Gemcitabine, Dexamethasone and Cisplatin GDP Regimen
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1 Gemcitabine, Dexamethasone and Cisplatin GDP Regimen Available for Routine Use in Burton in-patient N/A Derby in-patient Burton day-case Derby day-case Burton outreach chemotherapy clinic N/A Derby outreach chemotherapy clinic Burton out-patient Derby out-patient Indication Treatment Intent Anti-Emetics Frequency & Duration Relapsed/refractory lymphoma Salvage Prechemotherapchemo Day Akynzeo 1hour pre- Day 8 2 Postchemotherapy Day 1 C Day 8 B Every 21 days for a maximum of 6 cycles After 2 cycles responding patients may be considered for high dose chemotherapy and autologous stem cell transplant. Day 1 Dexamethasone 40mg Oral once daily for 4 days. Give 1 st dose 30mins before chemotherapy Akynzeo 300mg/0.5mg Oral as a single dose 1 hour before cisplatin chemotherapy Gemcitabine 1000mg/m 2 intravenous infusion in 250ml sodium chloride 0.9% infused over 30 minutes Sodium chloride 0.9% 1000ml Intravenous infusion over 1 hour Sodium chloride 0.9% 500ml Intravenous infusion over 30 minutes (if urine output remains low) Mannitol 10% 100ml Intravenous infusion over 10 Provided urine output is satisfactory (see notes) minutes Cisplatin 75mg/m 2 Intravenous infusion in 500ml sodium chloride 0.9% over 1 hour (protect infusion from light) Mannitol 10% 100ml Intravenous infusion over 10 minutes REVIEWED BY K.GRAHAM AUTHORISED BY: Dr J Addada PAGE 1 of 6
2 Sodium chloride 0.9% + 20mmol magnesium sulphate + 20 mmol potassium chloride 1000ml Intravenous infusion over 2 hours Drinking water 2000ml Oral over the next 24 hours Allopurinol 300mg Oral once a day for 14 days for 1-2 cycles (reduce to 100mg if CrCl<20ml/min) Fluconazole 100mg Oral once a day for 21 days Aciclovir 400mg Oral twice daily for 21 days Cotrimoxazole 480mg Oral once daily for 21 days Omeprazole 20mg Oral once a day for 4 days Metoclopramide 10mg Oral four times daily for 4 days, then as required Day 8 Ondansetron 8mg As a single oral dose Dexamethasone 8mg As a single oral dose Gemcitabine 1000mg/m 2 Intravenous infusion in 250ml sodium chloride 0.9% infused over 30 minutes Dexamethasone 4mg Oral twice daily for 2 days Metoclopramide 10mg Oral four times daily for 2 days, then as required For mobilising cycles: Day 9 Lenograstim 263mcg (BSA<1.8m 2 ) OR 368mcg (BSA>1.8m 2 ) Notes: Subcutaneous injection ONCE daily (in the evening) until adequate stem cell harvest. Supply 7 doses. Baseline investigations Day 1: FBC, U&Es, measured or calculated CrCl and LFTs. Day 8: FBC Consider audiology testing in patients with impaired hearing at baseline. REVIEWED BY K.GRAHAM AUTHORISED BY: Dr J Addada PAGE 2 of 6
3 Dose modifications and toxicities 1. Haematological toxicity Day 1: Delay until neutrophils 1x10 9 /l and platelets (unsupported) 100x10 9 /l, unless cytopenias are disease related. Consider GCSF(filgrastim biosimilar 300mcg sc) to maintain dose intensity for patients with prolonged neutropenia resulting in delays to chemotherapy, or a prior episode of febrile neutropenia. The schedule of GCSF will depend on the timing of neutropenia but typically alternate day dosing starting on Day 9 for 4 doses is used. GCSF should not be given within 24 hours of chemotherapy. Day 8: Neutrophil count Platelet % Gemcitabine dose counts 1x10 9 /l and 100x10 9 /l 100% or % (or 100% with GCSF for isolated low neutrophils). Note GCSF should not be given within 24 hours of chemotherapy. <0.5 or <50 OMIT; or delay 1 week 2. Renal impairment Cisplatin Creatinine Clearance Dose % ml/min <45 Omit, consider carboplatin Gemcitabine Creatinine Clearance Dose % ml/min <30 Consider dose reduction- clinical decision REVIEWED BY K.GRAHAM AUTHORISED BY: Dr J Addada PAGE 3 of 6
