A A AText only | Accessibility | Privacy and cookies

Browse site A to Z

Search results

Go To Advanced Search

Trastuzumab (21 day-Maintenance)

Description
Chemotherapy Protocol BREAST CANCER TRASTUZUMAB (21 day- Maintenance) Regimen • Breast Cancer – Trastuzumab (21 day-Maintenance) Indication • Adjuvant treatment of breast cancer
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Trastuzumab-21-day-Maintenance.pdf

Trastuzumab (21 day-Load)

Description
Chemotherapy Protocol BREAST CANCER TRASTUZUMAB (21 day-Load) Regimen • Breast Cancer – Trastuzumab (21 day-Load) Indication • Adjuvant treatment of breast cancer
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Trastuzumab-21-day-Load.pdf

Trastuzumab Main

Description
Chemotherapy Protocol GASTROINTESTINAL (UPPER) CANCER TRASTUZUMAB (21 day-Maintenance) Regimen • GI (upper) – Trastuzumab (21 day-Maintenance) Indication • Trastuzumab, in combination with
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Upper-gastro-intestinal/TrastuzumabMainVer1.2.pdf

Docetaxel-Pertuzumab-Trastuzumab Ver 1.3

Description
Chemotherapy Protocol BREAST CANCER DOCETAXEL-PERTUZUMAB-TRASTUZUMAB This protocol may require funding Regimen • Breast Cancer – Docetaxel-Pertuzumab-Trastuzumab Indication • Locally advanced
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Docetaxel-Pertuzumab-Trastuzumab.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
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Carboplatin-Docetaxel-Trastuzumab.pdf

