Treatment Modalities and the Impact of Granulocyte Colony-Stimulating Factor in AML Patients Treated With Venetoclax and Azacitidine: A DATAML Registry Study.
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Lapierre Léopoldine, Laemmel Lucie, Bérard Emilie, Rigolot Lucie, Bidet Audrey, Higué Jules, Banos Anne, Béziat Guillaume, Jeddi Ramzi, Branco Benoit, Calmettes Claire, Gadaud Noémie, Gauthier Martin, Ghenim Leila, Laboure Gaelle, Salvado Clémentine, Tabrizi Reza, Thomazeau Joséphine, Vaillant Willy, Tavitian Suzanne, Balardy Laurent, Leguay Thibaut, Canali Alban, Klein Emilie, Sarry Audrey, Mougenot Madeline, Baraniecki Eva, de Grande Anne-Charlotte, Bories Pierre, Largeaud Laetitia, Heiblig Maël, Belhabri Amine, Tauveron-Jalenques Urbain, Tavernier Emmanuelle, Carré Martin, Pigneux Arnaud, Vergez François, Bertoli Sarah, Dumas Pierre-Yves, Récher Christian
Аннотация
PATIENTS AND METHODS: We analyzed treatment patterns, adverse events, responses and outcomes in 199 patients treated with AZA-VEN in the DATAML registry.
RESULTS: 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.
CONCLUSION: 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.