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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.


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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 study

Sylvie Castaigne, Sylvie Chevret, Eric Archimbaud, Pierre Fenaux, Dominique Bordessoule, Hervé Tilly, Thierry de Revel, Marc Simon, Brigitte Dupriez, Michel Renoux, Maud Janvier, Jean-Michel Micléa, Xavier Thomas, Christian Bastard, Claude Preudhomme, Francis Bauters, Laurent Degos, and Hervé Dombret

From 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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