Randomized Study of Intensified Anthracycline Doses for Induction and Recombinant Interleukin-2 for Maintenance in Patients With Acute Myeloid Leukemia Age 50 to 70 Years: Results of the ALFA-9801 Study. - CNRS - Centre national de la recherche scientifique Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2010

Randomized Study of Intensified Anthracycline Doses for Induction and Recombinant Interleukin-2 for Maintenance in Patients With Acute Myeloid Leukemia Age 50 to 70 Years: Results of the ALFA-9801 Study.

Cecile Pautas
  • Fonction : Auteur
Fatiha Merabet
  • Fonction : Auteur
Claude Gardin
  • Fonction : Auteur
Selim Corm
  • Fonction : Auteur
Jean-Henri Bourhis
  • Fonction : Auteur
Oumedaly Reman
  • Fonction : Auteur
Nathalie Contentin
  • Fonction : Auteur
Thierry de Revel
  • Fonction : Auteur
Claude Preudhomme
Hervé Dombret
Sylvie Castaigne
  • Fonction : Auteur

Résumé

PURPOSE: In patients with acute myeloid leukemia (AML), induction chemotherapy is based on standard doses of anthracyclines and cytarabine. High doses of cytarabine have been reported as being too toxic for patients older than age 50 years, but few studies have evaluated intensified doses of anthracyclines. PATIENTS AND METHODS: In this randomized Acute Leukemia French Association 9801 (ALFA-9801) study, high doses of daunorubicin (DNR; 80 mg/m(2)/d x 3 days) or idarubicin (IDA4; 12 mg/m(2)/d x 4 days) were compared with standard doses of idarubicin (IDA3; 12 mg/m(2)/d x 3 days) for remission induction in patients age 50 to 70 years, with an event-free survival (EFS) end point. After two consolidation courses based on intermediate doses of cytarabine, patients in continuous remission were randomly assigned to receive or not receive maintenance therapy with recombinant interleukin-2 (rIL-2; 5 x 10(6) U/m(2) x 5 days each month) for a total duration of 12 months. A total of 468 patients entered the study (median age, 60 years). RESULTS: Overall complete remission rate was 77% with significant differences among the three randomization arms (83%, 78%, and 70% in the IDA3, IDA4, and DNR arms, respectively; P = .04). However, no significant differences were observed in relapse incidence, EFS, or overall survival among the three arms. In the 161 patients randomly assigned for maintenance therapy, no difference in outcome was observed between the rIL-2 and the no further treatment arms. CONCLUSION: Neither intensification of anthracycline doses nor maintenance with rIL-2 showed a significant impact on AML course, at least as scheduled in this trial.

Domaines

Immunologie

Dates et versions

hal-00453228 , version 1 (04-02-2010)

Identifiants

Citer

Cecile Pautas, Fatiha Merabet, Xavier Thomas, Emmanuel Raffoux, Claude Gardin, et al.. Randomized Study of Intensified Anthracycline Doses for Induction and Recombinant Interleukin-2 for Maintenance in Patients With Acute Myeloid Leukemia Age 50 to 70 Years: Results of the ALFA-9801 Study.. Journal of Clinical Oncology, 2010, epub ahead of print. ⟨10.1200/JCO.2009.23.2652⟩. ⟨hal-00453228⟩
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