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FEC 75 (5-Fluorouracil, Epirubicin, Cyclophosphamide) Cumbria, Northumberland, Tyne & Wear Area Team DRUG ADMINISTRATION SCHEDULE Day Drug Dose Route Diluent & Rate 1 Sodium Chloride 0.9% 250/500ml Infusion Fast Running 1 Dexamethasone 8mg Oral Over at least 2 minutes Oral 1 Ondansetron 8mg 1 Fluorouracil 600mg/m2 Intravenous Via fast running NaCl Drip 1 Epirubicin 75 mg/m2 Intravenous Via fast running NaCl Drip 1 Cyclophosphamide 600mg/m2 Intravenous Via fast running NaCl Drip *Ondansetron IV must be infused over 15 minutes in patients over 65 years of age. NUMBER OF DAYS PER CYCLE 21 DAYS for 6 cycles APPROVED INDICATIONS Adjuvant Treatment for breast cancer PREMEDICATI ON As above PREMEDICATI ON Ondansetron and Dexamethasone IV prior to FEC. RECOMMENDED TAKE HOME MEDICATION Oral Ondansetron 8mg Twice Daily for 2 to 3 days Oral Dexamethasone 4mg Twice Daily for 1 to 3 days Oral Metoclopramide 10mg Three Times Daily INVESTIGATIONS / MONITORING REQUIRED Baseline: - FBC, LFTs. U&Es - CXR, Bone Scan, Liver Ultra-sound Scan (as per unit guidelines) – but recommended in ≥ 4 positive lymph nodes. - ECG prior to commencement of treatment - ECHO/MUGA scan pre- treatment and alternative cycles if significant cardiac history, or previous anthracycline therapy. Before each treatment: - FBC, U&Es, LFTs ASSESSMENT OF RESPONSE There will be no visible disease to monitor as this is adjuvant treatment. BO21-FEC-75-protocol-CRP09-v1.3 Issued 29 May 2014 Page 1 of 3 Expiry Date: 29 May 2016 FEC 75 (5-Fluorouracil, Epirubicin, Cyclophosphamide) Cumbria, Northumberland, Tyne & Wear Area Team REVIEW BY CLINICIAN To be reviewed by either a Nurse, Pharmacist or Clinician before every cycle. NURSE / PHARMACIST LED REVIEW On cycles where not seen by clinician. ADMINISTRATION NOTES - Epirubicin in vesicant and must be given through a fast running drip Risk of cardiotoxicity with cumulative doses of Epirubicin. Seek advice if the total lifetime dose of Doxorubicin will exceed 900 mg/m2 EXTRAVASATION See NECN/Local Policy TOXICITIES • • • • • • • • Nausea & Vomiting Total Alopecia Stomatitis / Mucositis Cardiomyopathy and arrhythmia's Haemorrhagic cystitis due to cyclophosphamide. Encourage patient to drink 2 to 3 litres of fluid a day. Myelosuppression. Nail Pigmentation Patients with heart disease may experience coronary artery spasm with 5-FU DOSE MODIFICATION Haematological Toxicity: Delay 1 week if WBC<3.0, ANC <1.0 Platelets <100 No dose modification for CTC grade I/II ANC Grade III/IV ANC → delay chemotherapy until recovered. On recovery give 25% dose reduction Note: GCSF should be considered for secondary prophylaxis in adjuvant therapy after an episode of febrile neutropenia or neutropenic sepsis. Single dose Pegylated GCSF is preferred. Non- Haematological Toxicity: If patient has Grade III/IV nausea & vomiting give Oral Ondansetron 8mg BD for 5 days & Dexamethasone 4mg QDS for 1 day and then Dexamethasone 4mg once daily for a further 4 to 5 days. Alternatively consider adding in Aprepitant (or refer to NECN antiemetic guideline). Hepatic Dysfunction: Bilirubin Epirubicin Dose < 19µmol/l 20 - 51µmol/l > 51µmol/l 100% 50% 25% BO21-FEC-75-protocol-CRP09-v1.3 Issued 29 May 2014 Cyclophosphamide Dose 100% 100% 100% 5Fu Dose 100% 100% 100% Page 2 of 3 Expiry Date: 29 May 2016 FEC 75 (5-Fluorouracil, Epirubicin, Cyclophosphamide) Cumbria, Northumberland, Tyne & Wear Area Team Renal Dysfunction: CrCl (or GFR) Epirubicin Dose > 20 ml/min 10-20 ml/min <10 ml/min 100% 100% 100% Cyclophosphamide Dose 100% 75% 50% 5Fu Dose 100% 100% 100% TREATMENT LOCATION Suitable for administration within Cancer Units and Cancer Centres REFERENCES: 1. Benefit of a High-Dose Epirubicin Regimen in Adjuvant Chemotherapy for NodePositive Breast cancer Patients with Poor Prognostic Factors: 5-Year Follow-up Results of French Adjuvant Study Group 05 Randomized Trial; Journal of Clinical Oncology, Vol 19, No 3 (Feb 1), 2001: pp 602-11 Comment in: Journal of Clinical Oncology, Vol 19, No 3 (Feb 1), 2001: pp 599- 601. 2. Bonneterre J., Roche H., Kerbrat P., Bremond A., Fumoleau P., Namer P., Goudier M., Schraub S., Fargeot P., Chapelle-Marcillac I.; Epirubicin Increases long-term Survival in Adjuvant Chemotherapy of patients with Poor-Prognosis, Node-Positive, Early Breast Cancer: 10-Year Follow-up Results of the French Adjuvant Study Group 05 Randomized Trial; Journal of Clinical Oncology, Vol 23, No 12 (April 20), 2005: pp 2686-93 3. Levine MN, Bramwell VH, Pritchard KI et al. Randomized trial of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. J Clin Oncol 1998;16(8):2651-8. Document Control Document Title: FEC 75 protocol CRP09 B019 Document No: CRP09 B021 Author: Current Version: Steve Williamson, Consultant Pharmacist Approval Signature* Calum Polwart, Cancer Pharmacist Nicola Storey, Consultant Oncologist Date Approved: Approved by: 1.3 29 May 2014 Due for Review: June 2014 Summary of Changes 1.1 Version agreed 1.2 Protocol reviewed. Anti-emetics reviewed. Renal impairment advice amended 1.3 Protocol reviewed and reissued, Antiemetic advice updated BO21-FEC-75-protocol-CRP09-v1.3 Issued 29 May 2014 Page 3 of 3 Expiry Date: 29 May 2016