4 Ensure cisplatin is commenced by hours at the latest so an adequate renal output can be maintained. The urine output should be kept at > 100 ml/hour before (for at least 2 hours from commencing hydration), during and after chemotherapy (8 hours). Accurate fluid balance sheet must be kept. Mannitol 10% infusion is the preferred diuretic. If urine output remains <100ml/hr, a further dose of 100ml may be given by intravenous infusion over 10 minutes. Urine output should increase within 30 minutes of commencing the mannitol infusion. If urine output remains <100ml/hr after 30 minutes, a 20 mg stat IV bolus of furosemide may be given to increase urine output. If 30 minutes after the furosemide dose urine output has still not improved, the Consultant should be contacted for advice. Patients must be advised to drink 2 litres of fluid in the 24 hours after administration of cisplatin. 3. Hepatic impairment Gemcitabine Bilirubin Dose % micromol/l 27 80% of dose initially and increase if tolerated. Raised transaminases do not seem to cause dose limiting toxicity. Cisplatin- no dose reduction necessary for hepatic impairment. REVIEWED BY K.GRAHAM AUTHORISED BY: Dr J Addada PAGE 4 of 6
5 4. Neurotoxicity/ Ototoxicity Cisplatin can cause peripheral neuropathy and ototoxicity. These should be graded accordingly. Toxicity Neuropathy (motor) Neuropathy (sensory) Grade Mild objective Objective Paralysis weakness weakness with function, with activities but not of daily living with activities of daily living Subjective weakness but no objective findings Loss of deep tendon reflexes or parasthesia (including tingling) but not with function Objective sensory loss or parasthesia (including tingling) with function, but not with activities of daily living Sensory loss or parasthesia with activities of daily living Permanent sensory loss that interferes with function Grade Toxicity Hearing - Hearing loss not requiring intervention and not with ADL Hearing loss requiring hearing aid / intervention, i.e. with ADL Profound bilateral hearing loss (>90dB) Disabling Tinnitus - Tinnitus not with ADL Tinnitus with ADL REVIEWED BY K.GRAHAM AUTHORISED BY: Dr J Addada PAGE 5 of 6
6 5. Alcohol content of gemcitabine Doses of gemcitabine not available as ready- made infusions contain up to approximately 11g of ethanol (1.5units). Patients should be advised not to drive on the day of treatment. Where alcohol content is a concern please contact pharmacy for advice about alternative formulations. 5. Other toxicities If there is any grade 2 toxicity (or above) proceed as follows: Cisplatin Grade 2 toxicity Dose % 1 st occurrence 80 2 nd occurrence 60 Unresolved or omit recurrent tinnitus Gemcitabine should be discontinued at the first sign of microangiopathic haemolytic anaemia (e.g. rapidly falling Hb with thrombocytopaenia, elevated bilirubin, creatinine, blood urea nitrogen or LDH). Supportive Care 1. Consider GCSF to maintain dose intensity for patients with febrile neutropenia or prolonged neutropenia. 2. Allopurinol 300mg once daily for the 1-2 cycles. (Reduce dose to 100mg if GFR < 10ml/min). 3. Co-trimoxazole 480mg ONCE daily. In cases of allergy to co-trimoxazole, consider dapsone 100mg daily. 4. Aciclovir 400mg twice daily. 5. Omeprazole 20mg daily for 4 days. 6. Fluconazole 100mg daily. References 1. Crump, M. et al (2013). Randomised Comparison of Gemcitabine, dexamethasone and Cisplatin Versus Dexamethasone, Cytarabine and Cisplatin Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed and Refractory Aggressive Lymphomas: NCIC-CTG LY12. Journal of Clinical Oncology The North London Cancer Network. Dosage Adjustment for Cytotoxics in Liver and Renal Impairment. Jan 2009 REVIEWED BY K.GRAHAM AUTHORISED BY: Dr J Addada PAGE 6 of 6
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