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Docetaxel-Nintedanib v1

Description: Chemotherapy Protocol NSCLC CANCER DOCETAXEL-NINTEDANIB Regimen NSCLC – Docetaxel-Nintedanib Indication Advanced or metastatic NSCLC of adenocarcinoma origin that has progressed after platinum-based combination regimen WHO Performance status 0, 1, 2 Toxicity Drug Docetaxel Nintedanib Adverse Effect Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue Haemorrhage, venous thromboembolism The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Regimen FBC, U&E’s and LFT’s prior to each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing cycle one the following treatment criteria must be met; Version 1 (Oct 2015) Page 1 of 8 NSCLC –Docetaxel-Nintedanib Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L (unless due to bone marrow involvement) equal to or more than 100x109/L (unless due to bone marrow involvement) Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL The dose of nintedanib does not need to be reduced for haematological toxicity. Toxicity Neutrophil Febrile Neutropenia Platelets Grade (NCI-CTC) 1 2 3 4 3 4 Greater than or equal to 100x109/L Less than 100x109/L Docetaxel (75mg/m2) 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 75mg/m2 Docetaxel (60mg/m2) 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Stop Stop Stop 60mg/m2 Delay until greater than or equal to 100x109/L then 60mg/m2 Stop Kidney Impairment Drug Docetaxel Nintedanib Creatinine Clearance (ml/min) N/A N/A Dose (% of original dose) No dose adjustment needed Safety in those with a CrCl of less than 30ml/min is not established Liver Impairment Drug Docetaxel Bilirubin (μmol/L) AST/ALT (units) Alk Phos (units) N/A Greater than ULN 1.5xULN or greater and/or 3.5xULN or greater and 2.5xULN or greater and 6xULN or greater Dose (% of original dose) Give 75% Not Recommended Version 1 (Oct 2015) Page 2 of 8 NSCLC –Docetaxel-Nintedanib Nintedanib There is no safety data in those with Child Pugh B or C hepatic impairment Should liver impairment occur during treatment then dose adjust as below. AST / ALT and bilirubin elevations Elevation of AST and/or ALT values to more than 2.5xULN in conjunction with total bilirubin elevation equal to or greater than 1.5xULN or elevation of AST and/or ALT values to more than 5xULN Elevation of AST and/or ALT values to more than 3xULN in conjunction with an increase of total bilirubin to more than 2x ULN and ALKP less than 2xULN Dose adjustment After treatment interruption and recovery of transaminase-values to less than or equal to 2.5xULN in conjunction with bilirubin to normal, dose reduction from 200 mg twice daily to 150 mg twice daily and, if a 2nd dose reduction is considered necessary from 150 mg twice daily to 100 mg twice daily. Unless there is an alternative cause established, nintedanib should be permanently discontinued Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. Docetaxel Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 75mg/m2 to 60mg/m2 once the neuropathy has resolved to NCI-CTC grade 2 or below. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 75mg/m2 or a NCI-CTC grade 4 toxicity develops consider stopping treatment. Excessive tearing / lacrimation are related to cumulative docetaxel doses and occur after a median of 400mg/m². Symptomatic treatment with hypromellose 0.3% eye drops four times a day may help. However, if the ocular irritation continues reduce the docetaxel dose to 80% of the original dose in the first instance. Delay the docetaxel where a NCI-CTC grade 3 cutaneous toxicity is present on day one of the cycle until it resolves to NCI-CTC grade 1 or below. The subsequent doses of docetaxel should be reduced from 75mg/m2 to 60mg/m2. If it occurs with a dose of 60mg/m2 or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCI-CTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one then reduce the docetaxel dose as described. Docetaxel should be stopped in response to a NCI-CTC grade 4 cutaneous toxicity. Nintedanib CTCAE* Adverse Reaction Diarrhoea equal to or greater than CTC grade 2 for more than 7 consecutive days despite anti-diarrhoeal treatment Or diarrhoea equal to or greater than grade 3 despite anti-diarrhoeal treatment Version 1 (Oct 2015) Dose Adjustment After treatment interruption and recovery to grade 1 or baseline, dose reduction from 200 mg twice daily to 150 mg twice daily and, if a 2nd dose reduction is considered Page 3 of 8 NSCLC –Docetaxel-Nintedanib Vomiting equal to or greater than grade 2 and / or nausea greater than or equal to grade 3 despite anti-emetic treatment Other non-haematological or haematological adverse reaction of greater than or equal to grade 3 necessary, from 150 mg twice daily to 100 mg twice daily. Regimen Docetaxel is highly myelosuppressive and in those with poor bone marrow reserves (for example due to extensive prior treatment, bone metastasis or extensive skeletal radiation) consider a starting dose of 55mg/m² with a view to increase to 75mg/m² if well tolerated. 21 day cycle for 4 cycles (docetaxel). Nintedanib can be continued until intolerance or disease progression occurs (an additional 8 cycles will be set in Aria, making twelve cycles in total) Drug Docetaxel Nintedanib Dose 75mg/m2 200mg twice a day Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Continuous Oral Dose Information Docetaxel will be dose banded as per the CSCCN agreed bands Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the doses Administration Information Hypersensitivity reactions tend to occur with the first or second infusion of docetaxel. The docetaxel infusion should not be interrupted for minor symptoms such as flushing or localised rashes. Immediately discontinue the infusion for severe reactions which include profound hypotension, bronchospasm and generalised erythema. Docetaxel doses of more than 200mg should be diluted in 500ml sodium chloride 0.9% (maximum concentration 0.74mg/ml) Nintedanib should not be administered on the same day as docetaxel. Extravasation Docetaxel – exfoliant Additional Therapy Version 1 (Oct 2015) Page 4 of 8 NSCLC –Docetaxel-Nintedanib Antiemetics 15-30 minutes before docetaxel - metoclopramide 10mg oral or intravenous As take home medication - metoclopramide 10mg three times a day when required oral To prevent fluid retention and hypersensitivity reactions prescribe dexamethasone 8mg twice a day orally for three days starting 24 hours before the docetaxel administration. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone premedication administer dexamethasone 20mg, or nearest equivalent dose, once only intravenous bolus. Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Coding Procurement – X70.8 Delivery – X72.9 References 1. Reck M, Kaiser R, Mellemgaard A et al. Docetaxel plus nintedanib versus docetaxel plus placebo in patients with previously treated non-small cell lung cancer (LUME – lung 1): a phase three, double blind randomised controlled trial. Lancet Oncol 2014; 15 (2): 143-155. Version 1 (Oct 2015) Page 5 of 8 NSCLC –Docetaxel-Nintedanib REGIMEN SUMMARY Docetaxel-Nintedanib Cycle 1, 2, 3 Day Minus One 1. Dexamethasone 8mg twice a day oral* Day One 2. Dexamethasone 8mg twice a day oral (from TTO)* 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 5. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion 6. Metoclopramide 10mg three times a day when required oral 7. Nintedanib 200mg twice a day oral starting on day two of the cycle Administration Instructions Do not take nintedanib on the day of docetaxel administration. Cycle 4 Day Minus One 8. Dexamethasone 8mg twice a day oral* Day One 9. Dexamethasone 8mg twice a day oral (from TTO)* 10. Metoclopramide 10mg oral or intravenous 11. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 12. Metoclopramide 10mg three times a day when required oral 13. Nintedanib 200mg twice a day oral starting on day two of the cycle Administration Instructions Do not take nintedanib on the day of docetaxel administration Version 1 (Oct 2015) Page 6 of 8 NSCLC –Docetaxel-Nintedanib Cycle 5 – 12 inclusive Take Home Medicines 14. Nintedanib 200mg twice a day oral * In Aria Planner the dexamethasone 8mg twice daily will appear on days 1, 2, 3 of treatment. This is the supply for the next cycle. The administration instructions reflect this. On the last cycle no dexamethasone will appear for prescribing. Version 1 (Oct 2015) Page 7 of 8 NSCLC –Docetaxel-Nintedanib DOCUMENT CONTROL Version Date 1 Oct 2015 Amendment None Written By Dr Debbie Wright Pharmacist Approved By Dr Andrew Bates Consultant Clinical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1 (Oct 2015) Page 8 of 8 NSCLC –Docetaxel-Nintedanib
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/Docetaxel-Nintedanib-v1.pdf

