Objective To explore the predictive value of serum CEA and cytokeratin-19 fragments (CYFRA21-1)prior treatment for the epidermal growth factor receptor (EGFR) mutation and efficacy of tyrosine kinase inhibitors ( TKI ) in patients with non-small cell lung cancer.Methods The study was a clinical research.Totally 101 matched tissue and plasma samples were collected from Peking University People′s Hospital from 2012 to 2013.All clinical specimens were analyzed for EGFR mutations in exons of 18, 19, 20 and 21 by ADx-ARMS and direct sequencing, and the serum levels of CEA and CYFRA21-1 were analyzed by ECLI.The correlation between EGFR mutant status and efficacy of EGFR-TKI and clinicopathological parameters were analyzed by χ2 test, Log-rank text and Cox proportional hazards regression model.Results The mutation rate was 60.4%(61/101) by ADx-ARMS and 33.7%(34/101) by direct sequencing.Mutations were more frequently observed in the higher serum CEA level patients(≥5μg/L,78.8%).However, the rates of EGFR mutations of different CEA levels were similar.Among the patients receiving TKI therapy, the efficacy of EGFR-TKI was closely related to serum CYFRA21-1 level prior treatment and EGFR mutation (χ2 =8.903, P =0.003; χ2 =28.590, P <0.001 ).And serum CYFRA21-1 level prior treatment and EGFR mutation were independent factors for EGFR-TKI treatment affecting PFS (RR=0.298, P<0.001;RR=0.086, P<0.001).Conclusion The mutation rate of EGFR was significantly related with the expression level of CEA prior treatment, and serum CEA and CYFRA21-1 levels prior treatment could be potential predictors of EGFR-TKI efficacy.%目的：探讨非小细胞肺癌患者治疗前血清CEA和细胞角蛋白19（ CYFRA21-1）水平与表皮生长因子（ EGFR）基因突变的相关性并分析其对酪氨酸激酶抑制剂（ TKI）疗效的预测价值。方法本研究为临床研究，共收集北京大学人民医院2012至2013年101例非小细胞肺癌患者配对癌组织和外周血标本。采用ADx-ARMS法和直接测序法检测上述标本EGFR基因18、19、20、21外显子基因突变，同时采用电化学发光方法检测患者血清CEA和CYFRA21-1表达水平。采用χ2检验、Log-rank检验和cox回归，分析患者肿瘤标志物水平与EGFR突变和EGFR-TKI疗效的关系。结果双环探针扩增阻滞突变系统（ADx-ARMS）总突变检出率为60.4％（61／101），直接测序法为33.7％（34／101）。突变多见于治疗前血清CEA浓度升高（≥5μg／L，78.8％）患者，但突变率不随CEA浓度增加而升高。靶向治疗疗效方面，治疗前血清CYFRA21-1水平和EGFR突变状态与TKI治疗的无进展生存期（PFS）相关（χ2＝8.903，P＝0.003；χ2＝28.590，P＜0.001），同时也是影响靶向治疗患者PFS的独立因素（ RR＝0.298，P＜0.001；RR＝0.086，P＜0.001）。结论治疗前CEA浓度与EGFR突变相关，同时可与CYFRA21-1作为预测非小细胞肺癌接受EGFR-TKI治疗的疗效指标。（中华检验医学杂志，2015，38：407-411）
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