High-intensity therapy versus low-intensity therapy in advanced breast cancer patients.

The aim of this study was to evaluate the significance of response to the first two cycles of FEC (5-fluorouracil, 4-epirubicin, cyclophosphamide) in patients with advanced breast cancer. A total of 99 patients entered the study. They showed either high risk criteria and were previously untreated or showed low risk criteria and were pretreated by hormonal therapies. Eighty-two patients were evaluable. In 22 (27%) who had disease progression despite two cycles of FEC, further therapeutic attempts proved ineffective, the median survival being 2.8 months. The remaining patients responded either by stable disease (SD, n = 29; 35%), by partial or by complete remission (PR, CR, n = 31; 38%). These 60 patients were randomized to two regimes of maintenance therapy: FEC every 3 weeks or LMF (leukeran, methotrexate, 5-fluorouracil) every 6 weeks. The subsequent course of the disease was not different in both arms. It was neither influenced by the quality of early response, i.e. SD, PR, CR, nor by the intensity of chemotherapy. The prognostic impact of early response to two cycles of FEC proved to be higher than other prognostic parameters in the patients examined. Thus, early response may serve as a valid guide to adapt maintenance chemotherapy in individual patients with advanced breast cancer.