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Cyclophosphamide Docetaxel Epirubicin (100) Fluorouracil Pertuzumab Trastuzumab FE100CT-HP

Description: Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE-DOCETAXEL-EPIRUBICIN (100)- FLUOROURACILPERTUZUMAB-TRASTUZUMAB (FE100CT-HP) Regimen • Breast Cancer – Cyclophosphamide-Docetaxel-Epirubicin (100)-FluorouracilPertuzumab-Trastuzumab
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Cyclophosphamide-Docetaxel-Epirubicin-100-Fluorouracil-Pertuzumab-Trastuzumab-FE100CT-HP.pdf

Carboplatin-Docetaxel-Pertuzumab-Trastuzumab_IV-SC

Description: Chemotherapy Protocol BREAST CANCER CARBOPLATIN (AUC6)-DOCETAXEL- PERTUZUMABTRASTUZUMAB (IV/SC) Regimen • Breast Cancer – Carboplatin (AUC6)-Docetaxel-Pertuzumab-Trastuzumab (IV/SC) Indication
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Carboplatin-Docetaxel-Pertuzumab-Trastuzumab-IV-SC.pdf

Carboplatin-Docetaxel-Pertuzumab-Trastuzumab_IV

Description: Chemotherapy Protocol BREAST CANCER CARBOPLATIN (AUC 6)-DOCETAXEL-PERTUZUMABTRASTUZUMAB (IV) Regimen • Breast Cancer – Carboplatin (AUC6)-Docetaxel-Pertuzumab-Trastuzumab (IV) Indication • Neo
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Carboplatin-Docetaxel-Pertuzumab-Trastuzumab-IV.pdf

mini-RCHOP 21

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-DOXORUBICIN-PREDNISOLONE-RITUXIMAB-VINCRISTINE (mini-RCHOP 21) Regimen   Lymphoma – mini-RCHOP (21)-Cyclophosphamide-Doxorubicin-PrednisoloneRituximab-Vincristine Indication   CD20 positive Non-Hodgkin’s Lymphoma  Patients over 80 years old or with significant other co-morbidities and unlikely to tolerate full dose RCHOP. Toxicity  Drug Cyclophosphamide Doxorubicin Prednisolone Rituxumab Vincristine Adverse Effect Dysuria, haemorrhagic cystitis (rare), taste disturbances, myelosuppression, neutropenia, leukopenia, mucositis, alopecia, fever Cardiomyopathy, alopecia, urinary discolouration (red), infections, bone-marrow suppression, leucopenia, neutropenia, anorexia, nausea, vomiting, mucositis, stomatitis, diarrhoea, alopecia. Weight gain, gastro-intestinal disturbances, hyperglycaemia, infection, Cushing-like symptoms, hypokalaemia, sodium retention, osteoporosis, impaired wound healing, muscular atrophy, osteoporosis, Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy, neutropenia, infusion related reactions, angioedema, nausea, pruritus, rash, alopecia, fever, chills, asthenia, headache, decreased IgG levels. Peripheral neuropathy, constipation, jaw pain The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Version 1 (July 2022) Page 1 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine Monitoring Drugs  FBC, LFTs and U&Es prior to day one of treatment  Check hepatitis B status before starting rituximab  Ensure adequate cardiac function before starting therapy. Baseline LVEF should be measured in patients with a history of cardiac problems, cardiac risk factors or in the elderly. Discontinue doxorubicin if cardiac failure develops Dose Modifications The dose modifications listed are for haematological, liver and renal function and limited drug specific toxicities. 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. 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 Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Dose modifications based on haematological parameters apply to cyclophosphamide and doxorubicin only. Version 1 (July 2022) Page 2 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine Neutrophils (x109/L) Less than 1 on proposed day 1 of cycle Grade 4 neutropenia leading to infection despite G-CSF support Grade 4 neutropenia recurs despite 50% dose reduction in cyclophosphamide and doxorubicin Platelets (x109/L) Dose Modifications Delay therapy until neutrophils are greater than or equal to 1x109/L Consider G-CSF as secondary prophylaxis. Reconsider treatment options if not recovered after 14 days Reduce dose of cyclophosphamide and doxorubicin by 50% for all subsequent cycles Stop treatment Dose Modifications (cyclophosphamide and doxorubicin) Less than 100 on proposed day 1 of cycle Grade 4 thrombocytopenia following any cycle Grade 4 thrombocytopenia recurs despite 50% dose reduction in cyclophosphamide and doxorubicin Delay therapy until platelets are greater or equal to 100x109/L Reconsider treatment options if not recovered after 14 days Reduce dose of cyclophosphamide and doxorubicin by 50% for all subsequent cycles Stop treatment Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Bilirubin (μmol/L) AST/ALT Dose (units) (%of original dose) Cyclophosphamide more than 30 2-3xULN Clinical decision. Evidence that exposure to active metabolites may not be increased, suggesting dose reduction may not be necessary. There may be decreased efficacy in severe hepatic impairment. Doxorubicin Equal or less and 2-3xULN 75% than 20 Version 1 (July 2022) Page 3 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine Rituximab Vincristine 20-50 51-85 more than 85 N/A more than 51 more than 51 and/or More than 50% 3xULN N/A 25% N/A Omit N/A No dose adjustment needed and normal 50% and more than omit 180 Renal Impairment Drug Cyclophosphamide Creatinine Clearance (ml/min) more than 20 10-20 less than 10 Dose (% of original dose) 100% 75% 50% Doxorubicin less than 10 75% Rituximab N/A No dose adjustment needed Vincristine N/A No dose adjustment needed *Consider mesna in patients with pre-existing bladder disorders. Give an oral dose of 40% of the cyclophosphamide dose (rounded upwards to the nearest 400mg) at 0, 2 and 6 hours after the administration of the cyclophosphamide. 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. Doxorubicin Discontinue doxorubicin if cardiac failure develops Rituximab Infusion related adverse reactions have been observed in 12% of patients treated with rituximab. Version 1 (July 2022) Page 4 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine Rituximab administration is associated with the onset of cytokine release syndrome. This condition is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. It may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, acute renal failure, elevated lactate dehydrogenase (LDH) and can lead to acute respiratory failure and death. This effect on the lungs may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray. Cytokine release syndrome frequently occurs within one or two hours of initiating the first infusion. Hypersensitivity reactions, including anaphylaxis, have been reported following the intravenous administration of proteins. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes of starting the infusion. Medicinal products for the treatment of allergic reactions should be available for immediate use in the event of hypersensitivity developing during the administration of rituximab. Use of rituximab maybe associated with an increased risk of progressive multifocal leukoencephalopathy (PML). Patients must be monitored at regular intervals for any new or worsening neurological, cognitive or psychiatric symptoms that may be suggestive of PML. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed the rituximab must be permanently discontinued. The presence of a viral upper respiratory tract infection at the time of treatment may increase the risk of rituximab associated hepatotoxicity. Patients should be assessed for any cold or flu-like symptoms prior to treatment Vincristine Reduce the vincristine dose to if a NCI-CTC grade 2 motor or grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vincristine. Regimen 21 day cycle for 6 cycles Drug Cyclophosphamide Doxorubicin Rituximab Vincristine Prednisolone Dose 400mg/m2 25mg/m2 375mg/m2 1mg 40mg/m2 Days 1 1 1 1 1,2,3,4,5 Administration Intravenous bolus over 10 minutes Intravenous bolus over 10 minutes Intravenous infusion in 500ml sodium chloride 0.9% Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Oral Dose Information  Cyclophosphamide will be dose banded in accordance with the national dose bands (20mg/ml) Version 1 (July 2022) Page 5 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine  Doxorubicin will be dose banded in accordance with the national dose bands (2PM)  The maximum lifetime cumulative dose of doxorubicin is 450mg/m². However prior radiotherapy to mediastinal/pericardial area should receive a lifetime cumulative doxorubicin dose of no more than 400mg/m²  Prednisolone tablets will be rounded to the nearest 5mg (up if half way)  Rituximab will be dose rounded to the nearest 100mg (up if half way)  Vincristine dose will be dose banded in accordance with the national dose bands (1mg/ml). Administration Information Extravasation  Cyclophosphamide – neutral  Doxorubicin – vesicant  Rituximab – neutral  Vincristine – vesicant Other  Prednisolone should be taken in the morning with or after food. Administration of prednisolone begins on the morning of chemotherapy.  The rate of administration of rituximab varies. Please refer to the rituximab administration guidelines. Additional Therapy  Antiemetics 15-30 minutes prior to chemotherapy - ondansetron 8mg oral or intravenous bolus As take home medication - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral  Rituximab pre-medication 30 minutes prior to rituximab - chlorphenamine 10mg intravenous bolus - paracetamol 1000mg oral On the morning of treatment Version 1 (July 2022) Page 6 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine - prednisolone 40mg/m2 oral to be self administered by the patient on the morning of treatment and for four days after rituximab treatment (this is part of the chemotherapy schedule as well as rituximab pre-medication)  Rituximab infusion reactions - hydrocortisone 100mg intravenous bolus when required for rituximab infusion related reactions - salbutamol 2.5mg nebule when required for rituximab related bronchospasm - consider pethidine 25-50mg intravenous bolus for rituximab related rigors that fail to respond to steroids.  Allopurinol 300mg once a day for 7 days oral for the first cycle only   Anti-infective prophylaxis: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day oral on Monday, Wednesday and Friday only  Growth factor according to local formulary choice. For example: - filgrastim or bioequivalent 30 million units once a day for 7 days from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days from day 6 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous   Mouthcare for the prophylaxis or treatment of mucositis in accordance with local guidelines   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. References 1. Pevrade F, Jardin F, Thieblemont C et al. Attenuated immunochemotherapy regimen (R-miniCHOP) in elderly patients older than 80 years with diffuse large B-cell lymphoma: a multicentre, single-arm, phase 2 trial. Lancet Oncology (2011);12: 460 – 468. 2. Peyrade F et al. Rituximab and reduced dose CHOP (R-mini-CHOP) for patients over 80 years with diffuse large B-cell lymphoma (DLBCL) – Groupe d’Etude Des Lymphomes Del I’Adulte (GELA) Study LNH03-7B. Blood (2010): 116 (21): 853. 3. Sandoz Limited (2021). Cyclophosphamide 1000mg powder for solution for injection or infusion summary for product characteristic. Available from https://www.medicines.org.uk/emc. Accessed 04/07/2022. 4. Accord Healthcare Limited (2016). Doxorubicin 2mg/ml concentrate for solution for infusion summary of product characteristics. Available from https://www.medicines.org.uk/emc. Accessed 04/07/2022. Version 1 (July 2022) Page 7 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine 5. Roche products limited (2021). MabThera 100mg Concentrate for Solution for Infusion summary for product characteristics. Available from https://www.medicines.org.uk/emc. Accessed 04/07/2022. 6. Hospira UK Ltd (2022). Vincristine 1mg/ml injection summary for product characteristics. Available from https://www.medicines.org.uk/emc. Accessed 04/07/2022. 7. Accord-UK Ltd (2021). Prednisolone 25mg tablets summary of product characteristics. Available from https://www.medicines.org.uk/emc. Accessed 04/07/2022. Version 1 (July 2022) Page 8 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine REGIMEN SUMMARY mini-RCHOP (21)-Cyclophosphamide-Doxorubicin-Prednisolone-RituximabVincristine Cycle 1 1. Warning – Check patient has taken the prednisolone dose Administration instructions: Please check the patient has taken prednisolone on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone please administer prednisolone oral 30 minutes prior to rituximab infusion. 2. Chlorphenamine 10mg intravenous bolus Administration instructions: Administer 30 minutes prior to rituximab infusion 3. Paracetamol 1000mg oral Administration instructions: Administer 30 minutes prior to rituximab infusion 4. Rituximab 375mg/ m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines Administration instructions: Please check the patient has taken prednisolone on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone please administer prednisolone orally 30 minutes prior to rituximab infusion. The rate of administration of rituximab varies. Please refer to administration guidelines. 5. Ondansetron 8mg oral or intravenous injection Administration Instructions May be given as 8mg intravenous injection if the oral route is not appropriate 6. Doxorubicin 25mg/ m2 intravenous bolus over 10 minutes 7. Vincristine 1mg intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 400mg/ m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous bolus once only when required for the relief of rituximab related bronchospasm Administration Instructions When required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Administration Instructions when required for the relief of rituximab infusion related reactions Take Home Medicines 11. Prednisolone 40mg/ m2 once a day on the morning of the next treatment Administration instructions: Take the prescribed dose on the morning of day 1 of the cycle. This is the supply for your next cycle. The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference. 12. Prednisolone 40mg/ m2 once a day for 4 days oral starting on day 2 of the cycle Administration instructions: Take the prescribed dose in the morning for four days starting on day 2 of the cycle. The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference. 13. Metoclopramide 10mg three times a day when required oral Administration instructions: Version 1 (July 2022) Page 9 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine Please dispense 28 tablets or nearest equivalent pack size 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Administration Instructions Take 8mg twice a day for three days starting on the evening of day 1 of the cycle 15. Allopurinol 300mg once a day oral for 7 days 16. Growth factor according to local formulary choice. Administration Instructions Dispense according to local formulary choice. For example: - filgrastim or bioequivalent 30 million units once a day for 7 days from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days from day 6 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous 17. Aciclovir 400mg twice a day oral for 21 days Administration Instructions Please supply 21 days or an original pack if appropriate 18. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral for 21 days. Administration instructions This may be given as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. Cycles 2, 3, 4 and 5 1. Warning – Check patient has taken the prednisolone dose Administration instructions: Please check the patient has taken prednisolone on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone please administer prednisolone orally 30 minutes prior to rituximab infusion. 2. Chlorphenamine 10mg intravenous bolus Administration instructions: Administer 30 minutes prior to rituximab infusion 3. Paracetamol 1000mg oral Administration instructions: Administer 30 minutes prior to rituximab infusion 4. Rituximab 375mg/ m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines Administration instructions: Please check the patient has taken prednisolone on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone please administer prednisolone orally 30 minutes prior to rituximab infusion. The rate of administration of rituximab varies. Please refer to administration guidelines. 5. Ondansetron 8mg oral or intravenous injection Administration Instructions May be given as 8mg intravenous injection if the oral route is not appropriate 6. Doxorubicin 25mg/ m2 intravenous bolus over 10 minutes 7. Vincristine 1mg intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 400mg/ m2intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous bolus once only when required for the relief of rituximab infusion related reactions Administration Instructions when required for the relief of rituximab infusion related reactions Version 1 (July 2022) Page 10 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related Bronchospasm Administration Instructions when required for the relief of rituximab infusion related reactions Take Home Medicines 11. Prednisolone 40mg/ m2 once a day on the morning of the next treatment Administration instructions: Take the prescribed dose on the morning of day 1 of the cycle. This is the supply for your next cycle. The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 12. Prednisolone 40mg/ m2 once a day for 4 days starting on day 2 oral Administration instructions: Take the prescribed dose in the morning for four days starting on day 2 of the cycle. The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference. 13. Metoclopramide 10mg three times a day when required oral Administration instructions: Please dispense 28 tablets or nearest equivalent pack size 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Administration Instructions Take 8mg twice a day for three days starting on the evening of day 1 of the cycle 15. Growth factor according to local formulary choice. For example: Administration Instructions Dispense according to local formulary choice. For example: - filgrastim or bioequivalent 30 million units once a day for 7 days from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days from day 6 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous 16. Aciclovir 400mg twice a day oral for 21 days Administration Instructions Please supply 21 days or an original pack if appropriate 17. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral for 21 days. Administration instructions This may be given as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. Cycle 6 1. Warning – Check patient has taken the prednisolone dose Administration instructions: Please check the patient has taken prednisolone on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone please administer prednisolone orally 30 minutes prior to rituximab infusion. 2. Chlorphenamine 10mg intravenous bolus Administration instructions: Administer 30 minutes prior to rituximab infusion 3. Paracetamol 1000mg oral Administration instructions: Administer 30 minutes prior to rituximab infusion 4. Rituximab 375mg/ m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines Administration instructions: Version 1 (July 2022) Page 11 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine Please check the patient has taken prednisolone on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone please administer prednisolone orally 30 minutes prior to rituximab infusion. The rate of administration of rituximab varies. Please refer to administration guidelines. 5. Ondansetron 8mg oral or intravenous injection Administration Instructions May be given as 8mg intravenous injection if the oral route is not appropriate 6. Doxorubicin 50mg/ m2 intravenous bolus over 10 minutes 7. Vincristine 1mg intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 8. Cyclophosphamide 400mg/ m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous bolus once only when required for the relief of rituximab infusion related reactions Administration Instructions when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related Bronchospasm Administration Instructions when required for the relief of rituximab infusion related reactions Take Home Medicines 11. Prednisolone 40mg/ m2 once a day for 4 days starting on day 2 of the cycle oral Administration instructions: Take the prescribed dose in the morning for four days starting on day 2 of the cycle The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference. 12. Metoclopramide 10mg three times a day when required oral Administration instructions: Please dispense 28 tablets or nearest equivalent pack size 13. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Administration Instructions Take 8mg twice a day for three days starting on the evening of day 1 of the cycle 14. Growth factor to be continued until the neutrophil count is above 1x109/L. For Administration Instructions Dispense according to local formulary choice. For example: - filgrastim or bioequivalent 30 million units once a day for 7 days from day 6 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days from day 6 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous 15. Aciclovir 400mg twice a day oral for 21 days Administration Instructions Please supply 21 days or an original pack if appropriate 16. Co-trimoxazole 960mg once a day on Monday, Wednesday and Friday oral for 21 days. Administration instructions This may be given as 480mg twice a day on Mondays, Wednesdays and Fridays according to local practice. Version 1 (July 2022) Page 12 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine DOCUMENT CONTROL Version 1 Date July 2022 Amendment n/a Written by Approved by Alexandra Pritchard Dr Rob Lown Pharmacist Consultant 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 NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the summary of product characteristics and relevant published papers. Version 1 (July 2022) Page 13 Lymphoma-mini-RCHOP (21) - Cyclophosphamide-Doxorubicin-Prednisolone-Rituximab-Vincristine
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/mini-RCHOP-21.pdf

