Efficacy and safety analysis of venetoclax combined with azacitidine regimen for treatment of newly diagnosed elderly patients with AML
10.3760/cma.j.cn115356-20240305-00031
- VernacularTitle:维奈克拉联合阿扎胞苷方案治疗老年初治AML患者的效果及安全性分析
- Author:
Xiuli CHEN
1
;
Zhenjie CAI
;
Rongrong ZHENG
;
Rong ZHENG
;
Wuqiang LIN
Author Information
1. 莆田市第一医院血液内科，莆田 351100
- Keywords:
Leukemia, myeloid, acute;
Venetoclax;
Azacitidine;
Treatment outcome
- From:
Journal of Leukemia & Lymphoma
2025;34(3):149-154
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To investigate the efficacy and safety of the combination therapy of venetoclax (VEN) and azacitidine (AZA) in treatment of newly diagnosed elderly patients with acute myeloid leukemia (AML).Methods:A retrospective cohort study was conducted. The clinical data of 17 newly diagnosed elderly AML patients who received VEN+AZA regimen at the First Hospital of Putian City from April 2021 to June 2023 were collected. Treatment outcomes and adverse events were analyzed. Survival curves were plotted by using the Kaplan-Meier method, and intergroup comparisons were performed by using the log-rank test.Results:Among the 17 patients, the median age [ M ( Q1, Q3)] was 70 (68, 74) years, with 11 males (64.7%) and 6 females (35.3%). The median number of treatment courses was 4.0 (2.5, 8.5). After the first course, the composite complete remission (cCR) rate was 41.2% (7/17), minimal residual disease (MRD) negativity rate was 5.9% (1/17), and overall response rate (ORR) was 82.4% (14/17). By the end of follow-up in September 2023, the cCR rate reached 64.7% (11/17), MRD negativity rate was 52.9% (9/17), and ORR was 88.2% (15/17). The median number of courses to achieve cCR was 1.0 (1.0, 2.0), and to achieve MRD negativity was 3.0 (2.0, 3.5). The follow-up rate was 88.2% (15/17), and the median follow-up time was 17.3 months (95% CI: 7.0-27.6 months). The median progression-free survival (PFS) time was 6.5 months (95% CI: 1.7-11.3 months), and median overall survival (OS) time was 12.0 months (95% CI: 0.3-23.7 months). The median OS time after progression was 1.5 months (95% CI: 1.0-2.0 months). All patients experienced hematological adverse events, with 94.1% (16/17) experiencing grade ≥ 3 hematological adverse events. The most common non-hematological adverse event was infection (88.2%, 15/17), with the lung being the most frequent site of infection (82.4%, 14/17), while 41.2% (7/17) of patients had pre-existing infections before treatment. Conclusions:The VEN+AZA regimen demonstrates high remission rates and significant efficacies in treating newly diagnosed elderly AML patients. Although adverse events occur in nearly all patients, most are able to tolerate the treatment.
