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Molecular classification and prognosis in younger adults with acute myeloid leukemia and intermediate-risk cytogenetics treated or not by gemtuzumab ozogamycin: Final results of the GOELAMS/FILO acute myeloid leukemia 2006-intermediate-risk trial

Anne Bouvier 1 Jean-Francois Hamel 2, 3 Jacques Delaunay 4 Eric Delabesse 5, 6 Pierre-Yves Dumas 7, 8 Marie-Pierre Ledoux 9 Pierre Peterlin 10 Isabelle Luquet 11 Gabrielle Roth Guepin 12 Claude Eric Bulabois 13 Maria Pilar Gallego Hernanz 14 Gaelle Guillerm 15 Romain Guieze 16 Yosr Hicheri 17 Celestine Simand 9 Chantal Himberlin 18 Mathilde Hunault-Berger 1, 19, 20 Marc Bernard 21 Eric Jourdan 22 Denis Caillot 23 Veronique Dorvaux 24 Emmanuelle Tavernier 25 Etienne Daguindau 26 Anne Banos 27 Mario Ojeda-Uribe 28 Emmanuel Gyan 29, 30, 31 Magda Alexis 32 Jean-Pierre Marolleau 33, 34 Pascal Turlure 35 Didier Bouscary 36, 37 Catherine Humbrecht Hacene Zerazhi 38 Marie-Christine Bene 10 Arnaud Pigneux 8 Martin Carre 13 Norbert Ifrah 3, 39 Odile Blanchet 40, 3 Norbert Vey 41, 42 Christian Recher 43 Pascale Cornillet-Lefebvre 44 
1 CRCINA-ÉQUIPE 7 - Innate Immunity and Immunotherapy
CRCINA - Centre de Recherche en Cancérologie et Immunologie Nantes-Angers
30 LNOx - ERL 7001 LNOx (Leukemic Niche & redOx metabolism / Niche leucémique et métabolisme redOx)
CHRU Tours - Centre Hospitalier Régional Universitaire de Tours, CNRS - Centre National de la Recherche Scientifique : EMR7001 / ERL7001, CNRS GDR 3697 Micronit - Microenvironnement des niches tumorales, GICC EA 7501 - Groupe innovation et ciblage cellulaire (GICC), EA 7501 [2018-...]
Abstract : In this randomized phase 3 study, the FILO group tested whether the addition of 6 mg/m(2) of gemtuzumab ozogamycin (GO) to standard chemotherapy could improve outcome of younger patients with de novo acute myeloid leukemia (AML) and intermediate-risk cytogenetics. GO arm was prematurely closed after 254 inclusions because of toxicity. A similar complete remission rate was observed in both arms. Neither event-free survival nor overall survival were improved by GO in younger AML patients (<60 years) ineligible for allogeneic stem-cell transplantation. (P = .086; P = .149, respectively). Using unsupervised hierarchical clustering based on mutational analysis of seven genes (NPM1, FLT3-ITD, CEBPA, DNMT3A, IDH1, IDH2, and ASXL1), six clusters of patients with significant different outcome were identified. Five clusters were based on FLT3-ITD, NPM1, and CEBPA mutations as well as epigenetic modifiers (DNMT3A, IDH1/2, ASXL1), whereas the last cluster, representing 25% of patients, had no mutation and intermediate risk. One cluster isolated FLT3-ITD mutations with higher allelic ratio and a very poor outcome. The addition of GO had no impact in these molecular clusters. Although not conclusive for GO impact in AML patients <60 years, this study provides a molecular classification that distinguishes six AML clusters influencing prognosis in younger AML patients with intermediate-risk cytogenetic.
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Submitted on : Thursday, March 10, 2022 - 4:47:08 PM
Last modification on : Wednesday, November 23, 2022 - 6:10:04 PM

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Anne Bouvier, Jean-Francois Hamel, Jacques Delaunay, Eric Delabesse, Pierre-Yves Dumas, et al.. Molecular classification and prognosis in younger adults with acute myeloid leukemia and intermediate-risk cytogenetics treated or not by gemtuzumab ozogamycin: Final results of the GOELAMS/FILO acute myeloid leukemia 2006-intermediate-risk trial. European Journal of Haematology, 2021, 107 (1), pp.111-121. ⟨10.1111/ejh.13626⟩. ⟨hal-03604930⟩

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