EGFR突变的晚期非小细胞肺癌患者接受一代TKI靶向治疗的效果及预后预测因子分析

洪雅萍; 黄韵坚; 黄漳州; 陈胜佳; 钟巧凤; 曾洪福; 庄武

doi:10.19401/j.cnki.1007-3639.2022.07.006

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EGFR突变的晚期非小细胞肺癌患者接受一代TKI靶向治疗的效果及预后预测因子分析

论著 | 更新时间：2025-12-31

- EGFR突变的晚期非小细胞肺癌患者接受一代TKI靶向治疗的效果及预后预测因子分析
- Efficacy and prognostic predictors of first-generation EGFR TKI-targeted therapy in patients with EGFR-mutated advanced non-small cell lung cancer
- 中国癌症杂志 2022年32卷第7期页码：624-634
- 作者机构：
  
  福建医科大学附属肿瘤医院,福建省肿瘤医院胸部肿瘤内科,福建福州 350014
- 作者简介：
  
  [ "洪雅萍（ORCID: 0000-0002-6758-3066）,硕士,主治医师,E-mail: yipinghong2018@163.com。" ]
  庄武（ORCID: 0000-0001-7381-4732）,学士,主任医师,福建省肿瘤医院26区胸部肿瘤内科主任,E-mail: zhuangwu2008@126.com。
- 基金信息：
  
  福建省肿瘤放射与免疫治疗临床医学研究中心(2020Y2012)
- DOI：10.19401/j.cnki.1007-3639.2022.07.006
  中图分类号： R734.2
- 收稿：2022-02-14，
  
  纸质出版：2022-07-30
- 稿件说明：
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洪雅萍, 黄韵坚, 黄漳州, 等. EGFR突变的晚期非小细胞肺癌患者接受一代TKI靶向治疗的效果及预后预测因子分析[J]. 中国癌症杂志, 2022,32(7):624-634.

Yaping HONG, Yunjian HUANG, Zhangzhou HUANG, et al. Efficacy and prognostic predictors of first-generation EGFR TKI-targeted therapy in patients with EGFR-mutated advanced non-small cell lung cancer[J]. China Oncology, 2022, 32(7): 624-634.
洪雅萍, 黄韵坚, 黄漳州, 等. EGFR突变的晚期非小细胞肺癌患者接受一代TKI靶向治疗的效果及预后预测因子分析[J]. 中国癌症杂志, 2022,32(7):624-634. DOI： 10.19401/j.cnki.1007-3639.2022.07.006.

Yaping HONG, Yunjian HUANG, Zhangzhou HUANG, et al. Efficacy and prognostic predictors of first-generation EGFR TKI-targeted therapy in patients with EGFR-mutated advanced non-small cell lung cancer[J]. China Oncology, 2022, 32(7): 624-634. DOI： 10.19401/j.cnki.1007-3639.2022.07.006.

