Continuous infusion intermediate-dose cytarabine, mitoxantrone, plus etoposide for refractory or early relapsed acute myelogenous leukemia

Abstract

6711 Background: Little attention has been paid to continuous infusion of intermediate- to high-dose cytarabine to increase the duration of drug exposure. We conducted a prospective phase II clinical trial to evaluate the efficacy and toxicity of continuous infusion intermediate-dose cytarabine-based salvage chemotherapy regimen in refractory and early relapsed AML. Methods: The chemotherapy regimen consisted of cytarabine (1 g/m2/d, 24-h iv infusion, d 1–5), mitoxantrone (12 mg/m2/d, short iv infusion, d 1–3), and etoposide (150 mg/m2/d, short iv infusion, d 1–3). Results: Of 33 patients enrolled in this study, 19 had refractory leukemia and 14 had relapsed leukemia. Seventeen patients (51.5%) achieved complete remission (CR). The cause of treatment failure was resistant leukemia in 13 and indeterminate in 3. Common severe non-hematologic toxicities were febrile neutropenia (87.9%), metabolic abnormalities (51.5%), gastrointestinal toxicities (27.3%), and hepatic toxicities (21.2%). These toxicities were manageable. Median duration of CR was 117 days and median overall survival was 219 days with 2 surviving patients in CR on 664 days and 1145 days after salvage chemotherapy. Conclusions: Continuous infusion intermediate-dose cytarabine along with mitoxantrone and etoposide could induce CR in significant portion of the patients with refractory or early relapsed AML, but remission duration was short. Continued efforts to improve treatment outcomes in patients with refractory or relapse AML should be made. No significant financial relationships to disclose.