Real-World Study of 21-Day Venetoclax Plus Azacitidine Regimen in the Treatment of Newly Diagnosed Unfit-Acute Myeloid Leukemia.
10.19746/j.cnki.issn.1009-2137.2025.05.007
- Author:
Li-Ying AN
1
;
Min CHEN
1
;
Jin WEI
1
;
Xing-Li ZOU
1
;
Pan ZHAO
1
;
Zhu YANG
1
;
Xun NI
1
;
Xiao-Jing LIN
1
Author Information
1. Department of Hematology， The Affiliated Hospital of North Sichuan Medical College， Nanchong 637000， Sichuan Province， China.
- Publication Type:Journal Article
- Keywords:
Venetoclax;
acute myeloid leukemia;
real-world study
- MeSH:
Humans;
Leukemia, Myeloid, Acute/drug therapy*;
Aged;
Middle Aged;
Bridged Bicyclo Compounds, Heterocyclic/therapeutic use*;
Sulfonamides/therapeutic use*;
Azacitidine/therapeutic use*;
Aged, 80 and over;
Male;
Female;
Retrospective Studies;
Nucleophosmin;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*;
Remission Induction;
Mutation;
Treatment Outcome
- From:
Journal of Experimental Hematology
2025;33(5):1279-1286
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To observe the efficacy and safety of 21-day venetoclax (VEN) plus azacitidine (AZA) (21-day VA) in newly diagnosed unfit acute myeloid leukemia (AML) patients in the real-world.
METHODS:The clinical data of patients with unfit-AML who received 21-day VA regimen from December 2020 to July 2024 in our center and completed at least 1 cycle of therapeutic effect assessment was retrospectively collected to analyze the safety, efficacy and its influencing factors.
RESULTS:A total of 59 patients were enrolled in our study, with a median age of 67(48-87) years old. After 1 cycle of therapy, the composite complete remission (cCR) rate was 74.5%, 54.2% of cases were negative for minimal residual disease (MRD). Among them, the MRD negative rate of patients with NPM1 mutation was significantly higher than that of patients without NPM1 mutation ( P =0.032). The median follow-up of patients was 19(2-38) months, the best cCR and MRD negative rates were 78% and 64.4%, respectively, the median overall survival (OS) time was 12 months, and the median progression free survival (PFS) time was 5 months. Multivariate Cox regression analysis showed less than 4 cycles of VA chemotherapy were independent risk factor for PFS and OS ( P < 0.05). After achieving remission, anemia and thrombocytopenia improved with the increase of the number of chemotherapy cycle.
CONCLUSION:In real-world, 21-day VA regimen still shows significant efficacy in the treatment of newly diagnosed unfit-AML, without adversely affecting remission rate and MRD negative rate of the first cycle.
