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临床因素对获得性表皮生长因子受体 T790M 突变的非小细胞肺癌患者奥希替尼治疗反应的影响:长期生存分析。

Clinical Factors Affecting the Response to Osimertinib in Non-Small Cell Lung Cancer Patients with An Acquired Epidermal Growth Factor Receptor T790M Mutation: A Long-Term Survival Analysis.

机构信息

Department of Pulmonary, Shanghai Chest Hospital, Shanghai Jiao Tong University, Shanghai, 230032, China.

出版信息

Target Oncol. 2020 Jun;15(3):337-345. doi: 10.1007/s11523-020-00724-y.

DOI:10.1007/s11523-020-00724-y
PMID:32495159
Abstract

BACKGROUND

Osimertinib is a standard therapy for advanced non-small cell lung cancer (NSCLC) patients with an acquired epidermal growth factor receptor (EGFR) T790M mutation; however, the exploration of clinical characteristics that may affect prognosis and long-term survival is still lacking.

OBJECTIVE

This retrospective study aimed to provide long-term survival data and explore meaningful prognostic factors in patients treated with osimertinib.

PATIENTS AND METHODS

A total of 246 patients with acquired EGFR T790M mutation who were treated with osimertinib were included in this study. Progression-free survival (PFS), overall survival from osimertinib initiation (OS1), overall survival from diagnosis of advanced disease (OS), and possible prognostic clinical features were analyzed.

RESULTS

The median PFS, OS1, and OS values were 12.17, 24.33, and 47.86 months, respectively. The median PFS of patients harboring EGFR exon 19 deletions/T790M (19del/T790M) and those harboring EGFR 21 L858R/T790M were 13.27 and 9.77 months (p = 0.001), respectively, while the median OS1 values were 25.03 and 18.30 months (p = 0.023), respectively; however, no significant difference was found in median OS (p = 0.060). Cox regression analysis revealed that coexisting mutation type and extrathoracic metastasis affected survival (PFS, OS1). In addition, gene biopsy specimen type (tissue or blood sample) was related to PFS (p = 0.032), which implied that liquid biopsy may be an independent poor prognostic factor.

CONCLUSIONS

This is the first reported survival analysis of osimertinib-treated Chinese patients, which indicates a median OS of 47.86 months. The EGFR T790M mutation is likely to coexist with 19del and indicate longer PFS and OS1 than EGFR 21 L858R/T790M. Additionally, the extrathoracic metastasis status and biopsy specimen type might also affect the survival of patients treated with osimertinib.

摘要

背景

奥希替尼是治疗具有获得性表皮生长因子受体(EGFR)T790M 突变的晚期非小细胞肺癌(NSCLC)患者的标准疗法;然而,对于可能影响预后和长期生存的临床特征的探索仍然缺乏。

目的

本回顾性研究旨在为接受奥希替尼治疗的患者提供长期生存数据并探讨有意义的预后因素。

患者和方法

共纳入 246 例接受奥希替尼治疗的获得性 EGFR T790M 突变患者。分析无进展生存期(PFS)、奥希替尼起始时的总生存期(OS1)、晚期疾病诊断时的总生存期(OS)和可能的预后临床特征。

结果

中位 PFS、OS1 和 OS 值分别为 12.17、24.33 和 47.86 个月。EGFR 外显子 19 缺失/T790M(19del/T790M)和 EGFR 21 L858R/T790M 患者的中位 PFS 分别为 13.27 和 9.77 个月(p=0.001),中位 OS1 值分别为 25.03 和 18.30 个月(p=0.023),但中位 OS 无显著差异(p=0.060)。Cox 回归分析显示共存突变类型和胸外转移影响生存(PFS、OS1)。此外,基因活检标本类型(组织或血液样本)与 PFS 相关(p=0.032),提示液体活检可能是一个独立的不良预后因素。

结论

这是首例报道的奥希替尼治疗中国患者的生存分析,中位 OS 为 47.86 个月。EGFR T790M 突变可能与 19del 共存,与 EGFR 21 L858R/T790M 相比,PFS 和 OS1 更长。此外,胸外转移状态和活检标本类型也可能影响奥希替尼治疗患者的生存。

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