ABSTRACT

This randomized trial compared continuous chemotherapy administered to the point of disease progression with intermittent therapy in which treatment was given for three cycles, stopped, and then repeated for three more cycles only when evidence of disease progression occurred. The chemotherapy in each treatment arm was doxorubicin combined with cyclophosphamide (AC) or cyclophosphamide combined with methotrexate, 5-fluourouracil, and prednisone (CMFP). Continuous therapy resulted in a significantly better response rate (p 0.02), a significantly longer time to disease progression (relative risk 1.8, 95% confidence interval (CI) 1.4-2.4) and a trend toward longer survival (relative risk 1.3, 95% CI 0.99-1.6). Furthermore, quality of life, which improved significantly during the first three cycles in both treatment arms, was thereafter better with continuous therapy. Continuous therapy was associated with better scores for physical well-being, mood, and appetite, and for quality of life indices as indicated by the patient and the physician.