摘要

背景和目的：

表皮生长因子受体-酪氨酸激酶抑制剂（epidermal growth factor receptor-tyrosine kinase inhibitor

EGFR-TKI）治疗已成为

EGFR

突变的晚期非小细胞肺癌（non-small cell lung cancer

NSCLC）的一线标准治疗

然而仍有10%~30%的

EGFR

敏感突变的NSCLC患者在接受TKI靶向治疗时出现原发性耐药。因此

研究EGFR-TKI的临床疗效

寻找其预后预测因子对于治疗携带

EGFR

敏感突变的晚期NSCLC患者具有重要的指导意义。本研究旨在探讨埃克替尼一线治疗

EGFR

突变的晚期NCSLC患者的疗效并寻找其预后预测因子。

方法：

筛选2016年1月

#x02014;2017年11月福建省肿瘤医院收治的携带

EGFR

突变的258例

#x02162;B~

#x02163;期NSCLC患者

并采外周血检测循环肿瘤DNA（circulating tumor DNA

ctDNA）中的

EGFR

突变情况

最终入组118例

均接受埃克替尼125 mg口服

每天3次。定期收集患者的生存资料。应用

检验比较不同

EGFR

突变组的临床病理学特征的差异。采用Kaplan-Meier生存曲线分析患者的无进展生存期（progression-free survival

PFS）和总生存期（overall survival

OS）

应用log-rank检验进行单因素分析

应用COX回归模型进行多因素分析。

结果：

118例患者的客观缓解率（objective response rate

ORR）为62.7%（95% CI：53.9%~71.6%）

疾病控制率（disease control rate

DCR）为92.4%（95% CI：87.5%~97.2%）

中位PFS为11.3个月（95% CI：9.1~13.5个月）

中位OS为32.0个月（95% CI：26.9~37.1个月）。不同

EGFR

表达类型之间的临床病理学特征差异无统计学意义（

0.05）

但不同

EGFR

突变组患者的最佳疗效差异有统计学意义（

=0.040）。单因素分析显示

外周血ctDNA的

EGFR

突变情况与患者的PFS和OS无关（

0.05）。多因素分析显示

基线乳酸脱氢酶（lactate dehydrogenase

LDH）表达水平、

EGFR

类型、胸腔积液及最佳疗效为PFS的独立预测因子。而患者的N分期、骨转移、PFS及出现

EGFR

T790M突变是OS的独立预测因子。

结论：

EGFR

突变的晚期NSCLC患者接受一线埃克替尼靶向治疗具有良好的疗效。外周血ctDNA中的

EGFR

突变情况与患者的临床疗效无关。骨转移与接受TKI靶向治疗患者的不良预后有关。

Abstract

Background and purpose:

Epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) treatment has become th

e first-line standard treatment for advanced non-small cell lung cancer (NSCLC) with

EGFR

mutation. However

10%-30% of NSCLC patients with

EGFR

sensitive mutation still have primary drug resistance when receiving TKI targeted therapy. Therefore

to study the clinical efficacy of EGFR-TKI and find out its prognostic predictors has important significance for the treatment of advanced NSCLC patients with

EGFR

sensitive mutation. The purpose of this research was to evaluate the efficacy of icotinib as first-line treatment in patients with

EGFR

-mutant advanced NSCLC and investigate the prognostic predictors.

Methods:

A total of 258 stage

#x02162;B-

#x02163; NSCLC patients with

EGFR

mutation who were admitted to Fujian Cancer Hospital from January 2016 to November 2017 were selected. One hundred and eighteen advanced NSCLC patients with

EGFR

mutation were enrolled

and baseline circulating tumor DNA (ctDNA)

EGFR

-mutant status was determined using the plasma test. All these patients received icotinib 125mg three times a day. The

test was used to compare the differences in clinicopathological characteristics between different

EGFR

mutation groups. Progression-free survival (PFS) and overall survival (OS) were estimated by the Kaplan-Meier survival curve. The log-rank test was used for univariate analysis

and the COX regression model was used for multivariate analysis.

Results:

The objective response rate (ORR) of 118 patients was 62.7% (95% CI: 53.9%-71.6%)

the disease control rate (DCR) was 92.4% (95% CI: 87.5%-97.2%)

and the median PFS was 11.3months (95% CI: 9.1-13.5 months)

and the median OS was 32.0 months (95% CI: 26.9-37.1 months). No statistically significant difference was found in the clinicopathological characteristics between different

EGFR

expression types (

0.05)

while the best efficacy between different

EGFR

mutation groups was significantly different (

=0.040). Univariate analysis showed that

EGFR

mutation status in plasma ctDNA test was not correlated with PFS and OS of patients (

0.05). Multivariate analysis showed that baseline lactate dehydrogenase (LDH) expression level

EGFR

types

pleural effusion and the best curative effect might be independent factors of PFS. The patient

#x02019;s N stage

bone metastasis

time to PFS and presence of

EGFR

T790M mutation might be independent predictors of OS.

Conclusion:

Icotinib as first-line treatment was effective in

EGFR

-mutant advanced NSCLC patients. The

EGFR

mutation status in plasma ctDNA test was not correlated with the clinical efficacy of patients. Bone metastasis was found to be an independent factor of worse prognosis.

关键词

Keywords

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