Intensive Chemotherapy and Tyrosine Kinase Inhibitor in Patients with De Novo BCR::ABL1+ Acute Myeloid Leukemia

To describe the impact of adding a tyrosine kinase inhibitor (TKI) to intensive chemotherapy (IC) on the outcome of de novo BCR::ABL1+ acute myeloid leukemia (AML), we retrospectively analyzed the data of 212 adult AML with ≥20% bone marrow blasts, BCR::ABL1+ or t(9;22)(q34.1;q11.2), no history of previous chronic myeloid leukemia and no prior exposure to BCR-ABL1 TKI. Eighty-nine patients were treated with IC alone and 123 with IC+TKI between 1999 and 2024. Complete remission (CR) or CR with incomplete hematologic recovery (CRi) was achieved in 52/77 patients (68%) with IC and 110/123 patients (89%) with IC+TKI (P<0.0001). With a median follow-up of 66.7 months, the median overall survival (OS) was 20.5 months with IC and not reached with IC+TKI. The 3-year and 5-year OS rates were 42.1% and 38.5% with IC and 70.9% and 62.9% with IC+TKI (P<0.0001) respectively. In multivariate analyses, the addition of TKI to IC was significantly and independently associated with an improved CR/CRi rate (odds ratio: 4.74 [95% confidence interval: 2.17-10.35]; P<0.001) and OS (hazard ratio: 0.40 [0.27-0.62]; P<0.001). Also, adding TKI to IC and alloHSCT in CR1 were independent prognostic factors for relapse-free survival (HR: 0.42; 95% CI: 0.23-0.75; P=0.004 and HR: 0.31; 95% CI: 0.17-0.55; P<0.0001). The outcome of de novo BCR::ABL1+ AML is strongly improved by the addition of a TKI to IC and should become the standard of care. The classification as adverse-risk should be reconsidered in the future ELN classification.

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Journal
Blood
Published
2026-09-18
DOI
https://doi.org/10.1182/blood.2026033895
Primary Topic
Acute Myeloid Leukemia Research
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article

Intensive Chemotherapy and Tyrosine Kinase Inhibitor in Patients with De Novo BCR::ABL1+ Acute Myeloid Leukemia

Hervé Dombret, Pau Montesinos, Christian Thiede, Laëtitia Largeaud et al.
Blood
Acute Myeloid Leukemia Research
article

Intensive Chemotherapy and Tyrosine Kinase Inhibitor in Patients with De Novo BCR::ABL1+ Acute Myeloid Leukemia

Hervé Dombret, Pau Montesinos, Christian Thiede, Laëtitia Largeaud, Emmanuelle Tavernier, Jean‐Baptiste Micol, Christian Récher, Martin Jädersten, Anne Stidsholt Roug, Chantal Himberlin, Daniel Tuyet Kristensen, Pierre‐Yves Dumas, Cécile Moluçon‐Chabrot, Rudy Birsen, Pierre Péterlin, Juan Manuel Alonso‐Domínguez, Christoph Röllig, Carsten Müller‐Tidow, Véronique Mansat‐De Mas, Sylvain Garciaz, Sarah Bertoli, Delphine Lebon, Amine Belhabri, Samy Chraïbi, Lovisa Vennström, Quentin Cabrera, Mika Kontro, Leo Ruhnke, Mathieu Leclerc, Juan Bergua, Claudia Sossa, Marion Simonet, Andreas Burchert, Sören Lehmann, Pia Ettala, Thomas Cluzeau, Céline Berthon, Niklas Landberg, Ludovic Gabellier, Martin Carré, Hubert Serve, Claudia Lengerke, Patricia García Ramírez, Hartmut Döhner, Corentin Orvain, Michael W.M. Kühn, Vladimir Lazarević, Camille Gondran, Marc Maynadié, Raimundo García, María Luz Amigo, Anna Robelius, Carmen Botella, Audrey Bidet, Peter JM Valk, Kamel Laribi, magda alexis, Claudia D Baldus, Konstanze Döhner, Jurjen Versluis, Hans-Jörg Tischler, Emilie Bérard, Emmanuel Raffoux, Arnaud Pigneux, Gabrielle Roth Guepin, Gunnar Juliusson, Daniela Späth, Josefina Serrano, Jiri Mayer
article en

