Treatment of patients with recurrent and primary refractory acute myelogenous leukemia using mitoxantrone and intermediate-dose cytarabine - A pharmacologically based regimen

BACKGROUND. Although chemotherapy can achieve a high rate of disease remiss ion induction in patients with newly diagnosed acute myelogenous leukemia ( AML), patients with recurrent or refractory AML generally have a poorer rat e of response. This study assessed the utility of mitoxantrone and intermed iate-dose cytarabine (Ara-C) in the treatment of patients with recurrent or refractory AML. METHODS. Forty-seven patients with recurrent or refractory AML were treated with Ara-C, 0.5 gm/m(2), intravenously (i.v.) every 12 hours x 12 doses on Days 1-6 and mitoxantrone, 5 mg/m(2), i.v. on Days 1-5. RESULTS. Twenty-nine of the 47 patients (62%) achieved a complete response. The median duration of disease remission was 112 days (range, 29 days-8 ye ars). Of the 25 patients age greater than or equal to 60 years, 19 (76%) ha d a complete disease remission and the median duration of disease remission in this group was 114 days (range, 33-370 days), although all patients sub sequently developed a disease recurrence. The chemotherapy generally was we ll tolerated, with a mean duration of neutropenia of 31 days and a mean dur ation of thrombocytopenia of 33 days. Three patients died of infectious com plications between 23-26 days after the initiation of chemotherapy, 1 patie nt died of sudden cardiac arrest 13 days after the initiation of chemothera py, and 1 patient developed cutaneous desquamation. Three patients develope d acute cerebellar dysfunction. CONCLUSIONS. The use of mitoxantrone and Ara-C is effective in the treatmen t of patients with recurrent and refractory AML. The subgroup of patients a ge greater than or equal to 60 years also had a high rate of disease remiss ion induction with this regimen, and the regimen generally was well tolerat ed. (C) 2000 American Cancer Society.