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

Gokhale Sumita, Gatalica Zoran, Mohammad Amin, A. I. Rampy, Gopalrao V.N. Velagaleti

Research output: Contribution to journalArticle

7 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)152-158
Number of pages7
JournalIndian Journal of Cancer
Volume41
Issue number4
StatePublished - Oct 1 2004

Keywords

  • Amplification
  • Breast cancer
  • DCIS
  • FISH
  • HER-2/neu
  • IHC
  • Pathvysion™
  • Validation

ASJC Scopus subject areas

  • Oncology

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    Sumita, G., Zoran, G., Amin, M., Rampy, A. I., & Velagaleti, G. V. N. (2004). FISH for HER-2/neu in breast cancer: Standardization makes the difference! Indian Journal of Cancer, 41(4), 152-158.