BACKGROUND: Although chemotherapy can achieve a high rate of disease remission induction in patients with newly diagnosed acute myelogenous leukemia (AML), patients with recurrent or refractory AML generally have a poorer rate of response. This study assessed the utility of mitoxantrone and intermediate-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/m2, intravenously (i.v.) every 12 hours x 12 doses on Days 1-6 and mitoxantrone, 5 mg/m2, 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 years). Of the 25 patients age > or = 60 years, 19 (76%) had a complete disease remission and the median duration of disease remission in this group was 114 days (range, 33-370 days), although all patients subsequently developed a disease recurrence. The chemotherapy generally was well tolerated, with a mean duration of neutropenia of 31 days and a mean duration of thrombocytopenia of 33 days. Three patients died of infectious complications between 23-26 days after the initiation of chemotherapy, 1 patient died of sudden cardiac arrest 13 days after the initiation of chemotherapy, and 1 patient developed cutaneous desquamation. Three patients developed acute cerebellar dysfunction. CONCLUSIONS: The use of mitoxantrone and Ara-C is effective in the treatment of patients with recurrent and refractory AML. The subgroup of patients age > or = 60 years also had a high rate of disease remission induction with this regimen, and the regimen generally was well tolerated.
BACKGROUND: Although chemotherapy can achieve a high rate of disease remission induction in patients with newly diagnosed acute myelogenous leukemia (AML), patients with recurrent or refractory AML generally have a poorer rate of response. This study assessed the utility of mitoxantrone and intermediate-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/m2, intravenously (i.v.) every 12 hours x 12 doses on Days 1-6 and mitoxantrone, 5 mg/m2, 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 years). Of the 25 patients age > or = 60 years, 19 (76%) had a complete disease remission and the median duration of disease remission in this group was 114 days (range, 33-370 days), although all patients subsequently developed a disease recurrence. The chemotherapy generally was well tolerated, with a mean duration of neutropenia of 31 days and a mean duration of thrombocytopenia of 33 days. Three patients died of infectious complications between 23-26 days after the initiation of chemotherapy, 1 patient died of sudden cardiac arrest 13 days after the initiation of chemotherapy, and 1 patient developed cutaneous desquamation. Three patients developed acute cerebellar dysfunction. CONCLUSIONS: The use of mitoxantrone and Ara-C is effective in the treatment of patients with recurrent and refractory AML. The subgroup of patients age > or = 60 years also had a high rate of disease remission induction with this regimen, and the regimen generally was well tolerated.
Authors: Mark S Berger; Lance H Leopold; James A Dowell; Joan M Korth-Bradley; Matthew L Sherman Journal: Invest New Drugs Date: 2002-11 Impact factor: 3.850