Assessment of tamoxifen as adjuvant therapy in stage II breast cancer: a long-term follow-up.

Results of a prospective, randomized clinical trial of three treatment regimens--cyclophosphamide, methotrexate, and 5-fluorouracil (C); C plus the antiestrogen, tamoxifen citrate (CT); and CT plus bacillus Calmette-Guerin (CTBCG)--in 311 women with stage II breast cancer are reported. The data were analyzed by univariate (product limit and log rank) analysis and by multivariate analysis. Estrogen receptors were measured in all primary tumors. The mean follow-up period was 78.2 months. The regimens containing tamoxifen citrate significantly decreased the risk of recurrence in patients with positive estrogen receptors. The addition of tamoxifen does not, however, appear to provide an advantage in overall survival. No benefit in disease-free or overall survival was observed resulting from the addition of BCG to the treatment regimen. The design of the study did not permit an evaluation of the efficacy of the chemotherapy used inasmuch as all patients received it.