotherapy and the remaining 3
oral doses should be administered as per normal prescription
This regimen has moderate-low emetic potential – refer to local protocol
Mouthwashes as per local policy
H2 antagonist or proton-pump inhibitor if required
Scalp cooling may be offered.
Loperamide if required.
FBC
Baseline - results valid for 14 days
LFT
Baseline - results valid for 14 days
U&E (inc. SrCr)
Baseline - results valid for 14 days
Baseline radiology
Baseline – results valid for 14 days
CXR/CT
FBC
Pre D1 – results valid for 72 hours
LFT
Pre D1 – results valid for 7 days
Controlled document
Document No
Version Number
ASWCS12 LU002
0.1.a
Last printed 25/03/2013 *ONLY VALID ON DATE OF PRINTING*
Page 1 of 3
Standard limits
for
administration to
go ahead – if blood
results not within
range, authorisation to
administer must be
given by
prescriber/consultant
U&E (inc. SrCr)
CXR
CT Scan
Neutrophil count
Platelet count
Bilirubin
AST/ALT
Alk Phos
Pre D1 – results valid for 7 days
Every cycle
Every 3 cycles.
≥1.5 x 109/L
≥100 x 109/L
≤ ULN
≤1.5 x ULN
≤2.5 x ULN
Dose modifications
Haematological
toxicity
Renal impairment
Hepatic
impairment
NCI Common
Toxicity Criteria
Day 1: If neutrophils <1.5 x 109/L and/or platelets <100 x 109/L delay 1 week or until
recovery.
If febrile neutropenia occurs, or neutrophils <0.5 x 109/L for more than 1 week,
reduce dose to 60mg/m2 for all subsequent cycles.
If platelets <25 x 109/L, consider dose reduction to 60mg/m2 after recovery – discuss
with consultant.
No dose adjustment for renal impairment
AST/ALT
≤1.5 x ULN
> 1.5 ULN
> 3.5 x ULN
Grade 3 cutaneous
reactions
Grade 2 neuropathy
Grade 3 or 4
neuropathy
Any other grade 3 or 4
toxicities
Adverse effects –
the contents of the
table indicate the
adverse effects that
should be documented
on consent to
treatment forms
Significant drug
interactions –
For full details consult
product literature/
reference texts
Alk Phos
Bilirubin
≤2.5 x ULN
< ULN
2.6 - 6 x ULN < ULN
> 6 x ULN
> ULN
Once patient recovered,
reduce dose to 60mg/m2.
Once patient recovered,
reduce dose to 60mg/m2.
Discontinue treatment
permanently
Discontinue treatment after
discussion with consultant
Docetaxel dose
100%
75%
Not recommended
If symptoms return, stop
docetaxel.
If symptoms return, stop
docetaxel.
Rare but Serious Side Effects
Secondary malignancy
Infusion-related reaction
Teratogenicity
Infertility
Cardiotoxicity
Anaphylaxis
Frequently occurring Side Effects
Myelosuppression
Nausea and vomiting
Stomatitis and mucositis
Diarrhoea; constipation
Fatigue
Peripheral neuropathy
Myalgia and arthralgia
Other
Alopecia; fluid retention; phlebitis; skin and nail changes, raised LFTs
CYP3A4 Enzyme inducers/inhibitors - in vitro studies suggest that CYP3A
inhibitors (such as ketoconazole,ritonavir, clarithromycin and erythromycin) may
raise docetaxel levels, whereas CYP3A inducers (such as rifampicin and
barbiturates) may reduce docetaxel levels.
Comments
N/A
Cumulative
N/A
Doses
References
• National Institute of Health and Clinical Excellence Guideline CG121. Lung Cancer. The diagnosis
Controlled document
Document No
Version Number
ASWCS12 LU002
0.1.a
Last printed 25/03/2013 *ONLY VALID ON DATE OF PRINTING*
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and treatment of lung cancer April 2011 [internet] Accessed online on 25/07/2012 available at
http://www.nice.org.uk/nicemedia/live/13465/54202/54202.pdf
•
•
•
•
•
•
Shepherd FA, Dancey J, Ramlau R, Mattson K, Gralla R, O’Rourke M, et al. Prospective
Randomized Trial of Docetaxel Versus Best Supportive Care in Patients With Non–Small-Cell
Lung Cancer Previously Treated With Platinum-Based Chemotherapy. J Clin Oncol 2000; 18 (10):
2095-2103.
Fossella FV, DeVore R, Kerr RN, Crawford J, Natale RR, Dunphy F, et al. Randomized Phase III
Trial of Docetaxel Versus Vinorelbine or Ifosfamide in Patients With Advanced Non–Small-Cell
Lung Cancer Previously Treated With Platinum-Containing Chemotherapy Regimens. J Clin Oncol
2000; 18 (2): 2354-2362.
Roszkowski K, Pluzanska A, Krzakowski M, Smith AP, Saigi E, Aasebo U, et al. A multicenter,
randomized, phase III study of docetaxel plus best supportive care versus best supportive care in
chemotherapy-naive patients with metastatic or non-resectable localized non-small cell lung
cancer (NSCLC). Lung Cancer 2000; 27(3):145-57.
Daniels S. North London Cancer Network. Dose adjustment for cytotoxics in hepatic impairment
[internet]. accessed 04/01/2012 available at
http://www.nlcn.nhs.uk/sites/default/files/pro_board_gu/2008/07/Hepatic%20impairment%20%20Dosage%20adjustment%20for%20cytotoxics.doc
Daniels S. North London Cancer Network. Dose adjustment for cytotoxics in renal impairment
[internet]. accessed 04/01/2012 available at
http://www.nlcn.nhs.uk/sites/default/files/pro_board_gu/2008/07/Renal%20impairment%20%20%20Dosage%20adjustment%20for%20cytotoxics.doc
Summary of Product Characteristics Taxotere® (Docetaxel) 160mg/8ml concentrate and solvent
for solution for infusion (Sanofi Aventis) [internet] accessed 25/07/2012 available from
http://www.medicines.org.uk/EMC/medicine/25464/SPC
Document title
Document number
Approval date
Written by
Docetaxel for NSCLC
ASWCS12 LU002
19/03/2013
Adam Dangoor, Consultant Medical Oncologist, BHOC
Checked by
Georgina Holmes, Pharmacist, UHBristol
Georgina Holmes
Authorised by
Jeremy Braybrooke, Consultant Oncologist, BHOC
Jeremy Braybrooke
Review date
Document reviewed by
Version number
Summary of changes
19/03/2015
Controlled document
Adam Dangoor
Digitally signed by Adam Dangoor
DN: cn=Adam Dangoor, o=University Hospitals Bristol NHS Foundation
Trust, ou=Consultant in Medical Oncology,
[email protected], c=GB
Date: 2013.03.25 14:56:52 Z
Digitally signed by Georgina Holmes
DN: cn=Georgina Holmes, o=NHS, ou=NHS,
[email protected], c=GB
Date: 2013.03.25 14:57:19 Z
Digitally signed by Jeremy Braybrooke
DN: cn=Jeremy Braybrooke, o, ou,
[email protected], c=GB
Date: 2013.03.25 14:57:46 Z
0.1.a
Version
Document No
Version Number
ASWCS12 LU002
0.1.a
Last printed 25/03/2013 *ONLY VALID ON DATE OF PRINTING*
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