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Effects of azacitidine compared with conventional care regimens in elderly (>/= 75 years) patients with higher-risk myelodysplastic syndromes.

Author(s): Seymour JF, Fenaux P, Silverman LR, Mufti GJ, Hellstrom-Lindberg E, Santini V, List AF, Gore SD, Backstrom J, McKenzie D, Beach CL

Affiliation(s): Peter MacCallum Cancer Centre and University of Melbourne, Victoria 3002, Australia. john.seymour@petermac.org

Publication date & source: 2010-12, Crit Rev Oncol Hematol., 76(3):218-27. Epub 2010 May 6.

Publication type: Randomized Controlled Trial; Research Support, Non-U.S. Gov't

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 x 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. Copyright (c) 2010 Elsevier Ireland Ltd. All rights reserved.

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