Biomarkers of response to epidermal growth factor receptor inhibitors in non-small-cell lung cancer working group: Standardization for use in the clinical trial setting
Biomarkers of response to epidermal growth factor receptor inhibitors in non-small-cell lung cancer working group: Standardization for use in the clinical trial setting
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DOI：
10.1200/jco.2007.12.9858
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发表时间：
2008-02-20
影响因子：
45.3
通讯作者：
Johnson, Bruce E.
中科院分区：
文献类型：
--
作者：
Eberhard, David A.;Giaccone, Giuseppe;Johnson, Bruce E.
关于表皮生长因子受体（EGFR）抑制剂治疗后分子评估与患者结局之间相关性的文献主体持续增长。在未来，确定如何最有效地将评估治疗益处可能性的分子测定整合到临床实践中将是重要的。尽管EGFR靶向治疗（如厄洛替尼）已被批准在未经分子检测的情况下使用，但免疫组织化学、荧光原位杂交和EGFR基因突变分析都已被提议作为候选药物，以帮助预测非小细胞肺癌（NSCLC）患者EGFR靶向治疗的反应或生存获益。需要从正在进行的随机研究中进行进一步的前瞻性验证，以充分确定哪些检测方法最适合帮助预测患者结局。此外，在广泛的临床应用之前，对这些测定进行标准化将是至关重要的。在Genentech Inc、Roche Pharmaceuticals和OSI Pharmaceuticals，Inc的赞助下，召开了NSCLC分子检测工作组会议，以评价临床试验环境中可用的分子检测，并为未来临床试验中这些检测的应用和解释提供建议。列出了NSCLC分子检测工作组关于EGFR分子检测使用的建议，包括组织储存、处理和加工指南。分子测定标准化的建议也进行了讨论。
The body of literature on the correlations between molecular assessments and patient outcomes after treatment with epidermal growth factor receptor (EGFR) inhibitors continues to grow. It will be important in the future to determine how to most effectively integrate molecular assays that assess the likelihood of therapeutic benefit into clinical practice. Although EGFR-targeted therapies such as erlotinib have been approved for use without molecular testing, immunohistochemistry, fluorescence in situ hybridization, and mutational analyses of the EGFR gene have all been proposed as candidates to help predict response or survival benefit from EGFR-targeted therapy in patients with non-small-cell lung cancer (NSCLC). Further prospective validation from ongoing randomized studies will be needed to fully determine which assays are best to help predict patient outcome. In addition, it will be critical for these assays to undergo standardization before widespread clinical use. The Molecular Assays in NSCLC Working Group, under the sponsorship of Genentech Inc, Roche Pharmaceuticals, and OSI Pharmaceuticals, Inc, was convened to evaluate the available molecular assays for use in the clinical trial setting and provide recommendations for application and interpretation of these tests for future clinical trials. Recommendations of the Molecular Assays in NSCLC Working Group for the use of EGFR molecular assays are presented and include guidelines for tissue storage, handling, and processing. Recommendations for the standardization of molecular assays are also discussed.