Azacitidine prolongs overall survival compared with conventional care regimens in elderly patients with low bone marrow blast count acute myeloid leukemia.
OBJECTIVE
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.


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.


CONCLUSIONS
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.
Fenaux
Pierre
P
Service d'Hématologie Clinique, Hospital Avicenne, Assistance Publique-Hôpitaux de Paris (AP-HP), Université Paris XIII, Bobigny, France. pierre.fenaux@avc.aphp.fr
Mufti
Ghulam J
GJ
Hellström-Lindberg
Eva
E
Santini
Valeria
V
Gattermann
Norbert
N
Germing
Ulrich
U
Sanz
Guillermo
G
List
Alan F
AF
Gore
Steven
S
Seymour
John F
JF
Dombret
Hervé
H
Backstrom
Jay
J
Zimmerman
Linda
L
McKenzie
David
D
Beach
C L
CL
Silverman
Lewis R
LR
D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001374:Azacitidine / Q000627:therapeutic use*; D001752:Blast Crisis / Q000473:pathology*; D001854:Bone Marrow Cells / Q000473:pathology*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007390:International Agencies; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality*; D007958:Leukocyte Count; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome
D000964:Antimetabolites, Antineoplastic; D001374:Azacitidine