Docetaxel

Description: Chemotherapy Protocol LUNG CANCER – NON-SMALL CELL (NSCLC) DOCETAXEL (75) Regimen NSCLC – Docetaxel (75) Indication Second line therapy of stage IIIB or IV NSCLC WHO Performance status 0, 1 Palliative intent Toxicity Drug Docetaxel Adverse Effect Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Disease A baseline chest x-ray should be performed before starting treatment and up to date (ideally within 1 month) cross section imaging should also be performed Regimen FBC, LFTs and U&Es prior to each cycle A chest x-ray should be performed before each cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.2 (January 2014) Page 1 of 8 NSCLC – Docetaxel (75) Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematology Prior to prescribing the following criteria must be met; Criteria Neutrophils Platelets Eligible Level 1.5x109/L or greater 100x109/L or greater Consider blood transfusion if the patient is symptomatic of anaemia or if the haemoglobin is less than 8g/dL If the neutrophils are less than 1.5 x109/, then in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment at a dose of 60mg/m2. If the myelosuppression recurs despite this dose reduction stop treatment. If the platelets are less than 100x109/L then in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If counts remain low continue with treatment at a dose of 60mg/m2. If the platelet level falls below 50 x 109/L stop treatment. Hepatic Impairment Drug Docetaxel Bilirubin (μmol/L) AST/ALT (units) Alk Phos (units) N/A Greater than ULN 1.5xULN or greater and/or 3.5xULN or greater and 2.5xULN or greater and 6xULN or greater Dose (% of original dose) Give 75% Not Recommended Renal Impairment Drug Docetaxel Creatinine Clearance (ml/min) N/A Dose (% of original dose) No dose adjustment needed Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose should then be reduced to 60mg/m2 or discontinued as appropriate. Version 1.2 (January 2014) Page 2 of 8 NSCLC – Docetaxel (75) Peripheral Neuropathy Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 75mg/m2 to 60mg/m2 once the neuropathy has resolved to NCI-CTC grade 2 or below. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 75mg/m2 or a NCI-CTC grade 4 toxicity develops consider stopping treatment. Lacrimation Excessive lacrimation is related to cumulative docetaxel doses and occurs after a median of 400mg/m². Symptomatic treatment with hypromellose 0.3% eye drops four times a day may help. However, if the ocular irritation continues reduce the docetaxel dose to 60mg/m2. Skin Delay the docetaxel where a NCI-CTC grade 3 cutaneous toxicity is present on day one of the cycle until it resolves to NCI-CTC grade 1 or below. The subsequent doses of docetaxel should be reduced from 75mg/m2 to 60mg/m2. If it occurs with a dose of 60mg/m2 or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCI-CTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one then reduce the docetaxel dose as described. Docetaxel should be stopped in response to a NCI-CTC grade 4 cutaneous toxicity. Stomatitis A NCI-CTC grade 2 stomatitis should result in a delay in treatment until it has become NCI-CTC grade 1 or below. Treatment may then be re-started at the previous dose. For a NCI-CTC grade 3 stomatitis delay treatment until it has recovered to NCI-CTC grade 1 or below then reduce the dose to 60mg/m2. Treatment should be stopped in relation to a NCI-CTC grade 4 stomatitis. Regimen 21 day cycle for 4 cycles Docetaxel is highly myelosuppressive and in those with poor bone marrow reserves (for example due to extensive prior treatment, bone metastasis or extensive skeletal radiation) consider a starting dose of 60mg/m² with a view to increase to 75mg/m² if well tolerated. Drug Docetaxel Dose 75mg/m2 Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Dose Information Docetaxel will be banded as per the CSCCN agreed bands. Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the doses Version 1.2 (January 2014) Page 3 of 8 NSCLC – Docetaxel (75) Docetaxel doses of more than 200mg should be diluted in 500ml sodium chloride 0.9% (maximum concentration 0.74mg/ml) Administration Information Docetaxel hypersensitivity reactions tend to occur with the first or second infusion. For minor symptoms such as flushing or localised rashes the infusion should not be interrupted. For severe reactions including profound hypotension, bronchospasm and generalised erythema discontinue the infusion immediately. Extravasation Docetaxel - exfoliant Additional Therapy Antiemetics 15-30 minutes prior to chemotherapy; - metoclopramide 10mg oral or intravenous As take home medication; - metoclopramide 10mg three times a day oral when required To prevent fluid retention and hypersensitivity reactions prescribe dexamethasone 8mg twice daily oral for three days starting 24 hours before docetaxel administration. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg intravenous Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Prophylactic antibiotics can be considered if required Growth factors may be considered according to local policy. Coding Procurement – X71.1 Delivery – X72.3 References 1.National Institute of Clinical Excellence (2005). CG24. The Diagnosis and Treatment of Lung Cancer. Methods, Evidence and Guidance. DOH: London. Version 1.2 (January 2014) Page 4 of 8 NSCLC – Docetaxel (75) 2.Fossella FV, DeVore R, Kerr RN et al. Randomised phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small cell lung cancer previously treated with platinum containing chemotherapy regimens. The TAX 320 study non-small cell lung cancer study group. J Clin Oncol; 2000: 18 (12): 2354-2362. 3.Shepherd FA, Dancey J, Ramlau R et al. Prospective randomised trial of docetaxel versus best supportive care in patients with non-small cell lung cancer previously treated with platinum based chermotherapy. J Clin Oncol 2000; 18 (10): 2095-2103. Version 1.2 (January 2014) Page 5 of 8 NSCLC – Docetaxel (75) REGIMEN SUMMARY Docetaxel (75) Cycle 1, 2, 3 Day Minus One 1. Dexamethasone 8mg twice a day oral* Day One 2. Dexamethsone 8mg twice a day oral (from TTO)* 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 75mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 5. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion* 6. Metoclopramide 10mg three times a day when required oral Cycle 4 Day Minus One 7. Dexamethasone 8mg twice a day oral* Day One 8. Dexamethsone 8mg twice a day oral (from TTO)* 9. Metoclopramide 10mg oral or intravenous 10. Docetaxel 75mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Take Home Medicines 11. Metoclopramide 10mg three times a day when required oral * In Aria Planner the dexamethasone 8mg twice daily will appear on days 1, 2, 3 of treatment. This is the supply for the next cycle. The patient should have been given the supply for cycle one in the pre-assessment or consent clinic. The administration instructions reflect this. Version 1.2 (January 2014) Page 6 of 8 NSCLC – Docetaxel (75) Document Control Version Date Amendment Written By 1.2 Jan 2014 Header and footer changed Dr Deborah Wright Name changed to Docetaxel Pharmacist (75) Toxicity removed and tabulated written in full Haematological criteria tabulated Renal and hepatic recommendations updated and tabulated Other toxicities added as per prostate regimens Regimen tabulated and recommendations on starting dose added Dosing information extended Hypersensitivity recommendations added Administartion routes written in full, bolus and stat removed Metoclopramide dose changed Name added under summary Cycle four added to exclude dexamethasone TTO. Document control tabulated Hospitals and disclaimer added 1.1 23rd Sept Font changed to Arial Dr Deborah Wright 2010 Header altered to include Pharmacist “Strength through Partnership” Drug names given capitals in regimen Extravasation moved to under Administration Information Footer changed to include regimen name and review date removed Standard paragraph added to introduction in dose modifications Dose modifications format (not information) changed Coding added Summary page added Document control added Approved By Donna Kimber Pharmacy Technician Donna Kimber Pharmacy Technician Version 1.2 (January 2014) Page 7 of 8 NSCLC – Docetaxel (75) This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (January 2014) Page 8 of 8 NSCLC – Docetaxel (75)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/Docetaxelver12.pdf

