Zhonghua Zhong Liu Za Zhi. 2025 Apr 23;47(4):283-297. doi: 10.3760/cma.j.cn112152-20241130-00546.
Anaplastic lymphoma kinase (ALK) fusion represents one of pivotal driver genes within the realm of non-small cell lung cancer (NSCLC). ALK-tyrosine kinase inhibitors (ALK-TKIs) have demonstrated remarkable therapeutic efficacy for patients afflicted with ALK-positive NSCLC. As of December 31, 2024, eight ALK-TKIs, including crizotinib, ceritinib, alectinib, ensartinib, brigatinib, lorlatinib, iruplinalkib, and invonalkib have garnered approval from the China National Medical Products Administration (NMPA) (Ranking according to the approval time for marketing by NMPA), providing targeted treatment agents for ALK-positive NSCLC patients. To standardize the application of ALK-TKIs, The Chinese Association for Clinical Oncologists and the Medical Oncology Branch of China International Exchange and Promotive Association for Medical and Health Care has organized experts to compile the "Clinical practice guideline on anaplastic lymphoma kinase-tyrosine kinase inhibitors for non-small cell lung cancer (2025 edition)". This guideline provides recommendations in four aspects, encompassing ALK fusion testing, ALK-TKI targeted therapy, ALK-TKI adverse events management, and patient post-treatment follow-up, thus serving as a valuable reference for the standardized treatment of Chinese ALK fusion-positive NSCLC.
间变性淋巴瘤激酶(ALK)融合是非小细胞肺癌(NSCLC)领域关键的驱动基因之一。ALK酪氨酸激酶抑制剂(ALK-TKIs)已证明对ALK阳性NSCLC患者具有显著的治疗效果。截至2024年12月31日,包括克唑替尼、色瑞替尼、阿来替尼、恩沙替尼、布加替尼、洛拉替尼、伊鲁阿克和应凡阿克在内的8种ALK-TKIs已获得国家药品监督管理局(NMPA)批准(按NMPA批准上市时间排序),为ALK阳性NSCLC患者提供了靶向治疗药物。为规范ALK-TKIs的应用,中国临床肿瘤学会和中国国际医疗保健促进会肿瘤内科分会组织专家编写了《非小细胞肺癌间变性淋巴瘤激酶-酪氨酸激酶抑制剂临床实践指南(2025年版)》。本指南从ALK融合检测、ALK-TKI靶向治疗、ALK-TKI不良反应管理和患者治疗后随访四个方面给出推荐,为中国ALK融合阳性NSCLC的规范化治疗提供了有价值的参考。