Cuadros Marta, Villegas Román
Andalusian Agency for Health Technology Assessment, The Emerging Technologies' Observatory, Sevilla, Spain.
Appl Immunohistochem Mol Morphol. 2009 Jan;17(1):1-7. doi: 10.1097/PAI.0b013e318169fc1c.
HER2 status is of great clinical value in breast tumors for the identification of those patients who are eligible for trastuzumab therapy. There is a debate about the advantages and disadvantages of immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH) and where, when, how, and who would perform HER2 testing. The purpose of this study was to analyze clinical and analytic validity and clinical utility for HER2 testing (IHC and FISH) for the appropriate selection of breast cancer patients who were suitable for trastuzumab therapy. A systematic review of the literature was carried out using online databases (MedLine, Embase, Centre for Reviews and Dissemination and the Cochrane Library). It brings up to date the cost-effectiveness analysis published by Technology Assessment Unit of the McGill University Health Centre (MUHC). The articles that were selected according to the following inclusion criteria: (1) included breast cancer patients, (2) used IHC and FISH assays, (3) reported the sensibility, specificity, reliability of IHC and FISH, or concordance between both techniques, and (4) were published in any language. A critical appraisal was performed using an ad hoc scale based on CASPe (Critical Appraisal Skills Programme Spanish) criteria. Literature search generated 17 studies that satisfied the inclusion criteria. Most articles evaluated the HercepTest and PathVysion assays. FISH was considered the gold standard test. We calculated the FISH positivity rate in each IHC score category. The percentage of FISH positive results (median) was estimated as 3.5 for IHC0, 5.8 for IHC1+, 17 for IHC2+, and 83.5 for IHC3+. Our findings have shown high concordance rates between IHC and FISH in tumors IHC0 and IHC1+, and discordance rates among cases with IHC2+ and IHC3+. In these cases, FISH is considered gold standard for confirming or excluding HER2 amplification.
HER2状态在乳腺肿瘤中具有重要的临床价值，可用于识别那些适合接受曲妥珠单抗治疗的患者。关于免疫组织化学（IHC）和荧光原位杂交（FISH）的优缺点以及谁、何时、如何进行HER2检测存在争议。本研究的目的是分析HER2检测（IHC和FISH）的临床和分析有效性以及临床实用性，以便为适合曲妥珠单抗治疗的乳腺癌患者做出恰当选择。我们使用在线数据库（MedLine、Embase、循证医学图书馆和考克兰图书馆）对文献进行了系统综述。它更新了麦吉尔大学健康中心（MUHC）技术评估部门发表的成本效益分析。根据以下纳入标准选择文章：（1）纳入乳腺癌患者；（2）使用IHC和FISH检测；（3）报告IHC和FISH的敏感性、特异性、可靠性或两种技术之间的一致性；（4）以任何语言发表。我们使用基于CASPe（西班牙批判性评估技能计划）标准的专门量表进行了批判性评估。文献检索产生了17项符合纳入标准的研究。大多数文章评估了HercepTest和PathVysion检测。FISH被认为是金标准检测。我们计算了每个IHC评分类别中的FISH阳性率。IHC0的FISH阳性结果百分比（中位数）估计为3.5%，IHC1+为5.8%，IHC2+为17%，IHC3+为83.5%。我们的研究结果表明，在IHC0和IHC1+的肿瘤中，IHC和FISH之间的一致性率较高，而在IHC2+和IHC3+的病例中存在不一致率。在这些情况下，FISH被认为是确认或排除HER2扩增的金标准。
