Regimen : Cisplatin and Radiotherapy for Head and Neck Cancers

Indication Chemo-radiation for head and neck cancers

Regimen details Day Drug Dose Route
1 Cisplatin 40 mg/m² IV
(Max dose 70mg)
Administration 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

Note: Patients with low Magnesium levels (<0.7 mmol/l) should have an
additional 2g magnesium sulphate added to the pre-hydration bag
Frequency Weekly for a maximum of 6 weeks during radical radiotherapy
Extravasation Exfoliant (Group 4)
Premedication Pre-hydration as above
Emetogenicity This regimen has moderate-high emetogenic potential – refer to local
protocol
Additional If magnesium levels are consistently low, consider supplementation with
recommended oral magnesium glycerophosphate [Note: unlicensed product] 24 mmol
supportive Mg2+ per day in divided doses.
medication
Pre-treatment FBC Baseline – results valid for 14 days
evaluation U+E Baseline – results valid for 14 days
LFT Baseline – results valid for 14 days

Regular FBC Results valid for 72 hrs

investigation U+E Results valid for 72 hrs
LFT Results valid for 72 hrs

Standard limits for Neutrophil count 1.5x 109/L

administration to go Platelet count 100 x 109/L
ahead – if blood results
not within range, Haemoglobin 10 x g/dL (However if Hb<12 g/dL a 2 unit blood
authorisation to administer transfusion should be arranged)
must be given by
prescriber/consultant
Creatinine clearance ≥ 45 ml/hour
Bilirubin <1.5 x ULN

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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
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
Grade 3-4 Discontinue Cisplatin
Ototoxicity Grade 2 Reduce dose to 30mg/ m2
Grade 3-4 Discontinue Cisplatin
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 Version Number 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. Meta-
Analyses 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/tiki-
download_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/tiki-
download_file.php?fileId=620
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[internet] accessed 10/11/2010 available from
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• Baxter K, editor. Stockley’s Drug Interactions. Pharmaceutical Press; 2009. Accessed on
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Document title Weekly Cisplatin and Radiotherapy for H&N Cancer

Document number ASWCS10 HN001
Approval date 25/03/2011
Written by Matthew Beasley, Consultant Clinical Digitally signed by Matthew Beasley

Oncologist, BHOC
Matthew Beasley DN: cn=Matthew Beasley, o, ou, email=james.
carr@aswcs.nhs.uk, c=GB
Date: 2012.07.20 11:36:29 +01'00'

Checked by James Carr, Network Pharmacist,

James Carr
Digitally signed by James Carr
DN: cn=James Carr, o=ASWCS, ou=Network

ASWCS Pharmacist, email=james.carr@aswcs.nhs.uk, c=GB

Date: 2012.07.20 11:37:10 +01'00'

Authorised by Jeremy Braybrooke, Chair ASWCS

Jeremy Digitally signed by Jeremy Braybrooke
DN: cn=Jeremy Braybrooke, o, ou,
Network Chemotherapy Group
Review date 25/03/2012 Braybrooke email=james.carr@aswcs.nhs.uk, c=GB
Date: 2012.07.20 11:37:39 +01'00'

Document reviewed by
Version number
Summary of changes Version 1.1.b: Wording of administration section amended to improve clarity
1.2.b: Amended July 2012 to included option of Mannitol 10%

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ASWCS10 HN001 1.2.b

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