Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia - PubMed (original) (raw)
Clinical Trial
. 2010 Feb 1;28(4):562-9.
doi: 10.1200/JCO.2009.23.8329. Epub 2009 Dec 21.
Ghulam J Mufti, Eva Hellström-Lindberg, Valeria Santini, Norbert Gattermann, Ulrich Germing, Guillermo Sanz, Alan F List, Steven Gore, John F Seymour, Hervé Dombret, Jay Backstrom, Linda Zimmerman, David McKenzie, C L Beach, Lewis R Silverman
Affiliations
- PMID: 20026804
- DOI: 10.1200/JCO.2009.23.8329
Clinical Trial
Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia
Pierre Fenaux et al. J Clin Oncol. 2010.
Abstract
Purpose: In a phase III randomized trial, azacitidine significantly prolonged overall survival (OS) compared with conventional care regimens (CCRs) in patients with intermediate-2- and high-risk myelodysplastic syndromes. Approximately one third of these patients were classified as having acute myeloid leukemia (AML) under current WHO criteria. This analysis compared the effects of azacitidine versus CCR on OS in this subgroup.
Patients and methods: Patients were randomly assigned to receive subcutaneous azacitidine 75 mg/m(2)/d or CCR (best supportive care [BSC] only, low-dose cytarabine (LDAC), or intensive chemotherapy [IC]).
Results: Of the 113 elderly patients (median age, 70 years) randomly assigned to receive azacitidine (n = 55) or CCR (n = 58; 47% BSC, 34% LDAC, 19% IC), 86% were considered unfit for IC. At a median follow-up of 20.1 months, median OS for azacitidine-treated patients was 24.5 months compared with 16.0 months for CCR-treated patients (hazard ratio = 0.47; 95% CI, 0.28 to 0.79; P = .005), and 2-year OS rates were 50% and 16%, respectively (P = .001). Two-year OS rates were higher with azacitidine versus CCR in patients considered unfit for IC (P = .0003). Azacitidine was associated with fewer total days in hospital (P < .0001) than CCR.
Conclusion: In older adult patients with low marrow blast count (20% to 30%) WHO-defined AML, azacitidine significantly prolongs OS and significantly improves several patient morbidity measures compared with CCR.
Comment in
- "I am older, not elderly," said the patient with acute myeloid leukemia.
Schiffer CA. Schiffer CA. J Clin Oncol. 2010 Feb 1;28(4):521-3. doi: 10.1200/JCO.2009.25.8616. Epub 2009 Dec 21. J Clin Oncol. 2010. PMID: 20026796 No abstract available. - Caution using hypomethylating agents in myelodysplasia or myeloid leukemia with complex cytogenetics.
Turturro F, Leary C, Stephens J, Veillon D, Lowery-Nordberg M. Turturro F, et al. J Clin Oncol. 2010 Aug 1;28(22):e380-1. doi: 10.1200/JCO.2010.28.5775. Epub 2010 May 10. J Clin Oncol. 2010. PMID: 20458054 No abstract available.
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