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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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CLINICAL TRIALS AND OBSERVATIONS
Postremission 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 Gardin1,
Pascal Turlure2,
Thierry Fagot3,
Xavier Thomas4,
Christine Terre5,
Nathalie Contentin6,
Emmanuel Raffoux7,
Stephane de Botton8,
Cecile Pautas9,
Oumedaly Reman10,
Jean-Henri Bourhis11,
Pierre Fenaux1,
Sylvie Castaigne5,
Mauricette Michallet4,
Claude Preudhomme8,
Thierry de Revel3,
Dominique Bordessoule2,
Herve Dombret, for the Acute Leukemia French Association (ALFA)7
1 Department of Hematology, Hôpital Avicenne, University Paris 13, Bobigny;
2 Department of Hematology, Centre Hospitalier Universitaire, Limoges;
3 Department of Hematology, Hôpital Percy, Clamart;
4 Department of Hematology, Centre Hospitalier Universitaire, Lyon;
5 Department of Hematology, Hôpital Mignot, Versailles;
6 Department of Hematology, Centre Leon Becquerel, Rouen;
7 Department of Hematology, Hôpital Saint-Louis, University Paris 7, Paris;
8 Department of Hematology, Centre Hospitalier Universitaire, Lille;
9 Department of Hematology, Hôpital Henri Mondor, University Paris 12, Creteil;
10 Department of Hematology, Centre Hospitalier Universitaire, Caen; and
11 Department of Hematology, Institut Gustave Roussy, Villejuif, France
In elderly patients with acute myeloid leukemia (AML) treated intensively, no best postremission strategy has emerged yet. This clinical trial enrolled 416 patients with AML aged 65 years or older who were considered eligible for standard intensive chemotherapy, with a first randomization comparing idarubicin with daunorubicin for all treatment sequences. After induction, an ambulatory postremission strategy based on 6 consolidation cycles administered monthly in outpatients was randomly compared with an intensive strategy with a 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 anthracycline arms. Among the 236 patients who reached CR, 164 (69%) were randomized for the postremission comparison. In these patients, the multivariate odds ratio in favor of the ambulatory arm was 1.51 for disease-free survival (P =.05) and 1.59 for overall survival from CR (P =.04). Despite repeated courses of chemotherapy associated with a longer time under treatment, the ambulatory arm was associated with significantly shorter rehospitalization duration and lower red blood cell unit and platelet transfusion requirements than observed in the intensive arm. In conclusion, more prolonged ambulatory treatment should be preferred to intensive chemotherapy as postremission therapy in elderly patients with AML reaching CR after standard intensive remission induction.
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