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Blood, 15 October 2004, Vol. 104, No. 8, pp. 2467-2474. Prepublished online as a Blood First Edition Paper on May 13, 2004; DOI 10.1182/blood-2003-10-3561.
NEOPLASIA 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 studyFrom the Department of Onco-Hematology, Centre Hospitalier de Versailles, Le Chesnay; the Department of Biostatistics, Hôpital Saint-Louis, Paris; the Department of Hematology, Hôpital Edouard Herriot, Lyon; the Department of Hematology, Centre Hospitalier Régional Universitaire, Lille; the Department of Hematology, Centre Hospitalier Universitaire, Limoges; the Department of Hematology, Centre Henri Becquerel, Rouen; the Department of Hematology, Centre Hospitalier Inter-Armées, Clamart; the Department of Hematology, Centre Hospitalier, Lens; the Department of Hematology, Centre Hospitalier, Valenciennes; the Department of Hematology, Centre Hospitalier de la Côte Basque, Bayonne; the Department of Hematology, Centre René Huguenin, Saint Cloud; and Department of Hematology, Hôpital Saint-Louis, Paris, France.
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.
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