Carboplatin-Docetaxel-Trastuzumab

Description: Chemotherapy Protocol BREAST CANCER CARBOPLATIN (AUC6)-DOCETAXEL-TRASTUZUMAB (TCH) Regimen • Breast Cancer – Carboplatin (AUC6)-Docetaxel-Trastuzumab (TCH) Indication • Adjuvant treatment of high risk (node positive or negative tumour greater than or equal to one centimetre) HER2 positive breast cancer that has failed to adequately respond to an anthracycline containing therapy or where anthracycline therapy is contra-indicated. • WHO Performance status 0, 1, 2 Toxicity Drug Carboplatin Docetaxel Trastuzumab Adverse Effect Neuropathy, nephrotoxicity, ototoxicity, thrombocytopenia Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue, alopecia, neutropenia Cardiotoxicity, acute respiratory distress syndrome, infusion related effects 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 • EDTA or calculated creatinine clearance before the first cycle • HER2 status prior to initiating therapy • Cardiac function must be assessed prior to starting trastuzumab. Thereafter in the adjuvant setting it should be assessed every 12 weeks unless there is clinical evidence of cardiac failure. In the metastatic setting cardiac function should be assessed every 12 weeks for 24 weeks then every 24 weeks thereafter, again, unless there is clinical evidence suggestive of cardiac failure • Blood pressure prior to each trastuzumab administration Version 1.3 (July 2024) Page 1 of 11 Breast-Carboplatin(AUC6)-Docetaxel-Trastuzumab(TCH) 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. This is especially true in the adjuvant / neoadjuvant setting where dose delays and reductions may be less appropriate. The following is a general guide only. Haematological Prior to prescribing the following treatment criteria must be met; Criteria Neutrophils Platelets Eligible Level equal to or more than 1x109/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 counts on day one are below these criteria for neutrophil and/or platelets then delay carboplatin and docetaxel treatment for seven days. Only re-start treatment when these levels are reached. If patients experience a febrile neutropenia or a treatment delay due to neutrophil count of less than 0.5 x109/L or platelets less than 50 x109/L for more than seven days, then reduce the dose of carboplatin and docetaxel to 80% of the original dose. If the neutropenia or thrombocytopenia recurs despite this decrease in dose intensity, the dose should either be further reduced to 50% of the original dose or treatment stopped. Haematological dose modifications are not necessary for trastuzumab. If patients do not tolerate trastuzumab it should be stopped. These modifications refer to carboplatin and docetaxel only. Liver Impairment Drug Bilirubin (μmol/L) AST/ALT (units) Alk Phos (units) Carboplatin Docetaxel Trastuzumab N/A Greater than ULN No dose adjustment needed 1.5xULN or greater and 2.5xULN or greater and/or 3.5xULN or greater and 6xULN or greater No dose adjustment needed Dose (% of original dose) Consider 75% Not Recommended Version 1.3 (July 2024) Page 2 of 11 Breast-Carboplatin(AUC6)-Docetaxel-Trastuzumab(TCH) Renal Impairment Drug Carboplatin Docetaxel Trastuzumab Creatinine Clearance (ml/min) 20ml/min or less Dose (% of original dose) Contra-indicated No dose adjustment necessary No dose adjustment 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. Docetaxel Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 75mg/m2 to 60mg/m2. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 75mg/m2 or a NCI-CTC grade 4 toxicity develops stop 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 60mg/m2 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 to 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. Trastuzumab The LVEF should be fifty or above before starting cycle one of trastuzumab. Subsequent Echocardiograms The flow chart below describes the process to be followed if there is an asymptomatic decline in LVEF during trastuzumab treatment. Version 1.3 (July 2024) Page 3 of 11 Breast-Carboplatin(AUC6)-Docetaxel-Trastuzumab(TCH) In general patients who develop symptomatic cardiac dysfunction should have trastuzumab discontinued, be commenced on ACE inhibitor therapy and be referred to a cardiologist. Further treatment should be discussed with the relevant oncology consultant. Version 1.3 (July 2024) Page 4 of 11 Breast –Carboplatin (AUC6)-Docetaxel-Trastuzumab(TCH) Regimen The starting dose of carboplatin AUC6 is used with calculated GFR. AUC5 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC6 is 900mg. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. 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 6 cycles then trastuzumab alone for a further 12 cycles (18 cycles of trastuzumab in total) Cycle 1 Drug Dose Days Administration Carboplatin Docetaxel Trastuzumab AUC 6 (max dose) 75mg/m2 8mg/kg 2 Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion in 250ml 2 sodium chloride 0.9% over 60 minutes Intravenous infusion in 250ml 1 sodium chloride 0.9% over 90 minutes Cycle 2, 3, 4, 5, 6 Drug Dose Days Administration Carboplatin Docetaxel Trastuzumab AUC 6 (max dose) 75mg/m2 6mg/kg 1 Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion in 250ml 1 sodium chloride 0.9% over 60 minutes Intravenous infusion in 250ml 1 sodium chloride 0.9% over 30 minutes Version 1.3 (July 2024) Page 5 of 11 Breast –Carboplatin (AUC6)-Docetaxel-Trastuzumab(TCH) Cycle 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 Drug Dose Days Administration Trastuzumab 6mg/kg Intravenous infusion in 250ml 1 sodium chloride 0.9% over 30 minutes Dose Information • Carboplatin will be dose banded in accordance with the national dose bands (10mg/ml) • The maximum dose of carboplatin for AUC 6 is 900mg. This will be set as 890mg in ARIA to comply with the national bands • Docetaxel will be dose banded in accordance with the national dose bands • Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the doses • Trastuzumab will be dose banded in accordance with national dose bands (21mg/ml) • If the patient misses a dose of trastuzumab by fourteen days or less, then the usual maintenance dose of 6mg/kg should be given as soon as possible. Do not wait until the next planned cycle. Subsequent maintenance doses should be given according to the previous schedule • If the patient misses a dose of trastuzumab by more than fourteen days, a reloading dose of 8mg/kg should be given over 90 minutes. Subsequent maintenance doses should then be given every 21 days from that point 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) • Trastuzumab is associated with hypersensitivity reactions. Patients should be observed for six hours following the start of the first infusion of trastuzumab and for two hours following the start of subsequent infusions. If the patient has tolerated the first two infusions with no infusion related effects consideration can be given to reducing this observation period further Extravasation • Carboplatin - irritant Version 1.3 (July 2024) Page 6 of 11 Breast –Carboplatin (AUC6)-Docetaxel-Trastuzumab(TCH) • Docetaxel – exfoliant • Trastuzumab – neutral Additional Therapy • Antiemetics 15-30 minutes before chemotherapy - ondansetron 8mg 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 oral 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 pre-medication administer dexamethasone 20mg once only dose intravenous bolus. • For treatment of trastuzumab infusion reactions ‘once only when required’ doses of the following should be prescribed; - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg oral • Growth factors according to local policy • 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 References 1. Valero V, Forbes J, Pegram MD et al. Multicentre phase III randomised trial comparing docetaxel and trastuzumab with docetaxel, carboplatin and trastuzumab as first line chemotherapy for patients with HER2 positive gene amplified metastatic breast cancer (BCIRG007 study); two highly active therapeutic regimens. J Clin Oncol 2011; 29 (2): 149156. Version 1.3 (July 2024) Page 7 of 11 Breast –Carboplatin (AUC6)-Docetaxel-Trastuzumab(TCH) REGIMEN SUMMARY Carboplatin (AUC6)-Docetaxel-Trastuzumab (TCH) Cycle 1 Day One 1. Dexamethasone 8mg twice a day oral* Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat 15-30 minutes before chemotherapy. 2. Trastuzumab 8mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes 3. Chlorphenamine 10mg intravenous when required for infusion related reactions 4. Hydrocortisone 100mg intravenous when required for infusion related reactions 5. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Day Two 6. Dexamethasone 8mg twice a day oral (from TTO)* Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat 15-30 minutes before chemotherapy. 7. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as 8mg intravenous if required 8. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 9. Carboplatin AUC6 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions This recommended maximum dose is 900mg based on a creatinine clearance of 125ml/min. This will be set at 890mg in ARIA to comply with national dose bands Take Home Medicines (given on day 1) 10. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion 11. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28x10mg tablets or nearest equivalent pack size Version 1.3 (July 2024) Page 8 of 11 Breast –Carboplatin (AUC6)-Docetaxel-Trastuzumab(TCH) Cycles 2, 3, 4, 5 Day One 12. Dexamethasone 8mg twice a day oral Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat 15-30 minutes before chemotherapy. 13. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes 14. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as 8mg intravenous if required 15. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 16. Carboplatin AUC6 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions This recommended maximum dose is 900mg based on a creatinine clearance of 125ml/min. This will be set at 890mg in ARIA to comply with national dose bands 17. Chlorphenamine 10mg intravenous when required for infusion related reactions 18. Hydrocortisone 100mg intravenous when required for infusion related reactions 19. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Take Home Medicines 20. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion 21. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28x10mg tablets or nearest equivalent pack size Cycle 6 Day One 22. Dexamethasone 8mg twice a day oral Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat 15-30 minutes before chemotherapy. 23. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes 24. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as 8mg intravenous if required Version 1.3 (July 2024) Page 9 of 11 Breast –Carboplatin (AUC6)-Docetaxel-Trastuzumab(TCH) 25. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 26. Carboplatin AUC6 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions This recommended maximum dose is 900mg based on a creatinine clearance of 125ml/min. This will be set at 890mg in ARIA to comply with national dose bands 27. Chlorphenamine 10mg intravenous when required for infusion related reactions 28. Hydrocortisone 100mg intravenous when required for infusion related reactions 29. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses Take Home Medicines 30. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28x10mg tablets or nearest equivalent pack size Cycle 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 Day One 31. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes 32. Chlorphenamine 10mg intravenous when required for infusion related reactions 33. Hydrocortisone 100mg intravenous when required for infusion related reactions 34. Paracetamol 1000mg oral when required for infusion related reactions Administration Instructions Please check if the patient has taken paracetamol. Maximum dose is 4g per 24 hours. There should be 4 hours between doses *Cycle one dexamethasone must be prescribed in advance of the chemotherapy. 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 1.3 (July 2024) Page 10 of 11 Breast –Carboplatin (AUC6)-Docetaxel-Trastuzumab(TCH) DOCUMENT CONTROL Version Date Amendment 1.3 July Trastuzumab updated with national 2024 dose banding Carboplatin dose bands changed 1.2 Aug 2022 Docetaxel dose bands changed Coding removed Administration instructions added to summary Header changed Dose modification tabulated Hepatic impairment updated Carboplatin paragraph amended 1.1 August 2014 under regimen Metoclopramide dose changed to 10mg Bolus removed from intravenous bolus throughout text OPCS codes updated Disclaimer added 1 Jan 2013 None Written By Alexandra Pritchard Pharmacist Approved By Nanda Basker Pharmacist Dr Debbie Wright Donna Kimber Pharmacist Pharmacy Technician Donna Kimber Pharmacy Technician Dr Debbie Wright Pharmacist Dr Debbie Wright Pharmacist Dr Jenny Marshall 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 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 (July 2024) Page 11 of 11 Breast –Carboplatin (AUC6)-Docetaxel-Trastuzumab(TCH)
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Carboplatin(AUC6)Docetaxel

Description: Chemotherapy Protocol BREAST CANCER CARBOPLATIN (AUC6)-DOCETAXEL Regimen • Breast Cancer – Carboplatin (AUC6)-Docetaxel Indication • Neo-adjuvant or adjuvant treatment of triple negative breast cancer • WHO Performance status 0, 1, 2 Toxicity Drug Carboplatin Docetaxel Adverse Effect Neuropathy, nephrotoxicity, ototoxicity, thrombocytopenia Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue, alopecia, neutropenia 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 day one of each cycle • EDTA or calculated creatinine clearance before the first 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. This is especially true in the adjuvant / neoadjuvant setting where dose delays and reductions may be less appropriate. The following is a general guide only. Haematological Prior to prescribing the following treatment criteria must be met; Version 1.1 (Aug 2022) Page 1 of 8 Breast-Carboplatin(AUC6)-Docetaxel Criteria Neutrophils Platelets Eligible Level equal to or more than 1x109/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 (80g/L) If counts on day one are below these criteria for neutrophil and/or platelets then delay carboplatin and docetaxel treatment for seven days. Only re-start treatment when these levels are reached. If patients experience a febrile neutropenia or a treatment delay due to neutrophil count of less than 0.5 x109/L or platelets less than 50 x109/L for more than seven days, then reduce the dose of carboplatin and docetaxel to 80% of the original dose. If the neutropenia or thrombocytopenia recurs despite this decrease in dose intensity, the dose should either be further reduced to 50% of the original dose or treatment stopped. Liver Impairment Drug Carboplatin Docetaxel Bilirubin (μmol/L) AST/ALT (units) Alk Phos (units) N/A Greater than ULN No dose adjustment needed 1.5xULN or greater and 2.5xULN or greater and/or 3.5xULN or greater and 6xULN or greater Dose (% of original dose) Consider 75% Not Recommended Renal Impairment Drug Carboplatin Docetaxel Creatinine Clearance (ml/min) 20ml/min or less Dose (% of original dose) Contra-indicated No dose adjustment 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. Docetaxel Peripheral neuropathy at NCI-CTC grade 3 should result in a dose reduction from 75mg/m2 to 60mg/m2. If the NCI-CTC grade 3 neuropathy occurred at doses lower than 75mg/m2 or a NCI-CTC grade 4 toxicity develops stop 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 60mg/m2 in the first instance. Version 1.1 (Aug 2022) Page 2 of 8 Breast-Carboplatin(AUC6)-Docetaxel 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 to 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. Regimen The starting dose of carboplatin AUC 6 is used with calculated GFR. AUC 5 may be considered with EDTA clearance, seek advice from the appropriate consultant before prescribing. The recommended maximum dose when using a calculated creatinine clearance at AUC 6 is 900mg. This will be set as 890mg in ARIA to comply with national dose bands. If you have an obese patient or an individual with a calculated creatinine clearance above 125ml/min please seek advice from the relevant consultant. It should be noted that the dose of carboplatin may need to be altered if there is a change (improvement or reduction) in renal function of more than 10% from the previous cycle. 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 6 cycles. Drug Dose Days Administration Carboplatin Docetaxel AUC 6 (Maximum dose) 75mg/m2 1 Intravenous infusion in 500ml glucose 5% over 60 minutes Intravenous infusion in 250ml 1 sodium chloride 0.9% over 60 minutes Dose Information • Carboplatin will be dose banded in accordance with national dose bands (10mg/ml) • The maximum dose of carboplatin for AUC 6 is 900mg. This will be set as 890mg in ARIA to comply with national dose bands • Docetaxel will be dose banded in accordance with the national dose bands (20mg/ml) • Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the dos Version 1.1 (Aug 2022) Page 3 of 8 Breast-Carboplatin(AUC6)-Docetaxel 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 that 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) Extravasation • Carboplatin - irritant • Docetaxel – exfoliant Additional Therapy • Antiemetics This regimen is considered moderately emetogenic. The anti-emetics included in ARIA reflect this. However, it is important to assess, not just the drugs being prescribed, but also the individual patient characteristics. Risk factors for emesis include age (younger patients may be more susceptible), sex (female patients are at higher risk), previous history of nausea and vomiting with chemotherapy, pregnancy, anaesthetics or a history of travel sickness, among others. Consider a combination of an NK1R antagonist, a 5HT3 receptor antagonist and dexamethasone is high risk patients. 15-30 minutes before chemotherapy (day 1) - ondansetron 8mg 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 oral 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 pre-medication administer dexamethasone 20mg once only dose intravenous bolus. • Growth factors according to local formulary choice. For example: - filgrastim or bioequivalent 30million units once a day for 7 days starting from day 3 subcutaneous - lenograstim or bioequivalent 33.6million units once a day for 7 days starting from day 3 subcutaneous Version 1.1 (Aug 2022) Page 4 of 8 Breast –Carboplatin (AUC6)-Docetaxel - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous • Consider oral loperamide 4mg after the first loose stool and then 2mg after each loose motion thereafter. Do not use for longer than 48 hours (maximum daily dose is 16mg) without advice. • 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 References 1. Sharma P, Lopez-Tarruella S, Garcia Saenz JA et al. Pathological response and survival in triple negative breast cancer following neoadjuvant carboplatin plus docetaxel. Clin Cancer Res 2018; 24 (23): 5820-5829. Version 1.1 (Aug 2022) Page 5 of 8 Breast –Carboplatin (AUC6)-Docetaxel REGIMEN SUMMARY Carboplatin (AUC6)-Docetaxel Cycles 1, 2, 3, 4, 5 Day One 1. Dexamethasone 8mg twice a day oral (from TTO)* Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg (or equivalent dose) IV stat 15-30 minutes before chemotherapy. If the patient has already taken a dose of dexamethasone do not administer this dose. 2. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as 8mg intravenous if required 3. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg (or equivalent dose) IV stat 15-30 minutes before chemotherapy. 4. Carboplatin AUC6 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions This recommended maximum dose is 900mg based on a creatinine clearance of 125ml/min. This will be set at 890mg in ARIA to comply with national dose bands Take Home Medicines 5. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion. Administration Instructions This is the supply for the next cycle. Take in the morning and at lunchtime 6. Metoclopramide 10mg three times a day when required oral Administration Instructions Please 28x10mg tablets or nearest equivalent pack size. 7. Ondansetron 8mg twice a day for three days starting on the evening of day one of the cycle Administration Instructions Start on the evening of day one of the cycle 8. Growth factor according to local formulary choice Administration Instructions Growth factors according to local formulary choice. For example; - filgrastim or bioequivalent 30million units once a day for 7 days starting from day 3 subcutaneous - lenograstim or bioequivalent 33.6million units once a day for 7 days starting from day 3 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous Version 1.1 (Aug 2022) Page 6 of 8 Breast –Carboplatin (AUC6)-Docetaxel Cycle 6 Day One 9. Dexamethasone 8mg twice a day oral (from TTO)* Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg (or equivalent dose) IV stat 15-30 minutes before chemotherapy. If the patient has already taken a dose of dexamethasone do not administer this dose. 10. Ondansetron 8mg oral or intravenous Administration Instructions Administer 15-30 minutes prior to SACT. This may be given as 8mg intravenous if required 11. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg (or equivalent dose) IV stat 15-30 minutes before chemotherapy. 12. Carboplatin AUC6 intravenous infusion in 500ml glucose 5% over 60 minutes Administration Instructions This recommended maximum dose is 900mg based on a creatinine clearance of 125ml/min. This will be set at 890mg in ARIA to comply with national dose bands Take Home Medicines 13. Metoclopramide 10mg three times a day when required oral Administration Instructions Please suppy 28x10mg tablets or nearest original pack. 14. Ondansetron 8mg twice a day for three days starting on the evening of day one of the cycle Administration Instructions Start on the evening of day one of the cycle 15. Growth factor according to local formulary choice Administration Instructions Growth factors according to local formulary choice. For example; - filgrastim or bioequivalent 30million units once a day for 7 days starting from day 3 subcutaneous - lenograstim or bioequivalent 33.6million units once a day for 7 days starting from day 3 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 2 subcutaneous *Cycle one dexamethasone must be prescribed in advance of the chemotherapy. 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 1.1 (Aug 2022) Page 7 of 8 Breast –Carboplatin (AUC6)-Docetaxel DOCUMENT CONTROL Version 1.1 1 Date Aug 2022 March 2019 Amendment Carboplatin national dose bands Administration Instructions added to summary None Written By Approved By Dr Deborah Wright Donna Kimber Pharmacist Pharmacy Technician Dr Deborah Wright Pharmacist Dr Peter Simmonds Consultant Medical Oncologist Dr E Papadimitraki 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 that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1.1 (Aug 2022) Page 8 of 8 Breast –Carboplatin (AUC6)-Docetaxel
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Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT)

