PVACE-BOP (Hodgkin s Lymphoma)

Transcription

1 DRUG ADMINISTRATION SCHEDULE Day Drug Dose Route Diluent Rate 1 Ondansetron 8mg IV / Oral vinblastine 6mg/m 2 (Max: 10mg) IV Infusion Etoposide 100mg/m 2 IV infusion Patients over 65 years by 15 min infusion if given IV 50ml Sodium 1000ml 0.9% Sodium Chloride 5 mins 1 hour 2 & 3 Etoposide 200mg/m 2 ORAL Once Daily For 2 days 1 to 14 8* 15 to & 22** Chlorambucil Procarbazine 6mg/m 2 (Max: 10mg) 100mg/m 2 (Max: 150mg) Ondansetron 8mg IV / Oral Doxorubicin 25mg/m 2 IV bolus vincristine 1.4mg/m 2 (Max: 2mg) ORAL Once Daily For 14 days ORAL Once Daily For 14 days IV infusion Patients over 65 years by 15 min infusion if given IV via 0.9% Sodium Chloride Drip 50ml Sodium 5 mins Prednisolone 40mg ORAL Once Daily For 14 days via 0.9% Sodium Hydrocortisone 100mg IV bolus Chloride Drip 2 Bleomycin 6000 iu/m 2 IV infusion 100ml 0.9% (Max: iu) Sodium Chloride * Day 8 and 15 may be interchanged if blood counts low on day 8 see dose modifications below ** Omit day 15 & 22 bleomycin on cycle 4 and 5 if patient is to receive mantle radiotherapy CYCLE LENGTH AND NUMBER OF DAYS 28 Day cycle, usually given for a maximum of 6 cycles APPROVED INDICATIONS Classical Hodgkin s Disease: for patients aged < 60 years with high risk HD ( SNLG index >0.5 (and some with intermediate risk) RECOMMENDED TAKE HOME MEDICATION Allopurinol 300mg once daily with first cycle of treatment Metoclopramide 10mg three times daily if required Gastro prophylaxis (Proton Pump Inhibitor or H2 Antagonist) should be considered with the steroid. Co-trimoxazole 960mg three times per week to continue until 6 months after treatment stops Page 1 of 5

2 INVESTIGATIONS / MONITORING REQUIRED Prior to first cycle: FBC, U&E s, LFT s, LDH, Chest X-Ray, CT scan, ECG, Consider ECHO Prior to each cycle: FBC, U&E s, LFT s ASSESSMENT OF RESPONSE Measure palpable disease. CT scan at mid-point of treatment and after completion of therapy. REVIEW BY CLINICIAN Prior to each cycle, unless being reviewed by a Nurse Specialist or Pharmacist under a locally agreed framework. Minimum consultant review annually. NURSE / PHARMACIST LED REVIEW As per locally agreed framework, or under share care with GP. 3 monthly review when stable. ADMINISTRATION NOTES Vinblastine and vincristine are for intravenous administration only. Administration by other routes may be fatal. Prior to starting vinblastine and vincristine ensure the venous access device is sufficiently patent by flushing well with Sodium. If there is doubt about the patency of the access device it must not be used. Vinblastine and vincristine is to be given by intravenous infusion in 50ml of Sodium over 5 minutes. (Rate: 600ml/hr = about 200 drops per minute on a standard 20drop per ml IV giving set.). Administration should normally be free-flow rather than via a volumetric pump. Vinblastine and vincristine is highly vesicant during administration a nurse should remain with the patient and observe the infusion site carefully for signs of extravasation. In the event that extravasation is suspected the infusion must immediately be stopped and appropriate treatment started (according to the extravasation policy). Following administration of vinblastine and vincristine flush well with Sodium Procarbazine dose can be taken in three divided doses. (Total daily dose: 100mg/m 2 ) Patients must not drink alcohol while taking procarbazine (risk of disulfiram type reaction) Patients requiring blood transfusion will require irradiated blood products. If FBC is low on Day 8, some clinicians will swap day 15 and day 8 to avoid delaying treatment. Doxorubicin is cardio-toxic and has a maximum life-time exposure of mg/m 2. Patients with underlying cardiac disease, or previous anthracycline exposure should be considered for ECHO/MUGA. Doxorubicin may discolour urine red Page 2 of 5

3 Bleomycin can cause pulmonary fibrosis. Patients should receive premedication with hydrocortisone before receiving bleomycin to minimise the risks. Etoposide capsules are supplied in 50mg and 100mg. 100mg capsules are very large and patients with swallowing difficulties would be better prescribed multiples of 50mg. Doses should be rounded to the nearest 50mg Procarbazine is supplied as 50mg capsules. Dose should be rounded to the nearest 50mg. Chlorambucil is supplied as 2mg tablets. Doses should be rounded to the nearest 2mg. TOXICITIES Common: Mild Nausea/Vomiting, Mucositis, Myelosuppression, Fatigue, Constipation, Dyspepsia, Glucose Intolerance, Alopecia Less Common: Fever, Flushing or Rash, Allergic Reaction, Pulmonary Toxicity, Neurotoxicity (paraesthesia), SiADH, cardiotoxicty, arrhythmias. DOSE MODIFICATION / TREATMENT DELAYS Haematological Toxicity: (Note: where haematological disease is affecting bone marrow function, lower treatment parameters may be acceptable. This should be clearly documented for the specific patient.) On Day 1: > 1.0 > 100 Give 100% of Day 1 doses Give 75% of Day 1 doses < 0.5 < 75 Delay Treatment On Day 8: > 1.0 > Give Day 8 doses Give Day 15 doses on Day 8 instead. Give Day 8 on Day 15 or 22 if ANC > 1.0 and PLT > On Day 15 or 22: 0.5 > 75 Give Day 15 or 22 doses as planned < Delay by 1 week (or omit) Page 3 of 5

4 Renal Function: Hepatic Function: CrCl (ml/min) Etoposide Bleomycin Doxorubicin >50ml/min 100% 100% 100% 30 50ml/min 80% 75% 100% 10 29ml/min 75% 75% 100% <10ml/min 75% 50% Reduce dose AST (iu/l) Bilirubin Vinblastine/ Chlorambucil Procarbazine (µmol/l) Vincristine < 60 AND < % 100% 100% OR % 100% 100% Normal AND > 51 50% 100% 100% > 180 iu/l AND > 51 Omit Consider 100% > 180 iu/l OR > 85 Omit reduction Contraindicated Bilirubin (µmol/l) Etoposide Doxorubicin < % 100% % 50% Clinical > 51 25% decision Free etoposide concentration may be increased by low plasma protein, further increasing toxicity. TREATMENT LOCATION Suitable for administration in chemotherapy day units, under the supervision of haematology teams from Level 1 4 Haematology Services. REFERENCES: Proctor SJ et al. A population based study of intensive multi-agent chemotherapy with or without auto-transplant for the highest risk Hodgkin s disease patients identified by Scotland and Newcastle Lymphoma Group (SNLG) Prognostic Index. European Journal of Cancer 38(6): (2001) Page 4 of 5

5 Document Control Document Title: Document No: Author: Approved by: CRP08 H025 Due for Review: April 2014 Summary of Changes Calum Polwart, Network Pharmacist NECN Ann Lenard/ Diane Plews 1.0a Final Version Approved Current Version: Approval Signature* Date Approved: /03/ a Updated to include NPSA guidance on vinca alkaloids 2.1 Updated to include restriction on chlorambucil dose to 10mg 2.2 Protocol updated. Typing errors corrected. Page 5 of 5