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Feasibility and efficacy of 5-azacytidine used early in the therapy of adult acute nonlymphocytic leukemia: an ECOG pilot study.

Ten of 19 adult patients (53%) with acute non-lymphocytic leukemia achieved a complete remission (CR) after receiving combination therapy with daunorubicin and cytosine arabinoside. The early administration of 5-azacytidine to treatment failures did not enhance the CR rate. Patients gaining CR received six monthly cycles of single-agent chemotherapy (5-azacytidine, daunorubicin, and cytosine arabinoside) sequentially as consolidation therapy over the next 7 months and no subsequent maintenance therapy. The median duration of CR is 10 months which is similar to previous studies. The early administration of 4-azacytidine did not increase the duration of remission, but was not associated with significant toxicity.