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 ORIGINAL ARTICLE
Year : 2004  |  Volume : 41  |  Issue : 4  |  Page : 152-158

FISH for HER-2/neu in breast cancer: Standardization makes the difference!


1 Department of Pathology, University of Texas Medicine Branch, Glveston, TX, USA
2 Department of Pediatrics, University of Texas Medicine Branch, Glveston, TX, USA

Correspondence Address:
V N Velagaleti Gopalrao
Department of Pediatrics, University of Texas Medicine Branch, Glveston, TX
USA
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Source of Support: None, Conflict of Interest: None


PMID: 15659867

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CONTEXT : Overexpression of HER-2/neu oncogene in breast cancer patients is correlated with disease free survival (DFS) and overall survival (OS). The most commonly used methods for the detection of HER-2/neu status are immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH). However, therse is a lot of controversy with regard to the best method. Most of the FISH studies chose arbitrary cut-off levels for positive results (10%) and had no validation. AIM : In order to address these issues, we designed a pilot study of 38 samples with known IHC status representing all 4 categories. SETTINGS AND DESIGN : FISH was performed using Vysis Pathvysion™ probe. For validation, 5 cases of reduction mammoplasty were analyzed using same protocols. RESULTS : Our results showed significant discordance between FISH and IHC. The rate of discordance was much higher in the 0, 1+, and 2+ categories compared to published literature. This could be due to the lower cut-off rates for positive amplification established by validation in our study (5.7% vs 10%). Our analysis showed that FISH positive and IHC negative patients have a poor prognosis in terms of DFS and OS compared to FISH negative and IHC negative patients. Further, our results also showed that IHC in comparison to FISH has a comparable specificity (98%), but has a very low sensitivity (46%). CONCLUSION : Based on these results, we consider FISH to be the gold standard for detecting HER-2/neu status in breast cancer.






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