Results of clinical trials with a CMitF (cyclophosphamide, mitoxantrone, and 5-fluorouracil) regimen versus a CAF (cyclophosphamide, adriamycin, and 5-fluorouracil) regimen in advanced/relapsed breast cancer
Taguchi, T.; Sakai, K.; Terasawa, T.; Wada, H.
Gan to Kagaku Ryoho. Cancer and ChemoTherapy 13(9): 2820-2828
1986
ISSN/ISBN: 0385-0684 PMID: 3530139 Document Number: 285151
Randomized clinical trials were conducted in patients with advanced/relapsed breast cancer, using CMitF (mitoxantrone, cyclophosphamide, and 5-fluorouracil) regimen in comparison with CAF (cyclophosphamide, adriamycin, and 5-fluorouracil) regimen. The response rate was 50% (13/26) for the CMitF group and 50% (10/20) for the CAF group. Classified by disease site, CAF group showed a tendency for a higher response rate in soft tissue, but in bone and viscera the rates were similar for both regimen groups. The median weeks to response (range) was 5 (3-21) weeks for the CMitF group, and 8 (3-22) weeks for CAF group, a tendency for slightly earlier response thus being shown in the CMitF group. The median duration of response (range) was 10 (4-47) weeks for the CMitF group, and 9 (4-50) weeks for CAF group, whereas by the method of Kaplan-Meier, at 40 weeks after the start of therapy, the proportion showing response still continued to be 60% for the CMitF group, which was a higher rate than the 27% for CAF group. The survival rate at 48 weeks was for both groups with no difference shown. Leukopenia, gastrointestinal symptoms and alopecia were major side effects in both groups, but the incidence and severity grade of gastrointestinal symptoms (nausea and vomiting) and alopecia were significantly less in the CMitF group than in CAF group. In both groups, the WBC nadir was 2,100/microliter and the time to nadir was 14 days, with no difference shown in hematological toxicity between the two groups. No severe cardiac, hepatic, or renal toxicity was noted.