title: Impact of post-remission therapy in patients aged 65-70 years with de novo acute myeloid leukemia: a comparison of two concomitant randomized ALFA trials with overlapping age inclusion criteria.
abstract: BACKGROUND
  There is no standard post-remission therapy in older patients with acute myeloid leukemia.
  
  
  METHODS
  From 1999 to 2006, the Acute Leukemia French Association group ran two concurrent randomized trials with overlapping inclusion criteria for patients aged 65 to 70 with acute myeloid leukemia, with different post-remission strategies: two intensive courses in the 9801 trial, one intensive course or six outpatient courses in the 9803 trial. We analyzed the outcome of these patients per protocol and per post-remission therapy.
  
  
  RESULTS
  Two hundred and eleven patients aged 65 to 70 years with de novo acute myeloid leukemia were enrolled in trial 9801 (n=76) or 9803 (n=135). The patients in the two trials had comparable white blood cell counts (P=0.3), cytogenetics (P=0.49), and complete remission rates (70% and 57%, respectively; P=0.17). Overall survival was identical in both trials (32% and 34% at 2 years, respectively; P=0.71). Overall survival after complete remission was identical in the 103 of 130 patients who received the planned post-remission courses (n=44 with two intensive courses, n=28 with one intensive course, n=31 with six outpatient courses; 41%, 55%, and 58% at 2 years, respectively; P=0.34). Even in patients with favorable or normal karyotype (n=97), overall survival from complete remission was not improved by more intensive post-remission therapy.
  
  
  CONCLUSIONS
  In patients aged 65 to 70 years with de novo acute myeloid leukemia in complete remission after standard intensive induction chemotherapy, there is no apparent benefit from intensive post-remission therapy. (ClinicalTrials.gov Identifiers: NCT00931138 and NCT00363025).
authors: Department of Hematology, Hôpital Saint-Louis, AP-HP, EA-3518, University Paris 7, Paris 1, Avenue C. Vellefaux, 75010 Paris, France.
authors: Raphael
authors: R
authors: Itzykson
authors: Claude
authors: C
authors: Gardin
authors: Cécile
authors: C
authors: Pautas
authors: Xavier
authors: X
authors: Thomas
authors: Pascal
authors: P
authors: Turlure
authors: Emmanuel
authors: E
authors: Raffoux
authors: Christine
authors: C
authors: Terré
authors: Pierre
authors: P
authors: Fenaux
authors: Sylvie
authors: S
authors: Castaigne
authors: Hervé
authors: H
authors: Dombret
authors: Nicolas
authors: N
authors: Boissel
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use; D005260:Female; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000175:diagnosis / Q000401:mortality / Q000628:therapy*; D008297:Male; D011379:Prognosis; D012074:Remission Induction; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents