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Recommendations for HER2 testing in the UK.

I O Ellis1, M Dowsett, J Bartlett

  • 1Department of Histopathology, City Hospital, Hucknall Road, Nottingham NG5 1PB, UK. ian.ellis@nottingham.ac.uk

Journal of Clinical Pathology
|March 27, 2001
PubMed
Summary
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Accurate HER2 testing is crucial for breast cancer patients receiving trastuzumab treatment. Standardized immunohistochemistry and fluorescence in situ hybridization (FISH) ensure reliable results from archival tissue.

Area of Science:

  • Oncology
  • Pathology
  • Molecular Diagnostics

Background:

  • Trastuzumab (Herceptin) is a key treatment for metastatic breast cancer.
  • Accurate determination of Human Epidermal growth factor Receptor 2 (HER2) status is essential for trastuzumab therapy.
  • Testing requires reliable methods using archival tumor samples.

Purpose of the Study:

  • To establish standardized diagnostic procedures for HER2 testing in breast cancer.
  • To ensure reliable HER2 status determination for guiding trastuzumab treatment decisions.

Main Methods:

  • Recommended immunohistochemistry (IHC) as the primary analysis.
  • Utilized fluorescence in situ hybridization (FISH) for ambiguous IHC results.
  • Developed guidelines for standardized, quality-controlled testing procedures.

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Main Results:

  • Established preferred diagnostic pathway: IHC followed by FISH for equivocal cases.
  • Implemented standardized procedures to ensure reliable HER2 status determination.
  • Created a network of reference laboratories for quality assurance and support.

Conclusions:

  • Standardized HER2 testing is a prerequisite for effective trastuzumab treatment in breast cancer.
  • The combination of IHC and FISH provides reliable HER2 status assessment.
  • Reference laboratories play a vital role in maintaining testing quality and providing expertise.