Weekly oral idarubicin in postmenopausal women with advanced breast cancer. A phase II study.

Sixty postmenopausal women with advanced breast cancer entered a phase II study, evaluating idarubicin (IDA) in a weekly schedule. Starting dose was 22.5 mg/m2, and median age was 65 years. Five patients were considered ineligible and the response rate among 55 eligible patients was 33%. Median time to treatment failure was 19 weeks and median duration of tumor regression for 18 responding patients was 40 weeks. Hematologic toxicity was moderate and non-hematologic toxicity was mild. The study shows that IDA, administered orally in a weekly schedule, has pharmacodynamic properties comparable to IDA in a 3-weekly schedule and to doxorubicin in the treatment of advanced breast cancer.