[Phase II trial of mitoxantrone in patients with relapsed and refractory acute leukemia]

Mitoxantrone, a new anthracenedione, was administered to twenty-five evaluable patients with relapsed or refractory acute leukemia between January 1982 and September 1984. Two patients were not evaluable because of early death. There were 18 males and 7 females with a median age of 42 yrs (range 6-70 yrs). Four of these were less than 14 yrs and 6 more than 55 yrs. The initial dose employed was 3 mg/m2/day X 5 days. Eventually a starting dose of 10 mg/m2 X 5 days was used. Among 16 patients with acute nonlymphocytic leukemia, there was one complete and 3 partial remissions. One of 4 patients with acute lymphocytic leukemia achieved a complete remission. Also, a complete remission was obtained in a patient with T-cell lymphoma/leukemia. The overall remission rate was 24% with a complete remission rate of 12%. Remissions occurred at doses of more than 6 mg/m2/day X 5 days. Four of the 6 patients who had attained a remission received one of the anthracyclines. Bone marrow depression was the dose-limiting factor. Mucositis occurred in 6 patients to whom higher doses were administered. This mucositis was thought to be due to drug-related toxicity. The trials were too short to evaluate possible cardiac toxicity. These data indicate that mitoxantrone is a promising single drug for the treatment of relapsed or refractory acute leukemia.