Download FEC 75 (5-Fluorouracil, Epirubicin, Cyclophosphamide)

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