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Current use of HER2 tests.

G Schaller1, K Evers, S Papadopoulos

  • 1Frauenklinik, Universitätsklinikum Benjamin Franklin, Berlin, Germany. schaller@ukbf.fu-berlin.de

Annals of Oncology : Official Journal of the European Society for Medical Oncology
|August 28, 2001
PubMed
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Accurate HER2 detection is crucial for trastuzumab therapy. Combining immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) improves HER2 assay reliability, enhancing patient selection for effective treatment.

Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Biomarker Analysis

Background:

  • Human Epidermal growth factor Receptor 2 (HER2) overexpression is a key predictor for trastuzumab (Herceptin) efficacy in cancer therapy.
  • Accurate measurement of HER2 expression is vital for patient stratification and treatment success.

Purpose of the Study:

  • To evaluate various methods for detecting HER2 overexpression.
  • To determine the optimal diagnostic approach for selecting patients for trastuzumab therapy.

Main Methods:

  • Immunohistochemistry (IHC) for HER2 protein detection in paraffin sections.
  • Fluorescence in situ hybridization (FISH) for HER2 gene amplification analysis.
  • Enzyme-linked immunosorbent assay (ELISA) for quantifying shed HER2 antigen in serum.

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Main Results:

  • IHC offers precise protein localization but is subject to assessment variability.
  • FISH provides objective gene amplification data but requires specialized equipment.
  • Serum HER2 levels via ELISA are easily obtained but do not reliably reflect tumor HER2 status.

Conclusions:

  • A combination of IHC and FISH offers improved accuracy and comparability for HER2 assays.
  • Optimized HER2 testing protocols can enhance trastuzumab therapy efficacy by better selecting responsive patients.