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Updated: Feb 26, 2026
Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells
Published on: May 9, 2025
The Rapidly Evolving Landscape of Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Endometrial Carcinoma
Context.—:
Trastuzumab in combination with standard chemotherapy has been included in the guideline recommendations for human epidermal growth factor receptor 2 (HER2)-positive advanced-stage and recurrent endometrial carcinomas since 2019. A novel antibody drug conjugate, trastuzumab deruxtecan, gained tumor agnostic approval for HER2-positive metastatic solid tumors, including endometrial, ovarian, and cervical cancer, in 2024.
Objective.—:
To provide a detailed overview of HER2 protein expression, gene amplification, and mutation in gynecologic malignancies in light of the newly available anti-HER2 therapies. Tumor-specific HER2 testing and scoring algorithms are discussed, including the implications of the DESTINY-PanTumor02 trial results and the significance of the HER2-low tumor category.
Data Sources.—:
Review of the literature and personal experience of the author.
Conclusions.—:
The clinical indications and demand for HER2 testing in gynecologic malignancies beyond endometrial cancer are expanding. It is essential for practicing pathologists to stay up to date on the latest clinical developments and use evidence-based HER2 testing and scoring criteria.
Insights
Human epidermal growth factor receptor 2 (HER2) targeted therapies are advancing in gynecologic cancers. Updated testing and scoring are crucial for effective treatment selection in endometrial, ovarian, and cervical cancers.
Area of Science:
- Gynecologic Oncology
- Molecular Pathology
- Oncology Therapeutics
Background:
- Human epidermal growth factor receptor 2 (HER2) targeted therapies, including trastuzumab, are established for advanced-stage and recurrent HER2-positive endometrial cancer since 2019.
- Trastuzumab deruxtecan, a novel antibody drug conjugate, received tumor-agnostic approval in 2024 for HER2-positive metastatic solid tumors, encompassing endometrial, ovarian, and cervical cancers.
Purpose of the Study:
- To comprehensively review HER2 protein expression, gene amplification, and mutation in gynecologic malignancies.
- To discuss tumor-specific HER2 testing and scoring algorithms in the context of new anti-HER2 therapies.
- To highlight the impact of the DESTINY-PanTumor02 trial and the emerging significance of the HER2-low tumor category.
Main Methods:
- Literature review
- Analysis of author's personal experience
- Discussion of clinical trial data (DESTINY-PanTumor02)
Main Results:
- Clinical indications for HER2 testing in gynecologic malignancies are expanding beyond endometrial cancer.
- The DESTINY-PanTumor02 trial provides crucial data on anti-HER2 therapies in diverse tumor types.
- The HER2-low tumor category represents a new frontier in HER2-targeted treatment strategies.
Conclusions:
- Pathologists must remain updated on evolving anti-HER2 therapies and their clinical implications.
- Evidence-based HER2 testing and scoring criteria are essential for accurate patient stratification.
- The expanding use of HER2-targeted agents necessitates refined diagnostic approaches in gynecologic oncology.
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