Objective: To retrospectively analyze the clinical data of newly diagnosed acute myeloid leukemia (AML) patients treated with venetoclax combined with azacitidine (Ven/Aza) or standard "3+7" regimen and similar regimens, collect real-world study data, compare the treatment response and adverse events between the two regimens, as well as perform survival analysis.
Methods: To retrospectively analyze the efficacy, survival, and adverse reactions of newly diagnosed AML patients treated with Ven/Aza (24 cases) and "3+7" regimens (117 cases ) in our hospital from September 2009 to March 2023, as well as factors influencing outcomes. A propensity score matching (PSM) was performed on age and Eastern Cooperative Oncology Group performance status (ECOG PS) to obtain a 1:1 matched cohort of 20 pairs, and the efficacy and survival before and after the matching were compared.
Results: The median age of patients in the Ven/Aza group was 69 years, while that in the "3+7" group was 56 years (P <0.001). Objective remission rate (ORR) was 62.5% in Ven/Aza group and 74.8% in "3+7" group (P >0.05). The median overall survival (OS) in the Ven/Aza group was 522 days, while that in the "3+7" group was 1 002 days (P >0.05). After controlling the two variables of age and ECOG PS, a PSM cohort of 20 pairs was obtained, in which the ORR was 65% in Ven/Aza group and 60% in "3+7" group (P >0.05). The median OS was 522 days and 629 days, and median progression-free survival (PFS) was 531 days and 198 days between the two groups, respectively. There were no statistically significant differences in OS and PFS between the two groups (both P >0.05). Additionally, the incidence of adverse events in the Ven/Aza group was significantly reduced.
Conclusion: The overall cohort shows that the "3+7" regimen has advantages in efficacy and survival, but Ven/Aza regimen is relatively safer. After performing PSM on age and ECOG PS, the Ven/Aza group showed improved efficacy, and a longer median PFS compared to "3+7" group.
题目: 维奈克拉联合阿扎胞苷对比“3+7”或类似方案治疗初治急性髓系白血病的回顾性分析.
目的: 回顾性分析接受维奈克拉联合阿扎胞苷（Ven/Aza）方案和“3+7”及类似方案治疗的初治急性髓系白血病（AML）患者的临床资料，收集真实世界研究的数据，对比两种方案的治疗反应和不良反应，并进行生存分析。.
方法: 回顾性分析2009年9月到2023年3月在我院接受Ven/Aza方案（24例）和“3+7”方案（117例）方案治疗的初治AML患者的疗效、生存期和不良反应，以及影响结局的因素。根据年龄、ECOG PS进行倾向性匹配评分（PSM）后得到1∶1匹配的队列20对，并对匹配前后的疗效和生存情况做对比。.
结果: Ven/Aza组中位年龄为69岁，“3+7”组为56岁（P <0.001）。Ven/Aza组客观反应率为62.5%，“3+7”组为74.8%（P >0.05）。Ven/Aza组中位总生存期为522 d， “3+7”组为1 002 d（P >0.05）。控制年龄和ECOG PS这2个变量后，得到20对病例的PSM队列，其中Ven/Aza组的客观反应率为65%，“3+7”组为60%（P >0.05）；两组中位总生存期分别为522和629 d，中位无进展生存期分别为531和198 d，比较差异均无统计学意义（P >0.05）；Ven/Aza组不良反应的发生率明显降低。.
结论: 整体队列显示 “3+7”方案在疗效和生存上更有优势，但是Ven/Aza方案安全性更好。在控制年龄和ECOG PS的PSM后，Ven/Aza组的疗效好转，中位无进展生存期较“3+7”组更长。.
Keywords: acute myeloid leukemia; venetoclax; azacitidine.