Capecitabine-Cisplatin-Trastuzumab

Description
Chemotherapy Protocol GASTROINTESTINAL (UPPER) CANCER CAPECITABINE-CISPLATIN-TRASTUZUMAB Regimen • Gastrointestinal (Upper) Cancer – Capecitabine-Cisplatin-Trastuzumab Indication • Trastuzumab, in combination with capecitabine and cisplatin is recommended as an option for the treatment of people with human epidermal growth factor receptor 2 (HER2) positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior treatment for their metastatic disease and who have tumours expressing high levels of HER2 • WHO performance status 0, 1, 2 Toxicity Drug Capecitabine Cisplatin Trastuzumab Adverse Effect Palmar-plantar erythrodysesthesia, diarrhoea, mucositis, chest pain Neuropathy, nephrotoxicity, ototoxicity Cardio toxicity, 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 • Prior to starting therapy confirm a positive HER2 status • FBC, LFT’s and U&E’s prior to day one of treatment • Cardiac function must be assessed prior to starting trastuzumab and twelve weekly thereafter unless there are signs of cardiac impairment where four to eight weekly may be more appropriate. • Patients with complete or partial dihydropyrimidine dehydrogenase (DPD) deficiency are at increased risk of severe and fatal toxicity during treatment with capecitabine. All patients should be tested for DPD deficiency before initiation (cycle 1) to minimise the risk of these reactions. Version 1.3 (July 2024) Page 1 of 11 GI (upper)-Capecitabine-Cisplatin-Trastuzumab Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following criteria must be met. Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If the neutrophils are less than 1.5x109/L and/or the platelets are less than 100x109/L then delay treatment for 7 days and re-start treatment at the original dose. If a 14 day delay is required to allow counts to recover or there are two separate delays of 7 days during treatment the dose of the cisplatin should be reduced to 80% of the original dose. There is little need to adjust the dose of trastuzumab for haematological toxicity. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Hepatic Impairment Drug Capecitabine Cisplatin Trastuzumab Dose (% of original dose) There is little published information available. No dose reductions are necessary for those with mild to moderate hepatic dysfunction due to liver metastasis No dose reduction necessary No dose reduction necessary Version 1.3 (July 2024) Page 2 of 11 GI (upper)-Capecitabine-Cisplatin-Trastuzumab Renal Impairment Drug Capecitabine Cisplatin Trastuzumab Creatinine Clearance (ml/min) Dose (% of original dose) More than 51 30-50 less than 30 more than 60 100 75 Do not use 100 45-59 75 less than 45 Consider alternative 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. Dose limiting toxicities include diarrhoea, abdominal pain, emesis, stomatitis, palmar-plantar erythrodysesthesia and neurosensory toxicities among others. In general if any NCI-CTC grade 1 toxicity occurs treatment should be continued, without interruption, at the full dose. For toxicities NCI-CTC grade 3 or above, in general, treatment should be withheld until recovery to at least NCI-CTC grade 1 then re-started if medically appropriate. If recovery takes twenty-one days or longer then stop treatment. Capecitabine NCI-CTC Grade 2 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue at the same dose. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 then resume therapy at 75% of the original dose. If the same adverse effect develops on a third occasion once more interrupt treatment until it resolves to NCI-CTC grade 0-1 then continue at 50% of the original dose. Stop treatment if the toxicity re-appears on a fourth instance. NCI-CTC Grade 3 Interrupt treatment until the toxicity resolves to NCI-CTC grade 0-1 then continue treatment using 75% of the original dose with prophylaxis if appropriate. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 0-1 and then resume therapy at 50% of the original dose. If the same adverse effect develops on a third occasion discontinue capecitabine. NCI-CTC Grade 4 Discontinue treatment unless the responsible consultant considers it to be in the best interest of the patient to continue at 50% of the original dose once the toxicity has resolved to NCI-CTC grade 0-1. Version 1.3 (July 2024) Page 3 of 11 GI (upper)-Capecitabine-Cisplatin-Trastuzumab When capecitabine is stopped for toxicity the doses are omitted, not delayed. Consider stopping capecitabine therapy if chest pain occurs. Cisplatin Neurotoxicity occurring at a NCI-CTC grade 2 or above or a new functional deterioration in hearing and / or tinnitus that does not resolve between cycles should be approached by substituting the cisplatin for carboplatin. Trastuzumab Cardiac 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 4 of 11 GI (upper)-Capecitabine-Cisplatin-Trastuzumab 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 5 of 11 GI(upper) – Capecitabine-Cisplatin-Trastuzumab Regimen 21 day cycle for 6 cycles The capecitabine and cisplatin are given every 21 days for a maximum of 6 cycles. The trastuzumab is given until disease progression. Six cycles will be set in Aria after which the single agent trastuzumab regimen should be used. Cycle One Drug Capecitabine Cisplatin Trastuzumab Dose 1000mg/m2 twice a day 80mg/m2 8mg/kg Days Route 1-14 incl Oral 1 Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin per minute (minimum 120 minutes) 1 Intravenous Infusion in 250ml sodium chloride 0.9% over 90 minutes Cycle Two Onwards Drug Capecitabine Cisplatin Trastuzumab Dose 1000mg/m2 twice a day 80mg/m2 6mg/kg Days Route 1-14 incl Oral 1 Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin per minute (minimum 120minutes) 1 Intravenous Infusion in 250ml sodium chloride 0.9% over 30 minutes (if well tolerated at 90 minutes) Dose Information • Capecitabine will be dose banded in accordance with the national dose bands • Cisplatin will be dose banded in accordance with the national dose bands (1mg/ml) • Trastuzumab will be dose banded in accordance with