二线用药EGFR—TKIs治疗非选择型NSCLC疗效的Meta分析(1)
摘 要：目的 系统评价二线应用表皮生长因子受体酪氨酸激酶抑制剂与化疗比较治疗非选择型非小细胞肺癌患者的疗效。方法 自2008年1月～2014年12月对Pubmed、Cochrane library、EMBASE中检索相关的主题词及自由词，收集EGFR-TKIs与化疗相比二线治疗非选择型NSCLC的疗效的随机对照研究。按纳入标准及排除标准筛选文献，采用cochrane偏倚风险评估表对纳入文献进行质量评价，自纳入文献中提取有效数据，应用RevMan 5.3.5和STATA 12.0分析并对比非选择型NSCLC患者在EGFR-TKIs治疗中的疗效。敏感性分析和发表偏倚分析以评价结果的稳定性和可靠性。结果 共纳入5篇RCT，共2741例患者，Meta 分析显示：对于非选择型晚期NSCLC患者：二线EGFR-TKIs治疗的PFS(HR=0.98；95CI%：0.85～1.13；P=0.75)、OS(HR=1.01；95CI%：0.95～1.07；P=0.78)、ORR(RR=1.63；95CI%：0.93～2.86；P=0.09)与化疗相比无明显差异。结论 与化疗对比，作为二线用药的EGFR-TKIs应用于非选择型晚期NSCLC患者，不能起到有效的治疗作用。
, http://www.100md.com
关键词：表皮生长因子受体酪氨酸激酶抑制剂；非小细胞肺癌；Meta分析
中图分类号：R734.2 文献标识码：A DOI：10.3969/j.issn.1006-1959.2018.20.015
文章编号：1006-1959(2018)20-0049-05
Abstract：Objective To evaluate the efficacy of second-line application of epidermal growth factor receptor tyrosine kinase inhibitors in the treatment of patients with non-selective non-small cell lung cancer.Methods From January 2008 to December 2014，the related keywords and free words were searched for Pubmed，Cochrane library，and EMBASE.A randomized controlled trial comparing the efficacy of EGFR-TKIs with chemotherapy for second-line treatment of non-selective NSCLC was performed.The literature was selected according to the inclusion criteria and exclusion criteria.The quality of the included literature was evaluated using the cochrane bias risk assessment form.Effective data were extracted from the literature.RevMan 5.3.5 and STATA 12.0 were used to analyze and compare the efficacy of non-selective NSCLC patients in the treatment of EGFR-TKIs.Sensitivity analysis and publication bias analysis to assess the stability and reliability of the results.Results A total of 5 RCTs were included in a total of 2 741 patients. Meta-analysis showed：for non-selective advanced NSCLC patients：PFS for second-line EGFR-TKIs(HR=0.98；95CI%：0.85-1.13；P=0.75)，OS(HR=1.01；95CI%：0.95-1.07；P=0.78)，ORR(RR=1.63；95CI%：0.93-2.86；P=0.09)showed no significant difference compared with chemotherapy.Conclusion Compared with chemotherapy，EGFR-TKIs used as second-line drugs are not effective in the treatment of patients with non-selective advanced NSCLC.
