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

期刊

CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
卷 76, 期 3, 页码 218-227

出版社

ELSEVIER SCIENCE INC
DOI: 10.1016/j.critrevonc.2010.04.005

关键词

Azacitidine; Low-dose ara-C; Elderly; Myelodysplastic syndromes; MDS; Acute myeloid leukemia; AML; Survival

资金

  1. Celgene Corporation

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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)/day subcutaneously 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. (C) 2010 Elsevier Ireland Ltd. All rights reserved.

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