A phase II study of epirubicin in acute leukemia: a cooperative group study.

A new doxorubicin analogue, epirubicin (EPI), was evaluated in 41 patients with acute leukemia at 11 Japanese institutions participating in a phase II study between January 1983 and July 1985; during this period 35 patients were considered evaluable. There were 25 males and 10 females with a median age of 43 years (range, 19-71 years) and the median PS of 2 (range, 0-4). EPI was given to 25 patients who had previously been treated with intensive combination chemotherapy, of whom 22 had already received anthracyclines. Ten patients had not been treated previously. Two dose schedules were explored. The higher dose schedule (18 cases) consisted of the administration of 24 to 60 mg/m2 for 3 to 5 consecutive days, and the lower dose schedule (17 cases) consisted of 11 to 20 mg/m2 for 5 to 7 days. Remissions were obtained in 7 patients (20%), 2 of whom showed complete remission and 5 partial remission. The remission duration was 2, 2, 3, 5, 16, 16 and 29+ weeks, respectively. The expected myelosuppression was universal. Stomatitis occurred in 15 patients, of which 7 cases were severe. This stomatitis occurred frequently in the higher dose schedule, and was thought to be a dose-limiting factor. In others, alopecia, G.I. symptoms, and diarrhoea (4 patients) were seen. These results from a cooperative group study indicated that EPI was an effective drug for the treatment of acute leukemia.