Epirubicin-Cyclophosphamide-EC-Breast-Protocol-CRP09-B013v1-4.Pdf

EC (Epirubicin and Cyclophosphamide)

DRUG ADMINISTRATION Day Drug Daily Dose Route Diluent Rate Fast Sodium Chloride 0.9% 250/500ml Infusion Running Dexamethasone 8mg Oral

Day 1 Ondansetron 8mg Oral /Slow bolus/15 min infusion Via saline Epirubicin 75 or 90 mg/m2 IV Bolus drip Via saline Cyclophosphamide 600 mg/m2 IV Bolus 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 and Metastatic Breast Cancer  Epirubicin 90 mg/m2 used in adjuvant treatment;  Epirubicin 75 mg/m2 used in metastatic setting

PREMEDICATION As above

RECOMMENDED TAKE HOME MEDICATION Ondansetron 8mg twice daily for 2 to 3 days Dexamethasone 4mg twice daily for 1 to 3 days Metoclopramide 10 mg three times daily as required Suggested antiemetic regimen - may vary with local practice. See CINV policy for more details

INVESTIGATIONS / MONITORING REQUIRED FBC prior to each cycle LFT’s & U&E's every cycle ECG prior to commencement of treatment ECHO/MUGA scan pre- treatment and alternative cycles if significant cardiac history, or previous anthracycline therapy.

ASSESSMENT OF RESPONSE Metastatic: Tumour size and patient symptomatic response Adjuvant There will be no visible disease to monitor for adjuvant treatment.

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.

Epirubicin Cyclophosphamide (EC) breast-protocol-CRP09 B013v1 4 Page 1 of 3 Issue Date 28.02.18 Expiry Date: 01.03.2021

EC (Epirubicin and Cyclophosphamide)

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 Epirubicin will exceed 900 mg/m2

EXTRAVASATION See NCA / local Policy Epirubicin very vesicant must take prompt action if extravasation occurs.

TOXICITIES  Nausea & Vomiting  Total Alopecia  Stomatitis / Mucositis  Cardiomyopathy and arrhythmias  Haemorrhagic cystitis due to cyclophosphamide. Encourage patient to drink 2 to 3 litres of fluid a day.  Myelosuppression  Dry Skin

DOSE MODIFICATION Haematological Toxicity: Delay 1 week if 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 can be considered for secondary prophylaxis in adjuvant therapy after an episode of febrile neutropenia or neutropenic sepsis.

Non- Haematological Toxicity: Care must be taken if the patient has abnormal LFT’s. Bilirubin Epirubicin dose Cyclophosphamide Dose < 21 µmol/l 100% 100% 21 – 51 µmol/l 50% 100% > 51 µmol/l 25% 100%

If the AST, ALT or Alk Phos are abnormal in the absence of progressive disease, the following dose modifications should apply AST/ALT Alk Phos Epirubicin dose Cyclophosphamide Dose 2.5 – 5 x ULN ≤ 2.5 x ULN 75% 100% 2.5 – 5 x ULN 2.5 – 5 x ULN 75% 100% > 5 x ULN > 5 x ULN 50% or omit 100%

Renal Function CrCl (or GFR) Epirubicin Dose Cyclophosphamide Dose > 20 ml/min 100% 100% 10-20 ml/min 100% 75% <10 ml/min 100% 50%

Epirubicin Cyclophosphamide (EC) breast-protocol-CRP09 B013v1 4 Page 2 of 3 Issue Date 28.02.18 Expiry Date: 01.03.2021

EC (Epirubicin and Cyclophosphamide)

TREATMENT LOCATION Suitable for administration within Cancer Units and Cancer Centres

REFERENCES:

1. Early Breast Cancer Trialists Collaborative Group (1998). Lancet: 352: 930-42. 2. Fisher B et al (1997) J Clin Oncol; 15: 2483-93 3. Heidemann E, Steinke B, Harlapp J, et al. Randomized clinical trial comparing mitoxantron with doxorabicin, and with epirubicin, each combined with cyclophosphamide in the first line treatment of patients with metastatic breast cancer. Oncol 1990; 13: 27-7

Document Control Document Title: EC breast protocol CRP09 B013 Current Document No: CRP09 B013 Version: 1.4 Reviewer: Chris Beck Chemotherapy Pharmacist Date 28.02.18 Northern Cancer Alliance Approved: Approved by: Steve Williamson Consultant Due for 01.03.21 Pharmacist Northern Cancer Alliance Review Summary of Changes 1.1 Reformatted from old NCN/CCA version Protocol reviewed. Typing errors corrected. Anti-emetic advice reviewed.

1.2 Renal impairment advice added. 1.3 Protocol reviewed and reissued, Antiemetic advice updated Protocol reviewed & updated with Chemocare parameters, Epirubicin Dose 1.4 standardised to 75 and 90 mg/m2

Epirubicin Cyclophosphamide (EC) breast-protocol-CRP09 B013v1 4 Page 3 of 3 Issue Date 28.02.18 Expiry Date: 01.03.2021