Cisplatin and Pemetrexed

Description: Chemotherapy Protocol LUNG CANCER – NON-SMALL CELL (NSCLC) CISPLATIN-PEMETREXED Regimen NSCLC – Cisplatin-Pemetrexed Indication First line therapy of stage III or IV adenocarcinoma or large cell carcinoma of the lung WHO Performance status 0, 1 Palliative intent Toxicity Drug Cisplatin Pemetrexed Adverse Effect Neuropathy, nephrotoxicity, ototoxicity Diarrhoea, skin reactions, neuropathy The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Disease A baseline chest x-ray should be performed before starting treatment and up to date (ideally within 1 month) cross section imaging should also be performed Regimen FBC, LFTs and U&Es before each cycle A chest x-ray should be performed before each cycle Consider formal audiology test if relevant Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule Version 1.2 (January 2014) Page 1 of 8 NSCLC – Cisplatin-Pemetrexed for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematology Prior to prescribing the following treatment criteria must be met; Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If the neutrophils are less than 1.5x109/L then in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment using a 20% dose reduction. If the myelosuppression recurs despite this dose reduction stop treatment. If the platelets are less than 100x109/L then in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If the counts still fall within this range continue using a 20% dose reduction. If the platelet level falls below 50x109/L reduce the dose by 50%. Liver Impairment Drug Adjustment Cisplatin Pemetrexed No dose adjustment required Clinical decision Renal Impairment Drug Cisplatin Pemetrexed Creatinine Clearance (ml/min) more than 60 Dose (% of original dose) 100 45 - 59 75 less than 45 Consider carboplatin Do not administer if the creatinine clearance is less than 45ml/min Version 1.2 (January 2014) Page 2 of 8 NSCLC – Cisplatin-Pemetrexed Regimen 21 day cycle for 4 cycles Drug Dose Days Administration Cisplatin Pemetrexed 75mg/m2 500mg/m2 Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol 1 potassium chloride at a maximum rate of 1mg cisplatin/min (minimum time 120 minutes) Intravenous infusion in 100ml 1 sodium chloride 0.9% over 10 minutes Dose Information Cisplatin will be dose banded as per the CSCCN agreed bands Pemetrexed will be dose banded as per the CSCCN agreed bands Administration Information Cisplatin should be administered 30 minutes after the end of the pemetrexed infusion Extravasation Cisplatin – exfoliant Pemetrexed - inflammitant Additional Therapy Folic acid 5mg once daily starting 1 – 2 weeks prior to and continuing for three weeks after the last dose of pemetrexed. Hydroxocobalamin intramuscular injection 1mg every three months starting 1 – 2 weeks prior to pemetrexed. Antiemetics 15-30 minutes prior to chemotherapy; - aprepitant 125mg oral - ondansetron 8mg oral or intravenous Ensure the patient has taken dexamethasone po starting the day before pemetrexed. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 10mg stat iv 15-30 minutes before chemotherapy. Version 1.2 (January 2014) Page 3 of 8 NSCLC – Cisplatin-Pemetrexed As take home medication; - aprepitant 80mg once a day oral for 2 days - dexamethasone 4mg twice a day oral for 1 day starting the day before chemotherapy is due and dexamethasone 4mg once a day on the day of and the day after chemotherapy. - metoclopramide 10mg three times a day when required - ondansetron 8mg twice a day for 3 days Cisplatin pre and post hydration as follows; Pre Furosemide 40mg oral or intravenous bolus 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Post 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Patients should be advised to drink at least 3 litres of fluid in the 24 hours after administration of cisplatin. Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Prophylactic antibiotics can be considered if required Additional Information Consideration should be given to draining pleural or peritoneal effusions prior to pemetrexed administration Coding Procurement – X71.5 Delivery – X72.1 References 1.National Institute of Clinical Excellence (2009). TA135 Pemetrexed for the treatment of mesothelioma. London: DOH. 2.Santoro A, O’Brien ME, Stahel RA et al. Pemetrexed plus cisplatin or pemetrexed plus carboplatin for chemonaive patients with malignant pleural mesothelioma: results of the International Expanded Access Programme. J Thorac Oncol 2008; 3 (7): 756 – 763. Version 1.2 (January 2014) Page 4 of 8 NSCLC – Cisplatin-Pemetrexed REGIMEN SUMMARY Cisplatin-Pemetrexed Cycle 1, 2, 3 Day Minus One 1. Dexamethasone 4mg twice a day oral* Day One 2. Aprepitant 125mg oral 3. Dexamethasone 4mg once a day oral* 4. Ondansetron 8mg oral or intravenous 5. Furosemide 40mg oral or intravenous bolus 6. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 7. Pemetrexed 500mg/m2 intravenous infusion in 100ml sodium chloride 0.9% over 10 minutes 8. Cisplatin 75mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin/minute (minimum time 120 minutes) 9. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Take Home Medicines 10. Aprepitant 80mg once a day for 2 days oral starting on day two of the cycle 11. Dexamethasone 4mg twice a day oral for 1 day starting the day before the pemetrexed infusion and 4mg once a day on the day of and the day after pemetrexed. 12. Metoclopramide 10mg three times a day when required oral 13. Ondansetron 8mg twice a day for three days oral starting on the evening of day one of the cycle 14. Folic acid 5mg once a day oral (continuous) Version 1.2 (January 2014) Page 5 of 8 NSCLC – Cisplatin-Pemetrexed Cycle 4 15. Dexamethasone 4mg twice a day oral* Day One 16. Aprepitant 125mg oral 17. Dexamethasone 4mg once a day oral* 18. Ondansetron 8mg oral or intravenous 19. Furosemide 40mg oral or intravenous bolus 20. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 21. Pemetrexed 500mg/m2 intravenous infusion in 100ml sodium chloride 0.9% over 10 minutes 22. Cisplatin 75mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin/minute (minimum time 120 minutes) 23. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Take Home Medicines 24. Aprepitant 80mg once a day for 2 days oral starting on day two of the cycle 25. Metoclopramide 10mg three times a day when required oral 26. Ondansetron 8mg twice a day for three days oral starting on the evening of day one of the cycle 27. Folic acid 5mg once a day oral (continuous) Hydroxocobalamin will not be included as part of the Aria regime and must be prescribed separately on the cycle for which it is due. * In Aria Planner the dexamethasone 4mg twice daily will appear on days 1, and dexamethasone 4mg once a day on days 2 and 3 of treatment. This is the supply for the next cycle. The patient should have been given the supply for cycle one in the pre-assessment or consent clinic. The administration instructions reflect this. Version 1.2 (January 2014) Page 6 of 8 NSCLC – Cisplatin-Pemetrexed DOCUMENT CONTROL Version Date Amendment Written By 1.2 9th Jan Header changed to NHS badge Dr Deborah Wright 2014 In name “and” replaced with dash Pharmacist Adverse effects put in table and toxicity removed Dose modification tabulated Renal and hepatic function tabulated and updated Regimen tabulated Twice daily changed to twice a day Regimen name added to summary Summary re-numbered Bolus removed from ondansetron Metoclopramide dose changed to 10mg Cycle 6 added with no dexamethasone pre-med included Antiemetic TTO start added Document control tabulated Hospital representation and disclaimer added 1.1 23rd Sept Font changed to Arial Dr Deborah Wright 2010 Header altered to include “Strength Pharmacist through Partnership” Drug names given capitals in regimen Extravasation moved to under Administration Information Footer changed to include regimen name and review date removed Standard paragraph added to introduction in dose modifications Dose modifications format (not information) changed Administration Information added Granisetron removed from antiemetics Aprepitant incorporated as per superusers Coding added Summary page added Document control added Approved By Donna Kimber Pharmacy Technician Donna Kimber Pharmacy Technician Version 1.2 (January 2014) Page 7 of 8 NSCLC – Cisplatin-Pemetrexed This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (January 2014) Page 8 of 8 NSCLC – Cisplatin-Pemetrexed
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/CisplatinandPemetrexedver12.pdf

Ceritinib 450mg

Description: Ceritinib
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lung-cancer-non-small-cellNSCLC/Ceritinib-450mg.pdf

MesoCisPemVer1.3

Description: Chemotherapy Protocol MESOTHELIOMA CISPLATIN-PEMETREXED Regimen Mesothelioma – Cisplatin-Pemetrexed Indication First line therapy of advanced pleural mesothelioma where the disease is not suitable for surgical resection WHO Performance Status 0, 1 Toxicity Drug Cisplatin Pemetrexed Adverse Effect Neuropathy, nephrotoxicity, ototoxicity Diarrhoea, skin reactions, neuropathy The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Disease A baseline chest x-ray should be performed before starting treatment and up to date (ideally within 1 month) cross section imaging should also be performed Regimen FBC, LFTs and U&Es before each cycle A chest x-ray should be performed before each cycle Consider formal audiology test if relevant Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.3 (January 2016) Page 1 of 8 Mesothelioma – Cisplatin -Pemetrexed Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following treatment criteria must be met; Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL Subsequently if the neutrophils are less than 1.5 x109/L, then in the first instance delay treatment for 7 days. If counts recover at this point continue at the initial dose. If counts remain low continue with treatment using a 20% dose reduction. If the myelosuppression recurs despite this dose reduction stop treatment. If the platelets are less than 100x109/L then in the first instance delay treatment for 7 days. If the counts recover at this point continue at the initial dose. If the counts still fall within this range continue using a 20% dose reduction. If the platelet level falls below 50x109/L reduce the dose by 50%. Liver Impairment Drug Adjustment Cisplatin Pemetrexed No dose adjustment required Clinical decision Renal Impairment Drug Cisplatin Pemetrexed Regimen Creatinine Clearance (ml/min) more than 60 Dose (% of original dose) 100 50-60 75 40-50 50 less than 40 Do not use Do not administer if the creatinine clearance is less than 45ml/min Version 1.3 (January 2016) Page 2 of 8 Mesothelioma – Cisplatin -Pemetrexed 21 day cycle for 3-6 cycles (6 cycles will be set in Aria) Drug Dose Days Administration Cisplatin Pemetrexed 75mg/m2 500mg/m2 Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol 1 potassium chloride at a maximum rate of 1mg cisplatin/min (minimum time 120 minutes) Intravenous infusion in 100ml 1 glucose 5% or sodium chloride 0.9% over 10 minutes Dose Information Cisplatin will be dose banded as per the CSCCN agreed bands Pemetrexed will be dose banded as per the CSCCN agreed bands Administration Information Cisplatin should be administered 30 minutes after the end of the pemetrexed infusion Pemtrexed may be administered in 100ml of either glucose 5% or sodium chloride 0.9% over 10 minutes. The choice of fluid will be dependent on the product stocked by pharmacy. The fluid and volume will not appear in the prescription but can be located in the instructions notepad Extravasation Cisplatin – exfoliant Pemetrexed - inflammitant Additional Therapy Folic acid 5mg once daily starting 1 – 2 weeks prior to and continuing for three weeks after the last dose of pemetrexed. Hydroxocobalamin intramuscular injection 1mg every three months starting 1 – 2 weeks prior to pemetrexed. Antiemetics 15-30 minutes prior to chemotherapy; - aprepitant 125mg oral - ondansetron 8mg oral or intravenous bolus Ensure the patient has taken oral dexamethasone starting the day before Version 1.3 (January 2016) Page 3 of 8 Mesothelioma – Cisplatin -Pemetrexed pemetrexed. On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer an intravenous bolus dose of dexamethasone 10mg 15-30 minutes before chemotherapy. As take home medication; - aprepitant 80mg once a day for 2 days oral - dexamethasone 4mg twice a day for 1 day starting the day before chemotherapy is due and dexamethasone 4mg once a day on the day of and the day after chemotherapy oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Cisplatin pre and post hydration as follows; Pre Furosemide 40mg oral or intravenous bolus 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Post 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Patients should be advised to drink at least 3 litres of fluid in the 24 hours after administration of cisplatin. Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed Prophylactic antibiotics can be considered if required Additional Information Consideration should be given to draining pleural or peritoneal effusions prior to pemetrexed administration Coding Procurement – X71.5 Delivery – X72.1 References 1.National Institute of Clinical Excellence (2009). TA135 Pemetrexed for the treatment of mesothelioma. London: DOH. 2.Santoro A, O’Brien ME, Stahel RA et al. Pemetrexed plus cisplatin or pemetrexed plus carboplatin for chemonaive patients with malignant pleural mesothelioma: results of the International Expanded Access Programme. J Thorac Oncol 2008; 3 (7): 756 – 763. Version 1.3 (January 2016) Page 4 of 8 Mesothelioma – Cisplatin -Pemetrexed REGIMEN SUMMARY Cisplatin-Pemetrexed Cycle 1, 2, 3, 4, 5 Day Minus One 1. Dexamethasone 4mg twice a day oral* Day One 2. Aprepitant 125mg oral 3. Dexamethasone 4mg once a day oral (from TTO)* 4. Ondansetron 8mg oral or intravenous bolus 5. Furosemide 40mg oral or intravenous bolus 6. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 7. Pemetrexed 500mg/m2 intravenous infusion in 100ml glucose 5% or sodium chloride 0.9% over 10 minutes 8. Cisplatin 75mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin/minute (minimum time 120 minutes) 9. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Take Home Medicines 10. Aprepitant 80mg once a day for 2 days starting on day 2 oral 11. Dexamethasone 4mg twice a day oral for 1 day starting the day before the pemetrexed infusion and 4mg once a day on the day of and the day after pemetrexed. 12. Metoclopramide 10mg three times a day when required oral 13. Ondansetron 8mg twice a day for three days starting on the evening of day 1 of the cycle oral 14. Folic acid 5mg once a day oral (continuous) Hydroxocobalamin will not be included as part of the Aria regime and must be prescribed separately on the cycle for which it is due. Version 1.3 (January 2016) Page 5 of 8 Mesothelioma – Cisplatin -Pemetrexed Cycle 6 Day Minus One 1. Dexamethasone 4mg twice a day oral* Day One 2. Aprepitant 125mg oral 3. Dexamethasone 4mg once a day oral (from TTO)* 4. Ondansetron 8mg oral or intravenous bolus 5. Furosemide 40mg oral or intravenous bolus 6. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 7. Pemetrexed 500mg/m2 intravenous infusion in 100ml glucose 5% or sodium chloride 0.9% over 10 minutes 8. Cisplatin 75mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin/minute (minimum time 120 minutes) 9. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Take Home Medicines 10. Aprepitant 80mg once a day for 2 days starting on day 2 oral 11. Metoclopramide 10mg three times a day when required oral 12. Ondansetron 8mg twice a day for three days starting on the evening of day 1 of the cycle oral 13. Folic acid 5mg once a day oral (continuous) Hydroxocobalamin will not be included as part of the Aria regime and must be prescribed separately on the cycle for which it is due. * In Aria Planner the dexamethasone 4mg twice daily will appear on days 1, and dexamethasone 4mg once a day on days 2 and 3 of treatment. This is the supply for the next cycle. The patient should have been given the supply for cycle one in the pre-assessment or consent clinic. The administration instructions reflect this. Version 1.3 (January 2016) Page 6 of 8 Mesothelioma – Cisplatin -Pemetrexed DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.3 Jan 2016 Pemetrexed administration Dr Deborah Wright Donna Kimber instructions changed throughout the Pharmacist Pharmacy text Technician 1.2 Dec Header changed to NHS badge Dr Deborah Wright Liz Harrison 2013 In name “and” replaced with dash Pharmacist Pharmacist Adverse effects put in table and toxicity removed Dose modification tabulated Renal and hepatic function tabulated Clarification added on the number of cycles set in Aria Regimen tabulated Twice daily changed to twice a day Regimen name added to summary Summary re-numbered Metoclopramide dose changed to 10mg Cycle 6 added with no dexamethasone pre-med included Document control tabulated Hospital representation and disclaimer added 1.1 Sept Font changed to Arial Dr Deborah Wright Donna Kimber 2010 Header altered to include “Strength Pharmacist Pharmacy through Partnership” Technician Drug names given capitals in regimen Extravasation moved to under Administration Information Footer changed to include regimen name and review date removed Standard paragraph added to introduction in dose modifications Dose modifications format (not information) changed Administration information added Granisetron removed from antiemetics Aprepitant incorporated as per superusers Coding added Summary page added Document control added 1 Jan None Dr Deborah Wright Dr Andrew Bates 2010 Pharmacist Consultant Clinical Oncologist Dr Tim Gulliford Consultant Medical Version 1.3 (January 2016) Page 7 of 8 Mesothelioma – Cisplatin -Pemetrexed Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.3 (January 2016) Page 8 of 8 Mesothelioma – Cisplatin -Pemetrexed
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Cisplatin Doxorubicin Methotrexate Vinblastine (accelerated) ver1.1

