title: 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.
abstract: 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.
authors.affiliation: Centre Hospitalier de Versailles, Hôpital André Mignot, Service Hématologie et Oncologie, 177 rue de Versailles, 78150 Le Chesnay, France.
authors.forename: Cecile
authors.initials: C
authors.lastname: Pautas
authors.forename: Fatiha
authors.initials: F
authors.lastname: Merabet
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Raffoux
authors.forename: Claude
authors.initials: C
authors.lastname: Gardin
authors.forename: Selim
authors.initials: S
authors.lastname: Corm
authors.forename: Jean-Henri
authors.initials: JH
authors.lastname: Bourhis
authors.forename: Oumedaly
authors.initials: O
authors.lastname: Reman
authors.forename: Pascal
authors.initials: P
authors.lastname: Turlure
authors.forename: Nathalie
authors.initials: N
authors.lastname: Contentin
authors.forename: Thierry
authors.initials: T
authors.lastname: de Revel
authors.forename: Philippe
authors.initials: P
authors.lastname: Rousselot
authors.forename: Claude
authors.initials: C
authors.lastname: Preudhomme
authors.forename: Dominique
authors.initials: D
authors.lastname: Bordessoule
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
authors.forename: Christine
authors.initials: C
authors.lastname: Terré
authors.forename: Mauricette
authors.initials: M
authors.lastname: Michallet
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Sylvie
authors.initials: S
authors.lastname: Castaigne
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003630:Daunorubicin / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage; D007376:Interleukin-2 / Q000008:administration & dosage / Q000031:analogs & derivatives; D053208:Kaplan-Meier Estimate; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011994:Recombinant Proteins / Q000008:administration & dosage; D012008:Recurrence; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D007376:Interleukin-2; D011994:Recombinant Proteins; C082598:aldesleukin; D015255:Idarubicin; D003630:Daunorubicin