Phase II Evaluation of a High-Dose Mitoxantrone Based Induction Regimen in Untreated Adults with Acute Myeloid Leukemia

Abstract

To evaluate a regimen including high-dose mitoxantrone in previously untreated adults with AML, 45 patients aged 21-59 (median 41) were given cytarabine, 3 g/m² days 1-5, mitoxantrone, 80 mg/m day 2 and etoposide, 150 mg/m days 1,3,5. Post-remission therapy consisted of 5 cycles combining the same agents at reduced doses. Complete remission was seen in 36 patients. The observed 3-year survival is 28%. Cytogenetic pattern and CD34 expression correlated with response and survival. Significant toxicity included myelosuppression, mucositis, diarrhea and hyperbilirubinemia. Ventricular ejection fraction was generally reduced, with clinical cardiac dysfunction in only 2 patients. This high-dose mitoxantrone combination can be administered to young adults with AML with tolerable toxicity and results comparable to those of other dose-intensive regimens.

Key Words:

• acute leukemia
• myelogenous
• mitoxantrone
• high-dose
• cytarabine
• etoposide