Treatment Modalities and the Impact of Granulocyte Colony-Stimulating Factor in AML Patients Treated With Venetoclax and Azacitidine: A DATAML Registry Study.

Authors

Léopoldine Lapierre, Lucie Laemmel, Emilie Bérard, Lucie Rigolot, Audrey Bidet, Jules Higué, Anne Banos, Guillaume Béziat, Ramzi Jeddi, Benoit Branco, Claire Calmettes, Noémie Gadaud, Martin Gauthier, Leila Ghenim, Gaelle Laboure, Clémentine Salvado, Reza Tabrizi, Joséphine Thomazeau, Willy Vaillant, Suzanne Tavitian, Laurent Balardy, Thibaut Leguay, Alban Canali, Emilie Klein, Audrey Sarry, Madeline Mougenot, Eva Baraniecki, Anne-Charlotte de Grande, Pierre Bories, Laetitia Largeaud, Maël Heiblig, Amine Belhabri, Urbain Tauveron-Jalenques, Emmanuelle Tavernier, Martin Carré, Arnaud Pigneux, François Vergez, Sarah Bertoli, Pierre-Yves Dumas, Christian Récher

Published in

Clinical lymphoma, myeloma & leukemia. Jul 17, 2026. Epub Jul 17, 2026.

Abstract

Azacitidine-venetoclax (AZA-VEN) has become a standard treatment in older or chemotherapy-ineligible AML patients. While the registration trial showed a median overall survival (OS) of 14.7 months, most real-world studies have not reproduced this result.
We analyzed treatment patterns, adverse events, responses and outcomes in 199 patients treated with AZA-VEN in the DATAML registry.
The median age was 75.6 years, 48.7% had secondary AML (11% post-MPN); 11.7% had another cancer, and 9% had received AZA for prior myelodysplastic syndrome. Cytogenetic risk was intermediate (55.8%) or adverse (43.7%). The most frequent gene mutations were ASXL1 (33%), TET2 (27%), TP53 (26%), RUNX1 (24%) and SRSF2 (24%). The first cycle was performed on an outpatient basis in 39.4% of patients. The median number of cycles was 4 and 37% received > 6 cycles. Beyond cycle 6, reductions in treatment dose or duration were attributed to VEN in 55% of patients and to AZA for 43%. The complete remission (CR) plus CR with incomplete hematologic recovery (CRi) rate was 58.5%, and day-30 death rate was 3%. Median OS was 8.9 months. mPRS and refined-ELN2024 classifications were significantly associated with response and OS. In CR/CRi patients, G-CSF use was significantly and independently associated with improved OS (median, 10.1 months without versus 20.3 with G-CSF; P = .001). In an external cohort, G-CSF was also associated with a trend towards improved OS.
In real-world clinical practice, patients with more severe characteristics are typically selected for AZA-VEN, which could explain suboptimal outcomes. G-CSF should be prospectively explored in AZA-VEN treated patients.

PMID:
42586900
Bibliographic data and abstract were imported from PubMed on 13 Aug 2026.

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