Evaluation of HER-2/neu gene amplification and overexpression:: Comparison of frequently used assay methods in a molecularly characterized cohort of breast cancer specimens
Evaluation of HER-2/neu gene amplification and overexpression:: Comparison of frequently used assay methods in a molecularly characterized cohort of breast cancer specimens
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DOI：
10.1200/jco.2002.09.094
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发表时间：
2002-07-15
影响因子：
45.3
通讯作者：
Bernstein, L
中科院分区：
文献类型：
--
作者：
Press, MF;Slamon, DJ;Bernstein, L
目的：比较和评价HER-2/neu基因扩增和过表达的临床检测方法。材料与方法：对117例HER-2/neu扩增和过表达的乳腺癌标本进行4种不同的免疫组织化学分析和2种不同的荧光原位杂交(FISH)检测。结果：FISH法检测HER-2/neu基因扩增的准确率较高，Vosition PathVision法(Vosis，Inc.，Dners Grove，IL)和Ventana Informance(Ventana，Medical Systems，Inc.，Tucson，AZ)的准确率分别为97.4%和95.7%。免疫组织化学检测HER-2/neu过表达的准确率最高的是R60多克隆抗体(96.6%)，其次是10H8单抗(95.7%)、Ventana CB 11单抗(89.7%)和DAKO Herceptest(88.9%)。只有DACKO Herceptest和Ventana CB11免疫组织化学检测的灵敏度和总体准确性与更敏感的FISH检测有显著差异。结论：基于这些发现，FISH检测具有很高的准确性，而免疫组织化学R60和10H8检测的准确性与FISH检测几乎相同。在评估这些先前具有分子特征的乳腺癌标本方面，DAKO HercepTest和Ventana CB11免疫组织化学分析方法在评估这些先前具有分子特征的乳腺癌标本方面与VESIC FISH方法有显著不同。(C)2002年，由美国临床肿瘤学会提供。
Purpose: To compare and evaluate HER-2/neu clinical assay methods.Materials and Methods: One hundred seventeen breast cancer specimens with known HER-2/neu amplification and overexpression status were assayed with four different immunohistochemical assays and two different fluorescence in situ hybridization (FISH) assays.Results: The accuracy of the FISH assays for HER-2/neu gene amplification was high, 97.4% for the Vysis PathVision assay (Vysis, Inc, Downers Grove, IL) and 95.7% for the the Ventana INFORM assay (Ventana, Medical Systems, Inc, Tucson, AZ). The immunohistochemical assay with the highest accuracy for HER-2/neu overexpression was obtained with R60 polyclonal antibody (96.6%), followed by immunohistochemical assays performed with 10H8 monoclonal antibody (95.7%), the Ventana CB 11 monoclonal antibody (89.7%), and the DAKO HercepTest (88.9%; Dako, Corp, Carpinteria, CA). Only the sensitivities, and therefore, overall accuracy, of the DAKO Herceptest and Ventana CB11 immunohistochemical assays were significantly different from the more sensitive FISH assay.Conclusion: Based on these findings, the FISH assays were highly accurate, with immunohistochemical assays performed with R60 and 10H8 nearly as accurate. The DAKO HercepTest and the Ventana CB11 immunohistochemical assay were statistically significantly different from the Vysis FISH assay in evaluating these previously molecularly characterized breast cancer specimens. (C) 2002 by American Society of Clinical Oncology.