This report provides long-term results of the treatment of patients with newly-diagnosed AML with a single high dose of mitoxantrone combined with once daily cytarabine. One-hundred and sixty-five patients treated on four studies of high-dose mitoxantrone-based induction therapy are included. Patients with a prior antecedent hematologic disorder were eligible. The median follow-up time is 65.9 months (95% CI: 55.7-86.2 months). The overall complete remission rate was 64%, with responses in 78% of patients less than 60 years of age and 51% of patients 60 years of age or older. The median duration of response is 21.2 months and 8.0 months and overall survival is 15.4 months and 7.6 months, respectively. For a sub-set of patients who would be eligible for most US trials, the complete remission rate was 84% in younger patients and 60% in older patients. The median duration of response was 39.0 and 8.2 months and the median overall survival was 19.4 and 7.6 months, respectively. The efficacy of these regimens compared favorably to results reported with standard '3 + 7' regimens. Use of a once-daily cytarabine regimen resulted in almost no neurotoxicity and allowed for administration of consolidation in the outpatient setting.