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Journal of Clinical Oncology, Vol 23, No 22 (August 1), 2005: pp. 5166-5170
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.09.423
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Randomized Trial Comparing Cyclophosphamide, Epirubicin, and Fluorouracil With Cyclophosphamide, Methotrexate, and Fluorouracil in Premenopausal Women With Node-Positive Breast Cancer: Update of National Cancer Institute of Canada Clinical Trials Group Trial MA5

Mark N. Levine, Kathleen I. Pritchard, Vivien H.C. Bramwell, Lois E. Shepherd, Dongsheng Tu, Nancy Paul

From the Departments of Clinical Epidemiology and Biostatistics and Medicine, McMaster University, Hamilton; University of Toronto, Toronto; Queen's University, Kingston, Ontario; and Department of Oncology, University of Calgary, Calgary, Alberta, Canada

Address reprint requests to Mark Levine, MD, Clinical Trials Methodology Group, Henderson Research Centre, 711 Concession St, Hamilton, Ontario, Canada L8V 1C3; e-mail: mlevine{at}mcmaster.ca

PURPOSE: Certain anthracycline-containing adjuvant chemotherapy regimens are associated with improved relapse-free survival (RFS) and overall survival (OS) compared with the classic regimen of cyclophosphamide, methotrexate, and fluorouracil in women with early-stage breast cancer.

PATIENTS AND METHODS: Between 1989 and 1993, 710 pre- and perimenopausal women with axillary node–positive breast cancer were randomly assigned to either cyclophosphamide 75 mg/m2 orally days 1 through 14, epirubicin 60 mg/m2 intravenously days 1 and 8, and fluorouracil 500 mg/m2 intravenously days 1 and 8 (CEF) or CMF (cyclophosphamide 100 mg/m2 orally days 1 through 14, methotrexate 40 mg/m2 intravenously days 1 and 8, and fluorouracil 600 mg/m2 intravenously days 1 and 8). On the basis of follow-up to May 1997 (median follow-up time, 59 months), there was a statistically significant improvement in RFS and OS for CEF compared with CMF.

RESULTS: The trial results are now updated, with a median follow-up of 10 years for live patients. The 10-year RFS is 52% for patients who received CEF compared with 45% for CMF patients (hazard ratio [HR] for CMF v CEF = 1.31; stratified log-rank, P = .007). The 10-year OS for patients who received CEF and CMF are 62% and 58%, respectively (HR for CMF v CEF = 1.18; stratified log-rank, P = .085). The rates of acute leukemia have not changed since the original report, whereas the rates of congestive heart failure are slightly higher but acceptable (four patients [1.1%] in the CEF group v one patient [0.3%] in the CMF group).

CONCLUSION: The previously demonstrated benefit of CEF compared with CMF adjuvant chemotherapy is maintained with longer follow-up in the MA5 trial.

Supported in part by a grant-in-aid from Pharmacia Inc (now Pfizer).

Presented in part at the 25th Annual San Antonio Breast Cancer Symposium, San Antonio, TX, December 10-14, 2002.

Authors' disclosures of potential conflicts of interest are found at the end of this article.


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