Download Regimen : Cisplatin and Radiotherapy for Head and Neck Cancers

Regimen : Cisplatin and Radiotherapy for Head and Neck Cancers
Indication
Regimen details
Administration
Chemo-radiation for head and neck cancers
Day
Drug
Dose
Route
1
Cisplatin
40 mg/m²
IV
(Max dose 70mg)
Pre-hydration:
1000mls Sodium Chloride 0.9% with 20 mmol KCL and 2g MgSO4 over 2
hours, followed by
Mannitol 20% 100ml over 10 min OR Mannitol 10% 200ml over 15 min
Cisplatin in 500ml Sodium Chloride 0.9% over 60 minutes
Post-hydration:
Sodium Chloride 0.9% 1000mls with 20 mmol KCL and 2g MgSO4 over 2
hours
Frequency
Extravasation
Premedication
Emetogenicity
Additional
recommended
supportive
medication
Pre-treatment
evaluation
Note: Patients with low Magnesium levels (<0.7 mmol/l) should have an
additional 2g magnesium sulphate added to the pre-hydration bag
Weekly for a maximum of 6 weeks during radical radiotherapy
Exfoliant (Group 4)
Pre-hydration as above
This regimen has moderate-high emetogenic potential – refer to local
protocol
If magnesium levels are consistently low, consider supplementation with
oral magnesium glycerophosphate [Note: unlicensed product] 24 mmol
Mg2+ per day in divided doses.
FBC
U+E
LFT
Baseline – results valid for 14 days
Baseline – results valid for 14 days
Baseline – results valid for 14 days
Regular
investigation
FBC
U+E
LFT
Results valid for 72 hrs
Results valid for 72 hrs
Results valid for 72 hrs
Standard limits for
administration to go
ahead – if blood results
Neutrophil count
Platelet count
Haemoglobin
1.5x 109/L
100 x 109/L
10 x g/dL (However if Hb<12 g/dL a 2 unit blood
transfusion should be arranged)
Creatinine clearance
≥ 45 ml/hour
<1.5 x ULN
not within range,
authorisation to administer
must be given by
prescriber/consultant
Bilirubin
Controlled document
Document Number
ASWCS10 HN001
Version Number
1.2.b
Last printed 20/07/2012 11:35:00 * Only valid on day of printing
Page 1 of 3
Dose modifications
Haematological
toxicity
Renal impairment
Hepatic impairment
NCI Common
toxicity criteria
Adverse effects – the
contents of the table
indicate the adverse
effects that should
documented on consent to
treatment forms
Significant drug
interactions – For full
details consult product
literature/reference texts
Comments
Cumulative Doses
References
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Defer chemotherapy for 1 week if neutrophils<1.5 x 109/L or platelets < 100
x 109/L
CrCl
Cisplatin Dose
(ml/min)
>60
100%
50-59
75%
Or substitute with (a) Cetuximab or (b) Carboplatin AUC 2
<50
Consider Cetuximab
No dose reduction necessary.
Toxicity
Definition
Dose adjustment
Neurotoxicity Grade 2
Reduce dose to 30mg/m2
Discontinue Cisplatin
Grade 3-4
Ototoxicity
Grade 2
Reduce dose to 30mg/ m2
Discontinue Cisplatin
Grade 3-4
Rare or serious side effects
Frequently occurring side effects
Myelosuppression and risk of
Nausea/vomiting
sepsis
Nephrotoxicity
Thrombocytopenia
Ototoxicity
Constipation
Mucositis
Peripheral neuropathy
Alopecia
Fatigue
Electrolyte disturbances
Other diarrhoea; taste disturbance; allergic reactions
Allopurinol, colchicine, probenecid, sulfinpyrazone : increase in serum uric
acid concentration
Cephalosporins, aminoglycosides, amphotericin B : increase nephrotoxic
and ototoxic effects of cisplatin when administered simultaneously or 1-2
weeks after treatment with cisplatin.
Ciclosporin : excessive immunosuppression, with risk of
lymphoproliferation
Cyclizine, phenothiazines : may mask ototoxicity symptoms
Furosemide, hydralazine, diazoxide and propranolol : intensify
nephrotoxicity
Oral anticoagulants : require an increased frequency of the INR monitoring
Penicillamine : may diminish the effectiveness of cisplatin
Phenytoin : reduced serum levels of phenytoin (due to reduced absorption
and/or increased metabolism) can reduce epilepsy control-monitor
phenytoin levels in these patients.
None
Not applicable
Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T et al Chemoradiotherapy
versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III
randomized Intergroup study 0099. J Clin Oncol 16: 1310-1317.
Bachaud, J-M, Cohen-Jonathan E, Alzieu C, David J-M, Serrano E, Daly-Schveitzer N.
