EGFR-TKIs联合贝伐珠单抗治疗非小细胞肺癌疗效及安全性的Meta分析  

Meta-analysis of the efficacy and safety of EGFR-TKIs plus Bevacizumab versus EGFR-TKIs alone in non-small cell lung cancer

作　　者：杜林娟 石学军[1] DU Linjuan;SHI Xuejun(Department of Oncology,the Affiliated Yongchuan Hospital of Chongqing Medical University,Chongqing 402160,China)

机构地区：[1]重庆医科大学附属永川医院肿瘤内科,重庆402160

出　　处：《现代肿瘤医学》2021年第17期3016-3022,共7页Journal of Modern Oncology

基　　金：重庆市永川区公益类科技计划项目(编号:Ycstc,2017nc5008)。

摘　　要：目的:系统评价第一代EGFR-TKIs联合贝伐珠单抗治疗不可切除局部晚期及转移性EGFR敏感突变非小细胞肺癌的疗效及安全性。方法:计算机检索Pubmed、Cochrane Library、EMbase、CBM、CKNI、万方数据库等数据库,检索时间为建库至2019年09月,按照严格的纳入和排除标准筛选文献和提取资料后,采用RevMan 5.3软件进行Meta分析。结果:最终纳入9篇文献,包括1482名患者。这项研究终点是中位无进展生存期、客观缓解率、疾病控制率及安全性。Meta分析结果显示,第一代EGFR-TKIs联合贝伐珠单抗较EGFR-TKIs单药能有效改善不可切除局部晚期及转移性EGFR敏感突变非小细胞肺癌疾病控制率(disease control rate,DCR)[比值比(odds ratio,OR)=1.86,95%可信区间(confidence interval,CI)(1.40,2.46),P<0.0001]、客观缓解率(objective response rate,ORR)[OR=1.90,95%CI(1.46,2.48),P<0.00001]、中位无进展生存期(median progression free survival,mPFS)[风险比(hazard ratio,HR)=0.62,95%CI(0.54,0.71),P<0.00001],差异有统计学意义。安全性方面:Ⅲ级及以上不良反应,联合治疗组皮疹[OR=1.64,95%CI(1.20,2.24),P=0.002]、高血压[OR=6.50,95%CI(4.07,10.39),P<0.00001]、蛋白尿[OR=9.87,95%CI(2.97,32.81),P=0.0002]发生率高于EGFR-TKIs单药组,差异有统计学意义;腹泻[OR=1.09,95%CI(0.54,2.17),P=0.82]、出血事件[OR=1.74,95%CI(0.74,4.09),P=0.21]发生率差异无统计学意义。结论:在治疗不可切除局部晚期及转移性EGFR敏感突变非小细胞肺癌时,第一代EGFR-TKIs联合贝伐珠单抗与EGFR-TKIs单药相比能有效改善疾病控制率、客观缓解率及中位无进展生存期,不良反应主要有皮疹、高血压、蛋白尿,试验组发生率高于对照组,差异有统计学意义。Objective:To evaluate the efficacy and safety of EGFR-TKIs plus Bevacizumab verse EGFR-TKIs alone in advanced non-small cell lung cancer.Methods:The PubMed,Cochrane Library,Embase,CBM,CNKI,WanFang Data were electronically searched to collect randomized controlled trails.The search time ranged from inception to September 2019.After screening the literature and extracting data strictly,Meta-analysis was performed by RevMan 5.3.The endpoint of this study was median progression-free survival(mPFS),objective response rate(ORR),disease control rate(DCR)and security.Results:A total of 9 articles were included,including 1482 patients.Meta-analysis showed that the treatment of EGFR-TKIs plus Bevacizumab could improve the disease control rate(DCR)[OR=1.86,95%CI(1.40,2.46),P<0.0001]and objective response rate(ORR)[OR=1.90,95%CI(1.46,2.48),P<0.00001]in advanced non-small cell lung cancer compared with the treatment of EGFR-TKIs alone,the difference was statistically significant.Meanwhile,median progression-free survival(mPFS)[HR=0.62,95%CI(0.54,0.71),P<0.00001]was different,and the difference was statistically significant.In terms of≥gradeⅢadverse events,the experiment group had higher rates of rash[OR=1.64,95%CI(1.20,2.24),P=0.002],hypertension[OR=6.50,95%CI(4.07,10.39),P<0.00001],proteinuria[OR=9.87,95%CI(2.97,32.81),P=0.0002].There was no significant difference in diarrhea[OR=1.09,95%CI(0.54,2.17),P=0.82],and hemorrhage[OR=1.74,95%CI(0.74,4.09),P=0.21]between two groups.Conclusion:The treatment of EGFR-TKIs plus Bevacizumab in patients with non-small cell lung cancer can improve median progression-free survival,objective response rate,disease control rate.However,this program lead to increased incidence of adverse events such as rash,hypertension,proteinuria.

关 键 词：表皮生长因子受体酪氨酸激酶抑制剂 贝伐珠单抗 非小细胞肺癌 临床疗效 META分析 

分 类 号：R734.2[医药卫生—肿瘤]