, 百拇医药
Key words：Epidermal growth factor receptor tyrosine kinase inhibitors；Non-small cell lung cancer；Meta-analysis
21 世纪在肺癌治疗的领域达成的共识是传统治疗模式已经进入了一个平台期，肺癌的治疗急需寻找新的突破。随着分子生物学及遗产学的发展，分子靶向药物的研发与应用为非小细胞肺癌(non-small cell lung cance，NSCLC)的治疗开启了一条新途径，逐渐成为晚期非小细胞肺癌的希望。EGFR 酪氨酸激酶小分子抑制剂(EGFR-TKIs)已成为肺癌治疗领域研究的热点，逐渐成为非小细胞肺癌治疗不可或缺的重要方法之一，且目前多种指南推荐EGFR-TKI用于NSCLC EGFR突变患者的一线治疗甚至为维持治疗、突变状态不明患者的二线、三线治疗，因此较大比例的NSCLC患者在EGFR-TKI治疗中获益。IPASS及OPTIMAL等研究证实，EGFR 突变阳性者使用EGFR-TKI 的有效率为50%～80%，筛选可能受益人群将极大地提高晚期非小细胞肺癌的疗效。研究显示亚裔、不吸烟、女性、腺癌、肿瘤组织敏感性突变成为EGFR-TKI治疗敏感的优势人群，筛选可能受益人群将极大地提高晚期非小细胞肺癌的疗效[1]。2014年数据显示：中国NSCLC EGFR 突变检测率仅40%，近60%患者为突变状态未知人群，EGFR檢测率低成为肺癌个体化治疗中急需解决的问题[2]。本文采用Meta分析方法，系统评价并进一步验证EGFR-TKIs二线治疗非选择型NSCLC的疗效，以期广大临床医师推进NSCLC规范化及个体化精确治疗，现报道如下。, 百拇医药(田春琴 赵新汉 蒋冬梅)
, http://www.100md.com
关键词：表皮生长因子受体酪氨酸激酶抑制剂；非小细胞肺癌；Meta分析
中图分类号：R734.2 文献标识码：A DOI：10.3969/j.issn.1006-1959.2018.20.015
文章编号：1006-1959(2018)20-0049-05
Abstract：Objective To evaluate the efficacy of second-line application of epidermal growth factor receptor tyrosine kinase inhibitors in the treatment of patients with non-selective non-small cell lung cancer.Methods From January 2008 to December 2014，the related keywords and free words were searched for Pubmed，Cochrane library，and EMBASE.A randomized controlled trial comparing the efficacy of EGFR-TKIs with chemotherapy for second-line treatment of non-selective NSCLC was performed.The literature was selected according to the inclusion criteria and exclusion criteria.The quality of the included literature was evaluated using the cochrane bias risk assessment form.Effective data were extracted from the literature.RevMan 5.3.5 and STATA 12.0 were used to analyze and compare the efficacy of non-selective NSCLC patients in the treatment of EGFR-TKIs.Sensitivity analysis and publication bias analysis to assess the stability and reliability of the results.Results A total of 5 RCTs were included in a total of 2 741 patients. Meta-analysis showed：for non-selective advanced NSCLC patients：PFS for second-line EGFR-TKIs(HR=0.98；95CI%：0.85-1.13；P=0.75)，OS(HR=1.01；95CI%：0.95-1.07；P=0.78)，ORR(RR=1.63；95CI%：0.93-2.86；P=0.09)showed no significant difference compared with chemotherapy.Conclusion Compared with chemotherapy，EGFR-TKIs used as second-line drugs are not effective in the treatment of patients with non-selective advanced NSCLC.
, 百拇医药
Key words：Epidermal growth factor receptor tyrosine kinase inhibitors；Non-small cell lung cancer；Meta-analysis
21 世纪在肺癌治疗的领域达成的共识是传统治疗模式已经进入了一个平台期，肺癌的治疗急需寻找新的突破。随着分子生物学及遗产学的发展，分子靶向药物的研发与应用为非小细胞肺癌(non-small cell lung cance，NSCLC)的治疗开启了一条新途径，逐渐成为晚期非小细胞肺癌的希望。EGFR 酪氨酸激酶小分子抑制剂(EGFR-TKIs)已成为肺癌治疗领域研究的热点，逐渐成为非小细胞肺癌治疗不可或缺的重要方法之一，且目前多种指南推荐EGFR-TKI用于NSCLC EGFR突变患者的一线治疗甚至为维持治疗、突变状态不明患者的二线、三线治疗，因此较大比例的NSCLC患者在EGFR-TKI治疗中获益。IPASS及OPTIMAL等研究证实，EGFR 突变阳性者使用EGFR-TKI 的有效率为50%～80%，筛选可能受益人群将极大地提高晚期非小细胞肺癌的疗效。研究显示亚裔、不吸烟、女性、腺癌、肿瘤组织敏感性突变成为EGFR-TKI治疗敏感的优势人群，筛选可能受益人群将极大地提高晚期非小细胞肺癌的疗效[1]。2014年数据显示：中国NSCLC EGFR 突变检测率仅40%，近60%患者为突变状态未知人群，EGFR檢测率低成为肺癌个体化治疗中急需解决的问题[2]。本文采用Meta分析方法，系统评价并进一步验证EGFR-TKIs二线治疗非选择型NSCLC的疗效，以期广大临床医师推进NSCLC规范化及个体化精确治疗，现报道如下。, 百拇医药(田春琴 赵新汉 蒋冬梅)