Description: Chemotherapy Protocol UPPER GASTROINTESTINAL CANCER DOCETAXEL-FLUOROURACIL-FOLINIC ACID-OXALIPLATIN (FLOT) Regimen • Upper GI – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) Indication • Perioperative treatment for patients with resectable oesophagogastric [gastric or gastroesophageal junction (GEJ)] adenocarcinoma • WHO Performance status 0, 1 Toxicity Drug Docetaxel Fluorouracil Oxaliplatin Adverse Effect Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue Palmar-plantar erythrodysesthesia, diarrhoea, mucositis, chest pain Peripheral neuropathy (cumulative), acute laryngopharyngeal dysasthesia (increase duration of infusion) The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Monitoring • FBC, LFT’s and U&E’s prior to day one of treatment. • Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with fluorouracil. All patients should be tested for DPD deficiency before initiation (cycle 1) to minimise the risk of these reactions 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 1.1 (November 2020) Page 1 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) Please discuss all dose reductions / delays with the relevant consultant before prescribing, where appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Deteriorating organ function may be a sign of disease progression. Haematological Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL (80g/L) Prior to prescribing day one the following treatment criteria must be met; Criteria Eligible Level Neutrophil equal to or more than 1x109/L (unless due to bone marrow impairment) Platelets equal to or more than 100x109/L (unless due to bone marrow impairment) If these levels are not achieved wait seven days and if recovered resume treatment with the following dose reductions Dose Reductions Drug Docetaxel Fluorouracil Oxaliplatin Starting Dose (mg/m2) 50 2600 85 Dose Level 1 (mg/m2) 40 2000 65 Dose Level 2 (mg/m2) 30 1600 50 Neutrophil Count (x109/L) 0.5-0.99 Less than 0.5 Docetaxel Reduce by 1 dose level Reduce by 1 dose level Fluorouracil Maintain Dose Reduce by 1 dose level Oxaliplatin Reduce by 1 dose level Reduce by 1 dose level Platelet Count (x109/L) 10-49.9 Less than 10 Docetaxel Reduce by 1 dose level Reduce by 1 dose level Fluorouracil Maintain Dose Maintain Dose Oxaliplatin Reduce by 1 dose level Reduce by 2 dose level There is no need to dose adjust the folinic acid for haematological toxicity. Version 1.1 (November 2020) Page 2 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) Hepatic Impairment Drug Docetaxel Bilirubin (μmol/L) N/A AST/ALT (units) Greater than1.5xULN and ALP (units) Greater than 2.5xULN Dose (% of original dose) Give 75% Greater than ULN and / or Greatre than 3.5xULN and Greater than 6xULN Not recommended Drug Fluorouracil Bilirubin μmol/L More than 85 AST/ALT units More than 180 Dose Contra-indicated In moderate hepatic impairment reduce the initial dose by 33%. In severe hepatic impairment reduce the initial dose by 50%. The dose may be increased as tolerated. Drug Oxaliplatin Dose Limited information available but there is probably little need to adjust the dose. Renal Impairment Drug Docetaxel Creatinine Clearance (ml/min) Dose (% of original dose) N/A No dose adjustment needed Fluorouracil Consider dose adjustment in severe renal impairment Oxaliplatin Moderate renal impairment – treat at normal dose, and monitor renal function. Dose adjust according to toxicity. CrCl <20m/min – dose reduce 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. Dose limiting toxicities include diarrhoea, abdominal Version 1.1 (November 2020) Page 3 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) pain, emesis, stomatitis, palmar-plantar erythrodysesthesia and neurosensory toxicities among others. If any NCI-CTC grade 1toxicity occurs treatment should be continued, without interruption, at the full dose. For toxicities at NCI-CTC grade 3 or above treatment should be withheld until recovery to NCI-CTC grade 1 then re-started if medically appropriate. If recovery takes 21 days or longer stop treatment. Fluorouracil Diarrhoea occurring for the first time at NCI-CTC grade 2 should be approached by withholding the fluorouracil until it has resolved to NCI-CTC grade 1. Treatment can then be re-started at full dose. Treatment should again be delayed on development of a second NCI-CTC grade 2 diarrhoea and the fluorouracil re-started at 75% of the original dose when it has resolved to NCI-CTC grade 1. After resolution of a third episode of NCI-CTC grade 2 diarrhoea to NCI-CTC grade 1 the fluorouracil should be re-started using 50% of the original dose. On appearance of a NCI-CTC grade 3 diarrhoea withhold fluorouracil until it has resolved to NCI-CTC grade 1 and re-start treatment using 75% of the original dose. After a second episode at NCI-CTC grade 3 wait until the diarrhoea has resolved to NCI-CTC grade 1 and resume the fluorouracil using 50% of the original dose. For a third appearance of NCI-CTC grade 3 diarrhoea or the development of grade 4 toxicity at ant time stop fluorouracil therapy. Oxaliplatin If NCI-CTC grade 3-4 diarrhoea or stomatitis recurs despite appropriate reduction in the fluorouracil dose the oxaliplatin dose should be reduced to 75mg/m2. There are rare case reports of acute interstitial lung disease or lung fibrosis in association with oxaliplatin. Where an unexplained respiratory symptom occurs stop treatment until pulmonary investigations have been conducted to exclude an interstitial cause. Docetaxel 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 consider reducing the docetaxel dose. 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. If it occurs with a reduced dose or if there is no recovery after two weeks, docetaxel treatment should be stopped. Where a NCICTC grade 3 cutaneous toxicity occurs between cycles with recovery by day one Version 1.1 (November 2020) Page 4 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) 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. Treatment should be stopped in relation to a NCI-CTC grade 4 stomatitis. Hypersensitivity 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 Peripheral Neuropathy Neurosensory toxicity can occur with both docetaxel and oxaliplatin. The following table describes dose reductions for both agents. This tables applies where the neuropathy is NCI-CTC grade 3 or above or grade 2 that persist for longer than 7 days Toxicity Cold-related dysesthesia Paraesthesia without pain Paraesthesia with pain or functional impairment Duration Duration of of toxicity toxicity more 1-7 days than 7 days No reduction No reduction No reduction No reduction Reduce to 75% dose on subsequent cycles and No discuss with reduction consultant Omit oxaliplatin and docetaxel if recurs Persistent between cycles Withhold until recovery then restart at 75% dose for oxaliplatin and docetaxel. Withhold until recovery then restart at 75% dose for oxaliplatin and docetaxel Omit oxaliplatin and docetaxel and discuss with consultant Version 1.1 (November 2020) Page 5 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) Regimen 14 day cycle for 4 cycles then surgery should occur. A further 4 cycles should be prescribed post operatively. 8 cycles will be set in ARIA. Drug Docetaxel Fluorouracil Folinic Acid Oxaliplatin Dose 50mg/m2 2600mg/m2 350mg 85mg/m2 Days 1 1 1 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Intravenous infusion over 24 hours Intravenous infusion in 250ml glucose 5% over 120 minutes Intravenous infusion in 500ml glucose 5% over 120 minutes Dose Information • Docetaxel will be dose banded as per the national dose bands (20mg/ml) Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the dose. • Fluorouracil will be dose banded as per the national dose bands (50mg/ml) • Oxaliplatin will be dose banded as per the national dose bands (5mg/ml) Administration Information Extravasation • Fluorouracil – inflammitant • Oxaliplatin – exfoliant • Docetaxel – exfoliant Other • Central venous access and use of an ambulatory infusion pump is required. Additional Therapy • Antiemetics 15-30 minutes prior to chemotherapy - ondansetron 8mg oral or intravenous As take home medication; - metoclopramide 10mg three times a day when required oral Version 1.1 (November 2020) Page 6 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) - ondansetron 8mg twice a day oral starting on the evening of the day of chemotherapy • Oral loperamide 4mg after the first loose stool then 2-4mg four times a day when required for the relief of diarrhoea (maximum 16mg/24 hours). • Gastric protection with a proton pump inhibitor or H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed • To prevent fluid retention and hypersensitivity reactions prescribe dexamethasone 8mg twice a day 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 Additional Information • A glucose 5% flush should be administered before and after the oxaliplatin • The folinic acid may be replaced with calcium levofolinate 175mg intravenous infusion in 250ml glucose 5% over 120 minutes References 1. Al-Batran SE, Homann N, et al. Perioperative chemotherapy with docetaxel, oxaliplatin, and fluorouracil/leucovorin (FLOT) versus epirubicin, cisplatin, and fluorouracil or capecitabine (ECF/ECX) for resectable gastric or gastroesophageal junction (GEJ) adenocarcinoma (FLOT4-AIO). ASCO 2017; 35: 4004. Version 1.1 (November 2020) Page 7 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) REGIMEN SUMMARY Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) Cycles 1, 2, 3, 4, 5, 6, 7 Day Minus One 1 1. Dexamethasone 8mg twice a day oral* Day One 2. Dexamethasone 8mg oral (from TTO)* Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat, (10mg IV stat if on aprepitant)*, or equivalent dose, 15-30 minutes before chemotherapy. 3. Ondansetron 8mg oral or intravenous 4.Docetaxel 50mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat, (10mg IV stat if on aprepitant)*, or equivalent dose, 15-30 minutes before chemotherapy. 5. Oxaliplatin 85mg/m2 intravenous infusion in 500ml glucose 5% over 120 minutes 6. Folinic acid 350mg intravenous infusion in 250ml glucose 5% over 120 minutes 7. Fluorouracil 2600mg/m2 intravenous infusion over 24 hours Take Home Medicines 8. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion* 9. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28x10mg tablets or nearest equivalent pack size 10. Ondansetron 8mg twice a day for three days starting on the evening of the day of chemotherapy Administration Instructions Take 8mg twice a day for three days starting on the evening of day 1 of the cycle Cycle 8 Day Minus One 1 11. Dexamethasone 8mg twice a day oral* Version 1.1 (November 2020) Page 8 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) Day One 12. Dexamethasone 8mg oral (from TTO)* Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat, (10mg IV stat if on aprepitant)*, or equivalent dose, 15-30 minutes before chemotherapy. 13. Ondansetron 8mg oral or intravenous 14.Docetaxel 50mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat, (10mg IV stat if on aprepitant)*, or equivalent dose, 15-30 minutes before chemotherapy. 15. Oxaliplatin 85mg/m2 intravenous infusion in 500ml glucose 5% over 120 minutes 16. Folinic acid 350mg intravenous infusion in 250ml glucose 5% over 120 minutes 17. Fluorouracil 2600mg/m2 intravenous infusion over 24 hours Take Home Medicines 18. Metoclopramide 10mg three times a day when required oral Administration Instructions Please supply 28x10mg tablets or nearest equivalent pack size 19. Ondansetron 8mg twice a day for three days starting on the evening of the day of chemotherapy Administration Instructions Take 8mg twice a day for three days starting on the evening of day 1 of the cycle 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 1.1 (November 2020) Page 9 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT) DOCUMENT CONTROL Version Date Amendment Written/ By Approved By Updated monitoring with DPD 1.1 Nov 2020 testing Coding removed Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Stuart Martin 1 August 2018 None Pharmacist Dr Deborah Wright Dr Tim Iveson Consultant Medical Oncologist Pharmacist 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 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 that occur as a result of following these guidelines. These protocols should be used in conjunction with other references such as the Summary of Product Characteristics and relevant published papers. Version 1.1 (November 2020) Page 10 of 10 Gastrointestinal – Docetaxel-Fluorouracil-Folinic Acid-Oxaliplatin (FLOT)
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Upper-gastro-intestinal/Docetaxel-Fluorouracil-Folinic-Acid-Oxaliplatin-FLOT.pdf

RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Ver 1.2

Description: Chemotherapy Protocol LYMPHOMA CYCLOPHOSPHAMIDE-GEMCITABINE-PREDNISOLONE-RITUXIMAB-VINCRISTINE (RGCVP) Regimen Lymphoma–RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-RituximabVincristine Indication CD20 positive Non-Hodgkin’s Lymphoma in the elderly and patients considered unsuitable for anthracycline-based chemotherapy. Toxicity Drug Adverse Effect Cyclophosphamide Dysuria, haemorrhagic cystitis (rare), taste disturbances Gemcitabine Prednisolone Rituxumab Peripheral oedema, diarrhoea, constipation, rash, respiratory problems, influenza-like symptoms, radiosensitising Weight gain, GI disturbances, hyperglycaemia, CNS disturbances, cushingoid changes, glucose intolerance Severe cytokine release syndrome, increased incidence of infective complications, progressive multifocal leukoencephalopathy Vincristine Peripheral neuropathy, constipation, jaw pain 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 prior to day one of treatment Check hepatitis B status prior to starting treatment with rituximab Version 1.2 (Jan 2015) Page 1 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine 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. 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 Dose modifications for haematological toxicity in the table below are for general guidance only. Always refer to the responsible consultant as any dose reductions or delays will be dependent on clinical circumstances and treatment intent. Low counts can be a consequence of bone marrow infiltration as well as drug toxicity. Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL. Day 1 Dose modifications based on haematological parameters apply to cyclophosphamide, gemcitabine and vincristine only. Neutrophils (x109/L) 1 or greater Dose Modifications (cyclophosphamide, gemcitabine, vincristine) 100% 0.5 - 0.9 Less than 0.5 Febrile neutropenia Platelets (x109/L) 75 or above 75% Delay until neutrophils are 1x109/L or above then continue at full dose 1st occurrence - delay until recovery then continue at full dose 2nd occurrence – delay until recovery then reduce the dose to 75% of the original for all subsequent cycles Dose Modifications (cyclophosphamide, gemcitabine, vincristine) 100% 50 – 74 Less than 50 Thrombocytopenia with haemorrhage 75% Delay until platelets are 75x109/L or above then continue at full dose 1st occurrence - delay until recovery then continue at full dose 2nd occurrence – delay until recovery then reduce the dose to 75% of the original for all subsequent cycles. Version 1.2 (Jan 2015) Page 2 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Day 8 Dose modifications based on haematological parameters apply to gemcitabine only. Neutrophils (x109/L) 1 or greater Dose Modifications (gemcitabine only) 100% 0.5 - 0.9 75% Less than 0.5 Platelets (x109/L) 75 or above omit Dose Modifications (gemcitabine only) 100% 50 – 74 75% Less than 50 omit Hepatic Impairment Please note that the approach may be different where abnormal liver function tests are due to disease involvement. Drug Cyclophosphamide Bilirubin μmol/L AST/ALT units Dose (% of original dose) Evidence suggests no dose adjustment necessary Gemcitabine more than *30 N/A Dose escalate with caution Rituximab N/A N/A No dose adjustment needed *30-51 or 60-180 50% Vincristine more than 51 and normal more than 51 and more than180 * Lower limit reflects local practice and may vary from published sources 50% omit Version 1.2 (Jan 2015) Page 3 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Renal Impairment Drug Cyclophosphamide** Creatinine Clearance (ml/min) more than 20 10-20 less than10 Dose (% of original dose) 100% 75% 50% Gemcitabine more than or equal to 30 less than 30 100% Consider dose reduction Rituximab N/A No dose adjustment needed Vincristine N/A No dose adjustment needed **Consider mesna in patients with pre-existing bladder disorders. Give an oral dose of 40% of the cyclophosphamide dose (rounded upwards to the nearest 400mg) at 0, 2 and 6 hours after the administration of the cyclophosphamide. 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 toxicities reduce the dose of the causative agent(s) to 75% of the original dose. For all other non-haematological NCI-CTC grade 4 toxicities delay treatment until the adverse effect has resolved to NCI-CTC grade 1 or below. The dose of the causative agent(s) should then be reduced to 50% of the original dose or discontinued as appropriate. Rituximab Infusion related adverse reactions have been observed in 10% of patients treated with rituximab. Rituximab administration is associated with the onset of cytokine release syndrome. This condition is characterised by severe dyspnoea, often accompanied by bronchospasm and hypoxia, in addition to fever, chills, rigors, urticaria, and angioedema. It may be associated with some features of tumour lysis syndrome such as hyperuricaemia, hyperkalaemia, hypocalcaemia, acute renal failure, elevated lactate dehydrogenase (LDH) and can lead to acute respiratory failure and death. This effect on the lungs may be accompanied by events such as pulmonary interstitial infiltration or oedema, visible on a chest x-ray. Cytokine release syndrome frequently occurs within one or two hours of initiating the first infusion. Version 1.2 (Jan 2015) Page 4 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Hypersensitivity reactions, including anaphylaxis, have been reported following the intravenous administration of proteins. In contrast to cytokine release syndrome, true hypersensitivity reactions typically occur within minutes of starting the infusion. Medicinal products for the treatment of allergic reactions should be available for immediate use in the event of hypersensitivity developing during the administration of rituximab. Use of rituximab maybe associated with an increased risk of progressive multifocal leukoencephalopathy (PML). Patients must be monitored at regular intervals for any new or worsening neurological, cognitive or psychiatric symptoms that may be suggestive of PML. If PML is suspected, further dosing must be suspended until PML has been excluded. If PML is confirmed the rituximab must be permanently discontinued. The presence of a viral upper respiratory tract infection prior to treatment may increase the risk of rituximab associated hepatotoxicity. Patients should be assessed for any cold or flulike symptoms prior to treatment Vincristine Reduce the vincristine dose to 1mg if a NCI-CTC grade 2 motor or grade 3 sensory neurological toxicity occurs. For higher toxicity grades or if toxicity increases despite dose reduction stop the vincristine. Regimen 21 day cycle for 6 cycles Drug Cyclophosphamide Gemcitabine Rituximab Dose 750mg/m2 750mg/m2 (cycle 1) 875mg/m2 (cycle 2) 1000mg/m2 (cycle 3 onwards) 375mg/m2 Vincristine 1.4mg/m2 (max 2mg) Prednisolone 100mg Days 1 1&8 1 1 1, 2, 3, 4, 5 Administration Intravenous bolus over 10 minutes Intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Intravenous infusion in 500ml sodium chloride 0.9% Intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes Oral Consider initial dose reduction in patients over 70 years of age. Doses may be escalated up to full dose on subsequent cycles according to tolerability. Dose Information Cyclophosphamide will be dose banded according to the CSCCN agreed bands Gemcitabine will be dose banded according to the CSCCN agreed bands Rituximab will be dose rounded to the nearest 100mg (up if halfway) Vincristine dose will be rounded to the nearest 0.1mg (up if halfway) Version 1.2 (Jan 2015) Page 5 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine The maximum dose of vincristine is 2mg Administration Information Extravasation Cyclophosphamide – neutral Gemcitabine - neutral Rituximab - neutral Vincristine - vesicant Other Prednisolone should be taken in the morning with or after food. Administration of prednisolone begins on the morning of chemotherapy. The rate of administration of rituximab varies. Please refer to the rituximab administration guidelines Additional Therapy Antiemetics 15-30 minutes prior to chemotherapy on day 1 - ondansetron 8mg oral or intravenous As take home medication - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral 15-30 minutes prior to chemotherapy on day 8 - metoclopramide 10mg oral or intravenous Rituximab pre-medication 30 minutes prior to rituximab - chlorphenamine 10mg intravenous - paracetamol 1000mg oral On the morning of treatment - prednisolone 100mg oral to be self administered by the patient on the morning of treatment and for four days after rituximab treatment (this is part of the chemotherapy schedule as well as rituximab pre-medication) Version 1.2 (Jan 2015) Page 6 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Rituximab infusion reactions - hydrocortisone 100mg intravenous when required for rituximab infusion related reactions - salbutamol 2.5mg nebule when required for rituximab related bronchospasm - consider pethidine 25-50mg intravenous for rituximab related rigors that fail to respond to steroids. Allopurinol 300mg once a day oral for the first cycle only Growth factors to be started and continued until the neutrophil count is above 1x109/L. For example; - filgrastim or bioequivalent 30 million units once a day from day 9 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day from day 9 subcutaneous - pegfilgrastim or bioequivalent 6mg once only day 9 subcutaneous A seven day supply will be issued on day 8 of each cycle. Consider anti-infective prophylaxis in high risk patients, including: - aciclovir 400mg twice a day oral - co-trimoxazole 960mg once a day on Monday, Wednesday and Friday only 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. 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 – X71.5 Delivery – X72.1 & X72.4 References 1.A Phase II multicentre trial of Gemcitabine, CVP, and Rituximab (R-GCVP) for the treatment of patients with newly diagnosed Diffuse Large B-Cell Lymphoma, considered unsuitable for R-CHOP Chemotherapy. NCRI Version 6.0 1st April 2009 Version 1.2 (Jan 2015) Page 7 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine REGIMEN SUMMARY RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Cycle 1 Day 1 1. Warning – Check patient has taken the prednisolone dose Administration Instructions Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Gemcitabine 750mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day on the morning of the next treatment Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 12. Prednisolone 100mg once a day for 4 days oral (starting on day 2) Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 13. Metoclopramide 10mg three times a day when required oral 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment 15. Allopurinol 300mg once a day oral for 21 days Version 1.2 (Jan 2015) Page 8 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Cycle 1 Day 8 16. Metoclopramide 10mg oral or intravenous injection 17. Gemcitabine 750mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Take Home Medicines 18. Growth factor Administration Instructions Dispense according to local formulary. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 9 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 9 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 9 subcutaneous Cycle 2 Day 1 1. Warning – Check patient has taken the prednisolone dose Administration Instructions Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Gemcitabine 875mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions The dose of gemcitabine for this cycle has been automatically escalated. Please check that the dose is clinically appropriate for this patient. 9. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 10. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 11. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 12. Prednisolone 100mg once a day on the morning of the next treatment Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference Version 1.2 (Jan 2015) Page 9 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine 13. Prednisolone 100mg once a day for 4 days oral (starting on day 2) Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 14. Metoclopramide 10mg three times a day when required oral 15. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Cycle 2 Day 8 16. Metoclopramide 10mg oral or intravenous 17. Gemcitabine 875mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions The dose of gemcitabine for this cycle has been automatically escalated please check that the dose is clinically appropriate for this patient. Take Home Medicines 18. Growth factor Administration Instructions Dispense according to local formulary. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 9 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 9 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 9 subcutaneous Cycle 3 Day 1 1. Warning – Check patient has taken the prednisolone dose Administration Instructions Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Gemcitabine 1000mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions The dose of gemcitabine for this cycle has been automatically escalated. This is the dose for cycles 3, 4, 5, and 6. Please check that the dose is clinically appropriate for this patient. 9. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes Version 1.2 (Jan 2015) Page 10 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine 10. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 11. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 12. Prednisolone 100mg once a day on the morning of the next treatment Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 13. Prednisolone 100mg once a day for 4 days oral (starting on day 2) Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 14. Metoclopramide 10mg three times a day when required oral 15. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Cycle 3 Day 8 16. Metoclopramide 10mg oral or intravenous 17. Gemcitabine 1000mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions The dose of gemcitabine for this cycle has been automatically escalated. This is the dose for cycles 3, 4, 5, and 6. Please check that the dose is clinically appropriate for this patient. Take Home Medicines 18. Growth factor Administration Instructions Dispense according to local formulary. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 9 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 9 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 9 subcutaneous Cycles 4 and 5 Day 1 1. Warning – Check patient has taken the prednisolone dose Administration Instructions Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines Version 1.2 (Jan 2015) Page 11 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine 5. Ondansetron 8mg oral or intravenous 6. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Gemcitabine 1000mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions The dose of gemcitabine for this cycle has been automatically escalated. This is the dose for cycles 3, 4, 5, and 6. Please check that the dose is clinically appropriate for this patient. 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day on the morning of the next treatment Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 12. Prednisolone 100mg once a day for 4 days oral (starting on day 2) Administration Instructions The prednisolone may be dispensed as a single supply in one container or as two containers depending on local preference 13. Metoclopramide 10mg three times a day when required oral 14. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Cycle 4 and 5 Day 8 15. Metoclopramide 10mg oral or intravenous 16. Gemcitabine 1000mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions The dose of gemcitabine for this cycle has been automatically escalated. This is the dose for cycles 3, 4, 5, and 6. Please check that the dose is clinically appropriate for this patient. Take Home Medicines 17. Growth factor Administration Instructions Dispense according to local formulary. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 9 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 9 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 9 subcutaneous Version 1.2 (Jan 2015) Page 12 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Cycle 6 Day 1 1. Warning – Check patient has taken prednisolone dose Administration Instructions Please check the patient has taken prednisolone 100mg oral on the morning of rituximab administration. On occasions where individuals attend for treatment and have forgotten to take the prednisolone dose please administer prednisolone 100mg oral 30 minutes prior to rituximab administration. 2. Chlorphenamine 10mg intravenous 3. Paracetamol 1000mg oral 4. Rituximab 375mg/m2 intravenous infusion in 500ml sodium chloride 0.9% as per the rituximab administration guidelines 5. Ondansetron 8mg oral or intravenous 6. Vincristine 1.4mg/m2 (max 2mg) intravenous bolus in 50ml sodium chloride 0.9% over 10 minutes 7. Gemcitabine 1000mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions The dose of gemcitabine for this cycle has been automatically escalated. This is the dose for cycles 3, 4, 5, and 6. Please check that the dose is clinically appropriate for this patient. 8. Cyclophosphamide 750mg/m2 intravenous bolus over 10 minutes 9. Hydrocortisone 100mg intravenous once only when required for the relief of rituximab infusion related reactions 10. Salbutamol 2.5mg nebule once only when required for the relief of rituximab related bronchospasm Take Home Medicines 11. Prednisolone 100mg once a day for 4 days oral (starting on day 2) 12. Metoclopramide 10mg three times a day when required oral 13. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day one of treatment Cycle 6 Day 8 14. Metoclopramide 10mg oral or intravenous injection 15. Gemcitabine 1000mg/m2 intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes Administration Instructions The dose of gemcitabine for this cycle has been automatically escalated. This is the dose for cycles 3, 4, 5, and 6. Please check that the dose is clinically appropriate for this patient. Version 1.2 (Jan 2015) Page 13 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine Take Home Medicines 16. Growth factor Administration Instructions Dispense according to local formulary. For example; - filgrastim or bioequivalent 30 million units once a day for 7 days starting on day 9 subcutaneous - lenograstim or bioequivalent 33.6 million units once a day for 7 days starting on day 9 subcutaneous - pegfilgrastim or bioequivalent 6mg once only on day 9 subcutaneous Version 1.2 (Jan 2015) Page 14 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine DOCUMENT CONTROL Version Date Amendment Written By Approved By Header changed Toxicities removed Hepatic & renal tables updated Metoclopramide dose changed 1.2 Jan 2015 to 10mg Growth factor units updated Bolus removed from intravenous bolus throughout text Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Mucositis recommendation changed Ondansetron TTO clarified Disclaimer added Cycle 2 day 1 on page 11 1.1 changed to cycle 3 day 1. Sept 2012 Gemcitabine administration instructions cycle 3 to 6 inclusive Dr Deborah Wright Pharmacist Donna Kimber Pharmacy Technician amended in the summary. Dr Andrew Davies Rebecca Wills Consultant Medical Pharmacist Oncologist 1 July 2012 None Dr Deborah Wright Dr Alison Milne Pharmacist Consultant Haematologist 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 (Jan 2015) Page 15 of 15 Lymphoma- RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Lymphoma/RGCVP-Cyclophosphamide-Gemcitabine-Prednisolone-Rituximab-Vincristine-Ver-1.2.pdf

Docetaxel-Pertuzumab/TrastuzumabSC

Description: Chemotherapy Protocol BREAST CANCER Docetaxel-Pertuzumab/Trastuzumab SC Regimen • Breast Cancer – Docetaxel-Pertuzumab/Trastuzumab SC Indication • Treatment of metastatic breast cancer (MBC) in adult patients with HER2positive metastatic or locally recurrent unresectable breast cancer, who have not received previous anti-HER2 therapy or chemotherapy for their metastatic disease. • WHO Performance status 0, 1 Toxicity Drug Docetaxel Pertuzumab/Trastuzumab SC Adverse Effect Hypersensitivity, fluid retention, neuropathy, joint pains, nail changes, fatigue Injection related reactions, diarrhoea and other GI disturbances, left ventricular dysfunction, rash The adverse effects listed are not exhaustive. Please refer to the relevant Summary of Product Characteristics for full details. Diarrhoea can be severe in patients treated with the combination of pertuumab and trastuzumab . It is important to ensure patients are given appropriate therapy for the treatment of diarrhoea. This is not included in the regimen on Aria and must be added from the support folder. Monitoring Regimen • HER2 status before initiating therapy • LVEF to be assessed at baseline, prior to cycle four then every 4 cycles during maintenance monotherapy or as clinically indicated • Blood pressure on day 1 of each cycle • FBC, U&Es and LFTs prior to each cycle with docetaxel Version 1 (April 2021) Page 1 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC Dose Modifications Dose reductions are not recommended for pertuzumab / trastuzumab combination. If treatment with this combination is not tolerated it 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 Patients may continue pertuzumab / trastuzumab combination treatment during periods of reversible chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. The following guidelines apply to docetaxel only. Prior to prescribing cycle one the following treatment criteria must be met; Criteria Neutrophil Platelets Eligible Level (Docetaxel) Greater than or equal to 1.5x109/L (unless due to bone marrow impairment) Greater than or equal to 100x109/L (unless due to bone marrow impairment Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL Toxicity Neutropenia Grade (NCI-CTC) 1 2 3 4 Docetaxel 75mg/m2 Docetaxel 60mg/m2 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 75mg/m2 Delay until grade 1 then 60mg/m2 60mg/m2 Delay until grade 1 then 60mg/m2 Delay until grade 1 then 60mg/m2 Stop Febrile Neutropenia 3 Delay until grade 1 then 60mg/m2 Stop 4 Delay until grade 1 then 60mg/m2 Stop Platelets Greater than or equal to 100x109/L Less than 100x109/L 75mg/m2 Delay until greater than or equal to 100x109/L the 60mg/m2 60mg/m2 Stop Version 1 (April 2021) Page 2 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC Hepatic Impairment Drug Docetaxel Pertuzumab/ Trastuzumab SC Recommendation N/A 1.5xULN 2.5xUL or and N or greater greater Give 75% dose Greater than ULN and/ or 3.5xULN or greater and 6xULN or greater Not recommended No specific dose adjustments are recommended in hepatic impairment Renal Impairment Drug Recommendation Docetaxel No dose adjustment necessary Pertuzumab/Trastuzumab SC No dose adjustment necessary for mild or moderate renal impairment. No dose recommendations are available for severe renal impairment due to lack of data. Other Docetaxel 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. 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. Version 1 (April 2021) Page 3 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC Pertuzumab/Trastuzumab SC Left ventricular dysfunction Pertuzumab/trastuzumab should be withheld for at least 3 weeks for any signs and symptoms suggestive of congestive heart failure. The combination should be discontinued if symptomatic heart failure is confirmed, the patient commenced on ACE inhibitor therapy and referred to a cardiologist. Further treatment should be discussed with the relevant oncology consultant. Patients with metastatic breast cancer Patients should have a pre-treatment left ventricular ejection fraction (LVEF) of equal to or greater than 50 %. Pertuzumab/trastuzumab should be withheld for at least 3 weeks for: • a drop in LVEF to less than 40 % • a LVEF of 40 %-45 % associated with a fall of equal to or greater than 10 % points below pre-treatment value. Pertuzumab-trastuzumab may be resumed if the LVEF has recovered to > 45%, or to 40-45% associated with a difference of less than 10% points below pre-treatment values. Injection-related reactions Pertuzumab/trastuzumab has been associated with injection-related reactions. The injection may be slowed or paused if the patient experiences injection-related symptoms Treatment including oxygen, beta agonists, antihistamines, rapid intravenous fluids and antipyretics may also help alleviate systemic symptoms. The injection should be discontinued immediately and permanently if the patient experiences a NCI-CTCAE grade 4 reaction (anaphylaxis), bronchospasm or acute respiratory distress syndrome. Diarrhoea Pertuzumab/trastuzumab may elicit severe diarrhoea. Diarrhoea is most frequent during concurrent administration with taxane therapy. Elderly patients (equal to or greater than 65 years) have a higher risk of diarrhoea compared with younger patients (less than 65 years). Early intervention with loperamide, fluids and electrolyte replacement should be considered, particularly in elderly patients, and in case of severe or prolonged diarrhoea. Interruption of treatment should be considered if no improvement in the patient's condition is achieved. When the diarrhoea is under control treatment may be reinstated. Pulmonary events Severe pulmonary events have been reported with the use of trastuzumab in the post-marketing setting. Patients experiencing dyspnoea at rest due to complications of advanced malignancy and comorbidities may be at increased risk of pulmonary events. Therefore, these patients should not be treated with pertuzumab/trastuzumab. Caution should be exercised for pneumonitis, especially in patients being treated concomitantly with taxanes. Version 1 (April 2021) Page 4 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC Regimen 21 day cycle for 6 cycles of docetaxel and pertuzumab/trastuzumab. Pertuzumab-trastuzumab is then continued until disease progression or intolerance. This will be set up in ARIA with six cycles. Cycle 1 Drug Docetaxel Pertuzumab/trastuzumab SC Dose 75mg/m2 1200mg/600mg (Loading) Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 1 Subcutaneous injection over 8 minutes Cycle 2, 3, 4, 5, 6 Drug Docetaxel Pertuzumab/trastuzumab SC Dose 75mg/m2 600mg/600mg (Maintenance) Days 1 Administration Intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes 1 Subcutaneous injection over 5 minutes Cycle 7 onwards Drug Pertuzumab/trastuzumab SC Dose 600mg/600mg (Maintenance) Days Administration 1 Subcutaneous injection over 5 minutes Dose Information • The dose of docetaxel may be increased to 100mg/m2 from cycle two onwards if well tolerated. • Docetaxel induced fluid retention can lead to weight gain. This is not a reason to alter the doses • Docetaxel will be dose banded according to national dose banding tables (20mg/ml) • If the time between two sequential injections of pertuzumab/trastuzumab SC is less than 6 weeks, the maintenance dose of 600mg/600mg should be administered as soon as possible. Thereafter continue with the 3-weekly schedule. Version 1 (April 2021) Page 5 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC • If the time between two sequential injections of pertuzumab/trastuzumab SC is 6 weeks or more, a loading dose of 1200mg/600mg should be readministered followed by maintenance doses of 600mg/600mg every 3 weeks thereafter. 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) • Pertuzumab/trastuzumab SC has been associated with hypersensitivity and infusion related reactions. Patients should be observed for 30 minutes after the first injection and for 15 subsequent infusions. • Pertuzumab/trastuzumab SC should be administered before any taxane, and the observation period must be completed before starting administration of the taxane. • The pertuzumab/trastuzumab SC injection site should be alternated between the left and right thigh only. New injections should be given at least 2.5 cm from the previous site on healthy skin and never into areas where the skin is red, bruised, tender, or hard. The dose should not be split between two syringes or between two sites of administration. During the treatment course, other medicinal products for subcutaneous administration should preferably be injected at different sites. Extravasation • Docetaxel – exfoliant Additional Therapy • Antiemetics (docetaxel cycles only) 15-30 minutes before chemotherapy - 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 once only dose intravenous Version 1 (April 2021) Page 6 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC 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. • Diarrhoea is a common adverse effect, particularly on cycle one. Consider prescribing loperamide 4mg after the first loose motion then 2mg after each loose motion thereafter. This can be added from the support folder in Aria. • For treatment of pertuzumab/trastuzumab SC injection reactions ‘once only when required’ doses of the following should be prescribed; - chlorphenamine 10mg intravenous - hydrocortisone 100mg intravenous - paracetamol 1000mg once oral References 1. Baselga J, Cortes J, Sung-Bae K et al. Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer. N Engl J Med 2012; 366 (2): 109-119 2. Phesgo 600 mg/600 mg solution for injection / Phesgo 1200 mg/600 mg solution for injection SmPCs 01 January 2021 Version 1 (April 2021) Page 7 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC REGIMEN SUMMARY Docetaxel-Pertuzumab/Trastuzumab SC Cycle 1 Day One 1. Dexamethasone 8mg twice a day oral (from TTO)* Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg (or equivalent dose) IV stat 15-30 minutes before chemotherapy. If the patient has already taken a dose of dexamethasone do not administer this dose. 2. Pertuzumab/trastuzumab 1200mg/600mg (loading dose) subcutaneous injection over 8 minutes Administration Instructions Pertuzumab/trastuzumab 1200mg/600mg (pertuzumab 1200mg/trastuzumab 600mg) is a LOADING DOSE Administer as a single subcutaneous injection over 8 minutes (the whole dose should be given via a single syringe into a single administration site). The injection site should be alternated between the left and right thigh only. New injections should be given at least 2.5cm from the previous site on healthy skin and never into areas where the skin is red, bruised, tender or hard. Patients should be observed for 30 minutes after administration of the loading dose and for 15 minutes after each maintenance dose or according to local policy. Administer before any taxane, and the observation period must be completed before starting administration of the taxane. Pharmacy please state the brand dispensed by either adding the brand from “favourites” or writing below Brand: ………………………………………………………………………………………………………………… 3. Metoclopramide 10mg oral or intravenous 4. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat, or equivalent dose, 15-30 minutes before chemotherapy. 5. Chlorphenamine 10mg intravenous when required for infusion related reactions 6. Hydrocortisone 100mg intravenous when required for infusion related reactions 7. Paracetamol 1000mg oral when required for infusion related reactions Take Home Medicines 8. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion 9. Metoclopramide 10mg three times a day when required oral Version 1 (April 2021) Page 8 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC Cycle 2, 3, 4, 5 Day One 10. Pertuzumab/trastuzumab 600mg/600mg (maintenance) subcutaneous injection over 5 minutes Administration Instructions Pertuzumab/trastuzumab 600mg/600mg (pertuzumab 600mg/trastuzumab 600mg) is a maintenance dose Administer as a single subcutaneous injection over 5 minutes (the whole dose should be given via a single syringe into a single administration site). The injection site should be alternated between the left and right thigh only. New injections should be given at least 2.5cm from the previous site on healthy skin and never into areas where the skin is red, bruised, tender or hard. Patients should be monitored for 15 minutes after each injection or according to local policy Administer before any taxane, and the observation period must be completed before starting administration of the taxane. Pharmacy please state the brand dispensed by either adding the brand from “favourites” or writing below Brand: ………………………………………………………………………………………………………………… 11. Metoclopramide 10mg oral or intravenous Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat, or equivalent dose, 15-30 minutes before chemotherapy. 12. Chlorphenamine 10mg intravenous when required for infusion related reactions 13. Hydrocortisone 100mg intravenous when required for infusion related reactions 14. Paracetamol 1000mg oral when required for infusion related reactions Take Home Medicines 15. Dexamethasone 8mg twice a day oral for 3 days starting the day before the docetaxel infusion 16. Metoclopramide 10mg three times a day when required oral Cycle 6 Day one 17. Pertuzumab/trastuzumab 600mg/600mg (maintenance) subcutaneous injection over 5 minutes Administration Instructions Pertuzumab/trastuzumab 600mg/600mg (pertuzumab 600mg/trastuzumab 600mg) is a maintenance dose Administer as a single subcutaneous injection over 5 minutes (the whole dose should be given via a single syringe into a single administration site). The injection site should be alternated between the left and right thigh only. New injections should be given at least 2.5cm from the previous site on healthy skin and never into areas where the skin is red, bruised, tender or hard. Patients should be monitored for 15 minutes after each injection or according to local policy Administer before any taxane, and the observation period must be completed before starting administration of the taxane. Pharmacy please state the brand dispensed by either adding the brand from “favourites” or writing below Version 1 (April 2021) Page 9 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC Brand: ………………………………………………………………………………………………………………… 18. Metoclopramide 10mg oral or intravenous 19. Docetaxel 75mg/m² intravenous infusion in 250ml sodium chloride 0.9% over 60 minutes Administration Instructions Ensure the patient has taken the dexamethasone pre-medication the day before and the day of docetaxel administration (and the day after). On the occasions where individuals attend for treatment and have forgotten to take the dexamethasone pre-medication administer dexamethasone 20mg IV stat, or equivalent dose, 15-30 minutes before chemotherapy. 20. Chlorphenamine 10mg intravenous when required for infusion related reactions 21. Hydrocortisone 100mg intravenous when required for infusion related reactions 22. Paracetamol 1000mg oral when required for infusion related reactions Take Home Medicines 23. Metoclopramide 10mg three times a day when required oral Cycle 7, 8, 9, 10, 11 onwards Pertuzumab/trastuzumab 600mg/600mg (Maintenance) subcutaneous injection over 5 minutes Administration Instructions Pertuzumab/trastuzumab 600mg/600mg (pertuzumab 600mg/trastuzumab 600mg) is a maintenance dose Administer as a single subcutaneous injection over 5 minutes (the whole dose should be given via a single syringe into a single administration site). The injection site should be alternated between the left and right thigh only. New injections should be given at least 2.5cm from the previous site on healthy skin and never into areas where the skin is red, bruised, tender or hard. Patients should be monitored for 15 minutes after each injection or according to local policy Administer before any taxane, and the observation period must be completed before starting administration of the taxane. Pharmacy please state the brand dispensed by either adding the brand from “favourites” or writing below Brand: ………………………………………………………………………………………………………………… 24. Chlorphenamine 10mg intravenous when required for infusion related reactions 25. Hydrocortisone 100mg intravenous when required for infusion related reactions 26. Paracetamol 1000mg oral when required for infusion related reactions Cycle 12 27. Warning – Check further cycles required 28. Pertuzumab/trastuzumab 600mg/600mg (Maintenance) subcutaneous injection over 5 minutes Administration Instructions Pertuzumab/trastuzumab 600mg/600mg (pertuzumab 600mg/trastuzumab 600mg) is a maintenance dose Version 1 (April 2021) Page 10 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC Administer as a single subcutaneous injection over 5 minutes (the whole dose should be given via a single syringe into a single administration site). The injection site should be alternated between the left and right thigh only. New injections should be given at least 2.5cm from the previous site on healthy skin and never into areas where the skin is red, bruised, tender or hard. Patients should be monitored for 15 minutes after each injection or according to local policy Administer before any taxane, and the observation period must be completed before starting administration of the taxane. 29. Pharmacy please state the brand dispensed by either adding the brand from “favourites” or writing below 30. Brand: ………………………………………………………………………………………………………………… 31. Chlorphenamine 10mg intravenous when required for infusion related reactions 32. Hydrocortisone 100mg intravenous when required for infusion related reactions 33. Paracetamol 1000mg oral when required for infusion related reactions *Cycle one dexamethasone must be prescribed in advance of the chemotherapy. 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 (April 2021) Page 11 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC Version Date 1 March 2021 DOCUMENT CONTROL Amendment Written By None Rebecca Wills Pharmacist Approved By Dr Sanjay Raj 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 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 (April 2021) Page 12 of 12 Breast –Docetaxel-Pertuzumab/Trastuzumab SC
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Docetaxel-PertuzumabTrastuzumabSC.pdf

EC-DPH IV (Cyclophosphamide-Epirubicin-Docetaxel-Pertuzumab-Trastuzumab IV)

Description: Please refer to the most up to date Bluteq eligibility criteria for pertuzumab and trastuzumab before prescribing.
Url: /Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/EC-DPH-IV-Cyclophosphamide-Epirubicin-Docetaxel-Pertuzumab-Trastuzumab-IV.pdf

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