High-Dose Cytosine-Arabinoside and Mitoxantrone in Refractory Acute Myeloid Leukemia: A Clinical Phase I/II-Study

Abstract

In a multi-institutional study 26 patients with refractory acute myeloid leukemia were entered into a phase I/II study of HD-ara-C and mitox. HD-ara-C 3g/m² q 12 h was given by 3h infusion on days 1-4. Mitox was started at 12mg/m²/d on days 3, 4 and 5, and escalated to 4 and 5 doses of 10mg/m²/d on days 2-5 and 2-6, respectively. From 24 patients presently evaluable for response, 12 achieved a CR and 2 a PR. 7 patients died of infectious complications within the first 4 weeks of treatment while persistent AML was found in 3 cases. Except for one death, possibly related to acute cardiomyopathy, toxicity was mild to moderate consisting of nausea and vomiting, mucositis and diarrhea. These data indicate a high anti-leukemic activity of HD-ara-C/mitox in AML refractory against conventional chemotherapy.