Establish of new deteciton of EGFR mutation status using immunostaining in non-small cell lung cancer

为了建立NSCLC患者EGFR突变状态的检测算法，我们采用了PNA-LNA PCR夹钳法和免疫染色法。133例样本中，EGFR突变特异性抗体阳性37例（27.8%），阴性85例（63.9%），模棱两可11例（8.3%）。37例患者通过免疫染色显示EGFR阳性表达，其中35例（94.6%）在基于dna的分析中也检测出阳性。在85例免疫染色egfr阴性患者中，77例（90.6%）在基于dna的检测中也检测为阴性。在接受EGFR- tkis治疗的NSCLC患者中，EGFR阳性表达的患者开始EGFR- tkis治疗后的无进展生存期明显长于表达不明确和表达阴性的患者（P = 0.002）。我们的研究结果表明，EGFR突变特异性抗体的免疫染色是EGFR- tki抑制的一种新测试，可能是关于患者管理的有用指标。

To establish a testing algorithm for EGFR mutation status in NSCLC patients, we utilized PNA-LNA PCR clamp assay and immunostaining. In the 133 samples, positive, negative and equivocal results for EGFR mutation-specific antibodies were observed in 37 patients (27.8%), 85 patients (63.9%) and 11 patients (8.3%), respectively. Thirty-seven patients showed positive EGFR expression by immunostaining, and 35 (94.6%) of these also tested positive in the DNA-based assay. Of 85 EGFR-negative patients by immunostaining, 77 (90.6%) also tested negative in the DNA-based assay. In NSCLC patients treated with EGFR-TKIs, the progression-free survival after the start of EGFR-TKIs treatment was significantly longer in patients with EGFR positive expression than in those with equivocal and negative expression (P = 0.002). Our results suggest immunostaining for EGFR mutation-specific antibodies are a new test for EGFR-TKI inhibition and could be a useful indicator with regard to patient management.