Journal of Clinical Oncology, Vol 1, 138-145, Copyright © 1983 by American Society of Clinical Oncology
A randomized trial of five and three drug chemotherapy and chemoimmunotherapy in women with operable node positive breast cancer
DC Tormey, VE Weinberg, JF Holland, RB Weiss, OJ Glidewell, M Perloff, G Falkson, HC Falkson, PH Henry and LA Leone
Women with breast carcinoma and four or more involved ipsilateral axillary
lymph nodes were randomly assigned to receive an induction course and 2 yr
of maintenance chemotherapy with cyclophosphamide, methotrexate and
5-fluorouracil (CMF, 150 patients), CMF plus vincristine and prednisone
(CMFVP, 166 patients), or chemoimmunotherapy with CMF plus the methanol
extraction residue of BCG (CMF-MER, 85 patients). After 5 yr of accrual and
a median follow-up of 34 mo, CMFVP is superior to CMF (p less than 0.01)
with disease-free survival estimates at 4 yr of 60% for CMFVP compared to
45% for CMF. The disease- free survival advantage of CMFVP over CMF was
greater in postmenopausal (p = 0.02) than in premenopausal patients (p =
0.09). CMF-MER was similar to CMF alone. CMF related side effects were
similar in each regimen (see text), except for a greater incidence of
leukopenia during induction with CMF than with CMFVP (p less than 0.01).
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