the 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 Version 1.3 (July 2024) Page 6 of 11 GI(upper) – Capecitabine-Cisplatin-Trastuzumab 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 Extravasation • Cisplatin - exfoliant • Trastuzumab – neutral Other • Capecitabine should start on the evening of day 1 • Capecitabine should be taken with or after food • 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 Additional Therapy • Antiemetics 15-30 minutes prior to chemotherapy - aprepitant 125mg oral - dexamethasone 4mg oral or intravenous - ondansetron 8mg oral or intravenous As take home medication; - aprepitant 80mg once a day oral for 2 days - dexamethasone 4mg once a day oral for 3 days - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral • Cisplatin pre and post hydration as follows; Pre Furosemide 40mg oral or intravenous 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Version 1.3 (July 2024) Page 7 of 11 GI(upper) – Capecitabine-Cisplatin-Trastuzumab Post 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Patients should be advised to drink at least 3 litres of fluid in the 24 hours after administration of cisplatin. • 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 • 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). • Mouthwashes according to local or national guidelines for the prevention and 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 alert NPSA/2008/RRR001 must be followed when prescribing, dispensing or administering oral chemotherapy. • Ensure the total daily dose of capecitabine is divided into two doses given twelve hours apart (the first should be administered in the evening of day one of the cycle) Serious toxicity has occurred where the total daily dose has been given twice a day. • It must be made clear to all staff, including those in the community, that this is a short course of oral chemotherapy that must not be continued. • Patients should be assessed for suitability for oral chemotherapy prior to starting treatment. References 1. Bang YJ, Van Custem E, Fevereislova A et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for the treatment of HER2 positive advanced gastric or gastro-oesophageal junction cancer (TOGA): a phase 3, open label, randomised, controlled clinical trial. Lancet 2010; 376 (9742): 687-697. 2. National Institute for Health and Clinical Excellence (2010). NICE Technology Appraisal Guidance 208. Trastuzumab for the treatment of HER2-positive metastatic gastric cancer. DOH: London. Version 1.3 (July 2024) Page 8 of 11 GI(upper) – Capecitabine-Cisplatin-Trastuzumab REGIMEN SUMMARY Capecitabine-Cisplatin-Trastuzumab Day One Cycle One 1. Trastuzumab 8mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes 2. Aprepitant 125mg oral 3. Dexamethasone 4mg oral or intravenous 4. Ondansetron 8mg oral or intravenous 5. Furosemide 40mg oral or intravenous 6. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 7. Cisplatin 80mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin/minute (minimum time 120 minutes) 8. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 9. Chlorphenamine 10mg intravenous when required for infusion related reactions 10. Hydrocortisone 100mg intravenous when required for infusion related reactions 11. Paracetamol 1000mg oral when required for infusion related reactions Take Home Medicines 12. Capecitabine 1000mg/m2 twice a day for 14 days starting on the evening of day one of the cycle oral 13. Aprepitant 80mg once a day for 2 days starting on day two of the cycle oral 14. Dexamethasone 4mg once a day for 3 days starting on day two of the cycle oral 15. Metoclopramide 10mg three times a day when required oral 16. Ondansetron 8mg twice a day for 3 days starting on the evening of day one of the cycle oral Day One Cycle Two Onwards 1. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes (if well tolerated at 90 minutes) 2. Aprepitant 125mg oral Version 1.3 (July 2024) Page 9 of 11 GI(upper) – Capecitabine-Cisplatin-Trastuzumab 3. Dexamethasone 4mg oral or intravenous 4. Ondansetron 8mg oral or intravenous 5. Furosemide 40mg oral or intravenous 6. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 7. Cisplatin 80mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin/minute (minimum time 120 minutes) 8. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 9. Chlorphenamine 10mg intravenous when required for infusion related reactions 10. Hydrocortisone 100mg intravenous when required for infusion related reactions 11. Paracetamol 1000mg oral when required for infusion related reactions Take Home Medicines 12. Capecitabine 1000mg/m2 twice a day for 14 days starting on the evening of day one of the cycle oral 13. Aprepitant 80mg once a day for 2 days starting on day two of the cycle oral 13. Dexamethasone 4mg once a day for 3 days starting on day two of the cycle oral 14. Metoclopramide 10mg three times a day when required oral 15. Ondansetron 8mg twice a day for 3 days starting on the evening of day one of the cycle oral Version 1.3 (July 2024) Page 10 of 11 GI(upper) – Capecitabine-Cisplatin-Trastuzumab DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.3 July 2024 Trastuzumab updated with national dose banding Alexandra Pritchard Pharmacist Nanda Basker Pharmacist Updated monitoring with DPD testing 1.2 Nov 2020 Dose banding statement updated Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Coding removed Header changed Toxicities removed Renal recommendations updated for cisplatin Bolus removed from supportive 1.1 treatments May 2014 Metoclopramide dose changed to 10mg Dr Debbie Wright Pharmacist Donna Kimber Pharmacy Technician Pyridoxine removed from supportive treatments Mouthwashes updated TTOs clarified Disclaimer added 1 Feb 2012 None Dr Debbie Wright Pharmacist Dr Tim Iveson 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 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 1.3 (July 2024) Page 11 of 11 GI(upper) – Capecitabine-Cisplatin-Trastuzumab
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Upper-gastro-intestinal/Capecitabine-Cisplatin-Trastuzumab.pdf

