免疫组织化学法检测肺癌患者EGFR敏感突变的临床研究  

Clinical Significance of Immunohistochemistry in Detecting Epidermal Growth Factor Receptor Mutation in Lung Cancer

作　　者：杨振华[1] 叶亮[1] 方苏榕[1] 谷伟[1] 

机构地区：[1]南京医科大学附属南京医院(南京市第一医院)呼吸科,南京210006

出　　处：《肿瘤防治研究》2016年第4期272-276,共5页Cancer Research on Prevention and Treatment

基　　金：南京市科学技术委员会2013年度面上项目(H201341)

摘　　要：目的探讨免疫组织化学法(immunohistochemistry,IHC)检测EGFR突变的应用价值。方法通过针对del E746-A750、L858R突变的特异性抗体检测肺癌患者EGFR突变状态,并且与DNA直接测序法进行对照。结果 136例标本中IHC评分0分的48例,其中DNA直接测序法检测突变的3例、评分1+的53例中突变的11例、2+的27例中突变的22例、3+者中的8例均存在EGFR突变。以≤1+为阴性,≥2+为阳性,敏感度为71.43%,特异性为94.68%,阳性预测值(positive predictive value,PPV)为85.71%,阴性预测值(negative predictive value,NPV)为88.12%,κ值为0.683。结论免疫组织化学检测EGFR突变应以评分≤1+为阴性,≥2+为阳性来评估EGFR突变状态。Objective To explore the clinical value of immunohistochemistry（IHC） in screening the epidermal growth factor receptor（EGFR） mutation in lung cancer patients. Methods The two mutationspecific antibodies targeting the del E746-A750 mutation in exon 19 and L858 R mutation in exon 21 were used for IHC, and the method of direct DNA sequencing was served as control. Results In this investigation, we found 3（6.25%） cases scored 0, 11（20.75%） scored 1, 22（81.48%） scored 2, 8（100%） scored 3 assessed by IHC existed EGFR mutation in direct DNA sequencing analysis. When score≤1＋ was considered to be negative and score≥2＋ to be positive, the agreement between the two different detection methods was highest（κ=0.683）, which the sensitivity was 71.43% and specificity was 94.68%. In the same time, the positive predictive value（PPV） was 85.71% and the negative predictive value（NPV） was 88.12%. Conclusion The score of EGFR mutation assessed by IHC≤1 is considered to be negative mutation whereas score≥2 to be positive mutation.

关 键 词：免疫组织化学 DNA直接测序 EGFR突变 肺癌 

分 类 号：R734.2[医药卫生—肿瘤]