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Blood. 2015 Jul 16;126(3):291-9. doi: 10.1182/blood-2015-01-621664. Epub 2015 May 18.

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

Author information

1
Hôpital Saint Louis, Institut Universitaire d'Hématologie, University Paris Diderot, Paris, France;
2
Peter MacCallum Cancer Centre, East Melbourne, Australia, and University of Melbourne, Parkville, Australia;
3
Wroclaw Medical University, Wroclaw, Poland;
4
Medical University of Lodz, Lodz, Poland;
5
Algemeen Ziekenhuis Sint-Jan, Brugge, Belgium;
6
Samsung Medical Center, Seoul, Republic of Korea;
7
Cancer Care Manitoba, Winnipeg, Canada;
8
Barts Health National Health Service Trust, London, United Kingdom;
9
Princess Margaret Cancer Centre, Toronto, Canada;
10
Azienda Ospedaliero Universitaria S. Maria della Misericordia di Udine, Udine, Italy;
11
Centre Hospitalier Universitaire de Toulouse, Toulouse, France;
12
University of Alberta Hospital, Edmonton, Canada;
13
Hospital Central de Asturias, Oviedo, Spain;
14
Universitätsklinikum Leipzig, Leipzig, Germany;
15
Institute of Hematology and Medical Oncology "L. e A. Seràgnoli," Bologna, Italy;
16
Hospital Universitario Virgen del Rocio/Instituto de BioMedicinia de Sevilla, Sevilla, Spain;
17
Universitätsklinikum Essen Klinik für Hämatologie, Essen, Germany;
18
Dana-Farber Cancer Institute, Boston, MA;
19
Celgene Corporation, Summit, NJ; and.
20
Universitätsklinikum Ulm, Ulm, Germany.

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 (hazard ratio [HR] was 0.85; 95% CI, 0.69-1.03; stratified log-rank P = .1009). One-year survival rates with azacitidine and CCR were 46.5% and 34.2%, respectively (difference, 12.3%; 95% CI, 3.5%-21.0%). A prespecified analysis censoring patients who received AML treatment after discontinuing study drug showed median OS with azacitidine vs CCR was 12.1 months (95% CI, 9.2-14.2 months) vs 6.9 months (95% CI, 5.1-9.6 months; HR, 0.76; 95% CI, 0.60-0.96; stratified log-rank P = .0190). Univariate analysis showed favorable trends for azacitidine compared with CCR across all subgroups defined by baseline demographic and disease features. Adverse events were consistent with the well-established safety profile of azacitidine. Azacitidine may be an important treatment option for this difficult-to-treat AML population. This trial was registered at www.clinicaltrials.gov as #NCT01074047.

PMID:
25987659
PMCID:
PMC4504945
DOI:
10.1182/blood-2015-01-621664
[Indexed for MEDLINE]
Free PMC Article

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