埃罗妥珠单抗治疗复发/难治性多发性骨髓瘤疗效及安全性meta分析

A meta-analysis of the efficacy and safety of Erotuzumab in the treatment of relapsed/refractory multiple myeloma

目的通过meta分析评估单克隆抗体埃罗妥珠单抗对复发/难治性多发性骨髓瘤(RRMM)的疗效及安全性。方法运用计算机对Embase、Pubmed、Cochrane Library、web of science、中国知网(CNKI)、万方医学网等数据库进行检索,筛选2000年1至2020年9月有关埃罗妥珠单抗治疗RRMM的Ⅰ~Ⅲ期临床试验,提取相关数据,合并计算疗效及安全性指标,计算相对危险度(RR)值及95%可信区间(95%CI),比较研究组和对照组患者的疗效及安全性。结果埃罗妥珠单抗治疗RRMM的完全缓解及SCR占5%(95%CI:0.03~0.08,I^(2)=23.2%)],非常好的部分缓解及以上(VGPR)占28%(95%CI:0.18~0.38,I^(2)=82.0%),部分缓解(PR)占37%(95%CI:0.29~0.45,I^(2)=64.4%),疾病进展占3%(95%CI:0.02~0.05,I^(2)=40.3%)。随机对照试验的总体缓解率的RR为1.22(95%CI:1.11~1.34,I^(2)=64.2%),VGPR的RR为1.40(95%CI:1.10~1.78,I^(2)=0%),PR的RR为1.20(95%CI:1.01~1.41,I^(2)=54.2%),淋巴细胞减少的RR为2.15(95%CI:1.88~2.48,I^(2)=0%),感染的RR为1.25(95%CI:1.0~1.56,I^(2)=42.2%),中性粒细胞减少的RR为0.78(95%CI:0.65~0.94,I^(2)=34.9%)。结论埃罗妥珠单抗治疗RRMM具有较高的缓解率。既往治疗线数与RRMM患者对埃罗妥珠单抗的疗效反应息息相关。研究组较对照组总体缓解率、VGPR、PR明显改善,降低了3~4级中性粒细胞减少发生率,增加了感染和淋巴细胞减少发生率。

Objective To evaluate the efficacy and safety of elotuzumab in the treatment of relapsed/refractory multiple myeloma using a meta-analysis.Methods By selected theⅠ-Ⅲphase of clinical trial on the treatment RRMM of elotuzumab and extract the relevant data.then combined the treatment efficacy and safety index,finaly,calculated and compared the RR values of randomized controlled trials.Results The results showed that the combined CR+SCR,VGPR,PR and PD were 5%(95%CI:0.03-0.08,I^(2)=23.2%),28%(95%CI:0.18-0.38,I^(2)=82.0%),37%(95%CI:0.29-0.45,I^(2)=64.4%)and 3%(95%CI:0.02-0.05,I^(2)=40.3%)in the treatment of RRMM with elotuzumab.The RR of ORR,VGPR and PR were 1.22(95%CI:1.11-1.34,I^(2)=64.2%),1.40(95%CI:1.10-1.78,I^(2)=0%),and 1.20(95%CI:1.01-1.41,I^(2)=54.2%)respectively in the randomized controlled trials.The RR of lymphocytopenia,infection,neutropenia was 2.15(95%CI:1.88-2.48,I^(2)=0%),1.25(95%CI:1.0-1.56,I^(2)=42.2%),0.78(95%CI:0.65-0.94,I^(2)=34.9%).Conclusion Elotuzumab has a high remission rate in treatment of RRMM.Subgroup analysis showed that the number of previous treatment lines was closely related to the response of RRMM patients to elotuzumab.The results of the randomized controlled trial showed that the ORR,VGPR and PR of the experimental group were significantly improved compared with the control group,and the incidence of grade 3-4 neutropenia was decreased,and the incidence of infection and lymphocytopenia was increased.