4-Demethoxydaunorubicin administered orally in advanced breast cancer. A phase II study

Twenty-five patients with advanced breast cancer were treated with 4-demethoxydaunorubicin (4-DMDR), a new antitumor analogue of daunorubicin, at the dose of 15-20 mg/m2/day x 3 days by oral route every 3-4 weeks. All patients were previously treated with chemotherapy and/or hormone therapy but none with anthracyclines. Of 23 evaluable patients, 1 complete and 5 partial remissions (26%) were observed for a median duration of 4+ months. Leukopenia and nausea occurred in 61% of the patients, vomiting in 30%, diarrhea in 17% and alopecia in 43%. There were 2 cases with minimal and transient EKG variations. 4-DMDR, administered orally in advanced breast cancer, was found to be generally well tolerated. Nevertheless, randomized trials with adriamycin or epirubicin are necessary to compare and to define the therapeutic activity and the toxicity of 4-DMDR.