Journal of Clinical Oncology, Vol 14, 35-45, Copyright © 1996 by American Society of Clinical Oncology
Adjuvant cyclophosphamide, methotrexate, and fluorouracil versus fluorouracil, epirubicin, and cyclophosphamide chemotherapy in premenopausal women with axillary node-positive operable breast cancer: results of a randomized trial. The International Collaborative Cancer Group
RC Coombes, JM Bliss, J Wils, F Morvan, M Espie, D Amadori, P Gambrosier, M Richards, M Aapro, A Villar-Grimalt, C McArdle, FR Perez-Lopez, P Vassilopoulos, EP Ferreira, CE Chilvers, G Coombes, EM Woods and M Marty
Medical Oncology Unit, Charing Cross Hospital, United Kingdom.
PURPOSE: To determine whether a combination chemotherapy regimen that
contains epirubicin (fluorouracil, epirubicin, and cyclophosphamide [FEC])
is superior to the standard cyclophosphamide, methotrexate, and
fluorouracil (CMF) combination in premenopausal women with axillary
node-positive operable breast cancer. PATIENTS AND METHODS: The
International Collaborative Cancer Group (ICCG) conducted a large
randomized trial in which two alternative schedules were used according to
participating center: CMF1 versus FEC1 and CMF2 versus FEC2. RESULTS: Seven
hundred fifty-nine patients were entered onto the trial. At a median
follow-up time of 4.5 years, no significant benefit for the
anthracycline-containing regimen was observed in terms of relapse-free (P =
.61) or overall survival (P = .13). FEC1 and CMF1 appear to be of similar
efficacy, but there is a suggestion that FEC2 may be superior to CMF2,
since patients who received FEC2 had improved overall (P = .02) and
relapse-free survival (P = .03) rates. Nausea and vomiting and alopecia
were more common in the epirubicin-containing regimen (P = .001).
CONCLUSION: We conclude that the FEC2 regimen, in which epirubicin replaced
the methotrexate in CMF, is the preferable adjuvant chemotherapy regimen
for premenopausal patients with operable axillary node-positive breast
cancer.
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