Blinatumomab治疗成人复发/难治性费城染色体阴性B系急性淋巴细胞白血病的一项系统综述和单个率的Meta分析

Blinatumomab for Relapsed/Refractory Philadelphia Chromosome-negative B-lineage Acute Lymphoblastic Leukemia in Adults:A Systematic Review and Meta-analysis of Single Rate

目的系统评价Blinatumomab在患有复发/难治性费城染色体阴性B系急性淋巴细胞白血病(Ph-B-ALL)的成人中的疗效和安全性,为临床实践及研究提供参考。方法计算机检索Pubmed、Embase,WebofScience的随机对照试验(RCT),前瞻性研究,回顾性研究,检索截止时间2022年10月31日。由2名评价员按照纳入与排除标准筛选文献和提取资料,采用Stata17.0软件进行Meta分析。结果最终纳入9篇文献,包括763例患者,其中RCT2篇,前瞻性研究2篇,回顾性研究5篇。患者的CR,ORR(CR/CRi/CRh),MRD阴性率分别为35%(95%CI0.31~0.38),47%(95%CI 0.42~0.51),71%(95%CI0.69~0.79)。患者的中位OS和RFS分别为8.29(95%CI6.62~9.95)个月和5.53(95%CI 3.74~7.32)个月。最常见的不良事件是血液学毒性和感染。结论Blinatumomab治疗复发/难治性成人Ph-B-ALL安全且有效。

Objective To evaluate the efficacy and safety of Blinatumomab in adults with relapse/refractory Philadelphia chromosome-negative B-lineage acute lymphoblastic leukemia(Ph-B-ALL),in order to provide a reference for clinical practice and research.Methods Pubmed,Embase,Web of Science was searched and then all information about Blinatumomab for the treatment of relapse/refractory ALL in randomized controlled trials(RCT),prospective studies,retrospective studies was collected,and last search was updated on October 31,2022.Two reviewers screened documents,extracted information according to inclusion and exclusion criteria,and used Stata 17.0 software for Meta-analysis.Results Finally,nine studies including 763 patients,contained 2 RCT articles,two prospective studies,and five retrospective studies were selected.The results of Meta-analysis showed that CR,ORR(CR/CRi/CRh)and MRD negative rate of 35%(95%CI 0.31-0.38)and 47%(95%CI 0.42-0.51)and 71%(95%CI 0.69-0.79)in patients,respectively.Median OS and RFS for enrolled patients were 8.29(95%CI 6.62-9.95)months and 5.53(95%CI 3.74-7.32)months,respectively.The most common adverse events were hematological toxicity and infections.Conclusion Blinatumomab were effective and safe in the treatment of relapse/refractory Ph-B-ALL in adults.