奥希替尼治疗晚期非小细胞肺癌患者颅内转移性疾病疗效和安全性的Meta分析

Effectiveness and safety of osimertinib in intracranial metastatic disease patients with advanced non-small cell lung cancer: a meta-analysis

目的系统评价奥希替尼治疗晚期非小细胞肺癌(NSCLC)患者颅内转移性疾病(IMD)的疗效和安全性。方法检索PubMed、Embase、Cochrane Library、SinoMed、万方数据和中国知网数据库从建库到2020年9月关于奥希替尼治疗晚期NSCLC患者IMD的观察性研究和随机对照试验(RCT),筛选文献提取数据,评价纳入研究的偏倚风险,采用RevMan 5.3进行Meta分析。结果共纳入20项研究,960例患者。Meta分析结果显示,奥希替尼治疗IMD患者的汇总客观缓解率(ORR)为64%(95%CI:60%~68%),汇总疾病控制率(DCR)为90%(95%CI:89%~92%)。亚组分析显示,一线治疗的汇总ORR和DCR分别为71%(95%CI:53%~88%)和90%(95%CI:84%~95%),中国人的汇总ORR和DCR分别为66%(95%CI:61%~71%)和88%(95%CI:82%~93%)。安全性方面,3级及以上不良事件汇总发生率为9%(95%CI:4%~14%),致命性肺炎和间质性肺炎汇总发生率分别为2%(95%CI:1%~3%)和1%(95%CI:0~2%)。结论奥希替尼治疗晚期NSCLC患者IMD具有显著的抗肿瘤活性,且安全性良好,用于一线治疗效果好。

AIM To systematically evaluate the efficacy and safety of osimertinib in intracranial metastatic disease(IMD) patients with advanced non-small cell lung cancer(NSCLC). METHODS The databases of PubMed, Embase, Cochrane Library, SinoMed, Wanfang data and CNKI were searched for observational studies and randomized controlled trials(RCT) of osimertinib in the treatment of IMD in advanced NSCLC from the establishment of database to September 2020. The literatures were screened, basic data were extracted and the risk of bias in the included study independently were evaluated. RevMan 5.3 software was used for meta-analysis. RESULTS Twenty studies with 960 patients were included in this meta-analysis. Meta-analysis results showed that the pooled overall response rate(ORR) and pooled disease control rate(DCR) of IMD patients were 64%(95%CI :60% to 68%) and 90%(95%CI :89% to 92%), respectively. The pooled ORR and DCR of first-line treatment were 71%(95%CI :53% to 88%) and 90%(95%CI :84% to 95%). The pooled ORR and DCR of Chinese patients with IMD were 66%(95%CI :61% to 71%) and 88%(95%CI :82% to 93%), respectively. In terms of safety, the pooled rate of adverse events of grade 3 or higher was 9%(95%CI :4% to 14%), and the pooled incidence of fatal pneumonia and interstitial lung disease was 2%(95%CI:1% to 3%) and 1%(95%CI:0 to 2%). CONCLUSION Osimertinib has significant anti-tumor activity and good safety in IMD patients with advanced NSCLC, especially in the first-line treatment.