title: 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.
abstract: 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.
authors.affiliation: Department of Hematology, Hôpital Avicenne, University Paris 13, Bobigny, France.
authors.forename: Claude
authors.initials: C
authors.lastname: Gardin
authors.forename: Pascal
authors.initials: P
authors.lastname: Turlure
authors.forename: Thierry
authors.initials: T
authors.lastname: Fagot
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Christine
authors.initials: C
authors.lastname: Terre
authors.forename: Nathalie
authors.initials: N
authors.lastname: Contentin
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Stephane
authors.initials: S
authors.lastname: de Botton
authors.forename: Cecile
authors.initials: C
authors.lastname: Pautas
authors.forename: Oumedaly
authors.initials: O
authors.lastname: Reman
authors.forename: Jean-Henri
authors.initials: JH
authors.lastname: Bourhis
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
authors.forename: Sylvie
authors.initials: S
authors.lastname: Castaigne
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Claude
authors.initials: C
authors.lastname: Preudhomme
authors.forename: Thierry
authors.initials: T
authors.lastname: de Revel
authors.forename: Dominique
authors.initials: D
authors.lastname: Bordessoule
authors.forename: Herve
authors.initials: H
authors.lastname: Dombret
mesh_terms: D000208:Acute Disease; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000627:therapeutic use; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use; D001803:Blood Transfusion; D003630:Daunorubicin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D006760:Hospitalization; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage*; D007951:Leukemia, Myeloid / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; D015255:Idarubicin; D003630:Daunorubicin