晚期NSCLC患者血清EGFR基因突变状态的测定及意义

Detection and Evaluation of EGFR Mutation Status in Serum of Patients with Advanced Non-small Cell Lung Cancer Treated with EGFR-TKIs

背景与目的小分子酪氨酸激酶抑制剂(tyrosine kinase inhibitors,TKIs)对于表皮生长因子受体(epidermal growth factor receptor,EGFR)基因突变的肺癌患者显示出良好的治疗效果。本研究旨在探讨晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者血清EGFR基因突变状态与EGFR-TKIs疗效的关系。方法检测80例一线口服EGFR-TKIs晚期NSCLC患者血清EGFR基因的突变状态,对患者进行长期随访并评价治疗效果。结果 80例患者血清EGFR基因突变27例(33.8%),其中外显子19缺失突变12例(44.4%),外显子21点突变15例(55.6%);血清EGFR基因突变患者的有效率(55.6%,15/27)高于野生型患者(17.0%,9/53),差异具有统计学意义(χ2=0.370,P<0.001);血清EGFR基因突变患者中位无进展生存时间(progress free survival,PFS)明显长于野生型患者(9.8个月vs5.7个月,P=0.014)。结论血清EGFR基因突变患者一线口服EGFR-TKIs的疗效优于野生型患者,血清EGFR基因状态可为EGFR-TKIs的一线治疗提供有效依据。

Background and objective Epidermal growth factor receptor tyrosine kinase inhibitors （EGFR-TKIs） has shown a high response rate in the treatment of lung cancer in patients with （EGFR） mutation. The aim of this study is to evaluate the relationship between EGFR mutation status in serum and predicting benefit from EGFR-TKIs therapy in patients with advanced non-small cell lung cancer （NSCLC）. Methods We examined EGFR mutation status in serum of 80 patients with advanced, EGFR-TKIs given as first-line therapy NSCLC. All patients were received long-term follow-up, and the drug efficacy were observed and evaluated. Results The EGFR mutation in serum was detected in 33.8% （27/80） of NSCLC patients examined, in which exon 19 deletion mutation was present at a frequency of 44.4% （12/27） and exon 21 point mutation was 55.6% （15/27）; The response rate to EGFR-TKI in patients with EGFR mutation in serum was （55.6%, 15/27）, which was remarkably higher than that in EGFR wild-type patients （17.0%, 9/53）, the difference was statistically significant （χ 2 =0.370, P0.001）; The median progression free survival （PFS） of patients with EGFR mutation in serum was remarkably better than that of EGFR wild-type patients （9.8 months vs 5.7 months, P=0.014）. Conclusion In patients with advanced, EGFR-positive in serum NSCLC, EGFR-TKIs given as first-line therapy is associated with improved drug efficacy. The results suggest that it is feasible to use serum to detect EGFR mutation, which can predict a benefit from EGFR-TKIs given as first-line therapy.