Testing HER2 in Breast Cancer A Comparative Study on BRISH, FISH, and IHC
Testing HER2 in Breast Cancer A Comparative Study on BRISH, FISH, and IHC
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DOI：
10.1097/pai.0b013e3181f7118e
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发表时间：
2011-05-01
影响因子：
1.6
通讯作者：
Jensen, Vibeke
中科院分区：
文献类型：
--
作者：
Bruegmann, Anja;Lelkaitis, Giedrius;Jensen, Vibeke
新的明场原位杂交（BRISH）方法的基础上共杂交的探针的HER 2基因和染色体17着丝粒已经开发，并提供了一个有前途的替代荧光原位杂交（FISH）。本相关性研究的目的是测试HER 2状态在原发性乳腺癌与2 BRISH方法，FISH，和2免疫组化检测使用组织芯片technology.Materials和方法：组织核心（1.5毫米）收集218个连续的，档案福尔马林固定石蜡包埋的原发性乳腺癌成4个重复的组织芯片。采用DuoCISH（Dako）、Dual ISH（Ventana）、HER-2 pharmDxFISH（Dako）、HercepTest（Dako）和PATHWAY（4 B5; Ventana）5种研究方法成功制备了201例患者的肿瘤组织样本。DuoCISH与FISH具有相当高的阳性一致性（灵敏度为96%），但特异性较低，为93%，与FISH的总体一致性为93%。两种免疫组织化学方法与FISH之间的总体一致性几乎完美（Dako HercepTest 97%和Ventana PATHWAY（4 B5）98%）。关于特异性，2种方法执行相同（99.4%）。结论：BRISH方法提供了一种替代FISH在评估原发性乳腺癌的HER 2/CEN 17比率。双重ISH显示出与FISH几乎完美的一致性，并且是一种对所有乳腺癌进行现实的快速跟踪方法。BRISH提供了一个永久性的结果，使该方法有资格用于内部和外部质量保证。
New brightfield in-situ hybridization (BRISH) methods based on the cohybridization of probes to the HER2 gene and chromosome 17 centromere have been developed and provide a promising alternative to fluorescence in-situ hybridization (FISH). The aim of this correlation study was to test HER2 status in primary breast carcinomas with 2 BRISH methods, FISH, and 2 immunohistochemical assays using tissue microarray technology.Materials and Methods: Tissue cores (1.5mm) were collected from 218 consecutive, archival formalin-fixed paraffin-embedded primary breast carcinomas into 4 duplicate tissue microarrays. Tumor tissue samples from 201 patients were successfully prepared in all 5 investigated methods comprising DuoCISH (Dako), Dual ISH (Ventana), HER-2 pharmDxFISH (Dako), HercepTest (Dako), and PATHWAY (4B5; Ventana).Results: In this study the overall agreement between Dual ISH and FISH was 98.5% with a specificity of 99% and a sensitivity of 96%. DuoCISH had an equivalent high-positive agreement with FISH (sensitivity of 96%), but a lower specificity of 93% and an overall agreement of 93% with FISH. The overall agreement between the 2 immunohistochemical methods and FISH was almost perfect (Dako HercepTest 97% and Ventana PATHWAY (4B5) 98%). With regard to specificity the 2 methods performed equally (99.4%).Conclusions: BRISH methods provide an alternative to FISH in evaluating HER2/CEN17 ratio in primary breast carcinomas. Dual ISH showed an almost perfect agreement with FISH and is a fast track method realistic to perform on all breast carcinomas. BRISH provide a permanent result that makes the method eligible for use in internal and external quality assurance.