Description: Chemotherapy Protocol BLADDER CISPLATIN-DOXORUBICIN-METHOTREXATE-VINBLASTINE (Accelerated MVAC) Regimen Bladder-Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC) Indication First or second line treatment of locally advanced or metastatic urothelial cancer WHO performance status 0, 1, 2 Toxicity Drug Cisplatin Doxorubicin Methotrexate Vinblastine Adverse Effect Neuropathy, nephrotoxicity, ototoxicity Cardio toxicity, urinary discolouration (red) Stomatitis, conjunctivitis, renal toxicity Peripheral neuropathy, abdominal pain, constipation, jaw pain The presence of a third fluid compartment e.g. ascites or renal failure may delay methotrexate clearance hence increase toxicity. The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring FBC, LFTs and U&Es prior to day one of treatment Calculated or measured creatinine clearance prior to each cycle. EDTA may be considered prior to cycle one or if there are significant changes in renal function during treatment. Ensure adequate cardiac function before starting treatment. Baseline LVEF should be considered, particularly in patients with a history of cardiac problems or in the elderly. Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1.1 (May 2015) Page 1 of 7 Bladder-Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC) Please discuss all dose reductions / delays with the relevant consultant before prescribing, if appropriate. The approach may be different depending on the clinical circumstances. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Day 1 Neutrophils (x109/L) 1 or greater less than 1 Platelets (x109/L) 100 or greater Less than 100 Dose Modifications (cisplatin, doxorubicin, methotrexate, vinblastine) 100% 1st Occurrence. Delay until recovery. If this occurs within seven days resume treatment at the last dose administered. If this takes longer than seven days then give 75% of the last dose 2nd Occurrence Delay until recovery then give 75% of the last dose Dose Modifications (cisplatin, doxorubicin, methotrexate, vinblastine) 100% 1st Occurrence. Delay until recovery. If this occurs within seven days resume treatment at the last dose administered. If this takes longer than seven days then give 75% of the last dose 2nd Occurrence Delay until recovery then give 75% of the last dose Version 1.1 (May 2015) Page 2 of 7 Bladder-Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC) Hepatic Impairment Drug Bilirubin μmol/L Cisplatin N/A Dose (% of original dose) No dose adjustment needed AST/ALT units/L N/A Doxorubicin 20-51 52-85 80 or greater 50% 25% omit If the AST 2-3xULN then give 75% of the dose If the AST is greater than 3xULN then give 50% of the dose Methotrexate less than 50 51-85 86 or greater 100 75 If the AST is greater than 180 administer 75% of the dose omit Vinblastine 26-51 52 or greater 50 50 or omit* *If the AST is greater than 180 and bilirubin less than 52 administer 50% of the dose *If the AST is greater than 180 and the bilirubin 52 or greater omit vinblastine Renal Impairment Drug Cisplatin Creatinine Clearance (ml/min) 60 or more less than 60 Dose (% of original dose) 100% consider alternative Doxorubicin No dose reduction necessary Methotrexate 46-60 65 31-45 50 less than 30 omit Vinblastine No dose reduction necessary Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose of the causative agent should then be reduced to 75% of the original dose or discontinued as appropriate. Doxorubicin Version 1.1 (May 2015) Page 3 of 7 Bladder-Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC) Discontinue doxorubicin if cardiac failure develops. Regimen 14 day cycle for 6 cycles Drug Cisplatin Doxorubicin Dose 70mg/m2 30mg/m2 Days 1 1 Administration Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a rate of cisplatin of 1mg/min (minimum 120 minutes) Intravenous bolus over 10 minutes Methotrexate Vinblastine 30mg/m2 3mg/m2 1 Intravenous bolus over 10 minutes 1 Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Dose Information Cisplatin will be dose banded according to the CSCCN agreed bands Doxorubicin will be dose banded according to the CSCCN agreed bands Methotrexate will be dose banded according to the CSCCN agreed bands Vinblastine will be rounded to the nearest 1mg (up if halfway) Administration Information Extravasation Cisplatin - exfoliant Doxorubicin - vesicant Methotrexate - inflammitant Vinblastine - vesicant Additional Therapy Antiemetics 15-30 minutes prior to chemotherapy - aprepitant 125mg oral - dexamethasone 4mg oral or intravenous - ondansetron 8mg oral or intravenous Version 1.1 (May 2015) Page 4 of 7 Bladder-Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC) As take home medication - aprepitant 80mg oral daily for on days 2 and 3 - dexamethasone 4mg oral once a day for 3 days - metoclopramide 10mg oral three times a day as required - ondansetron 8mg oral twice a day for 3 days Cisplatin pre and post hydration as follows Pre Furosemide 40mg oral or intravenous 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Post 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Patients should be advised to drink at least 3 litres of fluid in the 24 hours after administration of cisplatin. Growth factors according to local formulary; - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 3 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 3 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous Mouthwashes according to local or national policy on the treatment of mucositis Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Additional Information The National Patient Safety Agency report NPSA/2008/RRR04 must be followed in relation to intravenous administration of vinca alkaloids. Coding (OPCS 4.6) Procurement – X70.4 Delivery – X72.1 References 1. Edeline et al. Accelerated MVAC chemotherapy in patients with advanced bladders cancer previously treated with a platinum-gemcitabine regimen. Eur Journal of Cancer (2012); 48: 1141-1146. 2. Sternberg CN, de Mulder PH, Schornagel JH et al. Randomised phase III trial of high dose intensity methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) chemotherapy and recombinant human granulocyte colony stimulating factor versus classic MVAC in advanced urothelial tract tumours: European Organization for Research and Treatment of Cancer Protocol No 30924. J Clin Oncol 2001; 19 (10): 2638-2646. Version 1.1 (May 2015) Page 5 of 7 Bladder-Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC) REGIMEN SUMMARY Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC) Day 1 1. Aprepitant 125mg oral 2. Dexamethasone 4mg oral or intravenous 3. Ondansetron 8mg oral or intravenous 4. Doxorubicin 30mg/m2 intravenous bolus over 10minutes 5. Vinblastine 3mg/m2 intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 6. Methotrexate 30mg/m2 intravenous bolus over 10 minutes 7. Furosemide 40mg oral or intravenous 8. Sodium chloride 0.9% 1000ml with magnesium sulphate 16mmol and potassium chloride 20mmol intravenous infusion over 60 minutes 9. Cisplatin 70mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion at a rate of cisplatin of 1mg/min (minimum 120 minutes) 10. Sodium chloride 0.9% 1000ml with magnesium sulphate 16mmol with potassium chloride 20mmol intravenous infusion over 60 minutes Take Home Medicines 11. Aprepitant 80mg once a day on days 2 and 3 oral 12. Dexamethasone 4mg once a day for 3 days oral starting the day after chemotherapy 13. Metoclopramide 10mg three times a day when required for nausea oral 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of treatment 15. Growth factors according to local formulary Administration Instructions - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 3 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 3 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous Version 1.1 (May 2015) Page 6 of 7 Bladder-Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC) DOCUMENT CONTROL Version Date Amendment Written By Header changed Metoclopramide dose changed to 10mg Bolus removed from intravenous bolus throughout text Tables reformatted. Vinblastine added to renal table. Vinblastine dose modifications in Donna Kimber 1.1 May 2015 hepatic impairment updated. Pharmacy Mucositis recommendation Technician changed Growth factors updated with new units OPCS code updated Dexamethasone TTO clarified Ondansetron TTO clarified Disclaimer added 1 Dec 2012 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Approved By Rebecca Wills Pharmacist Dr J Gale Consultant Medical Oncologist Dr M Wheater Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.1 (May 2015) Page 7 of 7 Bladder-Cisplatin-Doxorubicin-Methotrexate-Vinblastine (AccMVAC)
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InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) Ver1.2

