BACKGROUND: In a Phase III trial, 485 patients (≥65 years) with newly diagnosed acute myeloid leukemia received decitabine 20 mg/m(2) intravenously for 5 days every 4 weeks or a treatment choice (supportive care or cytarabine 20 mg/m(2) subcutaneously for 10 days every 4 weeks). MATERIALS AND METHODS: We summarized overall and progression-free survival by baseline white blood cell count using two analyses: <1, 1-5, >5×10(9)/L; ≤10 or >10×10(9)/L. RESULTS: There were 446 deaths (treatment choice, n=227; decitabine, n=219). Median overall survival was 5.0 (treatment choice) versus 7.7 months (decitabine; nominal P=0.037). Overall survival differences between white blood cell groups were not significant; hazard ratios (HRs) favored decitabine. Significant progression-free survival differences favored decitabine for groups 1-5×10(9)/L (P=0.005, HR =0.67), greater than 5×10(9)/L (P=0.027, HR =0.71), and up to 10×10(9)/L (P=0.003, HR =0.72). CONCLUSION: There was a trend toward improved outcome with decitabine, regardless of baseline white blood cell count.

Copernicus Memorial Hospital Lodz Poland

Department of Clinical Hematology University of Nantes Nantes France

Department of Haematology Royal North Shore Hospital Sydney NSW Australia

Department of Hematology Edouard Herriot Hospital Lyon France

Department of Hematology Wrocław Medical University Wrocław Poland

Department of Internal Medicine Masaryk University Hospital Brno Central European Institute of Technology Brno Czech Republic

Department of Leukemia University of Texas MD Anderson Cancer Center Houston TX USA

Institute of Hematology and Blood Transfusion Prague Czech Republic

Oncology Product Creation Unit Eisai Inc Woodcliff Lake NJ USA

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