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Capecitabine 1250 (14)

Description
Chemotherapy Protocol BREAST CANCER CAPECITABINE 1250 (14 day) Regimen • Breast Cancer – Capecitabine 1250 (14 day) Indication • Treatment of locally advanced or metastatic breast cancer where there has been an inadequate response to anthracycline containing therapy or when further anthracycline therapy is contra-indicated • WHO Performance status 0, 1, 2 Toxicity Drug Adverse Effect Capecitabine Palmar-plantar erythrodysesthesia, diarrhoea, mucositis, chest pain 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 • 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. 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. Version 1.2 (November 2020) Page 1 of 6 Breast – Capecitabine 1250 (14 day) Haematological Prior to prescribing cycle one the following treatment criteria must be met; Criteria Eligible Level Neutrophil equal to or more than 1x109/L Platelets equal to or more than 100x109/L Consider blood transfusion if patient symptomatic of anaemia or has a haemoglobin of less than 8g/dL On subsequent cycles if the counts on day one are below these criteria for neutrophil and/or platelets then delay treatment for seven days. Treatment should only be restarted when these levels are reached. The capecitabine may be resumed at the original dose or where the delay has been longer than seven days or has occurred for a second time with 80% of the original dose. If these levels are not reached despite a dose reduction consider stopping therapy. Liver Impairment Drug Capecitabine Dose (% of original dose) There is a lack of information available. In patients with mild to moderate hepatic dysfunction due to liver metastases, 100% of the dose dose is probably acceptable. Renal Impairment Drug Capecitabine Creatinine Clearance (ml/min) 51-80 30-50 less than 30 Dose (% of original dose) 100% 75% C/I 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 and palmar-plantar erythrodysesthesia among others. If chest pain occurs consider stopping capecitabine. NCI-CTC Grade 2 Interrupt treatment until the toxicity resolves to NCI-CTC grade 1 or below then continue at the same dose. If the toxicity recurs for a second time again interrupt treatment until it resolves to NCI-CTC grade 1 or below 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 1 or below then continue at 50% of the original dose. Stop treatment if the toxicity re-appears on a fourth instance. Version 1.2 (November 2020) Page 2 of 6 Breast – Capecitabine 1250 (14 day) NCI-CTC Grade 3 Interrupt treatment until the toxicity resolves to NCI-CTC grade 1 or below 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 NCICTC grade 1 or below 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 1 or below. When capecitabine is stopped for toxicity, the doses are omitted and not delayed. Regimen 21 day cycle for 6 cycles Drug Capecitabine Dose 1250mg/m2 twice a day Days 1-14 incl. Administration Oral Dose Information • Capecitabine will be dose banded in accordance with the national dose bands Administration Information • Capecitabine should start on the evening of day 1 • Capecitabine should be taken with or after food Additional Therapy • Antiemetics As take home medication; - metoclopramide 10mg three times a day when required oral • Loperamide 4mg oral 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 policy on the treatment of mucositis. • Gastric protection with a proton pump inhibitor or H2 antagonist may be considered in patients considered at high risk of GI ulceration or bleed. Version 1.2 (November 2020) Page 3 of 6 Breast – Capecitabine 1250 (14 day) 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. Reichardt P, von Minckwitz G, Thuss-Patience PC et al. Multicentre phase II study or oral capecitabine (“Xeloda”) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol 2003; 14 (8): 1227-33. Version 1.2 (November 2020) Page 4 of 6 Breast – Capecitabine 1250 (14 day) REGIMEN SUMMARY Capecitabine 1250 (14 day) Day One 1. Capecitabine 1250mg/m² twice a day for 14 days oral 2. Metoclopramide 10mg three times a day when required oral Version 1.2 (November 2020) Page 5 of 6 Breast – Capecitabine 1250 (14 day) DOCUMENT CONTROL Version Date Amendment Updated monitoring with DPD testing 1.2 Nov 2020 Dose banding statement updated Coding removed Header changed Toxicities removed Information tabulated throughout ≥ removed and written in full 1.1 August Hepatic and renal 2014 impairment updated Metoclopramide dose changed to 10mg Mucositis recommendation changed Disclaimer added 1 June 2011 None Written By Donna Kimber Pharmacy Technician Donna Kimber Pharmacy Technician Anna Bunch Pharmacist Approved By Rebecca Wills Pharmacist Dr Debbie Wright Pharmacist Dr Ellen Copson Consultant Medical Oncologist Dr Debbie Wright Pharmacist Dr Caroline Archer Consultant Medical Oncologist This chemotherapy protocol has been developed as part of the chemotherapy electronic prescribing project. This was and remains a collaborative project that originated from the former CSCCN. These documents have been approved on behalf of the following Trusts; Hampshire Hospitals NHS Foundation Trust NHS Isle of Wight Portsmouth Hospitals NHS Trust Salisbury Hospital NHS Foundation Trust University Hospital Southampton NHS Foundation Trust Western Sussex Hospitals NHS Foundation Trust All actions have been taken to ensure these protocols are correct. However, no responsibility can be taken for errors which occur as a result of following these guidelines. Version 1.2 (November 2020) Page 6 of 6 Breast – Capecitabine 1250 (14 day)
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Capecitabine1250-14.pdf

