Liu Heng, Xi Rui, Mao Dongfeng, Zhao Xiaochen, Wu Tao
Department of Hematology, the 940th Hospital of Joint Logistic Support Force of the Chinese People's Liberation Army, Lanzhou 730050, China.
Department of Hematology, the 940th Hospital of Joint Logistic Support Force of the Chinese People's Liberation Army, Lanzhou 730050, China.
Clin Lymphoma Myeloma Leuk. 2023 Mar;23(3):e139-e149. doi: 10.1016/j.clml.2022.12.009. Epub 2022 Dec 17.
The aim was to evaluate the efficacy and safety of blinatumomab monotherapy for the treatment of relapsed/refractory acute lymphoblastic leukemia (R/R B-ALL).
PubMed, Embase, Web of Science, and Cochrane Library were searched to collect clinical studies related to blinatumomab. The primary outcome measures were complete remission (CR), and minimal residual disease (MRD) response. Prognostic indicators included overall survival (OS) and relapse-free survival time (RFS). Grade ≥3 adverse reactions were mainly analyzed for safety, including cytokine release syndrome (CRS), neurological events and hematological toxicity. The heterogeneity was quantified by I statistic, which reflected the proportion of the true heterogeneity to the variance of the total effect size. Studies were considered heterogeneous if the I statistic was greater than 50%, and conversely, studies were homogeneous.
A total of 18 studies involving 1,373 patients were included. The analysis results showed a CR rate of 54% (95%CI:44%-64%) and an MRD response rate of 43% (95%CI:34%-51%). The CR rate was higher in patients with bone marrow (BM) blast <50% than in patients with BM blast ≥50% (71% vs. 34%). The median OS and RFS were 8.16 months (95%CI:6.64-9.69) and 6.02 months (95%CI:4.63-7.41), respectively. For safety analysis, the incidence of grade ≥3 adverse events (AEs) was 80% (95%CI:72%-88%), the incidence of grade ≥3 neurological toxicity was 7% (95%CI:4%-11%), and the incidence of grade ≥3 CRS was 3% (95%CI:2%-5%). However, the mixture of retrospective and prospective studies led to heterogeneity to some extent in this meta-analysis.
Blinatumomab is effective in the treatment of R/R B-ALL with a controlled occurrence of AEs and a reliable safety profile.
评估博纳吐单抗单药治疗复发/难治性急性淋巴细胞白血病（R/R B-ALL）的疗效和安全性。
检索PubMed、Embase、Web of Science和Cochrane图书馆，收集与博纳吐单抗相关的临床研究。主要结局指标为完全缓解（CR）和微小残留病（MRD）反应。预后指标包括总生存期（OS）和无复发生存时间（RFS）。安全性主要分析≥3级不良反应，包括细胞因子释放综合征（CRS）、神经系统事件和血液学毒性。异质性通过I统计量进行量化，其反映了真实异质性占总效应量方差的比例。如果I统计量大于50%，则认为研究具有异质性，反之则认为研究具有同质性。
共纳入18项研究，涉及1373例患者。分析结果显示CR率为54%（95%CI：44%-64%），MRD反应率为43%（95%CI：34%-51%）。骨髓原始细胞<50%的患者CR率高于骨髓原始细胞≥50%的患者（71%对34%）。中位OS和RFS分别为8.16个月（95%CI：6.64-9.69）和6.02个月（95%CI：4.63-7.41）。安全性分析方面，≥3级不良事件（AE）的发生率为80%（95%CI：72%-88%），≥3级神经毒性的发生率为7%（95%CI：4%-11%），≥3级CRS的发生率为3%（95%CI：2%-5%）。然而，回顾性研究和前瞻性研究的混合在一定程度上导致了本荟萃分析中的异质性。
博纳吐单抗治疗R/R B-ALL有效，不良事件发生率可控，安全性可靠。
