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Crit Rev Oncol Hematol. 2010 Dec;76(3):218-27. doi: 10.1016/j.critrevonc.2010.04.005. Epub 2010 May 6.

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

Author information

1
Peter MacCallum Cancer Centre and University of Melbourne, Victoria 3002, Australia. john.seymour@petermac.org

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00071799.

PMID:
20451404
PMCID:
PMC4000027
DOI:
10.1016/j.critrevonc.2010.04.005
[Indexed for MEDLINE]
Free PMC Article

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