Clinical review of aclacinomycin A in Japan.

Single agent activity of aclacinomycin A or aclarubicin (ACR) for acute leukaemia in adults was as follows: complete remission was achieved in 8 of 21 (38%) with untreated patients and 7 of 41 (17%) with prior chemotherapy; thus the overall complete remission rate was 24%. The optimal dose schedule was 14 mg/m2/d daily i.v. administration, and a median total dose of 200 mg/m2 and 16 days were necessary for induction of complete remission. In combination, with behenoyl ara-C, ACR, 6-mercaptopurine and prednisolone, complete remission was achieved in 40 of 60 (67%) previously untreated patients, and 41 of 65 (63%) with prior chemotherapy; thus the overall rate was 65%. In a phase II study of ACR for solid tumours, response was achieved in carcinoma of oesophagus (1/3), stomach (12/84, 14%), gall bladder (1/4), pancreas (1/8), lung (4/30, 13%), breast (6/33, 18%), uterus (1/4), ovary (3/9, 33%), head and neck (1/5) and sarcoma (1/5). Side-effects of ACR most frequently observed were nausea and vomiting (around 30%) and a moderate grade marrow suppression was noted. An ECG change was observed in 7%, but there were no cases of chronic heart failure.