Description: Chemotherapy Protocol GERM CELL CISPLATIN-IFOSFAMIDE-PACLITAXEL (TIP) Inpatient Regimen Regimen Germ Cell – InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) Indication Relapsed Metastatic Germ Cell Tumours after failure of first line therapy Toxicity Drug Cisplatin Ifosfamide Paclitaxel Adverse Effect Neuropathy, nephrotoxicity, ototoxicity Haemorrhagic cystitis, encephalopathy, nephrotoxicity Hypersensitivity, hypotension, bradycardia, peripheral neuropathy, myalgia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBC, LFTs and U&Es (magnesium, phosphate and calcium) prior to each cycle Serum albumin prior to each cycle EDTA or calculated creatinine clearance Urine dip test for blood every four hours the day of and the day after ifosfamide administration Fluid balance monitoring every four hours the day of and the day after ifosfamide administration. Urine output should be maintained above 100ml/hour AFP, HCG on day 1 of the cycle Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. Version 1.2 (July 2015) Page 1 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Prior to each cycle the following criteria should be met; Criteria Neutrophil Platelets Eligible Level equal to or more than 1x109/L equal to or more than 100x109/L After each cycle the following table applies to both ifosfamide and paclitaxel. Neutrophils (x109/L) 1 or above and 1 or above and 0.5 - 1 and 0.5 - 1 and Platelets (x109/L) 100 or above 75 - 100 75 - 100 50 - 75 Dose (% of original) (ifosfamide and paclitaxel) 100% 100% 75% 50% This is a potentially curative regimen. All dose reductions and delays should be discussed with the relevant consultant. In general if these levels are not met then treatment should be delayed for three days at a time. Treatment should re-start as soon as these haematological parameters are met. Dose delays rather than dose reductions are recommended. Cisplatin does not require a dose reduction based on haematological parameters. Hepatic Impairment Drug Cisplatin Bilirubin μmol/L N/A AST/ALT units/L N/A Dose No dose modification necessary Ifosfamide greater than ULN or greater than 2.5xULN or ALP greater than 2.5xULN Not recommended less than 25* and less than 10xULN 26-30* Paclitaxel 31-51* 52-85 more than 85 or greater than 10xULN *limits reflect local practice and may vary from published sources 175mg/m2 135mg/m2 75mg/m2 50mg/m2 omit Version 1.2 (July 2015) Page 2 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) Renal Impairment Drug Cisplatin* Ifosfamide Creatinine Clearance (ml/min) Dose (% of original dose) more than 60 100% If the creatinine clearance is 59ml/min or below please discuss with the relevant consultant* more than 60 40-59 less than 40 100% 70% clinical decision Paclitaxel no dose modification necessary *In the original trial(2) cisplatin was given at full dose unless the creatinine clearance fell below 40 ml/min, in which case it was discontinued. If the creatinine clearance subsequently recovered to above this level, the cisplatin was initially recommenced at 75% of the original dose. Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose of the causative agent(s) may then be reduced or discontinued at the discretion of the consultant. Ifosfamide In the case of a NCI-CTC grade 1 neurological toxicity, the dose of ifosfamide may be reduced for the next cycle. If a NCI-CTC grade 2 neurological toxicity appears or neurological toxicity worsens despite dose reduction, the ifosfamide should be stopped. Risk factors for CNS toxicity include a low albumin, renal impairment, prior administration of cisplatin, poor performance status, CNS tumour, bulky pelvic disease, concomitant psychotropic drugs and younger age. Methylene blue 50mg four times a day intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes can be used to prevent or treat ifosfamide induced encephalopathy. Version 1.2 (July 2015) Page 3 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) Regimen 21 day cycle for 4 cycles Drug Paclitaxel Cisplatin Ifosfamide Mesna Mesna* Dose 175mg/m2 20mg/m2 1000mg/m2 500mg/m2 500mg/m2 Days 1 1,2,3,4,5 1,2,3,4,5 1,2,3,4,5 Administration Intravenous infusion in 500ml sodium chloride 0.9% over 180 minutes Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride over 120 minutes Intravenous infusion in 500ml sodium chloride 0.9% over 60 minutes Intravenous infusion in 1000ml sodium chloride 0.9% over 8 hours *The last bag of mesna on day 5 of the cycle may be replaced with oral administration at a dose of 400mg/m2 (rounded upwards to the nearest 400mg capsule) at 0, 2 and 6 hours after the end of the ifosfamide infusion. Dose Information Aria is set to dose cap all regimens at 2.4m2. This regimen must NOT be capped. Please override any doses that are capped. Cisplatin will be dose banded according to the CSCCN agreed bands Ifosfamide will be dose banded according to the CSCCN agreed bands Mesna will be dose banded according to the CSCCN agreed bands Paclitaxel will be dose banded according to the CSCCN agreed bands Administration Information Extravasation Cisplatin - exfoliant Ifosfamide - neutral Mesna - neutral Paclitaxel - vesicant Other Paclitaxel should be administered using a PVC free administration set with a 0.22 micron in-line filter Hypersensitivity reactions tend to occur with the first or second infusion of paclitaxel. Paclitaxel infusions should be interrupted for minor symptoms such as flushing or Version 1.2 (July 2015) Page 4 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) localised rashes. If these resolve promptly (within 5 minutes) the infusion may be restarted at a lower rate with intensive monitoring. Immediately discontinue the infusion for severe reactions which include profound hypotension, bronchospasm and generalised erythema. In the event of a severe reaction the patient should not be rechallenged with the drug. Additional Therapy This is an inpatient regimen please ensure all supportive and take home medication not on Aria are prescribed on the inpatient chart or general electronic prescribing system. Paclitaxel premedication (this will be on Aria) 30 minutes prior to paclitaxel - chlorphenamine 10mg intravenous - dexamethasone 20mg intravenous - ranitidine 50mg intravenous Antiemetics Starting prior to chemotherapy - aprepitant 125mg once a day on day 1 and 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day on days 1, 2 ,3 ,4, 5 then 10mg three times a day when required for nausea oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral Cisplatin pre hydration with 500ml sodium chloride 0.9% with 8mmol magnesium sulphate over 30 minutes. The post hydration is incorporated as part of the ifosfamide and mesna administration. Consider furosemide 40mg oral or intravenous for the treatment of fluid overload. Growth factor support according to local policy, for example; - filgrastim or bioequivalent 30 million units once a day for seven days starting on day seven of the cycle subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for seven days starting on day seven of the cycle subcutaneous - pegfilgrastim or bioequivalent 6mg once a day for one day on day seven of the cycle Ciprofloxacin 500mg twice a day for 7 days starting on day 8 of the cycle oral Mouthwashes according to local or national policy on the treatment of mucositis Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Version 1.2 (July 2015) Page 5 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) Coding (OPCS) Procurement – X71.2 Delivery – Not Required (X72.1 for out-patients) References 1.Motzer RJ, Sheinfeld J, Mazumdar M. Paclitaxel, ifosfamide and cisplatin second line therapy for patients with relapsed testicular germ cell cancer. J Clin Oncol 2000; 18: 2413-2418. 2.Mead GM, Cullen MH, Huddart R et al. A phase II trial of TIP (paclitaxel, ifosfamide, cisplatin) given as second line (post BEP) chemotherapy for patients with metastatic germ cell cancer. Br J Cancer 2005; 93: 178-184. Version 1.2 (July 2015) Page 6 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) REGIMEN SUMMARY InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system Day 1 1. Warning – Check supportive medication prescribed Administration Instructions 1. aprepitant 125mg once a day on day 1 and 80mg once a day on days 2, 3 oral 2. dexamethasone 4mg once a day on days 2,3,4,5,6,7 oral 3. metoclopramide 10mg three times a day on days 1,2,3,4,5 then 10mg three times a day when required for the relief of nausea oral 4. ondansetron 8mg twice a day on days 1,2,3,4,5,6,7 oral 5. furosemide 40mg oral or intravenous when required for fluid overload 6. growth factor support according to local policy, for example; - filgrastim or bioequivalent 30 million units once a day for seven days starting on day seven of the cycle subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for seven days starting on day seven of the cycle subcutaneous - pegfilgrastim or bioequivalent 6mg once a day for one day on day seven of the cycle 7. ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 2. Chlorphenamine 10mg intravenous 3. Dexamethasone 20mg intravenous 4. Ranitidine 50mg in 20ml water for injection intravenous over 2 minutes 5. Paclitaxel 175mg/m2 in 500ml sodium chloride 0.9% intravenous infusion over 180 minutes 6. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 7. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 120 minutes 8. Ifosfamide 1000mg/m2 with mesna 500mg/m2 in 500ml sodium chloride 0.9% over 60 minutes 9. Mesna 500mg/m2 in 1000ml sodium chloride 0.9% over 8 hours Day 2, 3, 4, 5 10. Warning – Check supportive medication prescribed Administration Instructions 1. aprepitant 125mg once a day on day 1 and 80mg once a day on days 2, 3 oral 2. dexamethasone 4mg once a day on days 2,3,4,5,6,7 oral 3. metoclopramide 10mg three times a day on days 1,2,3,4,5 then 10mg three times a day when required for the relief of nausea oral 4. ondansetron 8mg twice a day on days 1,2,3,4,5,6,7 oral 5. furosemide 40mg oral or intravenous when required for fluid overload 6. growth factor support according to local policy, for example; - filgrastim or bioequivalent 30 million units once a day for seven days starting on day seven of the cycle subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for seven days starting on day seven of the cycle subcutaneous - pegfilgrastim or bioequivalent 6mg once a day for one day on day seven of the cycle Version 1.2 (July 2015) Page 7 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) 7. ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 11. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 12. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 120 minutes 13. Ifosfamide 1000mg/m2 with mesna 500mg/m2 in 500ml sodium chloride 0.9% over 60 minutes 14. Mesna 500mg/m2 in 1000ml sodium chloride 0.9% over 8 hours Version 1.2 (July 2015) Page 8 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP) DOCUMENT CONTROL Version Date Amendment Written By Header changed Metoclopramide dose changed to 10mg Bolus removed from intravenous bolus throughout text Donna Kimber 1.2 July 2015 Mucositis recommendation Pharmacy changed Technician Hepatic impairment table updated, statement added Growth factor units updated Disclaimer added Mesna dose altered to reflect 1.1 June 2013 that used in clinical trial (reference two) Dr Deborah Wright Pharmacist 1 Jan 2013 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Approved By Rebecca Wills Pharmacist Dr Mathew Wheater Consultant Medical Oncologist Dr Joanna Gale Consultant Medical Oncologist Dr Mathew Wheater Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (July 2015) Page 9 of 9 Germ Cell–InP-Cisplatin-Ifosfamide-Paclitaxel (TIP)
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InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) Ver1.2

