CISPLATIN Chemo-radiation regimen Gynaecological Cancer

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1 Systemic Anti Cancer Treatment Protocol CISPLATIN Chemo-radiation regimen Gynaecological Cancer PROCTOCOL REF: MPHAGYNCIX (Version No: 1.0) Approved for use in: Locally advanced cervical cancer (adjuvant/curative) Advanced vulval cancer Dosage: Dosage Dose Route Frequency Cisplatin 40mg/m 2 IV Infusion Repeat every 7 days (max. 70mg) 5 weeks concurrent with radiotherapy Supportive treatments: Dexamethasone tablets, 4mg twice daily for 3 days Domperidone 10mg tablets, to be taken three times a day when required Interactions Anticonvulsive substances - serum concentrations of anticonvulsive medicines may remain at sub therapeutic levels during treatment with cisplatin. Cisplatin may reduce the absorption of phenytoin resulting in reduced epilepsy control when phenytoin is given as current treatment. Aminoglycosides e.g. gentamicin - Increased risk of nephrotoxicity and ototoxicity Issue Date: May 2017 Page 1 of 6 Protocol reference: MPHAGYNCIX

2 Extravasation risk: Cisplatin - VESICANT Administration: Check renal function before commencing platinum. Use EDTA or Wright to calculate GFR. GFR must be above 50 ml/min for cisplatin based treatment. If GFR 50 ml/min discuss with a consultant. Day Drug Dose Route Diluent and rate 1 Dexamethasone 8mg Oral 30 minutes before chemotherapy 1 Ondansetron 16mg Oral 30 minutes before chemotherapy 1 Cisplatin 40mg/m 2 IV Infusion In 1000mL sodium chloride 0.9% over 60 minutes Repeat on day 8, 15, 22 and 29 to complete the course. Hypersensitivity As with all platinum based chemotherapy, patients may experience allergic reaction during administration. The infusion should be stopped and the following should be administered. Hydrocortisone 100 to 200mg IV Chlorphenamine 10 mg IV It should be strongly noted that patients who have severe reactions should not be re-challenged. Cisplatin dose guidelines Cisplatin is nephrotoxic and thus patients must have their renal function measured prior to each cycle. Issue Date: May 2017 Page 2 of 6 Protocol reference: MPHAGYNCIX

3 Creatinine Clearance (ml/min) Cisplatin dose > 50mL/min Give 100% 40 to 50 ml/min Give 75% < 40mL/min No further cisplatin Main Toxicities: Cardiac disorders Gastrointestinal General disorders and administration site conditions Haematological Hepatobiliary Nephrotoxicity Nervous system Ototoxicity Arrhythmia, bradycardia, tachycardia can occur Nausea, vomiting, diarrhoea, constipation, mucositis. Alopecia, rash, pyrexia (very common), asthenia, malaise, injection site extravasation, dehydration, hypokalaemia, hypophosphataemia, hypocalcaemia, tetany, muscle spasms and/or electrocardiogram changes occur as a result of damage to the kidney caused by cisplatin. Neutropenia, anaemia, thrombocytopenia Hepatic enzymes and blood bilirubin increased Cisplatin causes severe cumulative nephrotoxicity. A urine output of 100 ml/hour or greater will tend to minimize cisplatin nephrotoxicity. Hyperuricaemia and hyperalbuminaemia may predispose to cisplatin-induced nephrotoxicity. Cisplatin can cause peripheral neuropathy. Ototoxicity is common with cisplatin and is manifested by tinnitus and/or hearing loss in the high frequency range Issue Date: May 2017 Page 3 of 6 Protocol reference: MPHAGYNCIX

4 Investigations: Medical Assessment Nursing Assessment Pre Day 1 Day 8 Day 15 Day 22 Day 29 X X X X X X X FBC X X X X X X U&E & LFT X X X X X X Mg 2+ X X X X X X CrCl/Urine output X X X X X X CT scan Informed Consent X X PS recorded X X X X X X Toxicities documented X X X X X X Weight recorded X X X X X X Dose Modifications and Toxicity Management: Haematological toxicity Proceed on treatment day if:- ANC 1.0 x 10 9 /L Platelets 100 x 10 9 /L Omit on treatment day and contact the oncologist if:- ANC 0.9 x 10 9 /L Platelets 99 x 10 9 /L Non-haematological toxicities Issue Date: May 2017 Page 4 of 6 Protocol reference: MPHAGYNCIX

5 Grading and Management of Toxicity Toxicity should be grading according to the CTCAE v4.0 criteria. Following assessment treatment should be withheld for any toxicity until resolved to grade 0/1. For dose modification, follow the general guidance below and discuss with treating clinician. 1 st 2nd 3rd 4th Grade 2 Grade 3 Grade 4 continue at 100% of original dose with prophylaxis where possible continue at 75-80% of original dose continue at 50% of original dose Discontinue treatment continue at 75-80% of original dose with prophylaxis where possible resolved to grade0/1, then continue at 50% of original dose Discontinue treatment Discontinue treatment Peripheral Neuropathy Severe cases of neuropathies have been reported. These neuropathies may be irreversible and may manifest by paresthesia, a proprioceptive loss and a sensation of vibrations. A loss of motor function has also been reported. A neurologic examination should be carried out if clinically indicated. Neurotoxicity/Ototoxicity If patient develops Grade 2 neuropathy or ototoxicity, discuss with Consultant. Patients with functional hearing loss should have cisplatin omitted; carboplatin AUC 3-5 can be substituted. Hepatic Impairment No dose reduction necessary. Issue Date: May 2017 Page 5 of 6 Protocol reference: MPHAGYNCIX

6 References: Castro et al J Clin Oncol (15S) Pelvic radiation with cisplatin based chemotherapy and radiotherapy for locally advanced cervical uterine cancer Keys HM et al NEJM (15): Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma Issue Date: May 2017 Page 6 of 6 Protocol reference: MPHAGYNCIX

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