ArticleJournal of cancer research and clinical oncology2011
Prospective multi-centre study to validate chromogenic in situ hybridisation for the assessment of HER2 gene amplification in specimens from adjuvant and metastatic breast cancer patients.
Article in Journal of cancer research and clinical oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Who cites it
1 citing paper in PubMed.
- Chromogenic in situ hybridization compared with other approaches to evaluate HER2/neu status in breast carcinomas.Brazilian journal of medical and biological research = Revista brasileira de pesquisas medicas e biologica · 2013Review
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Authors and funding
8 authors.
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No grant is acknowledged in the PubMed record.
Abstract
purposeAs HER2 status is a strong predictor of the response to trastuzumab, clinical guidelines recommend that all breast tumours are first evaluated for HER2 protein expression by immunohistochemistry (IHC) followed by confirmatory testing for HER2 gene amplification using fluorescence in situ hybridisation (FISH) for 2+ cases. Alternatively, chromogenic in situ hybridisation (CISH) offers a simpler, less expensive approach to detect HER2 amplification.
methodsIn this prospective, multi-centre study, based on the largest dataset for HER2 testing in Germany to date, we evaluated the concordance between FISH and CISH in 399 samples from adjuvant and metastatic breast cancer patients. Tumour specimens from routine diagnostic practice were analysed by IHC, FISH and CISH in four reference centres.
resultsFISH and CISH results were strongly concordant (κ = 0.83), with 95% of cases showing agreement. Despite variable IHC scoring across testing centres, complete consensus among the three methods was observed for 246 cases, representing 91% of all IHC positive (3+) or negative (0/1+) cases. Confirmatory testing of 132 IHC equivocal (2+) cases also yielded highly concordant results between FISH and CISH.
conclusionsThese data validate CISH for the assessment of HER2 gene amplification in breast tumours and, confirm CISH as a valid alternative to FISH in HER2 testing.
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