MITOXANTRONE AND 5-AZACYTIDINE FOR REFRACTORY RELAPSED ANLL OR CML INBLAST CRISIS - A LEUKEMIA INTERGROUP STUDY

In an effort to determine if cell cycle active agents are augmented wh en given after non-cell cycle active agents, 104 patients with either multiply relapsed or refractory acute nonlymphocytic leukemia or blast crisis of chronic myelogenous leukemia were treated with mitoxantrone . Patients whose bone marrow did not show significant cytoreduction re ceived 5-azacytidine. Twenty-seven of the 93 evaluable patients (23%) with ANLL achieved a complete remission. A total of 28% of patients re ceiving mitoxantrone alone achieved remission compared to 15% for thos e receiving mitoxantrone and 5-azacytidine. Relapsed patients had a hi gher CR rate (36%) than refractory patients (15%). Nausea, vomiting, a nd stomatitis were common but rarely severe. The median duration of re mission was 3.7 months and patients with abnormal karyotypes had longe r remission durations than those with normal karyotypes. In this patie nt population, there was no evidence that 5-azacytidine given after mi toxantrone increased the complete remission rate. (C) 1993 Wiley-Liss, Inc.