International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts

H Dombret; JF Seymour; A Butrym; A Wierzbowska; D Selleslag; JH Jang; R Kumar; J Cavenagh; AC Schuh; A Candoni; C Récher; I Sandhu; TB Del Castillo; HK Al-Ali; G Martinelli; J Falantes; R Noppeney; RM Stone; MD Minden; H McIntyre; S Songer; LM Lucy; CL Beach; H Döhner

Journal article

International phase 3 study of azacitidine vs conventional care regimens in older patients with newly diagnosed AML with >30% blasts

H Dombret, JF Seymour, A Butrym, A Wierzbowska, D Selleslag, JH Jang, R Kumar, J Cavenagh, AC Schuh, A Candoni, C Récher, I Sandhu, TB Del Castillo, HK Al-Ali, G Martinelli, J Falantes, R Noppeney, RM Stone, MD Minden, H McIntyre Show all

Blood | Published : 2015

DOI: 10.1182/blood-2015-01-621664

Abstract

This multicenter, randomized, open-label, phase 3 trial evaluated azacitidine efficacy and safety vs conventional care regimens (CCRs) in 488 patients age ≥65 years with newly diagnosed acute myeloid leukemia (AML) with >30% bone marrow blasts. Before randomization, a CCR (standard induction chemotherapy, low-dose ara-c, or supportive care only) was preselected for each patient. Patients then were assigned 1:1 to azacitidine (n = 241) or CCR (n = 247). Patients assigned to CCR received their preselected treatment. Median overall survival (OS) was increased with azacitidine vs CCR: 10.4 months (95% confidence interval [CI], 8.0-12.7 months) vs 6.5 months (95% CI, 5.0-8.6 months), respectively..

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