The National Surgical Adjuvant Breast and Bowel Project (NSABP) implemented protocol B-15 to compare 2 months of
Adriamycin (
doxorubicin; Adria Laboratories, Columbus,
OH) and
cyclophosphamide (AC) with 6 months of conventional
cyclophosphamide,
methotrexate, and
fluorouracil (CMF) in patients with
breast cancer nonresponsive to
tamoxifen (TAM, T). A second aim was to determine whether AC followed in 6 months by intravenous (IV) CMF was more effective than AC without reinduction
therapy. Through 3 years of follow-up, findings from 2,194 patients indicate no significant difference in disease-free survival (DFS, P = .5), distant disease-free survival (DDFS, P = .5) or survival (S, P = .8) among the three groups. Since the outcome from AC and CMF was almost identical, the issue arises concerning which regimen is more appropriate for the treatment of
breast cancer patients. AC seems preferable since, following
total mastectomy, AC was completed on day 63 versus day 154 for conventional CMF; patients visited health professionals three times as often for conventional CMF as for AC; women on AC received
therapy on each of 4 days versus on each of 84 days for conventional CMF; and
nausea-control medication was given for about 84 days to conventional CMF patients versus for about 12 days to patients on AC. The difference in the amount of
alopecia between the two treatment groups was less than anticipated. While
alopecia was almost universally observed following AC
therapy, 71% of the CMF patients also had
hair loss and, in 41%, the loss was greater than 50%. This study and NSABP B-16, which evaluates the worth of AC
therapy in TAM-responsive patients, indicate the merit of 2 months of AC
therapy for all positive-node
breast cancer patients.