Cisplatin-Fluorouracil-Trastuzumab

Description
Chemotherapy Protocol GASTROINTESTINAL (UPPER) CANCER CISPLATIN-FLUOROURACIL-TRASTUZUMAB Regimen • Gastrointestinal (Upper) Cancer – Cisplatin-Fluorouracil-Trastuzumab Indication • Trastuzumab, in combination with cisplatin and fluorouracil is recommended as an option for the treatment of people with human epidermal growth factor receptor 2 (HER2) positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction who have not received prior treatment for their metastatic disease and who have tumours expressing high levels of HER2 • WHO performance status 0, 1, 2 Toxicity Drug Cisplatin Fluorouracil Trastuzumab Adverse Effect Neuropathy, nephrotoxicity, ototoxicity Palmar-plantar erythrodysesthesia, diarrhoea, chest pain Cardio toxicity, 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 • Prior to starting therapy confirm a positive HER2 status • FBC, LFT’s and U&E’s prior to day one of treatment • Cardiac function must be assessed prior to starting trastuzumab and twelve weekly thereafter unless there are signs of cardiac impairment where four to eight weekly may be more appropriate. If LVEF drops 10 ejection points from baseline and to below 50%, trastuzumab should be suspended and a repeat LVEF assessment performed within 21 days • 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 Version 1.3 (July 2024) Page 1 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab Dose Modifications The dose modifications listed are for haematological, liver and renal function only. Dose adjustments may be necessary for other toxicities as well. In principle all dose reductions due to adverse drug reactions should not be reescalated in subsequent cycles without consultant approval. It is also a general rule for chemotherapy that if a third dose reduction is necessary treatment should be stopped. Please discuss all dose reductions / delays with the relevant consultant before prescribing if appropriate. The approach may be different depending on the clinical circumstances. The following is a general guide only. Haematological Prior to prescribing the following criteria must be met. Criteria Neutrophil Platelets Eligible Level equal to or more than 1.5x109/L equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL If the neutrophils are less than 1.5x109/L and/or the platelets are less than 100x109/L then delay treatment for 7 days and re-start treatment at the original dose. If a 14 day delay is required to allow counts to recover or there are two separate delays of 7 days during treatment the dose of the cisplatin should be reduced to 80% of the original dose. There is little need to adjust the dose of trastuzumab for haematological toxicity. Hepatic / Renal Impairment Deteriorating liver or kidney function may be a sign of disease progression or drug toxicity. Hepatic Impairment Drug Cisplatin Fluorouracil Trastuzumab Dose (% of original dose) No dose reduction necessary If the bilirubin is more than 85umol/L and / or the AST more than 180umol/L fluorouracil is contra-indicated. In moderate hepatic impairment consider reducing the dose by 30% and for severe impairment by 50% No dose reduction necessary Version 1.3 (July 2024) Page 2 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab Renal Impairment Drug Cisplatin Fluorouracil Trastuzumab Creatinine Clearance (ml/min) more than 60 Dose (% of original dose) 100 45-59 75 less than 45 Consider carboplatin Consider dose reduction in severe renal impairment only 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. Dose limiting toxicities include diarrhoea, abdominal pain, emesis, stomatitis, palmar-plantar erythrodysesthesia and neurosensory toxicities among others. In general if any NCI-CTC grade 1 toxicity occurs treatment should be continued, without interruption, at the full dose. For toxicities NCI-CTC grade 3 or above, in general, treatment should be withheld until recovery to at least NCI-CTC grade 1 then re-started if medically appropriate. If recovery takes twenty-one days or longer then stop treatment. Cisplatin Neurotoxicity occurring at a NCI-CTC grade 2 or above or a new functional deterioration in hearing and / or tinnitus that does not resolve between cycles should be approached by substituting the cisplatin for carboplatin. 