Abstract

To describe the impact of adding a tyrosine kinase inhibitor (TKI) to intensive chemotherapy (IC) on the outcome of de novo BCR::ABL1+ acute myeloid leukemia (AML), we retrospectively analyzed the data of 212 adult AML with ≥20% bone marrow blasts, BCR::ABL1+ or t(9;22)(q34.1;q11.2), no history of previous chronic myeloid leukemia and no prior exposure to BCR-ABL1 TKI. Eighty-nine patients were treated with IC alone and 123 with IC+TKI between 1999 and 2024. Complete remission (CR) or CR with incomplete hematologic recovery (CRi) was achieved in 52/77 patients (68%) with IC and 110/123 patients (89%) with IC+TKI (P<0.0001). With a median follow-up of 66.7 months, the median overall survival (OS) was 20.5 months with IC and not reached with IC+TKI. The 3-year and 5-year OS rates were 42.1% and 38.5% with IC and 70.9% and 62.9% with IC+TKI (P<0.0001) respectively. In multivariate analyses, the addition of TKI to IC was significantly and independently associated with an improved CR/CRi rate (odds ratio: 4.74 [95% confidence interval: 2.17-10.35]; P<0.001) and OS (hazard ratio: 0.40 [0.27-0.62]; P<0.001). Also, adding TKI to IC and alloHSCT in CR1 were independent prognostic factors for relapse-free survival (HR: 0.42; 95% CI: 0.23-0.75; P=0.004 and HR: 0.31; 95% CI: 0.17-0.55; P<0.0001). The outcome of de novo BCR::ABL1+ AML is strongly improved by the addition of a TKI to IC and should become the standard of care. The classification as adverse-risk should be reconsidered in the future ELN classification.

Blood
Goethe University Frankfurt (DE), Uppsala University (SE), Université d'Orléans (FR), Centre National de la Recherche Scientifique (FR), Karolinska University Hospital (SE), University of Helsinki (FI), Inserm (FR), Université de Bourgogne (FR), Lund University (SE), Universidad de Alcalá (ES), Universidad Autónoma de Bucaramanga (CO), Johannes Gutenberg University Mainz (DE), Aarhus University (DK), Aix-Marseille Université (FR), Heidelberg University (DE), Université de Lille (FR), Helsinki University Hospital (FI), Centre Hospitalier Universitaire de Grenoble (FR), Sahlgrenska University Hospital (SE), Institut Gustave Roussy (FR), Erasmus MC (NL), Turku University Hospital (FI), University Hospital Heidelberg (DE), Aarhus University Hospital (DK), Princess Margaret Cancer Centre (CA), Karolinska Institutet (SE), Centre Hospitalier Universitaire de Bordeaux (FR), Centre Hospitalier Universitaire de Lille (FR), Centre Hospitalier Universitaire de Nice (FR), Hospital Universitari i Politècnic La Fe (ES), Centre Hospitalier Universitaire de Toulouse (FR), Hochschule für Angewandte Wissenschaften Kiel (DE), Centre Hospitalier Universitaire de Besançon (FR), Hospital General Universitario Morales Meseguer (ES), Hôpital Cochin (FR), Centre Hospitalier Universitaire de Montpellier (FR), Centre Hospitalier Universitaire Amiens-Picardie (FR), Institut universitaire du cancer de Toulouse Oncopole (FR), Centre Hospitalier Régional et Universitaire de Nancy (FR), University Hospital Brno (CZ), Centre Hospitalier Universitaire de Nîmes (FR), Centre Léon Bérard (FR), Centre Hospitalier Universitaire de Reims (FR), Hospital Universitario Príncipe de Asturias (ES), Institute Cancer De La Loire Lucien Neuwirth (FR), Hospital San Pedro de Alcántara (ES), University Hospital Schleswig-Holstein (DE), Hôpital Cardiologique du Haut-Lévêque (FR), Hospital Universitario Reina Sofía (ES), Hospital General Universitari de Castelló (ES), University Children's Hospital Tübingen (DE), Centre Hospitalier du Mans (FR), Centre Hospitalier Universitaire de Clermont-Ferrand (FR), Peuplements végétaux et bioagresseurs en milieu tropical (RE), Hospital General Universitario de Alicante Doctor Balmis (ES), Skåne University Hospital (SE), Centre Hospitalier d'Albi (FR), Centre de Recherche en Cancérologie de Marseille (FR), Hôpital Saint-Louis (FR), Centre hospitalier universitaire d'Orléans (FR), Erasmus MC Cancer Institute (NL), Institut Paoli-Calmettes (FR), University Hospital Ulm (DE), Centre Hospitalier Universitaire de Saint-Étienne (FR), Johannes Wesling Klinikum Minden (DE), Clinical Research Center Kiel (DE), Université d'Angers (FR), Technische Universität Dresden (DE), Erasmus University Rotterdam (NL), University of Lübeck (DE), Université de Reims Champagne-Ardenne (FR), Nantes Université (FR)
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