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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 • • 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 • • • • • • • • • • • • 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