Combined postoperative radiotherapy and Weekly Cisplatin infusion for locally advanced
Controlled document
Document Number
ASWCS10 HN001
Version Number
1.2.b
Last printed 20/07/2012 11:35:00 * Only valid on day of printing
Page 2 of 3
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head and neck carcinoma: Final report of a randomized trial. Int J Radiat Oncol Biol Phys
1996; 36 (5): 999 -1004
Prosnitz RG, Yao B, Farrell CL, Clough R, Brizel DM. Pretreatment anemia is correlated
with the reduced effectiveness of radiation and concurrent chemotherapy in advanced head
and neck cancer. Int J Radiat Oncol Biol Phys 2005; 61: 1087–1095.
Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefèbvre J-L, Greiner RH, et al for the
European Organization for Research and Treatment of Cancer Trial 22931. Postoperative
Irradiation with or without Concomitant Chemotherapy for Locally Advanced Head and Neck
Cancer. N Engl J Med 2004; 350:1945-1952.
Cooper JS, Pajak TF, Forastiere AA, Jacobs J, Campbell BH, Saxman SB, et al for the
Radiation Therapy Oncology Group 9501/Intergroup Postoperative Concurrent
Radiotherapy and Chemotherapy for High-Risk Squamous-Cell Carcinoma of the Head and
Neck. N Engl J Med 2004; 350:1937-1944.
Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, et al. Concurrent
Chemotherapy and Radiotherapy for Organ Preservation in Advanced Laryngeal Cancer. N
Engl J Med 2003; 349:2091-2098
Pignon JP, Bourhis. J, Domenge C, Designé L, on behalf of the MACH-NC Collaborative
Group. Chemotherapy added to locoregional treatment for head and neck squamous-cell
carcinoma: three meta-analyses of updated individual data. The Lancet, Volume 355, Issue
9208 Pages 949 - 955, 18 March 2000.
Pignon J-P,le Maître A, Bourhis J, on behalf of the MACH-NC Collaborative Group. MetaAnalyses of Chemotherapy in Head and Neck Cancer (MACH-NC): An Update. Int J Radiat
Oncol Biol Phys 2007 69(2 suppl): S112-S114.
Daniels S. North London Cancer Network. Dose adjustment for cytotoxics in hepatic
impairment [internet]. accessed 10/11/2010 available at http://www.bopawebsite.org/tikidownload_file.php?fileId=621
Daniels S. North London Cancer Network. Dose adjustment for cytotoxics in renal
impairment [internet]. accessed 10/11/2010 available at http://www.bopawebsite.org/tikidownload_file.php?fileId=620
Summary of Product Characteristics Cisplatin 1mg/ml Sterile concentrate (Hospira)
[internet] accessed 10/11/2010 available from
http://www.medicines.org.uk/EMC/medicine/623/SPC
Trissel LA. Handbook of Injectable Drugs, 15th edition. American Society for HealthSystems Pharmacists 2009. Accessed on line on 10/11/2010 available at
http://www.medicinescomplete.com/mc/hid/current/
Allwood M, Stanley A, Wright P, editors. The cytotoxics handbook. 4th ed. Radcliffe Medical
Press. 2002.
Baxter K, editor. Stockley’s Drug Interactions. Pharmaceutical Press; 2009. Accessed on
line on 10/11/2010 available at https://www.medicinescomplete.com/mc/
Document title
Document number
Approval date
Written by
Checked by
Authorised by
Review date
Document reviewed by
Version number
Summary of changes
Controlled document
Weekly Cisplatin and Radiotherapy for H&N Cancer
ASWCS10 HN001
25/03/2011
Digitally signed by Matthew Beasley
Matthew Beasley, Consultant Clinical
DN: cn=Matthew Beasley, o, ou, email=james.
Matthew
Beasley
[email protected], c=GB
Oncologist, BHOC
Date: 2012.07.20 11:36:29 +01'00'
Digitally signed by James Carr
James Carr, Network Pharmacist,
DN: cn=James Carr, o=ASWCS, ou=Network
Pharmacist, [email protected], c=GB
ASWCS
Date: 2012.07.20 11:37:10 +01'00'
Jeremy Braybrooke, Chair ASWCS
Digitally signed by Jeremy Braybrooke
Jeremy
DN: cn=Jeremy Braybrooke, o, ou,
Network Chemotherapy Group
[email protected], c=GB
Braybrooke
Date: 2012.07.20 11:37:39 +01'00'
25/03/2012
James Carr
Version
1.1.b: Wording of administration section amended to improve clarity
1.2.b: Amended July 2012 to included option of Mannitol 10%
Document Number
ASWCS10 HN001
Version Number
1.2.b
Last printed 20/07/2012 11:35:00 * Only valid on day of printing
Page 3 of 3