伊沙佐米治疗复发/难治性多发性骨髓瘤真实世界的疗效和安全性的单组率meta分析

Efficacy and safety of ixazomib in patients with relapsed/refractory multiple myeloma in the real world:meta‑analysis of single proportions

目的系统评价伊沙佐米在真实世界中治疗复发/难治性多发性骨髓瘤(RRMM)的疗效和安全性。方法检索国内外相关数据库(截至2022年4月),收集伊沙佐米治疗RRMM的真实世界研究文献。采用非随机研究方法学指标(MINORS)量表对文献进行质量评价。提取接受伊沙佐米治疗RRMM的有效率和不良事件发生率等数据。有效性指标包括总体缓解率(ORR)、≥非常好的部分缓解(≥VGPR)率和中位无进展生存时间(PFS),安全性指标包括不良事件(AE)发生率、因AE终止治疗率等。采用Stata 13.0软件进行单组率meta分析,对主要AE的发生情况进行描述性统计分析。结果共纳入12项研究,包括患者1006例。12项研究质量评价结果均为高质量。单组率meta分析结果显示,伊沙佐米治疗RRMM的ORR为65%[95%置信区间(CI):58%~72%],≥VGPR率为32%(95%CI:25%~38%),中位PFS为21.73(95%CI:14.37~29.08)个月,≥3级AE发生率为39%(95%CI:24%~55%),因AE终止治疗率为6%(95%CI:3%~10%)。发生率≥10%的AE包括中性粒细胞减少、血小板减少、感染、贫血、腹泻、乏力、周围神经病变、皮疹和骨痛。结论在真实世界中伊沙佐米治疗RRMM的疗效低于临床试验,但安全性相似。

Objective To systematically evaluate the efficacy and safety of ixazomib in patients with relapsed or refractory multiple myeloma(RRMM)in the real world.Methods Relevant databases at home and abroad were searched(up to April 2022),and the literature on real⁃world studies of ixazomib in the treatment of RRMM was collected.The quality of the literature was evaluated with the methodological index for non⁃randomized studies(MINORS)scale.Data such as the effectiveness rate and incidence of adverse events in RRMM patients treated with ixazomib were extracted.The effectiveness indicators included the overall response rate(ORR),very good partial response or better(≥VGPR)rate and median progression⁃free survival(PFS).The safety indicators included the incidence of adverse events(AEs)and the rate of treatment termination due to AEs,etc.Stata 13.0 software was used for meta⁃analysis of single proportions,and the occurrence of major adverse events was analyzed by descriptive statistics.Results A total of 12 studies were entered,including 1006 patients.The quality evaluation results showed that all of the 12 studies were with high quality.The meta⁃analysis of single proportions showed that ORR of ixazomib in the treatment of RRMM was 65%[95%confidence interval(CI):58%⁃72%],≥VGPR rate was 32%(95%CI:25%⁃38%),the median PFS was 21.73(95%CI:14.37-29.08)months,the incidence of≥grade 3 AEs was 39%(95%CI:24%⁃55%),and the incidence of treatment termination due to AEs was 6%(95%CI:3%⁃10%).AEs with an incidence of≥10%included neutropenia,thrombocytopenia,infection,anemia,diarrhea,fatigue,peripheral neuropathy,rashes,and bone pain.Conclusion In the real world,the efficacy of ixazomib in the treat⁃ment of RRMM is lower than that in clinical trials,but the safety is similar.