Comparison of 2 doses of daunorubicin(45mg/m2 vs 60mg/m2) in induction therapy of patients of de novo acute myeloid leukemia

Abstract

6581 Background: Standard induction regimen for the management of acute myeloid leukemia (AML) includes 45 mg/m2 of daunorubicin (DNR) × 3 days and 100 mg/m2 of ara-c × 7 days. Recent studies suggest that higher doses of DNR may have better outcome. Randomized studies to objectively authenticate these observations to the best of our knowledge are not available. This study was undertaken as a preliminary trial to compare the induction remission rates and toxicity of 60 mg/m2 of DNR with standard dose of 45 mg/m2. Methods: Sixty newly diagnosed AML patients, except AML—M3, from January 2003—May 2005 were randomized to either 45mg/m2 (group A ) or 60 mg/m2 (group B) of DNR for three days. The dose of ara-c was 100mg/m2 for 7 days in both groups. All denovo AML patients with 0–2 performance status (ECOG) were included in the study. Results: Fifty six patients were evaluable, 30 in group A and 26 in group B. The baseline demographic and clinical characteristics were comparable. Twenty (67%) patients in group A and 23 (88%) in group B (p=0.05) achieved complete remission (CR). Fifteen (50%) patients in group A and 22 (84.6%) in group B (p=0.006) achieved remission after single course of induction chemotherapy. Nine patients (30%) in group A and 3 (11.5%) in group B died due to uncontrolled sepsis (p=0.09). Five patients, all belonging to Group A, had persistent disease at the time of death. Though there was no significant difference with respect to major organ toxicities in both the groups, duration of grade 4 thrombocytopenia and duration of admission were significantly greater in group A (P=0.02 and P=0.005 respectively). Conclusions: This study indicates that daunorubicin in the dose of 60 mg/m2 is superior to 45mg/m2 as a remission induction therapy for AML patients with good performance status. Further follow up is required to ascertain whether higher remission rate leads to higher disease free and over all survival. No significant financial relationships to disclose.