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《中国Ⅳ期非小细胞肺癌表皮生长因子受体酪氨酸激酶抑制剂临床实践指南(2023年版)》

[China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)].

出版信息

Zhonghua Yi Xue Za Zhi. 2023 Oct 31;103(40):3160-3173. doi: 10.3760/cma.j.cn112137-20230505-00725.

DOI:10.3760/cma.j.cn112137-20230505-00725
PMID:37879869
Abstract

The incidence and mortality of lung cancer rank first among malignant tumors in China. Among them, non-small cell lung cancer (NSCLC) is the most important pathological type, accounting for 80%-85% of lung cancer patients, including adenocarcinoma, squamous cell carcinoma and other pathological subtypes. In recent years, with the discovery of epidermal growth factor receptor (EGFR) gene and the successful development of tyrosine kinase inhibitors (TKIs), the treatment efficacy of stage Ⅳ NSCLC patients with EGFR gene sensitive mutation has been greatly improved. As of August 23, 2023, the first generation EGFR-TKIs, gefitinib, icotinib, and erlotinib; the second generation EGFR-TKIs, afatinib and dacomitinib; and the third generation EGFR-TKIs, osimertinib, almonertinib, furmonertinib and befotertinib were all approved for marketing by China National Medical Products Administration (NMPA). In addition, multiple domestic third-generation EGFR-TKIs are undergoing clinical trials, such as rezivertinib (BPI-7711), limertinib (ASK120067), and oritinib (SH-1028). Meanwhile, mobocertinib and sunvozertinib, which targets EGFR 20ins mutations, were also approved by NMPA. With the increasing variety of EGFR-TKIs approved for marketing subsequently, it brings confusion to clinicians when choosing specific medications, and there is an urgent need to develop relevant treatment guidelines. Hence, the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care and the Chinese Association for Clinical Oncologists convened experts to integrate the research results of various EGFR-TKIs, and proposed the "China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)", to provide reference for better clinical practice.

摘要

肺癌的发病率和死亡率在中国恶性肿瘤中位居首位。其中,非小细胞肺癌(NSCLC)是最重要的病理类型,占肺癌患者的80%-85%,包括腺癌、鳞状细胞癌等病理亚型。近年来,随着表皮生长因子受体(EGFR)基因的发现以及酪氨酸激酶抑制剂(TKIs)的成功研发,表皮生长因子受体基因敏感突变的Ⅳ期非小细胞肺癌患者的治疗疗效得到了极大提高。截至2023年8月23日,第一代EGFR-TKIs吉非替尼、埃克替尼和厄洛替尼;第二代EGFR-TKIs阿法替尼和达可替尼;以及第三代EGFR-TKIs奥希替尼、阿美替尼、伏美替尼和贝福替尼均已获国家药品监督管理局(NMPA)批准上市。此外,多个国产第三代EGFR-TKIs正在进行临床试验,如瑞泽替尼(BPI-7711)、利美替尼(ASK120067)和奥瑞替尼(SH-1028)。同时,针对EGFR 20ins突变的莫博替尼和舒沃替尼也获NMPA批准。随着后续获批上市的EGFR-TKIs种类日益增多,给临床医生在选择具体用药时带来困惑,迫切需要制定相关治疗指南。因此,中国国际医疗保健交流促进会肿瘤内科分会和中国临床肿瘤学会召集专家,整合各类EGFR-TKIs的研究成果,提出了《Ⅳ期非小细胞肺癌表皮生长因子受体酪氨酸激酶抑制剂中国临床实践指南(2023年版)》,为更好地开展临床实践提供参考。

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[China clinical practice guideline for epidermal growth factor receptor tyrosine kinase inhibitors in stage Ⅳ non-small cell lung cancer (version 2023)].《中国Ⅳ期非小细胞肺癌表皮生长因子受体酪氨酸激酶抑制剂临床实践指南(2023年版)》
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引用本文的文献

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Amivantamab versus standard therapies among patients with advanced non-small cell lung cancer and epidermal growth factor receptor exon 20 insertion mutations after platinum-based therapy in China.在中国,铂类治疗后晚期非小细胞肺癌和表皮生长因子受体外显子20插入突变患者中,阿米万他单抗与标准疗法的对比研究。
BMC Pulm Med. 2025 Aug 1;25(1):364. doi: 10.1186/s12890-025-03826-3.
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[Research Status and Progress of Third-generation EGFR-TKIs 
in Elderly Patients with Non-small Cell Lung Cancer].[第三代表皮生长因子受体酪氨酸激酶抑制剂在老年非小细胞肺癌患者中的研究现状与进展]
Zhongguo Fei Ai Za Zhi. 2025 May 20;28(5):334-342. doi: 10.3779/j.issn.1009-3419.2025.101.09.
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New advances in the treatment of EGFR exon20ins mutant advanced NSCLC.
表皮生长因子受体第20外显子插入突变的晚期非小细胞肺癌治疗新进展
Am J Cancer Res. 2025 Apr 25;15(4):1852-1873. doi: 10.62347/WTMU5537. eCollection 2025.
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Furmonertinib for EGFR-mutant advanced non-small cell lung cancer: a glittering diamond in the rough of EGFR-TKI.伏美替尼用于表皮生长因子受体(EGFR)突变的晚期非小细胞肺癌:EGFR酪氨酸激酶抑制剂(EGFR-TKI)中的一颗璞玉。
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