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Guideline
. 2004 Mar;57(3):233-7.
doi: 10.1136/jcp.2003.007724.

Best Practice No 176: Updated recommendations for HER2 testing in the UK

I O Ellis  1 , J Bartlett, M Dowsett, S Humphreys, B Jasani, K Miller, S E Pinder, A Rhodes, R Walker
Affiliations
Guideline

Best Practice No 176: Updated recommendations for HER2 testing in the UK

I O Ellis et al. J Clin Pathol. 2004 Mar.

Abstract

This paper serves to update previously published guidance on rationale and methodology for HER2 laboratory testing following the recommendation for the use of HER2 targeted treatment in the management of advanced breast cancer in the UK. Emphasis is placed on the standardisation of methodology and assessment and strategies to achieve high quality performance. A two phase testing algorithm based on first line immunocytochemistry evaluation and second line fluorescence in situ hybridisation assessment of borderline cases is recommended. To ensure maintenance of expertise, an annual caseload volume of at least 250 cases is recommended for laboratories providing a testing service.

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Figures

Figure 1
Figure 1
Updated National Institute for Clinical Excellence (NICE) recommendations for the treatment of metastatic disease by trastuzumab (Herceptin).
Figure 2
Figure 2
Recommended testing algorithm. FISH, fluorescence in situ hybridisation; IHC, immunohistochemistry.
Figure 3
Figure 3
Recommended immunohistochemistry scoring method.
See this image and copyright information in PMC

Comment in

  • Guidelines for HER2 testing in the UK.
    Hsi ED, Tubbs RR. Hsi ED, et al. J Clin Pathol. 2004 Mar;57(3):241-2. doi: 10.1136/jcp.2003.009308. J Clin Pathol. 2004. PMID: 14990591 Free PMC article. No abstract available.

References

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    1. National Institute for Clinical Excellence. Technology Appraisal No. 34. Guidance on the use of trastuzumab for the treatment of advanced breast cancer 2002. (http://www.nice.org.uk/article.asp?a=29280).
    1. Ellis IO, Dowsett M, Bartlett J, et al. Recommendations for HER2 testing in the UK. J Clin Pathol 2000;53:890–2. - PMC - PubMed
    1. Press MF HG, Godolphin W, et al. Sensitivity of HER2/neu antibodies in archival tissue samples: potential source of errors in immunohistochemical studies of oncogene expression. Cancer Res 1994;54:2771–7. - PubMed
    1. Walker R. The significance of histological determination of HER-2 status in breast cancer. Breast 2000;9:130–3. - PubMed

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