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Related Experiment Video

Updated: Nov 9, 2025

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
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Performance of a HER2 testing algorithm specific for p53-abnormal endometrial cancer.

Lisa Vermij1, Naveena Singh2, Alicia Leon-Castillo1

  • 1Department of Pathology, Leiden University Medical Center, Leiden, the Netherlands.

Histopathology
|April 9, 2021
PubMed
Summary

A new, reproducible HER2 immunohistochemistry (IHC) scoring method for endometrial cancer (EC) improves HER2 testing accuracy. This approach ensures reliable identification of HER2-positive EC, crucial for targeted therapies.

Keywords:
HER2endometrial cancerimmunohistochemistryin-situ hybridisationinterobserver variability

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Area of Science:

  • Oncology
  • Pathology
  • Molecular Diagnostics

Background:

  • HER2 amplification is primarily found in p53-abnormal endometrial cancer (EC).
  • Accurate HER2 testing is vital for guiding treatment in EC, but optimal methods are lacking.
  • Current HER2 testing strategies may not be sufficiently tailored for the p53-abnormal EC subtype.

Purpose of the Study:

  • To develop and validate an EC-specific HER2 immunohistochemistry (IHC) scoring method.
  • To evaluate the reproducibility of the novel IHC scoring criteria.
  • To establish an optimal diagnostic algorithm for HER2 testing in p53-abnormal EC.

Main Methods:

  • Developed and applied EC-specific HER2 IHC scoring criteria to 78 p53-abnormal EC cases.
  • Assessed interobserver agreement among six gynaecopathologists using Fleiss' kappa and AC1.
  • Compared IHC results with HER2 dual in-situ hybridisation (DISH) and calculated sensitivity and specificity.

Main Results:

  • Substantial interobserver agreement was achieved with both three-tiered (κ=0.675, AC1=0.723) and two-tiered (κ=0.771, AC1=0.774) scoring systems.
  • A HER2 testing algorithm recommending DISH for cases with moderate membranous staining (>10% tumor) achieved 100% sensitivity and 97% specificity.
  • Performing DISH on all IHC-2+ and -3+ cases resulted in 100% sensitivity and specificity for identifying HER2-positive EC.

Conclusions:

  • The developed EC-specific HER2 IHC scoring method is reproducible and reliable.
  • An integrated HER2 testing strategy combining IHC screening with DISH confirmation offers perfect accuracy for identifying HER2-positive EC.
  • This approach provides an optimal diagnostic algorithm for HER2 testing in p53-abnormal endometrial cancer.