【摘要】 目的分析微滴式数字PCR(dd PCR)法检测血浆表皮生长因子受体(EGFR)突变状态,指导埃克替尼一线用药治疗晚期NCSLC的价值。方法筛选2016年1月-2017年11月在福建省肿瘤医院收治的且经dd PCR检测EGFR为敏感型突变的Ⅲb～Ⅳ期非小细胞肺癌患者82例为研究对象,埃克替尼125 mg口服,每天3次。采用χ2检验比较疾病控制率(DCR)和客观缓解率(ORR)在19DEL突变组与L858R突变组之间的差异。采用Kaplan-Meier生存曲线法分析无进展生存期(PFS),应用Log-rank检验进行单因素分析,应用COX风险比例回归模型进行多因素分析。结果 82例患者的ORR为65. 8%,DCR为89. 9%。19DEL突变组与L858R突变组相比,DCR和ORR均无统计学差异。82例患者的中位PFS为10. 8个月(95%CI 8. 1～13. 4个月)。单因素分析显示,EGFR表达类型(19DEL vs. L858R)及EGFR突变状态由阳性转为阴性与患者疗效相关。多因素分析显示,EGFR表达类型与EGFR突变状态由阳性转为阴性均为PFS的独立预测因子。结论基于dd PCR法血浆检测EGFR突变结果来指导一线EGFR-TKI治疗其适应证具有可行性。EGFR突变类型以及EGFR-TKI治疗2个月后EGFR突变状态的动态评估可以作为疗效预测因子。更多还原

【Abstract】 Objective To analyze the application value of micro-drop digital PCR in detecting plasma EGFR mutation status for guiding the first-line treatment of ectitanide in the treatment of advanced NSCLC. Methods Eighty-two patients with stage Ⅲb-Ⅳ non-small cell lung cancer who were diagnosed with EGFR-sensitive mutations by ddPCR from January 2016 to November2017 were enrolled. All patients were treated with ectinib 125 mg orally,3 times a day. The χ2 test was used to compare the difference between the disease control rate( DCR) and the objective response rate( ORR) between the 19 DEL mutation group and the L858 R mutation group. The progression-free survival( PFS) was analyzed by Kaplan-Meier survival curve method. Log-rank test was used for single factor analysis,and COX risk proportional regression model was used for multivariate analysis. Results 82 patients had an ORR of 65. 8% and a DCR of 89. 9%.There was no significant difference in DCR and ORR between the 19 DEL mutation group and the L858 R mutation group. Median PFS was 10. 8 months in 82 patients( 95% CI 8. 1 to 13. 4 months). Univariate analysis showed that the EGFR expression type( 19 DEL vs. L858 R) and the EGFR mutation status from positive to negative were associated with patient efficacy. Multivariate analysis showed that EGFR expression type and EGFR mutation status from positive to negative were independent predictors of PFS. Conclusion The use of microdroplet digital PCR( ddPCR) to detect the status of plasma EGFR mutations is useful for guiding the first-line treatment of ectitanide for advanced NCSLC. Dynamic assessment of EGFR mutation status and EGFR mutation status after 2 months of EGFR-TKI treatment can be used as a predictor of efficacy.更多还原