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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
Summary
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.
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.