Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology
Updated Molecular Testing Guideline for the Selection of Lung Cancer Patients for Treatment With Targeted Tyrosine Kinase Inhibitors Guideline From the College of American Pathologists, the International Association for the Study of Lung Cancer, and the Association for Molecular Pathology
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DOI：
10.5858/arpa.2017-0388-cp
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发表时间：
2018-03-01
影响因子：
4.1
通讯作者：
Yatabe, Yasushi
中科院分区：
文献类型：
--
作者：
Lindeman, Neat I.;Cagle, Philip T.;Yatabe, Yasushi
内容：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份循证指南，为肺癌的分子分析制定标准，以指导靶向抑制剂的治疗决策。新的证据促使人们对更多的实验室技术、靶向基因、患者人群和肿瘤类型进行评估。目的：系统地回顾和更新2013年指南，以确认其有效性;评估新的遗传发现、技术和疗法的证据;并发布循证更新。设计：美国病理学家学院、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，制定了一项循证指南，以帮助定义关键问题和文献检索词，结果：共起草了18条新的建议。该小组还更新了3建议从2013 guideline.Conclusions：2013年的指南在很大程度上重申了更新的建议，允许检测细胞学样本，需要提高检测灵敏度，并建议对使用免疫组化EGFR检测。关键的新建议包括对所有腺癌患者进行ROS 1检测;（ERBB 2、MET、BRAF、KRAS和RET），适用于执行下一代测序组的实验室;免疫组织化学作为荧光原位杂交的替代方法，用于ALK和/或ROS 1检测;在EGFR抑制剂继发性耐药患者中使用5%灵敏度试验检测EGFR T790 M突变;以及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。
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.