Azacitidine Prolongs Overall Survival Compared With Conventional Care Regimens in Elderly Patients With Low Bone Marrow Blast Count Acute Myeloid Leukemia

Pierre Fenaux(Université Paris Cité), Ghulam J. Mufti(Université Paris Cité), Eva Hellström‐Lindberg(Université Paris Cité), Valeria Santini(Université Paris Cité), Norbert Gattermann(Université Paris Cité), Ulrich Germing(Université Paris Cité), Guillermo Sanz(Université Paris Cité), Alan F. List(Université Paris Cité), Steven D. Gore(Université Paris Cité), John F. Seymour(Université Paris Cité), Hervé Dombret(Université Paris Cité), Jay T. Backstrom(Université Paris Cité), Linda Zimmerman(Université Paris Cité), David R. McKenzie(Université Paris Cité), C.L. Beach(Université Paris Cité), Lewis R. Silverman(Université Paris Cité)
Journal of Clinical Oncology
December 21, 2009
10.1200/jco.2009.23.8329
Cited by 958Open Access
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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.

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