Capecitabine 1000 (14)

Description
Chemotherapy Protocol BREAST CANCER CAPECITABINE 1000 (14 day) Regimen • Breast Cancer – Capecitabine 1000 (14 day) In
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/Capecitabine1000-14.pdf

Cyclophosphamide-Epirubicin (60)-Fluorouracil (FE60C)

Description
Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE-EPIRUBICIN (60)- FLUOROURACIL Regimen (FE60C) • Breast Cancer – Cyclophosphamide-Epirubicin (60)-Fluorouracil (FE60C) Indication • Metastatic breast cancer
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/FE60C.pdf

Cyclophosphamide (PO)-Fluorouracil-Methotrexate (CMF PO)

Description
Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE (PO)-FLUOROURACIL-METHOTREXATE (CMF-PO) Regimen • Breast Cancer – Cyclophosphamide
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/CyclophosphamideFluorouracilMethotrexateCMF-PO.pdf

Cyclophosphamide (IV)-Fluorouracil-Methotrexate (CMF IV)

Description
Chemotherapy Protocol BREAST CANCER CYCLOPHOSPHAMIDE–FLUOROURACIL-METHOTREXATE (CMF IV) Regimen • Breast Cancer – Cyclophosphamide I
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Breastcancer/CyclophosphamideFluorouracilMethotrexateCMF-IV.pdf

Lomustine-Procarbazine-Vincristine (PCV) ver 1.1

Description
Chemotherapy Protocol Central Nervous System LOMUSTINE-PROCARBAZINE-VINCRISTINE (PCV) Regimen CNS – Lomustine-Procarbazine-Vincristine (PCV) Indication Adjuvant treatment for grade III
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/CNS/Lomustine-Procarbazine-Vincristine-PCV-ver-1.1.pdf

DA_3+8_CADD

Description
Chemotherapy Protocol ACUTE MYELOID LEUKAEMIA Ambulatory Regimen AmB - DA (3+8) CADD–Cytarabine-Daunorubicin Regimen • Acute Myeloid Leukaemia – AmB - DA (3
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/AML/DA-3-8-CADD.pdf

DA_3+10

Description
Chemotherapy Protocol ACUTE MYELOID LEUKAEMIA DA (3+10)–Cytarabine-Daunorubicin In-Patient Regimen Regimen • Acute Myeloid Le
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/AML/DA-3-10.pdf

Cisplatin and Topotecan

Description
Chemotherapy Protocol GYNAECOLOGICAL CANCER CISPLATIN-TOPOTECAN (intravenous) Regimen Cervix-Cisplatin-Topotecan IV Indication Recurrent stage IVB cervical cancer in patients who
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Cervical-cancer/CisplatinandTopotecan.pdf

Cisplatin (40) and Radiotherapy

Description
Chemotherapy Protocol GYNAECOLOGICAL CANCER CISPLATIN (40)-RADIOTHERAPY Regimen Cervix-Cisplatin (40)-Radiotherapy Indication Locally advanced cervical, vaginal and vulval cancer with
Url
/Media/UHS-website-2019/Docs/Chemotherapy-SOPs1/Cervical-cancer/Cisplatin40andRadiotherapy.pdf
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