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一项关于非小细胞肺癌伴表皮生长因子受体(EGFR)外显子20插入突变患者的临床特征、治疗顺序及结局的真实世界研究。

A real‑world study of clinical characteristics, treatment sequence and outcomes of patients with non-small cell lung cancer and EGFR exon 20 insertion mutations.

作者信息

Suay Guillermo, Martín-Martorell Paloma, Aparisi Francisco, Arnal María, Guirado María, Azkárate Aitor, Garde-Noguera Javier, Cumplido-Burón José David, Insa Amelia, González-Muñoz José Francisco, Palanca Sarai, Díaz María, Sánchez-Hernández Alfredo, Juan-Vidal Óscar

机构信息

Medical Oncology Department, Biomarker and Precision Medicine Unit, La Fe University and Polytechnic Hospital, Valencia, Spain.

Medical Oncology Department, University Clinical Hospital, Valencia, Spain.

出版信息

Clin Transl Oncol. 2025 Jun;27(6):2568-2578. doi: 10.1007/s12094-024-03776-y. Epub 2024 Nov 5.

DOI:10.1007/s12094-024-03776-y
PMID:39499485
Abstract

OBJECTIVES

EGFR exon 20 insertion (EGFRex20ins) mutations are found in up to 4% of all patients with non-small cell lung cancer (NSCLC). These patients are often insensitive to EGFR-tyrosine kinase inhibitors (TKIs) and have worse prognosis than patients with more common EGFR mutations. In this multicenter, retrospective, real-world study, we sought to determine whether the administration of recently approved treatments that specifically target EGFRex20ins mutations could significantly improve outcomes in this patient population.

MATERIALS AND METHODS

We evaluated the clinical features of 41 patients diagnosed with NSCLC and EGFRex20ins mutations, their evolution, and response to treatments received across 7 hospitals in the Valencian Community, Spain, between 31st December 2012 and 31st December 2022.

RESULTS

32 patients (72%) developed metastatic disease, and 29 (71%) of them received oncological treatment. We found that administering a targeted therapy against EGFRex20ins mutations (amivantamab, mobocertinib and/or sunvozertinib) at some point during the course of treatment, significantly increased the median OS of metastatic patients from 8 months (95% CI 0-21.7) to 30 months (95% CI 11.1-48.8; Hazard ratio = 0.297, p = 0.02).

CONCLUSION

Our findings contribute to the evolving standard of care for this specific population and highlight the clinical benefits of targeted cancer therapies.

摘要

目的

在所有非小细胞肺癌(NSCLC)患者中,高达4%的患者存在表皮生长因子受体第20外显子插入(EGFRex20ins)突变。这些患者通常对表皮生长因子受体酪氨酸激酶抑制剂(TKIs)不敏感,且预后比具有更常见EGFR突变的患者更差。在这项多中心、回顾性、真实世界研究中,我们试图确定给予最近批准的特异性靶向EGFRex20ins突变的治疗方法是否能显著改善该患者群体的预后。

材料与方法

我们评估了2012年12月31日至2022年12月31日期间在西班牙巴伦西亚自治区7家医院确诊为NSCLC且存在EGFRex20ins突变的41例患者的临床特征、病情进展以及对所接受治疗的反应。

结果

32例患者(72%)发生了转移性疾病,其中29例(71%)接受了肿瘤治疗。我们发现,在治疗过程中的某个时间点给予针对EGFRex20ins突变的靶向治疗(阿美替尼、莫博替尼和/或舒沃替尼),可使转移性患者的中位总生存期从8个月(95%置信区间0 - 21.7)显著延长至30个月(95%置信区间11.1 - 48.8;风险比 = 0.297, p = 0.02)。

结论

我们的研究结果有助于完善针对这一特定人群的治疗标准,并突出了靶向癌症治疗的临床益处。

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Non-Small Cell Lung Cancer, Version 4.2024, NCCN Clinical Practice Guidelines in Oncology.非小细胞肺癌临床实践指南(第 4.2024 版),NCCN 肿瘤学临床实践指南
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Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up.癌基因成瘾性转移性非小细胞肺癌:ESMO诊断、治疗及随访临床实践指南
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Optimal therapy for concomitant EGFR and TP53 mutated non-small cell lung cancer: a real-world study.同时存在 EGFR 和 TP53 突变的非小细胞肺癌的最佳治疗:一项真实世界研究。
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Molecular Epidemiology and Treatment Patterns of Patients With EGFR Exon 20-Mutant NSCLC in the Precision Oncology Era: The European EXOTIC Registry.精准肿瘤学时代EGFR外显子20突变型非小细胞肺癌患者的分子流行病学和治疗模式:欧洲EXOTIC注册研究
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Frequency, underdiagnosis, and heterogeneity of epidermal growth factor receptor exon 20 insertion mutations using real-world genomic datasets.利用真实世界的基因组数据集评估表皮生长因子受体外显子 20 插入突变的频率、漏诊情况和异质性。
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