Wang Youyu, Xie Shenglong, He Bin
Thoracic Surgery, Sichuan Academy Medical Sciences and Sichuan Provincial People's Hospital Chengdu, P. R. China.
Am J Cancer Res. 2019 Mar 1;9(3):619-627. eCollection 2019.
EGFR-TKI had become the first-line treatment of metastatic NSCLC and widely used in clinical. It was reported that there was difference in response rate between NSCLC patients with or without EGFR mutation. However, there was no relevant studies about the difference in clinical response among patients with different kinds of EGFR mutation. In this study, we recruited 464 patients with NSCLC between March 2014 and March 2015. Circulating tumor DNA (ctDNA) was isolated from plasma and identified EGFR gene mutations. Demographic characteristics, pathological data, safety and three-year survival were compared in patients with different EGFR gene mutations. The primary objective was progression-free survival (PFS), and secondary objectives included overall response rate (ORR), disease control rate (DCR) and overall survival (OS). Among all the patients, the total mutation rate of EGFR gene was 45.04%, major occurred in 19 exon (40.19%) and 21 exon (48.80%), respectively. There was great difference in gender, smoking status, TNM stage among patients with 19 exon, 21 exon and other mutation of EGFR (All P < 0.05). The ORR (34.31% vs. 28.57%, 21.74%) and DCR (73.53% vs. 69.05%, 56.52%) in patients with 21 exon mutation was significantly higher than patients with 19 exon or other mutations. After three-year follow-up, the median PFS was 7.9 months in the 21 exon group, 6.4 months in the 19 exon group and 5.1 months in the other mutation group (P < 0.05). And the median OS in patients with EGFR 21 exon mutation was significantly higher than those of patients with EGFR 19 exon or other mutations. In conclusion, applied with chemotherapy and EGFR-TKI, Chinese NSCLC patients with EGFR gene 21 exon mutation could have better clinical response and long-term survival than those with other kinds of mutation.
表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI）已成为转移性非小细胞肺癌（NSCLC）的一线治疗方法并在临床上广泛应用。据报道，有或没有EGFR突变的NSCLC患者的缓解率存在差异。然而，关于不同类型EGFR突变患者临床反应差异的相关研究尚无。在本研究中，我们招募了2014年3月至2015年3月期间的464例NSCLC患者。从血浆中分离循环肿瘤DNA（ctDNA）并鉴定EGFR基因突变。比较了不同EGFR基因突变患者的人口统计学特征、病理数据、安全性和三年生存率。主要目标是无进展生存期（PFS），次要目标包括总缓解率（ORR）、疾病控制率（DCR）和总生存期（OS）。在所有患者中，EGFR基因的总突变率为45.04%，主要分别发生在19外显子（40.19%）和21外显子（48.80%）。EGFR 19外显子、21外显子和其他突变患者在性别、吸烟状态、TNM分期方面存在很大差异（所有P<0.05）。21外显子突变患者的ORR（34.31%对28.57%，21.74%）和DCR（73.53%对69.05%，56.52%）显著高于19外显子或其他突变患者。经过三年随访，21外显子组的中位PFS为7.9个月，19外显子组为6.4个月，其他突变组为5.1个月（P<0.05）。并且EGFR 21外显子突变患者的中位OS显著高于EGFR 19外显子或其他突变患者。总之，与化疗和EGFR-TKI联合应用时，EGFR基因21外显子突变的中国NSCLC患者比其他类型突变患者具有更好的临床反应和长期生存率。
