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

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.在中国，肺癌发病率和死亡率均居恶性肿瘤首位，其中非小细胞肺癌（NSCLC）是最主要的病理类型，占全部肺癌患者的80%~85%，包括腺癌、鳞癌等病理亚型。近年来，随着表皮生长因子受体（EGFR）基因的发现和相关酪氨酸激酶抑制剂（TKIs）的成功研发，EGFR基因敏感突变阳性Ⅳ期NSCLC患者的治疗效果得到了很大改善。截至 2023年8月23日，被中国国家药品监督管理局批准上市的第一代EGFR-TKIs包括吉非替尼、埃克替尼和厄洛替尼，第二代EGFR-TKIs包括阿法替尼和达可替尼，第三代EGFR-TKIs包括奥希替尼、阿美替尼、伏美替尼和贝福替尼。另外，还有多个国产第三代EGFR-TKIs正在进行临床试验，如瑞齐替尼（BPI-7711）、利厄替尼（ASK120067）、奥瑞替尼（SH-1028），另外还有针对EGFR 20ins突变的莫博赛替尼和舒沃替尼也已经获批上市。随着陆续获批上市的EGFR-TKIs种类越来越多，如何选择具体药物给临床应用带来了一些困惑，亟须制定相关治疗指南。有鉴于此，中国医疗保健国际交流促进会肿瘤内科学分会和中国医师协会肿瘤医师分会组织专家整合各类EGFR-TKIs的相关研究结果，编写了《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治疗指南（2023年版）》，以便更好地为临床应用提供借鉴。.