Description: Chemotherapy Protocol GERM CELL BLEOMYCIN-CISPLATIN-ETOPOSIDE (BEP 5 Day Modified) In-Patient Regimen Regimen Germ Cell – InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) Indication In patients 41 years and above with; - metastatic non-seminomatous germ cell tumours - metastatic seminoma where radiotherapy is not appropriate - renal impairment or a poor performance status Toxicity Drug Bleomycin Cisplatin Etoposide Adverse Effect Pulmonary toxicity, rigors, skin pigmentation, nail changes Neuropathy, nephrotoxicity, ototoxicity Hypotension on rapid infusion, alopecia, hyperbilirubineamia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBC, LFTs and U&Es on day one of the cycle AFP, HCG prior to day one of the cycle Chest x-ray Consider pulmonary function tests before starting therapy. These should be repeated if respiratory symptoms develop during treatment, particularly a drop in oxygen saturation on exercise. Bleomycin should be stopped until the results of such investigations are known. Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. Version 1.2 (July 2015) Page 1 of 8 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Patients are being treated with curative intent therefore dose modifications and delays should be kept to a minimum. Please discuss all dose reductions / delays with the relevant consultant before prescribing. The approach may be different depending on the clinical circumstances. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Prior to each cycle the following criteria must be met Criteria Neutrophil Platelets Eligible Level equal to or more than 0.5x109/L equal to or more than 100x109/L This is a curative regimen. All dose reductions and delays should be discussed with the relevant consultant. In general if these levels are not met then treatment should be delayed for three days at a time. Treatment should re-start as soon as these haematological parameters are met. Dose delays rather than dose reductions are recommended. Hepatic Impairment Drug Bleomycin Bilirubin μmol/L AST/ALT units/L Dose (% of original dose) Clinical decision Cisplatin N/A N/A No dose modification necessary Etoposide 26-51 greater than 51 or 60-180 Consider dose reducing to 50% or greater than 180 Clinical decision Version 1.2 (July 2015) Page 2 of 8 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) Renal Impairment Drug Bleomycin Creatinine Clearance (ml/min) 50 or more less than 50 Dose (% of original dose) 100% discuss with consultant and omit Cisplatin 60 or greater 100% If the creatinine clearance is 59ml/min or below please refer to the responsible consultant for advice Etoposide greater than 50 15-50 less than 15 100% 75% 50% Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose of the causative agent(s) may then be reduced or discontinued at the discretion of the consultant. Bleomycin The risk of bleomycin induced pneumonitis is greater in those individuals who are older than forty years of age, have a history of smoking, those with underlying lung disease, previous mediastinal radiotherapy or poor renal function. If pulmonary symptoms develop stop the bleomycin until they can be investigated fully and a diagnosis made. Regimen 21 day cycle for 4 cycles Drug Bleomycin Cisplatin Etoposide Dose 30,000 IU 20mg/m2 100mg/m2 Days 2 1,2,3,4,5 1,2,3,4,5 Administration Intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride over 60 minutes Intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Version 1.2 (July 2015) Page 3 of 8 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) Dose Information Aria is set to dose cap all regimens at 2.4m2. This regimen must NOT be capped. Please override any doses that are capped. Patients over the age of 40 are at increased risk of pulmonary toxicity and therefore the maximum cumulative dose of bleomycin is limited to 120 000IU in this protocol. Cisplatin will be dose banded according to the CSCCN agreed bands Etoposide will be dose banded according to the CSCCN agreed bands Administration Information Extravasation Bleomycin – neutral Cisplatin – exfoliant Etoposide – irritant Additional Therapy This is an inpatient regimen please ensure all supportive and take home medication not on Aria are prescribed on the inpatient chart or general electronic prescribing system. Antiemetics 15 – 30 minutes prior to chemotherapy - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral On days of bleomycin administration - hydrocortisone 100mg intravenous when required - chlorphenamine 10mg intravenous when required Cisplatin pre-hydration as follows - furosemide 40mg oral or intravenous as required - sodium chloride 0.9% 500ml with 8mmol magnesium sulphate over 30 minutes Cisplatin post hydration - sodium chloride 0.9% 500ml over 30 minutes Version 1.2 (July 2015) Page 4 of 8 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) Ciprofloxacin 500mg twice a day for 7 days starting on day 8 of the cycle Mouthwashes according to local or national policy on the treatment of mucositis Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Coding (OPCS) Procurement – X70.3 Delivery – N/A References 1.de Wit R, Roberts JT, Wilkinson PM et al. Equivalence of 3 cycle BEP versus 4 cycles and of the 5 day schedule versus 3 days per cycle in good-prognosis germ cell cancer: a randomised study of the European Organisation for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group and the Medical Research Council. J Clin Oncol 2001; 19: 1629-1640. 2.de Wit R, Stoter G, et al. Four cycles of BEP versus four cycles of VIP in patients with intermediate-prognosis metastatic testicular non seminoma: A randomised study of the EORTC Genitourinary Tract Cancer Cooperative Group. Br J Cancer 1998; 78(6): 828-832. 3.Nichols C, Catalano P, Crawford E et al. Randomised comparison of cisplatin and etoposide and either bleomycin or ifosfamide in the treatment of advanced disseminated germ cell tumours: An Eastern Cooperative Oncology Group, Southwest Oncology Group and Cancer and Leukemia Group B study. J Clin Oncol 1998; 16: 1287-1293. 5.Fossa SD, Kaye SB, Mead GM, Cullen MH, De Wit R, Borogi J, Van Groeningen C, De Mulder P, Stenning S and De Prijck L. Filgrastim (G-CSF) during combination chemotherapy of patients with poor prognosis metastatic germ cell malignancy (A phase III trial of the EORTC GU group/MRC testicular tumour working party) J Clin Oncol 1998: 16: 716-724 Version 1.2 (July 2015) Page 5 of 8 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) REGIMEN SUMMARY InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system Cycle 1, 2, 3, 4 Day 1 1. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 2. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 3. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 4. Sodium chloride 0.9% 500ml over 30 minutes 5. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Day 2 6. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 7. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 8. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 9. Sodium chloride 0.9% 500ml over 30 minutes 10. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Version 1.2 (July 2015) Page 6 of 8 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) 11. Bleomycin 30,000 IU in 100ml sodium chloride 0.9% intravenous infusion over 30 minutes Days 3, 4, 5 12. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 13. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 14. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 15. Sodium chloride 0.9% 500ml over 30 minutes 16. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Version 1.2 (July 2015) Page 7 of 8 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP) DOCUMENT CONTROL Version Date Amendment Written By Header changed Renal and hepatic dose mods updated for etoposide Metoclopramide dose changed to 10mg Donna Kimber 1.2 July 2015 Bolus removed from intravenous Pharmacy bolus throughout text Technician Mucositis recommendation changed OPCS code updated Disclaimer added Name changed throughout. 1.1 June 2013 Bleomycin dose reductions in renal impairment changed Dr Deborah Wright Pharmacist 1 Jan 2013 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Approved By Rebecca Wills Pharmacist Dr Mathew Wheater Consultant Medical Oncologist Dr Joanna Gale Consultant Medical Oncologist Dr Mathew Wheater Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (July 2015) Page 8 of 8 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day-Mod-BEP)
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InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) Ver1.2

