Comparison of venetoclax and azacitidine versus a cytarabine‐based treatment for patients with acute myeloid leukaemia in first relapse after chemotherapy. A real‐world study of the DATAML ‐ IPC ‐ AURAML consortium

Complete remission (CR) rates for patients with acute myeloid leukaemia (AML) treated with intensive chemotherapy (IC) have increasingly improved. Yet, relapse remains a concern with a dismal prognosis. In this report, results are presented of a retrospective analysis comparing salvage therapy based on intermediate (I) or high (H)-dose cytarabine (DAC) (n = 203) and venetoclax-azacitidine (VEN-AZA) (n = 114) for patients with AML in first relapse. Patients (median age 60 years, interquartile range [IQR] 48-67) had reached CR1 after a standard 7 + 3 (n = 305) or CPX351 schedule (n = 12). I/HDAC-based and VEN-AZA salvage, respectively, resulted in CR2 in 66.0% and 66.7% of the patients (p = 0.96). Allogeneic haematopoietic stem cell transplantation (allo-HSCT) was performed for 115 patients in CR2 and 18 in failure. Relapse-free survival was 13.2 (IQR 7.0-not reached [NR]) and 13.7 (IQR 7.8-NR) months while overall survival (OS) was 14.5 (IQR 6.2-NR) and 12.3 months (IQR 4.8-NR; p = 0.41) for patients who received I/HDAC-based salvage and VEN-AZA respectively. In multivariable analysis, relapsing patients ≥60 years with low/intermediate-risk cytogenetics and VEN-AZA had a better OS (p = 0.002), while I/HDAC was more efficient for those with poor risk cytogenetics and < 60-year-old (p = 0.002). VEN-AZA salvage therapy thus appears promising compared with conventional I/HDAC-based IC; this question warrants evaluation in randomized studies.

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Journal
British Journal of Haematology
Published
2026-09-04
DOI
https://doi.org/10.1111/bjh.70815
Primary Topic
Acute Myeloid Leukemia Research
Type
article
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article

Comparison of venetoclax and azacitidine versus a cytarabine‐based treatment for patients with acute myeloid leukaemia in first relapse after chemotherapy. A real‐world study of the DATAML ‐ IPC ‐ AURAML consortium

Gaspar Aspas Requena, Arnaud Pigneux, Maël Heiblig, Laëtitia Largeaud et al.
British Journal of Haematology
Acute Myeloid Leukemia Research
article

Comparison of venetoclax and azacitidine versus a cytarabine‐based treatment for patients with acute myeloid leukaemia in first relapse after chemotherapy. A real‐world study of the DATAML ‐ IPC ‐ AURAML consortium

Gaspar Aspas Requena, Arnaud Pigneux, Maël Heiblig, Laëtitia Largeaud, Emmanuelle Tavernier, Christian Récher, Émilie Klein, Pierre‐Yves Dumas, Sylvain Garciaz, Sarah Bertoli, Thibaut Leguay, Norbert Vey, Audrey Sarry, Clémence Santana, Martin Carré, Suzanne Tavitian, Anne Banos, Ziyad Acheaibi, Estelle Borgne, Anne‐Charlotte De Grande, Morgane Sighieri, Emilie Bérard
article en

Abstract

Complete remission (CR) rates for patients with acute myeloid leukaemia (AML) treated with intensive chemotherapy (IC) have increasingly improved. Yet, relapse remains a concern with a dismal prognosis. In this report, results are presented of a retrospective analysis comparing salvage therapy based on intermediate (I) or high (H)-dose cytarabine (DAC) (n = 203) and venetoclax-azacitidine (VEN-AZA) (n = 114) for patients with AML in first relapse. Patients (median age 60 years, interquartile range [IQR] 48-67) had reached CR1 after a standard 7 + 3 (n = 305) or CPX351 schedule (n = 12). I/HDAC-based and VEN-AZA salvage, respectively, resulted in CR2 in 66.0% and 66.7% of the patients (p = 0.96). Allogeneic haematopoietic stem cell transplantation (allo-HSCT) was performed for 115 patients in CR2 and 18 in failure. Relapse-free survival was 13.2 (IQR 7.0-not reached [NR]) and 13.7 (IQR 7.8-NR) months while overall survival (OS) was 14.5 (IQR 6.2-NR) and 12.3 months (IQR 4.8-NR; p = 0.41) for patients who received I/HDAC-based salvage and VEN-AZA respectively. In multivariable analysis, relapsing patients ≥60 years with low/intermediate-risk cytogenetics and VEN-AZA had a better OS (p = 0.002), while I/HDAC was more efficient for those with poor risk cytogenetics and < 60-year-old (p = 0.002). VEN-AZA salvage therapy thus appears promising compared with conventional I/HDAC-based IC; this question warrants evaluation in randomized studies.

British Journal of Haematology
Centre National de la Recherche Scientifique (FR), Université Toulouse III - Paul Sabatier (FR), Université de Bordeaux (FR), Inserm (FR), Université Fédérale de Toulouse Midi-Pyrénées (FR), Centre Hospitalier Universitaire de Grenoble (FR), Centre Hospitalier Universitaire de Bordeaux (FR), Centre Hospitalier Universitaire de Toulouse (FR), Centre Hospitalier Universitaire de Montpellier (FR), Institut universitaire du cancer de Toulouse Oncopole (FR), Bordeaux Population Health (FR), Institute Cancer De La Loire Lucien Neuwirth (FR), Hôpital Lyon Sud (FR), Centre Hospitalier de la Côte Basque (FR), Centre Hospitalier de Valence (FR), Centre de Recherche en Cancérologie de Marseille (FR), Institut Paoli-Calmettes (FR)
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