Zhong Wei, Wang Mengzhao, Li Longyun, Xia Ying, Chen Minjiang, Zhang Li, Zhao Jing
Department of Respiratory Diseases, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing 100730, China.
Zhongguo Fei Ai Za Zhi. 2012 Sep;15(9):513-20. doi: 10.3779/j.issn.1009-3419.2012.09.03.
It has been proven that the status of epidermal growth factor receptor (EGFR) gene mutation was related to effects of gefitinib in patients with advanced non-small cell lung cancer (NSCLC). The aim of this study is to reports distribution of EGFR gene mutations in advanced NSCLC and their influence on effect of gefitinib.
From Jan 2007 to Dec 2009, 160 patients with advanced non-squamous NSCLC received EGFR mutation tests, and EGFR exon 19 and 21 were amplified by mutant-enriched PCR and analyzed by sequencing. Among those patients, 111 received gefitinib therapy. Overall survival (OS) and progression free survival (PFS) were calculated using the Kaplan-Meier method and a Cox regression analysis was used to detect differences between strata.
The percentage of EGFR mutation in advanced non-squamous NSCLC was 55%, and it was only significantly related with pathological type. OS of the patients with or without EGFR gene mutations were 29.0 months (95%CI: 24.2-33.8) and 21.0 months (95% CI: 14.7-27.3) respectively, and the difference was not significant. PFS of patients with or without EGFR gene mutations were 17.0 months (95% CI: 5.6-17.6) and 11.6 months (95% CI 8.6-25.4), and the difference was significant (P = 0.022). Multivariate analysis shows that OS was significantly related with ECOG status, pathological type and EGFR mutation statuses, and PFS was significantly related to ECOG status, former regimens number and EGFR mutation statuses. There were no significant differences in OS and PFS between patients with EGFR exon 19 deletions and those with exon 21 point mutation.
PFS of patients with EGFR mutations was better than those without EGFR mutations, but OS was similar. There were no significant differences in OS and PFS between patients with EGFR exon 19 deletions and those with exon 21 point mutation.
已证实表皮生长因子受体（EGFR）基因突变状态与吉非替尼对晚期非小细胞肺癌（NSCLC）患者的疗效相关。本研究旨在报告晚期NSCLC中EGFR基因突变的分布及其对吉非替尼疗效的影响。
2007年1月至2009年12月，160例晚期非鳞状NSCLC患者接受了EGFR突变检测，通过富集突变的PCR扩增EGFR第19和21外显子并进行测序分析。其中111例患者接受了吉非替尼治疗。采用Kaplan-Meier法计算总生存期（OS）和无进展生存期（PFS），并使用Cox回归分析检测各亚组间的差异。
晚期非鳞状NSCLC中EGFR突变的比例为55%，且仅与病理类型显著相关。有或无EGFR基因突变患者的OS分别为29.0个月（95%CI：24.2 - 33.8）和21.0个月（95%CI：14.7 - 27.3），差异无统计学意义。有或无EGFR基因突变患者的PFS分别为17.0个月（95%CI：5.6 - 17.6）和11.6个月（95%CI 8.6 - 25.4），差异有统计学意义（P = 0.022）。多因素分析显示，OS与ECOG状态、病理类型和EGFR突变状态显著相关，PFS与ECOG状态、既往治疗方案数量和EGFR突变状态显著相关。EGFR第19外显子缺失患者与第21外显子点突变患者的OS和PFS无显著差异。
EGFR基因突变患者的PFS优于无EGFR基因突变患者，但OS相似。EGFR第19外显子缺失患者与第21外显子点突变患者的OS和PFS无显著差异。
