A randomized trial of two regimens of cyclophosphamide, methotrexate, 5-fluorouracil, and prednisone in advanced breast cancer.

One-hundred evaluable patients with progressive advanced breast carcinoma untreated by cytotoxic chemotherapy but resistant to hormone therapy and irradiation were randomly allocated to receive either a combination of cyclophosphamide (600 mg/m2), methotrexate (40 mg/m2), 5-fluorouracil (600 mg/m2) IV every 3 weeks and prednisone 20 mg/m2 PO daily, with diminishing doses (intermittent group), or a combination of cyclophosphamide (100 mg/m2 PO on days 1-15, alternating with a 15-day rest period), methotrexate 20 mg/m2 IV, 5-fluorouracil 500 mg/m2 IV weekly for 20 weeks and prednisone 20 mg/m2 PO daily, with diminishing doses in the remission induction period, followed by a maintenance regimen of cyclophosphamide 100 mg/m2 PO on days 1-15, methotrexate 20 mg/m2 IV on days 1, 8 and 15, 5-fluorouracil 500 mg/m2 IV on days 1, 8, and 15, and prednisone 20 mg/m2 PO on days 1-15, with a 3-week rest period between the courses (intensive group). Entry was from 1 December 1982 to 30 November 1983. Objective responses were seen in 20/49 (41%) patients in the intermittent group and 34/51 (67%) in the intensive group (chi 2 = 6.72; P less than 0.01). The estimated median duration of response was 11 months in the intermittent group and 14 months in the intensive group. The estimated median survival was greater in the intensive group, but the difference was not statistically significant, although this parameter can be influenced with alternative additional chemotherapy. Toxicity was similar in both groups. These data suggest there are no therapeutic and survival advantages to the 3-weekly IV protocol compared with our previous regimen CMFP.

RCT Entities:   Population Interventions Outcomes