Department of Pathology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Mod Pathol. 2011 Jun;24(6):794-800. doi: 10.1038/modpathol.2011.9. Epub 2011 Feb 11.
Amplification of the human epidermal growth factor receptor 2 (HER2) gene occurs in 20-25% of breast cancers, and is recognized as a prognostic and predictive marker. HER2 gene amplification, evaluated as a change in protein expression or gene copy number, can be identified by a number of methods. Fluorescence in situ hybridization (FISH) is considered the gold standard for HER2 gene copy number determination; however, a number of impediments prevent its wider use in a clinical setting. The aims of our study were to compare dual-color silver-enhanced in situ hybridization (SISH) with single-color SISH and FISH on formalin-fixed, paraffin-embedded sections, and to validate its use as a routine method for assessing HER2 status in breast cancers. A total of 146 invasive breast carcinoma cases were assessed for HER2 gene amplification by FISH and dual-color SISH. Dual-color SISH and FISH results exhibited a concordance rate of 97% (κ=0.912). A comparison of the single-color SISH method with dual-color SISH showed that 142 of 146 cases were in agreement (97%, κ=0.930). Our results showed that dual-color SISH is a viable alternative to FISH that offers a number of advantages in a clinical setting.
人类表皮生长因子受体 2 (HER2) 基因扩增发生在 20-25%的乳腺癌中，被认为是一种预后和预测标志物。HER2 基因扩增可通过多种方法评估，如蛋白表达或基因拷贝数的变化。荧光原位杂交 (FISH) 被认为是 HER2 基因拷贝数测定的金标准；然而，一些障碍阻止了它在临床环境中的更广泛应用。我们的研究旨在比较双染银增强原位杂交 (SISH) 与单染 SISH 和 FISH 在福尔马林固定、石蜡包埋切片上的应用，并验证其作为评估乳腺癌 HER2 状态的常规方法的有效性。对 146 例浸润性乳腺癌病例进行了 FISH 和双染 SISH 检测 HER2 基因扩增。双染 SISH 和 FISH 的结果显示出 97%的一致性（κ=0.912）。单染 SISH 方法与双染 SISH 的比较表明，146 例中有 142 例结果一致（97%，κ=0.930）。我们的研究结果表明，双染 SISH 是 FISH 的一种可行替代方法，在临床环境中具有许多优势。