Description: Chemotherapy Protocol GERM CELL BLEOMYCIN-CISPLATIN-ETOPOSIDE (BEP 5 Day) In-Patient Regimen Regimen Germ Cell – InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) Indication In patients 40 years and below with; - metastatic non-seminomatous germ cell tumours - metastatic seminoma - renal impairment or a poor performance status Toxicity Drug Bleomycin Cisplatin Etoposide Adverse Effect Pulmonary toxicity, rigors, skin pigmentation, nail changes Neuropathy, nephrotoxicity, ototoxicity Hypotension on rapid infusion, alopecia, hyperbilirubineamia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs FBC, and U&Es on day 1, 8, 15 of the cycle and LFTs day 1 AFP, HCG on day 1 of the cycle Chest x-ray Consider pulmonary function tests before starting therapy. These should be repeated if respiratory symptoms develop during treatment, particularly a drop in oxygen saturation on exercise. Bleomycin should be stopped until the results of such investigations are known. Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. Version 1.2 (July 2015) Page 1 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Patients are being treated with curative intent therefore dose modifications and delays should be kept to a minimum. Please discuss all dose reductions / delays with the relevant consultant before prescribing. The approach may be different depending on the clinical circumstances. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Prior to each cycle the following criteria should be met Criteria Neutrophil Platelets Eligible Level equal to or more than 0.5x109/L equal to or more than 100x109/L This is a curative regimen. All dose reductions and delays should be discussed with the relevant consultant. In general if these levels are not met then treatment should be delayed for three days at a time. Treatment should re-start as soon as these haematological parameters are met. Dose delays rather than dose reductions are recommended. Bleomycin should be administered on days 8 and 15 irrespective of the neutrophil and platelet count. Hepatic Impairment Drug Bleomycin Bilirubin μmol/L AST/ALT units/L Dose (% of original dose) Clinical decision Cisplatin N/A N/A No dose modification necessary Etoposide 26-51 greater than 51 or 60-180 Consider dose reducing to 50% or greater than 180 Clinical decision Version 1.2 (July 2015) Page 2 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) Renal Impairment Drug Bleomycin Creatinine Clearance (ml/min) 50 or more less than 50 Dose (% of original dose) 100% discuss and omit Cisplatin 60 or greater 100% If the creatinine clearance is 59ml/min or below please refer to the responsible consultant for advice Etoposide greater than 50 15-50 less than 15 100% 75% 50% Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose of the causative agent(s) may then be reduced or discontinued at the discretion of the consultant. Bleomycin The risk of bleomycin induced pneumonitis is greater in those individuals who are older than forty years of age, have a history of smoking, those with underlying lung disease, previous mediastinal radiotherapy or poor renal function. If pulmonary symptoms develop stop the bleomycin until they can be investigated fully and a diagnosis made. Regimen 21 day cycle Good prognosis – 3 cycles Intermediate / Poor prognosis – 4 cycles (if 4 cycles are required omit the day 8, 15 bleomycin on cycle 4 only) 3 cycles will be set in Aria Drug Bleomycin Cisplatin Etoposide Dose 30,000 IU 20mg/m2 100mg/m2 Days 2, 8, 15 1,2,3,4,5 1,2,3,4,5 Administration Intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride over 60 minutes Intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Version 1.2 (July 2015) Page 3 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) Dose Information Aria is set to dose cap all regimens at 2.4m2. This regimen must NOT be capped. Please override any doses that are capped. The maximum cumulative dose of bleomycin is 300 000 IU in people less than 40 years of age. Refer to SPC for further information in older patients. Cisplatin will be dose banded according to the CSCCN agreed bands Etoposide will be dose banded according to the CSCCN agreed bands Administration Information Extravasation Bleomycin – neutral Cisplatin – exfoliant Etoposide - irritant Additional Therapy This is an inpatient regimen please ensure all supportive and take home medication not on Aria are prescribed on the inpatient chart or general electronic prescribing system. Antiemetics 15 - 30 minutes prior to chemotherapy - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral 15-30 minutes prior to bleomycin on days 8 and 15 - dexamethasone 8mg oral or intravenous On days of bleomycin administration - hydrocortisone 100mg intravenous when required - chlorphenamine 10mg intravenous when required Cisplatin pre-hydration as follows - furosemide 40mg oral or intravenous as required - sodium chloride 0.9% 500ml with 8mmol magnesium sulphate over 30 minutes Version 1.2 (July 2015) Page 4 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) Cisplatin post hydration - sodium chloride 0.9% 500ml over 30 minutes Ciprofloxacin 500mg twice a day for seven days starting on day 8 of the cycle oral Mouthwashes according to local or national policy on the treatment of mucositis Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Other Information Day 8 and 15 of each cycle is normally administered in an out-patient setting Coding (OPCS 4.6) Procurement – X70.3 Delivery – N/A References 1.de Wit R, Roberts JT, Wilkinson PM et al. Equivalence of 3 cycle BEP versus 4 cycles and of the 5 day schedule versus 3 days per cycle in good-prognosis germ cell cancer: a randomised study of the European Organisation for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group and the Medical Research Council. J Clin Oncol 2001; 19: 1629-1640. 2.de Wit R, Stoter G, et al. Four cycles of BEP versus four cycles of VIP in patients with intermediate-prognosis metastatic testicular non seminoma: A randomised study of the EORTC Genitourinary Tract Cancer Cooperative Group. Br J Cancer 1998; 78(6): 828-832. 3.Nichols C, Catalano P, Crawford E et al. Randomised comparison of cisplatin and etoposide and either bleomycin or ifosfamide in the treatment of advanced disseminated germ cell tumours: An Eastern Cooperative Oncology Group, Southwest Oncology Group and Cancer and Leukemia Group B study. J Clin Oncol 1998; 16: 1287-1293. 5.Fossa SD, Kaye SB, Mead GM, Cullen MH, De Wit R, Borogi J, Van Groeningen C, De Mulder P, Stenning S and De Prijck L. Filgrastim (G-CSF) during combination chemotherapy of patients with poor prognosis metastatic germ cell malignancy (A phase III trial of the EORTC GU group/MRC testicular tumour working party) J Clin Oncol 1998: 16: 716-724 Version 1.2 (July 2015) Page 5 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) REGIMEN SUMMARY InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) Other than those listed below, supportive medication for this regimen will not appear in Aria as prescribed agents. The administration instructions for each warning describes the agents which must be prescribed on the in-patient chart or general electronic prescribing system Day 8 and 15 are administered on an outpatient basis Cycle 1, 2 Day 1 1. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 2. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 3. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 4. Sodium chloride 0.9% 500ml over 30 minutes 5. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Day 2 6. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 7. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 8. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 9. Sodium chloride 0.9% 500ml over 30 minutes Version 1.2 (July 2015) Page 6 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) 10. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes 11. Bleomycin 30,000 IU in 100ml sodium chloride 0.9% intravenous infusion over 30 minutes Days 3, 4, 5 12. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 13. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 14. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 15. Sodium chloride 0.9% 500ml over 30 minutes 16. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Day 8, 15 17. Dexamethasone 8mg oral or intravenous 18. Bleomycin 30,000 IU in 100ml sodium chloride 0.9% intravenous infusion over 30 minutes 19. Chlorphenamine 10mg intravenous when required 20. Hydrocortisone 100mg intravenous when required Cycle 3 Day 1 21. Warning – Check the number of cycles required Administration Instructions If 4 cycles are required omit the day 8 and 15 bleomycin from cycle 4 when adding this cycle 22. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions Version 1.2 (July 2015) Page 7 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 23. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 24. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 25. Sodium chloride 0.9% 500ml over 30 minutes 26. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Day 2 27. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 28. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes 29. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 30. Sodium chloride 0.9% 500ml over 30 minutes 31. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes 32. Bleomycin 30,000 IU in 100ml sodium chloride 0.9% intravenous infusion over 30 minutes Days 3, 4, 5 33. Warning – Check supportive medicines prescribed Administration Instructions - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral - furosemide 40mg when required oral - chlorphenamine 10mg intravenous for bleomycin reactions - hydrocortisone 100mg intravenous for bleomycin reactions - ciprofloxacin 500mg twice a day for 7 days starting on day 8 oral 34. Sodium chloride 0.9% 500ml with magnesium sulphate 8mmol intravenous infusion over 30 minutes Version 1.2 (July 2015) Page 8 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) 35. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 36. Sodium chloride 0.9% 500ml over 30 minutes 37. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Day 8, 15 38. Dexamethasone 8mg oral or intravenous 39. Bleomycin 30,000 IU in 100ml sodium chloride 0.9% intravenous infusion over 30 minutes 40. Chlorphenamine 10mg intravenous when required 41. Hydrocortisone 100mg intravenous when required Version 1.2 (July 2015) Page 9 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP) DOCUMENT CONTROL Version Date Amendment Written By Header changed Renal and hepatic dose mods for etposide updated Metoclopramide dose changed to 10mg Donna Kimber 1.2 July 2015 Bolus removed from intravenous Pharmacy bolus throughout text Technician Mucositis recommendation changed OPCS code updated Disclaimer added Name changed throughout. 1.1 June 2013 Bleomycin dose reductions in renal impairment changed Dr Deborah Wright Pharmacist 1 Jan 2013 None Rebecca Wills Pharmacist Dr Deborah Wright Pharmacist Approved By Rebecca Wills Pharmacist Dr Mathew Wheater Consultant Medical Oncologist Dr Joanna Gale Consultant Medical Oncologist Dr Mathew Wheater Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospitals NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (July 2015) Page 10 of 10 Germ Cell–InP-Bleomycin-Cisplatin-Etoposide (5 day BEP)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Germcell/InP-Bleomycin-Cisplatin-Etoposide-5-day-BEP-Ver1.2.pdf

