[A randomized trial of adriamycin, cyclophosphamide, ftorafur (ACF) and adriamycin, cyclophosphamide, ftorafur, methotrexate (ACFM) in patients with advanced breast cancer].

A prospective randomized trial was conducted to compare the clinical responses of sixty patients with advanced breast cancer to a combination of adriamycin, cyclophosphamide and oral ftorafur (ACF), or to a combination of ACF plus methotrexate (ACFM). The response rate was 12/28 (43%) for ACF compared with 18/30 (60%) for ACFM. Responses were seen more frequently in the cases which had less than 2 organs involved and responses of dominant metastatic sites were equal for the two arms. The duration of response for ACF was 21+ (3.5-49.5+) months as compared to 6.9 (1.9-30.8) months for ACFM (p less than 0.05). The median survival time from the start of chemotherapy for ACF was 20.8+ months, while that for ACFM was 13+ months. The major non-hematological toxicities were hair loss and GI symptoms. Hematological toxicity was similar in the two arms and manageable. No serious cardiac, renal and liver damage was seen in either arm. The response rate for ACFM was higher than that in ACF, but the addition of methotrexate to the ACF regimen did not increase complete response and prolong response duration.