Experimental and clinical studies on aclarubicin in the treatment of solid tumors.

Experimental and clinical studies were performed on aclarubicin in the treatment of solid tumors. In experimental cancer chemotherapy using human tumor xenografts transplanted to nude mice, aclarubicin showed a moderate antitumor effect (retardation of tumor growth) and nearly the same spectrum of activity in vivo as Adriamycin (doxorubicin). In in vitro sensitivity tests using 3H-thymidine uptake inhibition of a single cell suspension prepared from xenografts, aclarubicin showed a stronger inhibition than that of Adriamycin, mitomycin C and cyclophosphamide. In phase II clinical studies in patients with solid tumors, 3 intravenous dose schedules [schedule A: 20 mg (equal to 14 mg/m2) daily every other week, schedule B: 40 to 60 mg (28 to 42 mg/m2) twice a week, and schedule C: 60 to 100 mg (42 to 70 mg/m2) once a week] were investigated. Aclarubicin produced a 15 to 20% response rate for carcinomas of the stomach, lung, breast and ovary by schedules A and B. Dose-schedule limiting factors were digestive and hematologic toxicity.