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目的比较表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)与化疗二线治疗晚期非小细胞肺癌的有效性和安全性。方法检索Cochrane Library、Pub Med、Em Base等数据库,得到关于EGFR-TKIs与化疗二线比较治疗晚期非小细胞肺癌的随机对照试验(RCT)文献,进行数据提取和质量评价后,用Rev Man5.3软件进行Meta分析。结果共纳入14项RCT。EGFR-TKIs在欧洲人群中疗效如延长患者无进展生存期(PFS),不如化疗药物,差异有统计学意义[HR=1.14,95%CI(1.00,1.29),P<0.05];在亚洲人群、突变阳性人群及突变阴性人群中,2组差异无统计学意义;EGFR-TKIs在亚洲人群和EGFR突变阳性的人群中疗效如客观有效率(ORR),明显优于化疗人群,差异有统计学意义[RR=1.91,95%CI(1.12,3.26),P<0.05];突变阳性人群:RR=4.58,95%CI(1.05,20.00),P<0.05,在欧洲人群和突变阴性人群的差异无统计学意义;而在延长患者总生存期(OS)方面,各亚组分析显示,EGFR-TKIs与化疗差异均无统计学意义(P<0.05)。EGFR-TKIs组,皮疹、皮肤瘙痒、皮肤干燥、腹泻的发生率较化疗组更高,差异有统计学意义(P<0.05);但EGFR-TKIs可明显减少化疗引起的脱发、反胃、便秘、疲乏、虚弱、神经毒性、胸痛、肌痛、水肿以及血液系统方面的不良反应。结论 EGFR-TKIs较化疗药物在亚洲人群和EGFR突变阳性的患者中拥有较好的疗效,而在欧洲人群和EGFR突变阴性的患者中优势不明显,甚至疗效较化疗更差。同时,EGFR-TKI对消化系统和血液系统影响较化疗药物更小。
Objective To compare the efficacy and safety of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) with second-line chemotherapy for advanced non-small cell lung cancer. Methods The databases of Cochrane Library, Pub Med and Em Base were searched to obtain a randomized controlled trial (RCT) on EGFR-TKIs and second-line chemotherapy for advanced non-small cell lung cancer. After data extraction and quality evaluation, Meta-analysis software. Results A total of 14 RCTs were included. Efficacy of EGFR-TKIs in European population such as prolonging progression-free survival (PFS) was not as good as that of chemotherapeutic drugs (HR = 1.14,95% CI 1.00,1.29, P <0.05) , Mutation positive group and mutation negative group, there was no significant difference between the two groups; EGFR-TKIs in Asian population and EGFR mutation positive population such as Objective Effective Rate (ORR), significantly better than the chemotherapy group, the difference was statistically significant (RR = 1.91,95% CI 1.12,3.26, P <0.05). The mutation positive population: RR = 4.58,95% CI (1.05,20.00), P <0.05. The difference between the European population and the mutant negative population There was no significant difference between the two groups in terms of overall survival (OS). There was no significant difference between EGFR-TKIs and chemotherapy (P <0.05). The incidence of skin rashes, skin pruritus, skin dryness and diarrhea in EGFR-TKIs group was significantly higher than that in chemotherapy group (P <0.05), but EGFR-TKIs could significantly reduce the incidence of hair loss, nausea, Fatigue, weakness, neurotoxicity, chest pain, myalgia, edema, and adverse reactions in the blood system. Conclusion EGFR-TKIs have better efficacy than chemotherapeutics in Asian population and EGFR mutation-positive patients, but not in European population and EGFR mutation negative patients, even worse than chemotherapy. At the same time, EGFR-TKI has less effect on digestive system and blood system than chemotherapeutic drugs.