Zhang Danyang, Dong Xiaomin, Zhang Yue, Chen Xiaolei, Qu Jiaoyan, Chen Tingting, Zhou Hebing
Department of Hematology, The Affiliated Beijing Luhe Hospital of Capital Medical University, Beijing 101149, P.R. China.
Oncol Lett. 2025 Apr 28;29(6):318. doi: 10.3892/ol.2025.15064. eCollection 2025 Jun.
The combination of azacitidine (AZA) and venetoclax (VEN) for maintenance treatment in patients with intermediate-to-low-risk acute myeloid leukemia (AML) is a contentious issue. The aim of the present study was to investigate the relationship between the use of VEN plus AZA (VEN-AZA) and the relapse rate of intermediate-to-low-risk AML among adult Chinese participants. The primary endpoint was AML relapse, analyzed using time-to-event methods. A multivariate Cox proportional hazards model was used to compare outcomes between patients who continued VEN-AZA for maintenance treatment and those who discontinued such therapy. Among the 43 patients, 22 (51.1%) received VEN-AZA with treatment cycles every 2-3 months, while the remaining 21 patients discontinued maintenance therapy. The median ages for the two groups were 59 and 49 years, respectively, with an age range of 21-81 years. With a median follow-up of 29.6 months (range 7-74), the median progression-free survival (PFS) was not reached in the maintenance therapy group and was 47.3 months in the group that discontinued treatment. The number of grade 3-4 adverse events was low in the maintenance group, with neutropenia and thrombocytopenia as the primary hematological adverse events, and respiratory infection as the main non-hematological adverse event. Univariate analysis indicated that age, white blood cell count and maintenance therapy were associated with AML relapse. After adjusting for confounding factors, multivariate Cox proportional hazards model showed that maintenance treatment was associated with a reduced risk of relapse and a longer PFS time, compared with discontinued treatment (hazard ratio, 0.06; 95% confidence interval, 0-0.77). Therefore, patients treated with VEN-AZA exhibited a longer PFS time, suggesting that further clinical trials are warranted.
阿扎胞苷（AZA）与维奈克拉（VEN）联合用于中低危急性髓系白血病（AML）患者的维持治疗是一个有争议的问题。本研究的目的是调查在中国成年参与者中，VEN加AZA（VEN-AZA）的使用与中低危AML复发率之间的关系。主要终点是AML复发，采用事件发生时间方法进行分析。使用多变量Cox比例风险模型比较继续接受VEN-AZA维持治疗的患者与停止该治疗的患者的结局。在43例患者中，22例（51.1%）每2-3个月接受VEN-AZA治疗周期，其余21例患者停止维持治疗。两组的中位年龄分别为59岁和49岁，年龄范围为21-81岁。中位随访29.6个月（范围7-74个月），维持治疗组未达到中位无进展生存期（PFS），停止治疗组的中位PFS为47.3个月。维持治疗组3-4级不良事件数量较少，主要血液学不良事件为中性粒细胞减少和血小板减少，主要非血液学不良事件为呼吸道感染。单因素分析表明，年龄、白细胞计数和维持治疗与AML复发相关。在调整混杂因素后，多变量Cox比例风险模型显示，与停止治疗相比，维持治疗与复发风险降低和PFS时间延长相关（风险比，0.06；95%置信区间，0-0.77）。因此，接受VEN-AZA治疗的患者PFS时间更长，提示有必要进行进一步的临床试验。
