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HER2 protein overexpression or gene amplification is detected in approximately 20% of breast tumours, is associated with an aggressive phenotype and is predictive of response to trastuzumab therapy. The use of chromogenic in situ hybridisation (CISH) for evaluating HER2 status routinely is recognised in much of Europe but has yet to achieve widespread acceptance in the UK. CISH analysis for HER2 status was performed on 161 breast cancer cases. Results were compared with immunohistochemistry (IHC) and dual-colour fluorescence in situ hybridisation (FISH) data. There was 100% concordance between CISH and FISH, but only 93.8% concordance between CISH and IHC. Performing CISH ‘in-house’ was found to cost approximately 50% less than the FISH/IHC protocol at the reference laboratory. It is concluded that CISH is as accurate as FISH for diagnostic purposes and is more cost-effective than the IHC/FISH regimen currently favoured in the UK.1
Recent data show that amplification of the HER-2 gene is the most reliable predictor of response to trastuzumab therapy,2 indicating that a gene-based assay, rather than a protein overexpression assay, would be the most suitable type of analysis for HER2 status in breast tumour samples.
With the recent change in the licensing of trastuzumab to include its use as an adjuvant therapy (NICE 2006), it is important that patients most likely to benefit from its use are accurately identified. This change in the use of trastuzumab has increased the workload of histopathology laboratories significantly as well as creating an additional financial burden for hospital Trusts. We investigated the possibility of setting up HER2 …