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.
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.
Castaigne
Sylvie
S
Department of Onco-Hematology, Centre hospitalier de Versailles, 78150 Le Chesnay, France. scastaigne@ch-versailles.fr
Chevret
Sylvie
S
Archimbaud
Eric
E
Fenaux
Pierre
P
Bordessoule
Dominique
D
Tilly
Hervé
H
de Revel
Thierry
T
Simon
Marc
M
Dupriez
Brigitte
B
Renoux
Michel
M
Janvier
Maud
M
Micléa
Jean-Michel
JM
Thomas
Xavier
X
Bastard
Christian
C
Preudhomme
Claude
C
Bauters
Francis
F
Degos
Laurent
L
Dombret
Hervé
H
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