[A phase II study of mitoxantrone in acute leukemia. Hanshin Cooperative Study Group of Hematological Disorders]

A phase II study of mitoxantrone was conducted on acute leukemia. Mitoxantrone 4 mg/m2/day was administered for 5 consecutive days in most cases. For cases showing insufficient decrease of leukemic cells even at nadir, a second course of the same regimen was given. Enrolled were 38 cases in total, of which 34 were evaluable. In 14 cases for first remission induction, the drug efficacy was evaluated at the completion of the first or second course, then further combination drug therapy followed immediately. Of 14 cases for first remission induction, 6, or 43%, achieved CR and of 20 cases for reinduction of remission, 4, or 20%, achieved CR. Two out of 7 cases of ALL (29%) and 8 out of 27 cases of ANLL (30%) achieved CR. Of 19 cases with previous anthracycline therapy, 4 cases, or 21%, achieved CR, showing that the cross-resistance was partial. Gastrointestinal symptoms were the main side effects, but cases of symptoms severer than grade 3 were very rare. Cardiotoxicity occurred at a rate as low as 11%. Mitoxantrone thus appears to be a promising drug for the treatment of acute leukemia.