title: Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia.
abstract: OBJECTIVE
  In a phase III randomized trial, azacitidine significantly prolonged overall survival (OS) compared with conventional care regimens (CCRs) in patients with intermediate-2- and high-risk myelodysplastic syndromes. Approximately one third of these patients were classified as having acute myeloid leukemia (AML) under current WHO criteria. This analysis compared the effects of azacitidine versus CCR on OS in this subgroup.
  
  
  METHODS
  Patients were randomly assigned to receive subcutaneous azacitidine 75 mg/m(2)/d or CCR (best supportive care [BSC] only, low-dose cytarabine (LDAC), or intensive chemotherapy [IC]).
  
  
  RESULTS
  Of the 113 elderly patients (median age, 70 years) randomly assigned to receive azacitidine (n = 55) or CCR (n = 58; 47% BSC, 34% LDAC, 19% IC), 86% were considered unfit for IC. At a median follow-up of 20.1 months, median OS for azacitidine-treated patients was 24.5 months compared with 16.0 months for CCR-treated patients (hazard ratio = 0.47; 95% CI, 0.28 to 0.79; P = .005), and 2-year OS rates were 50% and 16%, respectively (P = .001). Two-year OS rates were higher with azacitidine versus CCR in patients considered unfit for IC (P = .0003). Azacitidine was associated with fewer total days in hospital (P < .0001) than CCR.
  
  
  CONCLUSIONS
  In older adult patients with low marrow blast count (20% to 30%) WHO-defined AML, azacitidine significantly prolongs OS and significantly improves several patient morbidity measures compared with CCR.
authors.affiliation: Service d'Hématologie Clinique, Hospital Avicenne, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris XIII, Bobigny, France. pierre.fenaux@avc.aphp.fr
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
authors.forename: Ghulam J
authors.initials: GJ
authors.lastname: Mufti
authors.forename: Eva
authors.initials: E
authors.lastname: Hellström-Lindberg
authors.forename: Valeria
authors.initials: V
authors.lastname: Santini
authors.forename: Norbert
authors.initials: N
authors.lastname: Gattermann
authors.forename: Ulrich
authors.initials: U
authors.lastname: Germing
authors.forename: Guillermo
authors.initials: G
authors.lastname: Sanz
authors.forename: Alan F
authors.initials: AF
authors.lastname: List
authors.forename: Steven
authors.initials: S
authors.lastname: Gore
authors.forename: John F
authors.initials: JF
authors.lastname: Seymour
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
authors.forename: Jay
authors.initials: J
authors.lastname: Backstrom
authors.forename: Linda
authors.initials: L
authors.lastname: Zimmerman
authors.forename: David
authors.initials: D
authors.lastname: McKenzie
authors.forename: C L
authors.initials: CL
authors.lastname: Beach
authors.forename: Lewis R
authors.initials: LR
authors.lastname: Silverman
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001374:Azacitidine / Q000627:therapeutic use*; D001752:Blast Crisis / Q000473:pathology*; D001854:Bone Marrow Cells / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007390:International Agencies; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality*; D007958:Leukocyte Count; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine