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Blood, 15 June 2007, Vol. 109, No. 12, pp. 5129-5135.
Prepublished online as a Blood First Edition Paper on March 6, 2007; DOI 10.1182/blood-2007-02-069666.


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Submitted February 1, 2007
Accepted March 5, 2007

Post-remission treatment of elderly patients with acute myeloid leukemia in first complete remission after intensive induction chemotherapy - results of the multicenter randomized Acute Leukemia French Association (ALFA) 9803 trial

Claude Gardin, Pascal Turlure, Thierry Fagot, Xavier Thomas, Christine Terre, Nathalie Contentin, Emmanuel Raffoux, Stephane de Botton, Cecile Pautas, Oumedaly Reman, Jean-Henri Bourhis, Pierre Fenaux, Sylvie Castaigne, Mauricette Michallet, Claude Preudhomme, Thierry de Revel, Dominique Bordessoule, and Herve Dombret*

Department of Hematology, Hopital Avicenne, Bobigny, France
Department of Hematology, Centre Hospitalier Universitaire, Limoges, France
Department of Hematology, Hopital Percy, Clamart, France
Department of Hematology, Centre Hospitalier Universitaire, Lyon, France
Department of Hematology, Hopital Mignot, Versailles, France
Department of Hematology, Centre Leon Becquerel, Rouen, France
Department of Hematology, Hopital Saint-Louis, Paris, France
Department of Hematology, Centre Hospitalier Universitaire, Lille, France
Department of Hematology, Hopital Henri Mondor, Creteil, France
Department of Hematology, Centre Hospitalier Universitaire, Caen, France
Department of Hematology, Institut Gustave Roussy, Villejuif, France

* Corresponding author; email: herve.dombret{at}sls.aphp.fr.

In elderly patients with acute myeloid leukemia (AML) treated intensively, no best post-remission strategy has emerged yet. This clinical trial enrolled 416 AML patients aged 65 years or more considered as eligible for standard intensive chemotherapy, with a first randomization comparing idarubicin to daunorubicin as anthracycline for all treatment sequences. After induction, an ambulatory post-remission strategy based on 6 consolidation cycles administered monthly in out-patients was randomly compared to an intensive strategy with 1 single intensive consolidation course similar to induction. Complete remission (CR) rate was 57% with 10% induction deaths and estimated overall survival was 27% at 2 years and 12% at 4 years, without notable differences between both anthracycline arms. Among the 236 patients who reached CR, 164 (69%) were randomized for the post-remission comparison. In these patients, the multivariate odds ratio in favor of the ambulatory arm was 1.51 for disease-free survival (P=0.05) and 1.59 for overall survival from CR (P=0.04). Despite repeated courses of chemotherapy associated with a longer time under treatment, the ambulatory arm was associated with significantly shorter re-hospitalization duration and lower red blood cell unit and platelet transfusion requirement than observed in the intensive arm. In conclusion, more prolonged ambulatory treatment should be preferred to intensive chemotherapy as post-remission therapy in elderly patients with AML reaching CR after standard intensive remission induction.


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