Vindesine-mitoxantrone (VM) versus vindesine-4'-epidoxorubicin (VE) in metastatic breast cancer: a prospective randomized trial

182 patients with metastatic breast cancer were randomized to V (mg/m2 i.v.) and M (10 mg/m2 i.v.) or E (40 mg/m2 i.v.) every 3 weeks x 3 and then every 4 weeks; they were stratified by sites of disease (visceral, bone, or soft-tissue dominant) and by prior chemotherapy. In a preliminary analysis there is a significant difference regarding frequency of alopecia (WHO Grade 3 or 4) favoring regimen VM; gastrointestinal, hematologic and neurotoxic side effects were mild and similar for both groups. Of 114 evaluable women there is a response rate (CR + PR) of 26% and 34% for VM and VE respectively (n.s.), and there is no significant difference between the 2 groups in time to progression and survival. Both regimens are well tolerated and seem to be equally effective. The median follow-up time is too short to draw final conclusions.