Results of adjuvant chemotherapy trials in breast cancer at M. D. Anderson Hospital and Tumor Institute.

Between 1974 and 1982, 796 patients with operable breast cancer following local therapy were treated with 3 consecutive doxorubicin-containing adjuvant therapy trials. The median follow-up of patients entered on the first trial was 102 months; the second trial, 71 months; and for the third trial, 41 months. The treatment program consisted of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC). We altered the study designs to determine the role of nonspecific immunotherapy with BCG and postoperative irradiation in the second trial and the impact of additional chemotherapy with alternate drugs after completion of FAC in the third trial. In the first study, an overall 39% reduction in mortality was observed, and, in stage II disease, reductions of 54% and 37% in mortality were observed for patients less than 50 and greater than or equal to 50 years of age, respectively, in comparison to the historical control group. The data of the second trial illustrated that BCG and postoperative irradiation had no significant impact on the disease-free and overall survival. In the third trial, patients with estrogen receptor-positive tumor treated with additional chemotherapy with alternate drugs following completion of FAC had significantly superior disease-free survival compared with patients who did not receive additional chemotherapy. The results of 3 studies show that intensive combination chemotherapy significantly reduced the risk of recurrence and death in patients with breast cancer.