A RANDOMIZED STUDY OF MITOXANTRONE PLUS CYTARABINE VERSUS DAUNOMYCIN PLUS CYTARABINE IN THE TREATMENT OF PREVIOUSLY UNTREATED ADULT PATIENTS WITH ACUTE NONLYMPHOCYTIC LEUKEMIA

Between May 1985 and November 1988, 143 adult patients with previously untreated acute nonlymphocytic leukemia were randomized to receive mi toxantrone and cytarabine (MTT + Ara-C) or daunomycin and cytarabine ( DNM + Ara-C) in order to compare the efficacy and acute and chronic to xicities. Therapy consisted of 3 days of MTT 12 mg/m(2)/i.v. or DNM 45 mg/m(2)/i.v.; both groups received Ara-C 100 mg/m(2) dally by continu ous infusion (CI) for 7 days. Those who failed to achieve a complete r emission after one induction course received a second induction course for 2 and 5 days at the same doses. All the patients who achieved com plete remission received two consolidations of 2 days of MTT or DNM an d 5 days of Ara-C in CI at the same dose as for induction. Of the 72 p atients on MTT + Ara-C, 38 (53%) achieved complete remission, compared with 29 (43%) of 67 treated with DNM + Ara-C. Three and 5 patients ha d partial remission, 7 and 18 failed to respond, 24 and 15 died in the first 21 days of induction, of those treated with MTT + Ara-C or DNM + Ara-C, respectively (p = 0.34). Median duration of complete remissio n and survival was 185 and 103 days or 165 and 160 days, respectively (p = 0.85). More early deaths were observed with MTT + Ara-C due to gr eater myelosuppression, and a higher incidence of failure with DNM + A ra-C. No significant differences between treatment groups were observe d in 21 categories of adverse events. The results demonstrate similar incidence of complete response, length of duration of complete remissi on, overall survival, and toxicity with MTT + Ara-C and DNM + Ara-C.