Context: In 2013, an evidence‐based guideline was published by the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology to set standards for the molecular analysis of lung cancers to guide treatment decisions with targeted inhibitors. New evidence has prompted an evaluation of additional laboratory technologies, targetable genes, patient populations, and tumor types for testing. Objective: To systematically review and update the 2013 guideline to affirm its validity; to assess the evidence of new genetic discoveries, technologies, and therapies; and to issue an evidence‐based update. Design: The College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology convened an expert panel to develop an evidence‐based guideline to help define the key questions and literature search terms, review abstracts and full articles, and draft recommendations. Results: Eighteen new recommendations were drafted. The panel also updated 3 recommendations from the 2013 guideline. Conclusions: The 2013 guideline was largely reaffirmed with updated recommendations to allow testing of cytology samples, require improved assay sensitivity, and recommend against the use of immunohistochemistry for EGFR testing. Key new recommendations include ROS1 testing for all adenocarcinoma patients; the inclusion of additional genes (ERBB2, MET, BRAF, KRAS, and RET) for laboratories that perform next‐generation sequencing panels; immunohistochemistry as an alternative to fluorescence in situ hybridization for ALK and/or ROS1 testing; use of 5% sensitivity assays for EGFR T790M mutations in patients with secondary resistance to EGFR inhibitors; and the use of cell‐free DNA to “rule in” targetable mutations when tissue is limited or hard to obtain.

中文翻译：

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选择肺癌患者接受靶向酪氨酸激酶抑制剂治疗的最新分子检测指南


背景：2013 年，美国病理学家学会、国际肺癌研究协会和分子病理学协会发布了一项循证指南，为肺癌的分子分析制定标准，以指导治疗决策靶向抑制剂。新的证据促使对额外的实验室技术、可靶向基因、患者群体和用于测试的肿瘤类型进行评估。目的：系统回顾和更新2013年指南，以确认其有效性；评估新的基因发现、技术和疗法的证据；并发布基于证据的更新。设计：美国病理学家学会、国际肺癌研究协会和分子病理学协会召集了一个专家小组，制定循证指南，帮助定义关键问题和文献检索术语，审查摘要和完整内容文章和建议草案。结果：起草了十八项新建议。该小组还更新了 2013 年指南中的 3 项建议。结论：2013 年指南在很大程度上得到了重申，并更新了建议，允许对细胞学样本进行检测，要求提高检测灵敏度，并建议反对使用免疫组织化学进行 EGFR 检测。 主要的新建议包括对所有腺癌患者进行 ROS1 检测；为执行下一代测序面板的实验室纳入额外的基因（ERBB2、MET、BRAF、KRAS 和 RET）；免疫组织化学作为 ALK 和/或 ROS1 检测荧光原位杂交的替代方法；对 EGFR 抑制剂继发耐药的患者使用 5% 敏感性测定法检测 EGFR T790M 突变；当组织有限或难以获得时，使用无细胞 DNA 来“控制”可靶向突变。