【作者】 郭晔；

【导师】 马克威；

【作者基本信息】 吉林大学 ， 临床医学， 2014， 硕士

【摘要】 目的应用meta分析评估EGFR-TKIs对比化疗一线治疗晚期非小细胞肺癌（NSCLC）的疗效性及安全性。方法在PubMed数据库、Embase数据库、中国知网、万方全文数据库等权威数据库及ASCO、ESMO等相关会议中，检索一线应用EGFR-TKIs与化疗对比治疗晚期NSCLC的随机对照试验（RCT）。按制定纳入标准及排除标准筛选文献，按Jadad量表对符合标准文献进行质量评估，提取有效数据，应用Revman5.0软件进行meta分析，并进行敏感性分析和发表偏倚分析评价结果的稳定性和可靠性。结果最终纳入9篇文献，来源于8项前瞻性、Ⅲ期、随机对照临床研究结果，共计2971例晚期NSCLC患者，其中EGFR突变患者1702例。Meta分析显示：在EGFR突变的晚期NSCLC患者中，一线接受EGFR-TKIs治疗的患者ORR明显高于接受化疗者(RR=2.16，95%CI：[1.72，2.71]，P＜0.00001)， EGFR-TKIs治疗与化疗相比能明显改善患者的PFS(HR=0.36，95%CI：[0.22，0.60]，P＜0.0001)，而两组患者的OS无统计学差异(HR=1.00，95%CI：[0.85，1.17]，P=1.00)；EGFR-TKIs治疗与化疗对比，安全性较高，可降低重度毒副作用发生的总数量(OR=0.34，95%CI：[0.20，0.57]，P＜0.0001)；应用EGFR-TKIs治疗与化疗对比显著发生的重度副作用有：皮疹(OR=8.47，95%CI：[4.41，16.26]，P＜0.00001)、腹泻(OR=5.60，95%CI：[2.91，10.75]，P＜0.00001)、口腔炎(OR=7.03，95%CI：[2.09，23.67]，P=0.002)。结论EGFR突变的晚期NSCLC患者，一线接受EGFR-TKIs治疗患者的ORR明显高于接受化疗者，且患者的PFS明显得到改善，而两组患者的OS无明显差异。应用EGFR-TKIs治疗严重毒副作用发生率低，主要严重毒副作用为皮疹、腹泻、口腔炎。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of EGFR-TKIs contrasted withchemotherapy as first-line treatment for advanced NSCLC by meta analysis.Method Relevant literatures were searched through authoritative databases andrelated meetings. All the clinic trials were RCTs, relevant with EGFR-TKIs versuschemotherapy as first-line treatment for advanced NSCLC. All literatures wereassessed by the inclusion and exclusion criteria, quality assessment and dataabstraction. The meta analysis was performed by RevMan5.0software. The stabilityand reliability were evaluated by sensitivity analysis and publication bias analysis.Results Nine literatures from a total of eight prospective, phase III, randomizedcontrolled trials(RCTs) were included into the meta analysis. Among all the2971advanced NSCLC patients, there were1702patients with EGFR mutations. In theadvanced NSCLC patients with EGFR mutations, this meta analysis showed astatistical significance in ORR(RR=2.16，95%CI：[1.72，2.71]，P＜0.00001) andPFS(HR=0.36，95%CI：[0.22，0.60]， P＜0.0001) for patients who receivedEGFR-TKIs compared with patients who received chemotherapy. No statisticalsignificance was observed in OS(HR=1.00，95%CI：[0.85，1.17]， P=1.00).EGFR-TKIs therapy compared with chemotherapy, reduced the ratio of severe sideeffects(OR=0.34，95%CI：[0.20，0.57]，P＜0.0001). Rash(OR=8.47，95%CI：[4.41，16.26]，P＜0.00001), diarrhea(OR=5.60，95%CI：[2.91，10.75]，P＜0.00001) andstomatitis(OR=7.03，95%CI：[2.09，23.67]，P=0.002) EGFR-TKIs therapy hadstatistical significance compared with chemotherapy.Conclusion In advanced NSCLC patients with EGFR mutations, EGFR-TKIs asfirst-line treatment improved ORR and PFS. Main severe side effects were rash, diarrhea and stomatitis.更多还原