奥希替尼治疗晚期非小细胞肺癌安全性的系统评价再评价

Safety of osimertinib for advanced non-small cell lung cancer with EGFR mutation: an overview of systematic reviews

目的:系统评价再评价奥希替尼用于EGFR突变晚期非小细胞肺癌患者的安全性。方法:计算机检索PubMed、Cochrane Library、Web of Science、Embase、中国知网(CNKI)、中国生物医学文献数据库(CBM)、万方和维普数据库,收集关于奥希替尼用于EGFR突变晚期非小细胞肺癌患者安全性的系统评价或Meta分析,检索时间截至2023年2月18日。2位研究者独立进行文献筛选、资料提取并采用AMSTAR工具评价纳入研究的方法学质量,PRISMA工具评价研究报告规范,GRAD分级系统评价证据质量。结果:最终纳入系统评价10篇。AMSTAR评价结果显示,纳入的系统评价评分为6~9分,质量均为中等质量及以上。PRISMA评价结果显示,8篇研究报告比较完整规范,质量等级高;GRADE分级系统评价结果显示,证据质量从中到极低不等。安全性评价结果显示:奥希替尼所有等级的不良事件、≥3级的不良事件的发生率低于第一、二代EGFR-TKIs和化疗方案;奥希替尼不良反应腹泻、皮疹、皮肤干燥、甲沟炎等发生率均高于化疗方案,但与其他EGFRTKIs相比,其皮疹发生率较低且具有统计学差异。结论:奥希替尼用于EGFR突变晚期非小细胞肺癌患者治疗的安全性较高,整体耐受性良好,但该次研究纳入相关系统评价数量有限且证据级别不高,期待进一步制作和更新系统评价,以提供更高质量的临床证据。

OBJECTIVE To systematically evaluate the safety of osimertinib for advanced non-small cell lung cancer with EGFR mutation.METHODS We electronically searched databases including PubMed、Cochrane Library、Web of Science、Embase、CNKI,CBM,VIP and Wanfang database to collect systematic reviews or Meta-analyses about the safety of osimertinib for advanced non-small cell lung cancer with EGFR mutation from inception to February 2023.Two reviewers independently screened literatures,extracted data,and AMSTAR tool,PRISMA statement and GRADE approach to assess methodology quality,reporting quality and the quality of evidence of included studies,respectively.RESULTS A total of 10 systematic reviews/Meta-analyses were included.The results of AMSTAR indicated the scores ranged from 6 to 9,all of which are of medium quality or above.The results of PRISMA assessment showed that all SR had good quality of reporting.The results of GRADE assessment showed that methodology quality is varies from medium to very low.The results of overview demonstrated that the total incidence of all-grade or grade 3 or above adverse events of osimertinib was lower than that of other EGFR-TKIs and standard chemotherapy regimens.The most common adverse events of osimertinib were diarrhea,rash,dry skin,and paronychia,of which the incidence was higher than that of the standard chemotherapy regimens,and compared with other EGFR-TKIs,the incidence of rash was the lowest and statistically significant.CONCLUSION The safety of osimertinib for advanced non-small cell lung cancer patients with EGFR mutation is superior and generally well tolerated,but the number and level of systematic reviews about the safety of osimertinib is limited.We expect conducting new and updating relevant systematic reviews to obtain high quality evidence in the future.