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...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。展开更多
Elotuzumab was approved by the US FDA in 2015 as a new drug for the treatment of multiple myeloma（MM）, and it became a new choice for MM patients. The drug is the first immunostimulatory drug to treat MM and used to...Elotuzumab was approved by the US FDA in 2015 as a new drug for the treatment of multiple myeloma（MM）, and it became a new choice for MM patients. The drug is the first immunostimulatory drug to treat MM and used to treat recurrent/refractory multiple myeloma（R/RMM） in combination with lenalidomide and dexamethasone. Therefore, we collected the reports from existing clinical trials to analyze the efficacy of the drug in clinical applications to better evaluate the effects of the drug on R/RMM. The search strategy used ＂elotuzumab＂ and ＂multiple myeloma＂ as keywords to search from the database of Cochrane, Embase, Pub Med and Medline. The heterogeneity among the studies was assessed using the Cochrane χ~2 test, and its extent was evaluated using I^2 statistics. A P value of less than 0.05 was considered as statistically significant. All meta-analyses were conducted with R Software 3.3.2. We identified eight prospective studies consisting of 608 MM patients. The meta-analysis showed that the overall response rate（ORR） was 63%, 162 patients（26.6%） achieved a very good partial response rate（VGPR）, and 34 patients（5.59%） achieved complete response rate（CR）. The most common adverse effects of the drug included anemia, lymphopenia, thrombocytopenia, neutropenia and fatigue. Therefore, elotuzumab combination regimens offered clinical benefits to R/RMM patients, and such a combination therapy was a suitable option for continuous treatment for R/RMM patients.展开更多
文摘目的通过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。
基金Zhejiang Public Welfare Technology Application Research Project(Grant No.2015C33285)Zhejiang Provincial Natural Science Foundation Project(Grant No.LY14H300002)+1 种基金Shaoxing Science and Technology Bureau General Project(Grant No.2015B70070)Zhejiang Medical and Health General Research Program(Grant No.2013KYB030)
文摘Elotuzumab was approved by the US FDA in 2015 as a new drug for the treatment of multiple myeloma（MM）, and it became a new choice for MM patients. The drug is the first immunostimulatory drug to treat MM and used to treat recurrent/refractory multiple myeloma（R/RMM） in combination with lenalidomide and dexamethasone. Therefore, we collected the reports from existing clinical trials to analyze the efficacy of the drug in clinical applications to better evaluate the effects of the drug on R/RMM. The search strategy used ＂elotuzumab＂ and ＂multiple myeloma＂ as keywords to search from the database of Cochrane, Embase, Pub Med and Medline. The heterogeneity among the studies was assessed using the Cochrane χ~2 test, and its extent was evaluated using I^2 statistics. A P value of less than 0.05 was considered as statistically significant. All meta-analyses were conducted with R Software 3.3.2. We identified eight prospective studies consisting of 608 MM patients. The meta-analysis showed that the overall response rate（ORR） was 63%, 162 patients（26.6%） achieved a very good partial response rate（VGPR）, and 34 patients（5.59%） achieved complete response rate（CR）. The most common adverse effects of the drug included anemia, lymphopenia, thrombocytopenia, neutropenia and fatigue. Therefore, elotuzumab combination regimens offered clinical benefits to R/RMM patients, and such a combination therapy was a suitable option for continuous treatment for R/RMM patients.
