title: Effects of azacitidine compared with conventional care regimens in elderly (≥ 75 years) patients with higher-risk myelodysplastic syndromes.
abstract: This analysis compared azacitidine (AZA) to conventional care regimens (CCR) and their associated overall survival (OS) and tolerability in the subset of 87 elderly (≥ 75 years) patients with higher-risk MDS (FAB: RAEB, RAEB-t, CMML and IPSS: Int-2 or High) from the AZA-001 trial. Patients were randomized to AZA (75 mg/m(2)/daysubcutaneously × 7 days every 28 days) (n=38) or CCR (n=49) and had median ages of 78 and 77 years, respectively. AZA significantly improved OS vs CCR (HR: 0.48 [95%CI: 0.26, 0.89]; p=0.0193) and 2-year OS rates were 55% vs 15% (p<0.001), respectively. AZA was generally well tolerated compared with CCR, which was primarily best supportive care (67%). Grade 3-4 anemia, neutropenia, and thrombocytopenia with AZA vs CCR were 13% vs 4%, 61% vs 17%, and 50% vs 30%, respectively. Given this efficacy and tolerability, AZA should be considered the treatment of choice in patients aged ≥ 75 years with good performance status and higher-risk MDS.
authors.affiliation: Peter MacCallum Cancer Centre and University of Melbourne, Victoria 3002, Australia. john.seymour@petermac.org
authors.forename: John F
authors.initials: JF
authors.lastname: Seymour
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
authors.forename: Lewis R
authors.initials: LR
authors.lastname: Silverman
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: Alan F
authors.initials: AF
authors.lastname: List
authors.forename: Steven D
authors.initials: SD
authors.lastname: Gore
authors.forename: Jay
authors.initials: J
authors.lastname: Backstrom
authors.forename: David
authors.initials: D
authors.lastname: McKenzie
authors.forename: C L
authors.initials: CL
authors.lastname: Beach
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*
chemical_list: D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine
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