Abstract

AbstractThis article reports the 10‐year results of a trial testing radical mastectomy with or without adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) in 386 women with breast cancer and positive axillary lymph nodes. The long‐term analysis confirmed that adjuvant chemotherapy was able to produce a significant relapse‐free survival improvement (43.4%) versus control (31.4%,p<0.001) and a trend in total survival (55.2% versus 47.3%,p=0.10). Both relapse‐free survival and total survival benefit were significant in premenopausal women. Relapsefree survival was not influenced by drug‐induced amenorrhea. In both treatment groups, the results were inversely related to the number of histologically involved axillary nodes. On relapse, salvage treatment applied in the control group failed to produce superior results compared to those achieved in the CMF group and yielded a similar median survival from first relapse between control (37 months) and CMF (32 months) patients. The incidence of severe myelosuppression and hair loss was low (less than 10%) and reversible. Prolonged chemotherapy was not associated with an increased incidence of second neoplasms. We conclude that CMF, as given in this study, was able to improve the course of premenopausal women with high‐risk breast cancer during the first decade following radical mastectomy.

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