2022年美国国立综合癌症网络（NCCN）《非小细胞肺癌临床诊疗指南》（第4版及第5版）解读

doi:10.16150/j.1671-2870.2023.01.002

摘要/Abstract

摘要：

肺癌是全球癌症相关死亡排名第一的癌症，每年约有180万患者死于肺癌，占所有癌症死亡病例的18.0%。非小细胞肺癌（non-small cell lung cancer，NSCLC）是肺癌的主要类型，在所有肺癌患者中占比超过85%。我国每年的新发肺癌病例超过70万，且每年有超过60万例患者死于肺癌，占所有癌症死亡患者的21.7%。2022年，美国国立综合癌症网络（National Comprehensive Cancer Network，NCCN）更新了第4版、第5版肺癌临床诊疗指南。相比第3版指南，第4版指南新增了ERBB2（HER2）突变在非小细胞肺癌诊治中的参考意义，更新的内容主要聚焦于HER2突变作为标准生物标志物的检测及HER2突变患者的治疗，推荐对转移性NSCLC患者行HER2突变检测，并推荐将德喜曲妥珠单抗及恩美曲妥珠单抗作为HER2突变阳性患者的二线治疗药物。但这2种药物在我国尚处于临床实验中，对于存在HER2突变的NSCLC患者，其治疗策略还需临床医师结合实际情况综合考量，且需更多的国内实验数据支持。第5版指南则扩大了纳武单抗的使用范围，标志着免疫检查点抑制剂的研究取得了新的进展。

关键词: 非小细胞肺癌, 生物标志物, 肿瘤突变负荷, 非酪氨酸激酶结构域

Abstract:

Lung cancer is the leading cause of cancer-related deaths worldwide, with approximately 1.8 million patients dying of lung cancer each year, accounting for 18.0% of all cancer deaths. Non-small cell lung cancer (NSCLC) is the main type of lung cancer and accounts for more than 85% of all lung cancer patients. In China, more than 700 000 new cases of lung cancer are diagnosed each year, and more than 600 000 patients die of lung cancer, accounting for 21.7% of all cancer deaths. In 2022, the National Comprehensive Cancer Network (NCCN) updated the guidelines for clinical diagnosis and treatment of lung cancer. Compared with the third edition of the guidelines, the fourth edition of the guidelines added the reference significance of ERBB2 (HER2) mutation in the diagnosis and treatment of （NSCLC）. The updated content was mainly focused on the detection of HER2 mutation as a standard biomarker and the treatment of patients with HER2 mutation. The detection of HER2 mutation is recommended for patients with metastatic NSCLC. Fam-trastuzumab deruxtecan and trastuzumab emtansine are recommended as second-line treatment options for patients with HER2 mutation. However, both are in clinical trials in China. The treatment strategies for NSCLC patients with HER2 mutations need to be considered comprehensively in light of the actual situation, and more data from domestic trials are needed. The fifth edition of the guidelines expanded the use of nivolumab, marking new progress in the study of immune checkpoint inhibitors.

Key words: Non-small cell lung cancer, Biomarkers, Tumor mutation load, Non-tyrosine kinase domain

中图分类号:

R734.2

陈国群, 蔡姣迪. 2022年美国国立综合癌症网络（NCCN）《非小细胞肺癌临床诊疗指南》（第4版及第5版）解读[J]. 诊断学理论与实践, 2023, 22(01): 8-13.

CHEN Guoqun, CAI Jiaodi. Interpretation of the Clinical Practice Guidelines for Non-small Lung Cancer (version 4 and version 5) of 2022 National Comprehensive Cancer Nerwork(NCCN)[J]. Journal of Diagnostics Concepts & Practice, 2023, 22(01): 8-13.

图/表 1

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组别	中位无事件生存期/月	无事件生存率（随访1年）	无事件生存率（随访2年）	病理完全缓解率	主要病理缓解率	3或4级手术相关的不良事件	3或4级治疗相关的不良事件
纳武单抗联合双铂化疗	31.6	76.1%	63.8%	24.0%	36.9%	11.4%	33.5%
双铂化疗	20.8	63.4%	45.3%	2.2%	8.9%	14.8%	36.9%