biostudies-literatureKantarjian HMNCI NIH HHS2670-7https://www.ebi.ac.uk/biostudies/studies/S-EPMC4874148biostudies-literatureUnknown30(21)<h4>Purpose</h4>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.<h4>Patients and methods</h4>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). Adverse events (AEs) were recorded.<h4>Results</h4>TJournal of clinical oncology : official journal of the American Society of Clinical OncologyMulticenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia.PMC4874148P30 CA016672P50 CA100632Mayer JLysak DThomas XGMinden MChou WCDmoszynska ACermak JKuo CYArthur CKantarjian HMFaderl SDelaunay JOriol AWierzbowska AMazur GBuckstein RGau JPRavandi FfalseMulticenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia.<h4>Purpose</h4>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.<h4>Patients and methods</h4>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). Adverse events (AEs) were recorded.<h4>Results</h4>T2012-01-01T00:00:00Z2012 Jul2026-05-30T14:00:27.184Z2019-03-27T02:14:10ZS-EPMC48741482268980510.1200/jco.2011.38.942910.1200/JCO.2011.38.9429