Amsacrine in refractory adult acute leukemia: a pilot study of the Southeastern Cancer Study Group.

A phase II pilot study of amsacrine in refractory adult acute leukemia was conducted by the Southeastern Cancer Study Group from May 1979 to August 1980. Amsacrine, 90 mg/m2, was given daily for 5-8 days to 45 patients with acute myeloblastic leukemia, 15 patients with acute lymphoblastic leukemia, and six patients with blastic transformation of chronic granulocytic leukemia. Of the 66 patients entered in the study, 59 (89%) were evaluable for response. Complete remissions were observed in eight of 41 evaluable patients with acute myeloblastic leukemia (20%) and in three of 12 with acute lymphoblastic leukemia (25%). Remissions were short-lived (median, 7.9 weeks; range, 2-27). Toxic effects included the expected myelosuppression (100%), as well as moderate to severe stomatitis (46%), hyperbilirubinemia (30%), and supraventricular tachycardia (1.5%). This cooperative group pilot study confirms previous reports from single institutions that amsacrine is a useful drug in the treatment of refractory adult acute leukemia and is worthy of further study.