{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Kantarjian HM"],"funding":["NCI NIH HHS"],"pagination":["2670-7"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC4874148"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["30(21)"],"pubmed_abstract":["<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>T"],"journal":["Journal of clinical oncology : official journal of the American Society of Clinical Oncology"],"pubmed_title":["Multicenter, 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."],"pmcid":["PMC4874148"],"funding_grant_id":["P30 CA016672","P50 CA100632"],"pubmed_authors":["Mayer J","Lysak D","Thomas XG","Minden M","Chou WC","Dmoszynska A","Cermak J","Kuo CY","Arthur C","Kantarjian HM","Faderl S","Delaunay J","Oriol A","Wierzbowska A","Mazur G","Buckstein R","Gau JP","Ravandi F"],"additional_accession":[]},"is_claimable":false,"name":"Multicenter, 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.","description":"<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>T","dates":{"release":"2012-01-01T00:00:00Z","publication":"2012 Jul","modification":"2026-05-30T14:00:27.184Z","creation":"2019-03-27T02:14:10Z"},"accession":"S-EPMC4874148","cross_references":{"pubmed":["22689805"],"doi":["10.1200/jco.2011.38.9429","10.1200/JCO.2011.38.9429"]}}