Effects of azacitidine compared with conventional care regimens in elderly (≥ 75 years) patients with higher-risk myelodysplastic syndromes.
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.
Seymour
John F
JF
Peter MacCallum Cancer Centre and University of Melbourne, Victoria 3002, Australia. john.seymour@petermac.org
Fenaux
Pierre
P
Silverman
Lewis R
LR
Mufti
Ghulam J
GJ
Hellström-Lindberg
Eva
E
Santini
Valeria
V
List
Alan F
AF
Gore
Steven D
SD
Backstrom
Jay
J
McKenzie
David
D
Beach
C L
CL
D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D001374:Azacitidine / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D009190:Myelodysplastic Syndromes / Q000188:drug therapy*
D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine
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