Department of Hematology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, Guangdong, P. R. China.
Hematology. 2021 Dec;26(1):312-320. doi: 10.1080/16078454.2021.1875600.
The present meta-analysis was performed to evaluate the efficacy, toxicities of both hypomethylating agents (decitabine and azaciticine) in the treatment of CMML patients.
All available cohort studies of patients with CMML treated with decitabine and azacitidine were identified. The primary endpoints of this meta-analysis were response to hypomethylating agents. Pooled estimates of treatment response and drug-related adverse events were calculated using fixed or random effect models.
Fourteen studies with 600 CMML patients (decitabine: n=196; azacitidine: n=404) were identified and included for meta-analysis. HMAs yielded a pooled ORR estimate of 43% (95% CI: 36%-50%) in patients with CMML. Patients received either azacitidine or decitabine exhibited comparable incidence of ORR (43% vs. 45%, P=0.810), while significantly higher incidence of mCR was observed in patients treated with decitabine (23% vs. 10%, P=0.000). Decitabine treatment was also associated with higher incidence of transfusion independence (42% vs. 20%, P=0.044). Both HMAs led to objective hematologic or non-hematologic AEs (27%-43%), while dosage modification/delay were more frequent in patients treated with azacitidine (81% vs. 67%, P=0.021).
This current study may provide preliminary data in evaluating the efficacy and safety of HMAs in patients with CMML. Decitabine and azacitidine are comparable effective and safe in treating CMML. However, it is necessary to point out that any comparison of decitabine and azacitidine with respect to clinical outcomes can only be done in the context of a randomized controlled trial.
本荟萃分析旨在评估低甲基化药物（地西他滨和阿扎胞苷）在治疗 CMML 患者中的疗效和毒性。
检索了所有关于 CMML 患者接受地西他滨和阿扎胞苷治疗的队列研究。本荟萃分析的主要终点是低甲基化药物的反应。使用固定或随机效应模型计算治疗反应和药物相关不良事件的汇总估计值。
确定并纳入了 14 项共 600 例 CMML 患者（地西他滨：n=196；阿扎胞苷：n=404）的研究进行荟萃分析。HMAs 在 CMML 患者中的总体缓解率（ORR）估计值为 43%（95%CI：36%-50%）。接受阿扎胞苷或地西他滨治疗的患者的 ORR 发生率相似（43%vs.45%，P=0.810），而接受地西他滨治疗的患者的完全缓解率（mCR）显著更高（23%vs.10%，P=0.000）。地西他滨治疗还与更高的输血独立性发生率相关（42%vs.20%，P=0.044）。两种 HMAs 均导致客观血液学或非血液学不良事件（27%-43%），而接受阿扎胞苷治疗的患者更常需要调整剂量/延迟治疗（81%vs.67%，P=0.021）。
本研究为评估 HMAs 在 CMML 患者中的疗效和安全性提供了初步数据。地西他滨和阿扎胞苷在治疗 CMML 方面同样有效且安全。然而，必须指出，只有在随机对照试验的背景下，才能对地西他滨和阿扎胞苷的临床结局进行任何比较。
