Purpose: This multicenter, randomized, open-label, phase III trial compared the efficacy and safety of decitabine with treatment choice (TC) in older patients with newly diagnosed acute myeloid leukemia (AML) and poor- or intermediate-risk cytogenetics. VSports手机版.

Patients and methods: Patients (N = 485) age ≥ 65 years were randomly assigned 1:1 to receive decitabine 20 mg/m(2) per day as a 1-hour intravenous infusion for five consecutive days every 4 weeks or TC (supportive care or cytarabine 20 mg/m(2) per day as a subcutaneous injection for 10 consecutive days every 4 weeks). The primary end point was overall survival (OS); the secondary end point was the complete remission (CR) rate plus the CR rate without platelet recovery (CRp) V体育安卓版. Adverse events (AEs) were recorded. .

Results: The primary analysis with 396 deaths (81. 6%) showed a nonsignificant increase in median OS with decitabine (7. 7 months; 95% CI, 6. 2 to 9. 2) versus TC (5. 0 months; 95% CI, 4. 3 to 6. 3; P = . 108; hazard ratio [HR], 0. 85; 95% CI, 0. 69 to 1. 04). An unplanned analysis with 446 deaths (92%) indicated the same median OS (HR, 0. 82; 95% CI, 0. 68 to 0 V体育ios版. 99; nominal P = . 037). The CR rate plus CRp was 17. 8% with decitabine versus 7. 8% with TC (odds ratio, 2. 5; 95% CI, 1. 4 to 4. 8; P = . 001). AEs were similar for decitabine and cytarabine, although patients received a median of four cycles of decitabine versus two cycles of TC. The most common drug-related AEs with decitabine were thrombocytopenia (27%) and neutropenia (24%). .

Conclusion: In older patients with AML, decitabine improved response rates compared with standard therapies without major differences in safety. An unplanned survival analysis showed a benefit for decitabine, which was not observed at the time of the primary analysis VSports最新版本. .