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

Author:

Dombret Hervé1,Seymour John F.2,Butrym Aleksandra3,Wierzbowska Agnieszka4,Selleslag Dominik5,Jang Jun Ho6,Kumar Rajat7,Cavenagh James8,Schuh Andre C.9,Candoni Anna10,Récher Christian11,Sandhu Irwindeep12,Bernal del Castillo Teresa13,Al-Ali Haifa Kathrin14,Martinelli Giovanni15,Falantes Jose16,Noppeney Richard17,Stone Richard M.18,Minden Mark D.9,McIntyre Heidi19,Songer Steve19,Lucy Lela M.19,Beach C. L.19,Döhner Hartmut20

Affiliation:

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

Key Points Azacitidine increased median overall survival by 3.8 months vs current commonly used AML treatments (10.4 vs 6.5 months; P = .1009). Azacitidine safety in patients age ≥65 years with AML (>30% blasts) was consistent with its known safety profile in other trials.

Publisher

American Society of Hematology

Subject

Cell Biology,Hematology,Immunology,Biochemistry

Reference28 articles.

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2. Incidence, survival and prevalence of myeloid malignancies in Europe.;Visser;Eur J Cancer,2012

3. Acute myeloid leukemia in the elderly.;Dombret;Semin Oncol,2008

4. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia.;Kantarjian;J Clin Oncol,2012

5. Intensive chemotherapy does not benefit most older patients (age 70 years or older) with acute myeloid leukemia.;Kantarjian;Blood,2010

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