Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology.
Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors: guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology.
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DOI：
10.1097/jto.0b013e318290868f
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发表时间：
2013-07
期刊：
影响因子：
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通讯作者：
Ladanyi M
中科院分区：
文献类型：
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作者：
Lindeman NI;Cagle PT;Beasley MB;Chitale DA;Dacic S;Giaccone G;Jenkins RB;Kwiatkowski DJ;Saldivar JS;Squire J;Thunnissen E;Ladanyi M
为指导EGFR和ALK导向治疗所需的肺癌分子分析建立循证建议，解决哪些患者和样本应该进行测试，以及何时和如何进行测试。选出了三位没有利益冲突的联合主席，分别来自三个赞助专业学会：美国病理学家学会、国际肺癌研究协会和分子病理学协会。写作和咨询小组由来自这些协会的其他专家组成。对电子数据库进行了三次无偏见的文献搜索，以获取从2004年1月至2012年2月发表的文章，从中筛选出1533篇文章的摘要，以确定521篇相关文章，然后详细审查这些文章与建议的相关性。对每项建议的证据都进行了正式评级。联合主席和小组成员在一次公开会议上提出了初步建议。每个指南部分被分配给至少两名专家小组成员。草稿在提交(版本4)之前分发给了编写小组(版本1)、咨询小组(版本2)和公众(版本3)。37项准则涉及14个主题，包括15项建议(证据等级A/B)。主要建议是使用EGFR突变和ALK融合检测来指导所有晚期腺癌患者分别选择使用表皮生长因子受体(EGFR)或间变性淋巴瘤激酶(ALK)抑制剂进行治疗，而不考虑性别、种族、吸烟史或其他临床危险因素，并将EGFR和ALK检测优先于其他分子预测测试。随着科学发现和临床实践超过随机临床试验的完成，由专家从业者开发的循证指南对于传达新兴的临床标准至关重要。目前，针对其他不太常见的致癌基因的基因改变的新治疗方法正在对肺癌进行评估，这些测试可能会在这些指南的未来版本中得到解决。
To establish evidence-based recommendations for the molecular analysis of lung cancers that are that are required to guide EGFR- and ALK-directed therapies, addressing which patients and samples should be tested, and when and how testing should be performed. Three cochairs without conflicts of interest were selected, one from each of the 3 sponsoring professional societies: College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. Writing and advisory panels were constituted from additional experts from these societies. Three unbiased literature searches of electronic databases were performed to capture articles published published from January 2004 through February 2012, yielding 1533 articles whose abstracts were screened to identify 521 pertinent articles that were then reviewed in detail for their relevance to the recommendations. Evidence was formally graded for each recommendation. Initial recommendations were formulated by the cochairs and panel members at a public meeting. Each guideline section was assigned to at least 2 panelists. Drafts were circulated to the writing panel (version 1), advisory panel (version 2), and the public (version 3) before submission (version 4). The 37 guideline items address 14 subjects, including 15 recommendations (evidence grade A/B). The major recommendations are to use testing for EGFR mutations and ALK fusions to guide patient selection for therapy with an epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) inhibitor, respectively, in all patients with advanced-stage adenocarcinoma, regardless of sex, race, smoking history, or other clinical risk factors, and to prioritize EGFR and ALK testing over other molecular predictive tests. As scientific discoveries and clinical practice outpace the completion of randomized clinical trials, evidence-based guidelines developed by expert practitioners are vital for communicating emerging clinical standards. Already, new treatments targeting genetic alterations in other, less common driver oncogenes are being evaluated in lung cancer, and testing for these may be addressed in future versions of these guidelines.