[A phase I study of 4'-epi-adriamycin, a new anthracycline anticancer agent]

A phase I study of 4'-Epi-Adriamycin, a new derivative of Adriamycin, was carried out in 36 cases with various malignant tumors, among which 30 cases were evaluable. Starting dose was 10 mg/m2 and this was increased up to 80 mg/m2. The dose limiting factor was leukopenia. Leukocyte nadir was reached about two weeks after administration and about nine days (mean) were needed for recovery. Other main side effects were anorexia, nausea vomiting, and alopecia. These side effects were mainly observed in cases given doses of over of 60 mg/m2. However, there were only a few serious cases suggesting that the clinical toxicities of 4'-Epi-Adriamycin were milder than those of Adriamycin. From the result of this study, it appeared that maximum tolerated dose of the drug is 80 mg/m2, and the dose recommended for the phase II study is 60 mg/m2 every three weeks.