title: Decitabine reduces transfusion dependence in older patients with acute myeloid leukemia: results from a post hoc analysis of a randomized phase III study.
abstract: This post hoc analysis of the DACO-016 phase III study evaluates the impact of decitabine on transfusion dependence and survival in 485 elderly patients with newly diagnosed acute myeloid leukemia (AML). Red blood cell (RBC) and platelet (PLT) transfusion independence, defined as no transfusions for ≥ 8 consecutive weeks, was measured in both decitabine (n = 242) and treatment choice (TC, n = 243) arms. More RBC transfusion dependent patients at baseline became transfusion independent with decitabine than with TC (26% vs. 13%; p = 0.0026). Similar results were obtained for patients who were PLT transfusion dependent at baseline (31% vs. 13%; p = 0.0069). When excluding patients who attained complete remission (CR), survival was improved in patients who achieved RBC or PLT transfusion independence, suggesting that reaching CR is not a prerequisite for deriving benefit from treatment with decitabine. In addition, patients who achieved transfusion independence with decitabine had increased treatment continuation, even in the absence of CR.
authors.affiliation: Janssen Global Services , LLC, Raritan, NJ , USA.
authors.forename: Jianming
authors.initials: J
authors.lastname: He
authors.forename: Liang
authors.initials: L
authors.lastname: Xiu
authors.forename: Peter
authors.initials: P
authors.lastname: De Porre
authors.forename: Ramesh
authors.initials: R
authors.lastname: Dass
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
mesh_terms: D000208:Acute Disease; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D001374:Azacitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D000077209:Decitabine; D018572:Disease-Free Survival; D017707:Erythrocyte Transfusion / Q000379:methods / Q000706:statistics & numerical data*; D006801:Humans; D007951:Leukemia, Myeloid / Q000628:therapy*; D015999:Multivariate Analysis; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D017713:Platelet Transfusion / Q000379:methods / Q000706:statistics & numerical data*; D016032:Randomized Controlled Trials as Topic; D012074:Remission Induction
chemical_list: D000964:Antimetabolites, Antineoplastic; D000077209:Decitabine; D001374:Azacitidine
keywords: Myeloid leukemias and dysplasias; decitabine; survival; transfusion dependence