Department of Molecular Pathology, Pathology and Laboratory Medicine Institute, Cleveland Clinic, Lerner College of Medicine, Cleveland, Ohio 44195, USA.
J Clin Pathol. 2010 Mar;63(3):210-9. doi: 10.1136/jcp.2009.062760.
Assessment of ERBB2 (HER2) status in breast carcinomas has become critical in determining response to the humanised monoclonal antibody trastuzumab. The current joint College of American Pathologists and the American Society of Clinical Oncology guidelines for the evaluation of HER2 status in breast carcinoma involve testing by immunohistochemistry and fluorescence in situ hybridisation (FISH). However, neither of these modalities is without limitations. Novel bright field in situ hybridisation techniques continue to provide viable alternatives to FISH testing. While these techniques are not limited to evaluation of the HER2 gene, the extensive number of studies comparing bright field in situ techniques with other methods of assessing HER2 status allow a robust evaluation of this approach. Analysis of the literature demonstrates that, when used to assess HER2 gene status, bright field in situ hybridisation demonstrates excellent concordance with FISH results. The average percentage agreement in an informal analysis of studies comparing HER2 amplification by chromogenic in situ hybridisation with FISH was 96% (SD 4%); kappa coefficients ranged from 0.76 to 1.0. Although a much smaller number of studies are available for review, similar levels of concordance have been reported in studies comparing HER2 amplification by methods employing metallography (silver in situ hybridisation) with FISH. A summary of the advancements in bright field in situ hybridisation, with focus on those techniques with clinical applications of interest to the practicing pathologist, is presented.
评估乳腺癌中的 ERBB2（HER2）状态对于确定针对人源化单克隆抗体曲妥珠单抗的反应至关重要。目前，美国病理学家学会和美国临床肿瘤学会联合制定的评估乳腺癌中 HER2 状态的指南涉及免疫组织化学和荧光原位杂交（FISH）检测。然而，这两种方法都有其局限性。新型亮场原位杂交技术继续为 FISH 检测提供可行的替代方法。虽然这些技术不限于评估 HER2 基因，但大量比较亮场原位技术与其他 HER2 状态评估方法的研究允许对这种方法进行稳健的评估。文献分析表明，当用于评估 HER2 基因状态时，亮场原位杂交与 FISH 结果具有极好的一致性。在比较显色原位杂交与 FISH 检测 HER2 扩增的研究中，非正式分析的平均百分比一致性为 96%（SD 4%）；kappa 系数范围从 0.76 到 1.0。虽然可用于审查的研究数量要少得多，但在比较采用金属学（银原位杂交）方法与 FISH 检测 HER2 扩增的研究中，也报告了类似水平的一致性。本文总结了亮场原位杂交的进展，重点介绍了对从事病理工作的临床医生有应用价值的技术。
