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一项针对表皮生长因子受体突变型非小细胞肺癌一线酪氨酸激酶抑制剂治疗的全国真实世界队列研究。

Nationwide Real-world Cohort Study of First-line Tyrosine Kinase Inhibitor Treatment in Epidermal Growth Factor Receptor-mutated Non-small-cell Lung Cancer.

机构信息

Department of Respiratory Medicine, Medical Center Leeuwarden, Leeuwarden, The Netherlands.

Department of Research, Comprehensive Cancer Organization, Utrecht, The Netherlands.

出版信息

Clin Lung Cancer. 2020 Nov;21(6):e647-e653. doi: 10.1016/j.cllc.2020.05.019. Epub 2020 May 22.

DOI:10.1016/j.cllc.2020.05.019
PMID:32636159
Abstract

BACKGROUND

Only a few randomized trials directly compared the relative efficacy of tyrosine kinase inhibitors (TKIs) in patients with advanced epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC), and most trials comprised selected series from Asian populations. Therefore, the aim of this study was to assess the overall survival (OS) of advanced EGFR-mutated NSCLC in a large white population and to evaluate variation between different TKIs and identify predictors of survival.

PATIENTS AND METHODS

Information about clinical characteristics, treatment, and survival for 873 patients with stage IV EGFR + NSCLC, diagnosed from 2015 through 2017, was derived from the Netherlands Cancer Registry. OS was evaluated by actuarial analysis and multivariable Cox regression. Prognostic factors are reported as hazard ratios and 95% confidence intervals.

RESULTS

A total of 596 (68%) patients received first-line treatment with regular TKIs, providing a median survival of 20.2 months. Forty-five percent of patients were 70 years and older, and 54% of patients had distant metastasis in multiple organs. In the multivariate analysis, survival was significantly worse for men, and patients with higher age, poorer performance, and ≥ 3 organs with metastasis. Compared with erlotinib, OS was worse for gefitinib users (adjusted hazard ratio, 1.30; 95% confidence interval, 1.02-1.64), predominantly in patients with brain metastasis.

CONCLUSION

Dutch patients with EGFR-mutated NSCLC who received first-line treatment with regular TKIs have a median OS of 20.2 months in a nationwide real-world cohort. In patients with brain metastasis, erlotinib showed superior results compared with gefitinib and was similar to afatinib.

摘要

背景

仅有少数随机试验直接比较了晚期表皮生长因子受体(EGFR)突变型非小细胞肺癌(NSCLC)患者中酪氨酸激酶抑制剂(TKI)的相对疗效,且大多数试验均由亚洲人群的精选系列组成。因此,本研究旨在评估大型白人人群中晚期 EGFR 突变型 NSCLC 的总生存期(OS),并评估不同 TKI 之间的差异,以及确定生存的预测因素。

患者和方法

从荷兰癌症登记处获取了 2015 年至 2017 年间诊断为 IV 期 EGFR+ NSCLC 的 873 例患者的临床特征、治疗和生存信息。通过生存分析和多变量 Cox 回归评估 OS。预后因素以风险比及其 95%置信区间报告。

结果

共有 596 例(68%)患者接受了一线常规 TKI 治疗,中位生存时间为 20.2 个月。45%的患者年龄在 70 岁及以上,54%的患者有多个器官的远处转移。在多变量分析中,男性、年龄较大、功能状态较差和有≥3 个器官转移的患者生存明显较差。与厄洛替尼相比,吉非替尼使用者的 OS 更差(调整后的风险比,1.30;95%置信区间,1.02-1.64),主要发生在有脑转移的患者中。

结论

在这项全国性真实世界队列研究中,接受一线常规 TKI 治疗的荷兰 EGFR 突变型 NSCLC 患者的中位 OS 为 20.2 个月。在有脑转移的患者中,厄洛替尼的结果优于吉非替尼,与阿法替尼相似。

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