title: Randomized comparison of double induction and timed-sequential induction to a "3 + 7" induction in adults with AML: long-term analysis of the Acute Leukemia French Association (ALFA) 9000 study.
abstract: Between 1990 and 1996, we conducted a randomized trial in adults with newly diagnosed acute myeloid leukemia (AML) in order to compare relapse-free interval (RFI) after double induction (arm B), timed-sequential induction (arm C), or control "3 + 7" induction (arm A). Patients achieving complete remission (CR) after induction +/- salvage received the same consolidation chemotherapy, which included a dosage stratification according to patient's age (younger or older than 50 years). This long-term analysis was performed in 592 patients (arm A/B/C, 197/198/197 patients). Overall CR rate was 76% without differences between the 3 arms, even if a salvage course was less frequently needed in arm B. Treatment-related mortality, either during the induction or the postremission phase, was not significantly higher in arms B and C than in arm A. Among the 449 CR patients, 250 relapsed (arm A/B/C, 90/87/73 patients) without significant differences in RFI in arms B and C versus arm A (P = .39 and .15, by the Gray test). However, when analyzing the 345 patients younger than 50, RFI was significantly improved in younger patients receiving timed-sequential induction (P = .038 by the Gray test), while not in those receiving double induction. Event-free survival and overall survival were similar in the 3 randomization arms.
authors.affiliation: Department of Onco-Hematology, Centre hospitalier de Versailles, 78150 Le Chesnay, France. scastaigne@ch-versailles.fr
authors.forename: Sylvie
authors.initials: S
authors.lastname: Castaigne
authors.forename: Sylvie
authors.initials: S
authors.lastname: Chevret
authors.forename: Eric
authors.initials: E
authors.lastname: Archimbaud
authors.forename: Pierre
authors.initials: P
authors.lastname: Fenaux
authors.forename: Dominique
authors.initials: D
authors.lastname: Bordessoule
authors.forename: Hervé
authors.initials: H
authors.lastname: Tilly
authors.forename: Thierry
authors.initials: T
authors.lastname: de Revel
authors.forename: Marc
authors.initials: M
authors.lastname: Simon
authors.forename: Brigitte
authors.initials: B
authors.lastname: Dupriez
authors.forename: Michel
authors.initials: M
authors.lastname: Renoux
authors.forename: Maud
authors.initials: M
authors.lastname: Janvier
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Micléa
authors.forename: Xavier
authors.initials: X
authors.lastname: Thomas
authors.forename: Christian
authors.initials: C
authors.lastname: Bastard
authors.forename: Claude
authors.initials: C
authors.lastname: Preudhomme
authors.forename: Francis
authors.initials: F
authors.lastname: Bauters
authors.forename: Laurent
authors.initials: L
authors.lastname: Degos
authors.forename: Hervé
authors.initials: H
authors.lastname: Dombret
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000375:Aging; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D005602:France; D006801:Humans; D007621:Karyotyping; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016879:Salvage Therapy; D055502:Secondary Prevention; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome