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

John F. Seymour, Pierre Fenaux, Lewis R. Silverman, Ghulam J. Mufti, Eva Hellström-Lindberg, Valeria Santini, Alan F. List, Steven D. Gore, Jay Backstrom, David McKenzie, C. L. Beach

Research output: Contribution to journalReview articlepeer-review

105 Scopus citations

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 (75mg/m2/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.

Original languageEnglish
Pages (from-to)218-227
Number of pages10
JournalCritical Reviews in Oncology/Hematology
Volume76
Issue number3
DOIs
StatePublished - Dec 2010

Keywords

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

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