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 or below. Treatment can then be re-started at full dose. Treatment should again be delayed on development of a second NCI-CTC grade 2 or above diarrhoea and the fluorouracil re-started at 75% of the original dose when it has resolved to NCI-CTC grade 1 or below. After resolution of a third episode of NCI-CTC grade 2 diarrhoea to NCI-CTC grade 1 or below, 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 or below 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 or below and resume the fluorouracil using 50% of the original dose. For a third appearance of NCI-CTC grade 3 diarrhoea or the development of NCI-CTC grade 4 toxicity at any time stop fluorouracil therapy. Trastuzumab The LVEF should be fifty or above before starting cycle one of trastuzumab. Version 1.3 (July 2024) Page 3 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab Subsequent Echocardiograms The flow chart below describes the process to be followed if there is an asymptomatic decline in LVEF during trastuzumab treatment. 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 consultant. Version 1.3 (July 2024) Page 4 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab Regimen 21 day cycle for 6 cycles The fluorouracil and cisplatin are given every 21 days for a maximum of 6 cycles. The trastuzumab is given until disease progression. Six cycles will be set in Aria after which the single agent trastuzumab regimen should be used. Cycle One Drug Cisplatin Fluorouracil Trastuzumab Dose 80mg/m2 1000mg/m2/day (total dose 4000mg/m2) 8mg/kg Days 1 1, 2, 3, 4 1 Route Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin per minute (minimum 120 minutes) Continuous intravenous infusion over 96 hours using an infusor device in sodium chloride 0.9% Intravenous Infusion in 250ml sodium chloride 0.9% over 90 minutes Cycle Two Onwards Drug Cisplatin Fluorouracil Trastuzumab Dose 80mg/m2 1000mg/m2/day (total dose 4000mg/m2) 6mg/kg Days 1 1, 2, 3, 4 1 Route Intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin per minute (minimum 120minutes) Continuous intravenous infusion over 96 hours using an infusor device in sodium chloride 0.9% Intravenous Infusion in 250ml sodium chloride 0.9% over 30 minutes (if well tolerated at 90 minutes) Dose Information • Cisplatin will be dose banded in accordance with the national dose bands (1mg/ml) Version 1.3 (July 2024) Page 5 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab • Fluorouracil will be dose banded in accordance with the national dose bands (50mg/ml) • Trastuzumab will be dose banded in accordance with the 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 Extravasation • Cisplatin – exfoliant • Fluorouracil - inflamitant • Trastuzumab – neutral Other • Central venous access and use of an ambulatory infusion pump is required • 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 Additional Therapy • Antiemetics prior to day one only 15-30 minutes prior to chemotherapy - aprepitant 125mg oral - dexamethasone 4mg oral or intravenous - ondansetron 8mg oral or intravenous As take home medication; - aprepitant 80mg once a day oral for 2 days - dexamethasone 4mg once a day oral for 3 days - metoclopramide 10mg three times a day when required oral - ondansetron 8mg twice a day for 3 days oral Version 1.3 (July 2024) Page 6 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab • Cisplatin pre and post hydration as follows; Pre Furosemide 40mg oral or intravenous 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Post 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes Patients should be advised to drink at least 3 litres of fluid in the 24 hours after administration of cisplatin. • 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 • 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). • Mouthwashes as per national or local guidelines for 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 References 1. Bang YJ, Van Custem E, Fevereislova A et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for the treatment of HER2 positive advanced gastric or gastro-oesophageal junction cancer (TOGA): a phase 3, open label, randomised, controlled clinical trial. Lancet 2010; 376 (9742): 687-697. 