BEP5day

Description: Chemotherapy Protocol GERM CELL BLEOMYCIN-CISPLATIN-ETOPOSIDE (BEP 5 Day) Regimen • Germ Cell – Bleomycin-Cisplatin-Etoposide (5 day BEP) Indication • In patients 40 years and below with; - metastatic non-seminomatous germ cell tumours - metastatic seminoma where radiotherapy is not appropriate - renal impairment or a poor performance status Toxicity Drug Bleomycin Cisplatin Etoposide Adverse Effect Pulmonary toxicity, rigors, skin pigmentation, nail changes Neuropathy, nephrotoxicity, ototoxicity Hypotension on rapid infusion, alopecia, hyperbilirubineamia The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring Drugs • FBC, LFTs and U&Es on day one of the cycle • AFP, HCG prior to day one of the cycle • Chest x-ray • Consider pulmonary function tests before starting therapy. These should be repeated if respiratory symptoms develop during treatment, particularly a drop in oxygen saturation on exercise. Bleomycin should be stopped until the results of such investigations are known. Dose Modifications The dose modifications listed are for haematological, liver and renal function and drug specific toxicities only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be re-escalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Version 1 (July 2017) Page 1 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP) Patients are being treated with curative intent therefore dose modifications and delays should be kept to a minimum. Please discuss all dose reductions / delays with the relevant consultant before prescribing. The approach may be different depending on the clinical circumstances. Haematological Consider a blood transfusion if the patient is symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Prior to each cycle the following criteria must be met Criteria Neutrophil Platelets Eligible Level equal to or more than 0.5x109/L equal to or more than 100x109/L This is a curative regimen. All dose reductions and delays should be discussed with the relevant consultant. In general if these levels are not met then treatment should be delayed for three days at a time. Treatment should re-start as soon as these haematological parameters are met. Dose delays rather than dose reductions are recommended. Hepatic Impairment Drug Bleomycin Bilirubin µmol/L AST/ALT units/L Dose (% of original dose) Clinical decision Cisplatin N/A N/A No dose modification necessary Etoposide 26-51 greater than 51 or 60-180 Consider dose reducing to 50% or greater than 180 Clinical decision Version 1 (July 2017) Page 2 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP) Renal Impairment Drug Bleomycin Creatinine Clearance (ml/min) 50 or more less than 50 Dose (% of original dose) 100% discuss with consultant and omit Cisplatin 60 or greater 100% If the creatinine clearance is 59ml/min or below please refer to the responsible consultant for advice Etoposide greater than 50 15-50 less than 15 100% 75% 50% Other Dose reductions or interruptions in therapy are not necessary for those toxicities that are considered unlikely to be serious or life threatening. For example, alopecia, altered taste or nail changes. For all other non-haematological NCI-CTC grade 3 and above toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose of the causative agent(s) may then be reduced or discontinued at the discretion of the consultant. Bleomycin The risk of bleomycin induced pneumonitis is greater in those individuals who are older than forty years of age, have a history of smoking, those with underlying lung disease, previous mediastinal radiotherapy or poor renal function. If pulmonary symptoms develop stop the bleomycin until they can be investigated fully and a diagnosis made. Regimen Good prognosis – 3 cycles Intermediate / Poor prognosis – 4 cycles (if 4 cycles are required omit the day 8, 15 bleomycin on cycle 4 only) 3 cycles will be set in Aria Version 1 (July 2017) Page 3 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP) 21 day cycle for 3 cycles Drug Bleomycin Cisplatin Etoposide Dose 30,000 IU 20mg/m2 100mg/m2 Days 2, 8, 15 1,2,3,4,5 1,2,3,4,5 Administration Intravenous infusion in 100ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride over 60 minutes Intravenous infusion in 1000ml sodium chloride 0.9% over 60 minutes Dose Information • Aria is set to dose cap all regimens at 2.4m2. This regimen must NOT be capped. Please override any doses that are capped. • Cisplatin will be dose banded according to the agreed bands • Etoposide will be dose banded according to the agreed bands Administration Information Extravasation • Bleomycin – neutral • Cisplatin – exfoliant • Etoposide – irritant Additional Therapy • Antiemetics 15 – 30 minutes prior to chemotherapy - aprepitant 125mg once a day on day 1 - aprepitant 80mg once a day on days 2, 3 - dexamethasone 4mg once a day on days 1, 2, 3, 4, 5, 6, 7 oral - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day on days 1, 2, 3, 4, 5, 6, 7 oral • On days of bleomycin administration - hydrocortisone 100mg intravenous when required - chlorphenamine 10mg intravenous when required • Cisplatin pre-hydration as follows - furosemide 40mg oral or intravenous as required - sodium chloride 0.9% 1000ml with 8mmol magnesium sulphate over 60 minutes Version 1 (July 2017) Page 4 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP) • Cisplatin post hydration - sodium chloride 0.9% 1000ml over 240 minutes • Ciprofloxacin 500mg twice a day for 7 days starting on day 8 of the cycle • Consider growth factor support according to local policy, for example; - filgrastim or bioequivalent 30 million units once a day for seven days starting on day seven of the cycle subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for seven days starting on day seven of the cycle subcutaneous - pegfilgrastim or bioequivalent 6mg once a day for one day on day seven of the cycle • Mouthwashes according to local or national policy on the treatment of mucositis • Gastric protection with a proton pump inhibitor or a H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Coding (OPCS) • Procurement – X70.3 • Delivery – N/A References 1.de Wit R, Roberts JT, Wilkinson PM et al. Equivalence of 3 cycle BEP versus 4 cycles and of the 5 day schedule versus 3 days per cycle in good-prognosis germ cell cancer: a randomised study of the European Organisation for Research and Treatment of Cancer Genitourinary Tract Cancer Cooperative Group and the Medical Research Council. J Clin Oncol 2001; 19: 1629-1640. 2.de Wit R, Stoter G, et al. Four cycles of BEP versus four cycles of VIP in patients with intermediate-prognosis metastatic testicular non seminoma: A randomised study of the EORTC Genitourinary Tract Cancer Cooperative Group. Br J Cancer 1998; 78(6): 828-832. 3.Nichols C, Catalano P, Crawford E et al. Randomised comparison of cisplatin and etoposide and either bleomycin or ifosfamide in the treatment of advanced disseminated germ cell tumours: An Eastern Cooperative Oncology Group, Southwest Oncology Group and Cancer and Leukemia Group B study. J Clin Oncol 1998; 16: 1287-1293. 5.Fossa SD, Kaye SB, Mead GM, Cullen MH, De Wit R, Borogi J, Van Groeningen C, De Mulder P, Stenning S and De Prijck L. Filgrastim (G-CSF) during combination chemotherapy of patients with poor prognosis metastatic germ cell malignancy (A phase III trial of the EORTC GU group/MRC testicular tumour working party) J Clin Oncol 1998: 16: 716-724 Version 1 (July 2017) Page 5 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP) REGIMEN SUMMARY Bleomycin-Cisplatin-Etoposide (5 day BEP) Cycle 1, 2, 3, 4 Day 1 1. Aprepitant 125mg oral 2. Dexamethasone 4mg oral or intravenous 3. Metoclopramide 10mg oral or intravenous 4. Ondansetron 8mg oral or intravenous bolus 5. Furosemide 40mg oral or intravenous when required for the maintenance of diuresis 6. Sodium chloride 0.9% 1000ml with magnesium sulphate 8mmol intravenous infusion over 60 minutes 7. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 8. Sodium chloride 0.9% 1000ml over 240 minutes 9. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Take Home Medicines 10. Dexamethasone 4mg once a day in the morning for 2 days starting on day 6 of the cycle oral 11. Metoclopramide 10mg up to three times a day when required for the relief of nausea oral 12. Ondansetron 8mg to be taken on the evening of days 1, 2, 3, 4 and 5 of chemotherapy and 8mg twice a day for 2 days starting on day 6 of the cycle oral 13. Ciprofloxacin 500mg twice a day for 7 days starting on day 8 of the cycle oral Day 2 14. Aprepitant 80mg oral 15. Dexamethasone 4mg oral or intravenous 16. Metoclopramide 10mg oral or intravenous 17. Ondansetron 8mg oral or intravenous bolus 18. Furosemide 40mg oral or intravenous when required for the maintenance of diuresis Version 1 (July 2017) Page 6 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP) 19. Sodium chloride 0.9% 1000ml with magnesium sulphate 8mmol intravenous infusion over 60 minutes 20. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 21. Sodium chloride 0.9% 1000ml over 30 minutes 22. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes 23. Bleomycin 30,000 IU in 100ml sodium chloride 0.9% intravenous infusion over 30 minutes 24. Chlorphenamine 10mg intravenous when required for bleomycin reactions 25. Hydrocortisone 100mg intravenous when required for bleomycin reactions Days 3 26. Aprepitant 80mg oral 27. Dexamethasone 4mg oral or intravenous 28. Metoclopramide 10mg oral or intravenous 29. Ondansetron 8mg oral or intravenous bolus 30. Furosemide 40mg oral or intravenous when required for the maintenance of diuresis 31. Sodium chloride 0.9% 1000ml with magnesium sulphate 8mmol intravenous infusion over 60 minutes 32. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 33. Sodium chloride 0.9% 1000ml over 240 minutes 34. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Days 4, 5 35. Dexamethasone 4mg oral or intravenous 36. Metoclopramide 10mg oral or intravenous 37. Ondansetron 8mg oral or intravenous bolus 38. Furosemide 40mg oral or intravenous when required for the maintenance of diuresis 39. Sodium chloride 0.9% 1000ml with magnesium sulphate 8mmol intravenous infusion over 60 minutes Version 1 (July 2017) Page 7 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP) 40. Cisplatin 20mg/m2 in 1000ml sodium chloride 0.9% with 20mmol potassium chloride intravenous infusion over 60 minutes 41. Sodium chloride 0.9% 1000ml over 240 minutes 42. Etoposide 100mg/m2 in 1000ml sodium chloride 0.9% intravenous infusion over 60 minutes Day 8, 15 43. Dexamethasone 8mg oral or intravenous 44. Bleomycin 30,000 IU in 100ml sodium chloride 0.9% intravenous infusion over 30 minutes 45. Chlorphenamine 10mg intravenous when required 46. Hydrocortisone 100mg intravenous when required Version 1 (July 2017) Page 8 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP) Version Date 1 July 2017 DOCUMENT CONTROL Amendment None Written By Dr Deborah Wright Pharmacist Approved By Dr Emma Killick Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1 (July 2017) Page 9 of 9 Germ Cell–Bleomycin-Cisplatin-Etoposide (5 day BEP)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Germcell/BEP5day.pdf

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