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Keywords:

  • acute myelogenous leukemia;
  • Ara-C;
  • mitoxantrone;
  • disease remission

Patients with recurrent or refractory acute myelogenous leukemia were treated with intermediate-dose cytarabine, 500 mg/m2, every 12 hours × 12 doses, and mitoxantrone, 5 mg/m2/day × 5 days. The complete remission rate for these patients was 62% and the regimen was well tolerated, including in elderly patients.

Abstract

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 × 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 ≥ 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 ≥ 60 years also had a high rate of disease remission induction with this regimen, and the regimen generally was well tolerated. Cancer 2000;88:2037–41. © 2000 American Cancer Society.