2. National Institute for Health and Clinical Excellence (2010). NICE Technology Appraisal Guidance 208. Trastuzumab for the treatment of HER2-positive metastatic gastric cancer. DOH: London. Version 1.3 (July 2024) Page 7 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab REGIMEN SUMMARY Cisplatin-Fluorouracil-Trastuzumab Day One Cycle One 1. Trastuzumab 8mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 90 minutes. 2. Aprepitant 125mg oral 3. Dexamethasone 4mg oral or intravenous 4. Ondansetron 8mg oral or intravenous 5. Furosemide 40mg oral or intravenous 6. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 7. Cisplatin 80mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin/minute (minimum time 120 minutes) 8. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 9. Fluorouracil 4000mg/m2 continuous intravenous infusion over 96 hours in sodium chloride 0.9% 10. Chlorphenamine 10mg intravenous when required for infusion related reactions 11. Hydrocortisone 100mg intravenous when required for infusion related reactions 12. Paracetamol 1000mg oral when required for infusion related reactions Take Home Medicines 13. Aprepitant 80mg once a day for two days oral starting on day 2 of the cycle 14. Dexamethasone 4mg once a day for 3 days oral starting on day 2 of the cycle 15. Metoclopramide 10mg three times a day when required oral 16. Ondansetron 8mg twice a day for 3 days oral starting on the evening of day 1 of the cycle Day One Cycle Two Onwards 1. Trastuzumab 6mg/kg intravenous infusion in 250ml sodium chloride 0.9% over 30 minutes (if well tolerated at 90 minutes) Version 1.3 (July 2024) Page 8 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab 2. Aprepitant 125mg oral 3. Dexamethasone 4mg oral or intravenous 4. Ondansetron 8mg oral or intravenous 5. Furosemide 40mg oral or intravenous 6. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 7. Cisplatin 80mg/m2 intravenous infusion in 1000ml sodium chloride 0.9% with 20mmol potassium chloride at a maximum rate of 1mg cisplatin/minute (minimum time 120 minutes) 8. 1000ml sodium chloride 0.9% with 20mmol potassium chloride and 16mmol magnesium sulphate over 60 minutes 9. Fluorouracil 4000mg/m2 continuous intravenous infusion over 96 hours in sodium chloride 0.9% 10. Chlorphenamine 10mg intravenous when required for infusion related reactions 11. Hydrocortisone 100mg intravenous when required for infusion related reactions 12. Paracetamol 1000mg oral when required for infusion related reactions Take Home Medicines 13. Aprepitant 80mg once a day for two days oral starting on day 2 of the cycle 14. Dexamethasone 4mg once a day for 3 days oral starting on day 2 of the cycle 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 1 of the cycle Version 1.3 (July 2024) Page 9 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab DOCUMENT CONTROL Version Date Amendment Written By Approved By 1.3 July 2024 Trastuzumab updated with national dose banding Alexandra Pritchard Pharmacist Nanda Basker Pharmacist Updated monitoring with DPD 1.2 Nov 2020 testing Dose banding updated Coding removed Donna Kimber Pharmacy Technician Rebecca Wills Pharmacist Header changed Toxicities removed Pyridoxine removed from 1.1 supportive therapies July 2014 Mouthwashes updated Bolus removed throughout text Dr Deborah Wright Pharmacist Donna Kimber Pharmacy Technician Metoclopramide dose changed to 10mg Disclaimer added 1 Feb 2012 None Dr Deborah Wright Pharmacist Dr Tim Iveson 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 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 1.3 (July 2024) Page 10 of 10 GI (upper) – Cisplatin-Fluorouracil-Trastuzumab
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Upper-gastro-intestinal/Cisplatin-Fluorouracil-Trastuzumab.pdf

EC-PPH Cyclophosphamide Epirubicin Paclitaxel Pertuzumab Trastuzumab

Description
Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE-EPIRUBICIN-PACLITAXEL-PERTUZUMABTRASTUZUMAB (EC-PPH) Regimen • Breast Cancer – Cyclophosphamide-Epirubicin-Paclitaxel-PertuzumabTrastuzumab (EC-PPH) Indication • Neo
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/EC-PPH-Cyclophosphamide-Epirubicin-Paclitaxel-Pertuzumab-Trastuzumab.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

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
1 to 10 of 10