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Updated: Sep 7, 2025

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
Mind the target: human epidermal growth factor receptor 2 in colorectal cancer
Rita Saúde-Conde1, Gertjan Rasschaert1,2, Giacomo Bregni1,3
1Gastrointestinal Unit - Department of Medical Oncology, Institut Jules Bordet.
Purpose Of Review:
In this article, we briefly summarise the current knowledge about human epidermal growth factor receptor 2 (HER2) alterations in colorectal cancer (CRC) and provide an overview of the latest published evidence especially regarding standardisation of detection methods/diagnostic criteria, prognostication, prediction and targeted treatments.
Recent Findings:
Over the last 18 months, the results of many studies have been presented confirming the therapeutic potential of established anti-HER2 agents either as a monotherapy or in combination, as well as new anti-HER2 agents like antibody-drug-conjugates and tyrosine kinase inhibitors. Also, we have seen confirmation of the utility of liquid biopsy and ctDNA analyses as tool for HER2 detection and patient selection.
Summary:
Despite concerning only 5% of metastatic CRC, HER2 represents a valuable target for emerging anti-HER2 therapies that might significantly improve the outcome of these patients. Standardising HER2 detection methods/diagnostic criteria, and producing high-quality, randomised evidence are the next challenges to meet the standards of regulatory authorities and ultimately have anti-HER2 agents available for use in routine practice.
Insights
Human epidermal growth factor receptor 2 (HER2) alterations are a targetable vulnerability in 5% of metastatic colorectal cancer (CRC) patients. Emerging anti-HER2 therapies show promise, with liquid biopsies aiding patient selection.
Area of Science:
- Oncology
- Molecular Diagnostics
- Pharmacology
Background:
- Colorectal cancer (CRC) is a significant global health concern.
- Human epidermal growth factor receptor 2 (HER2) alterations occur in approximately 5% of metastatic CRC cases.
- HER2 status impacts treatment strategies and patient outcomes.
Purpose of the Study:
- To summarize current knowledge on HER2 alterations in CRC.
- To review recent evidence on HER2 detection, prognostication, and targeted treatments.
- To highlight challenges in standardizing HER2 diagnostics for clinical practice.
Main Methods:
- Literature review of recent studies on HER2 in CRC.
- Analysis of evidence regarding anti-HER2 therapies (monotherapy, combination, antibody-drug conjugates, tyrosine kinase inhibitors).
- Evaluation of liquid biopsy and ctDNA analyses for HER2 detection and patient selection.
Main Results:
- Established and novel anti-HER2 agents demonstrate therapeutic potential in CRC.
- Liquid biopsy and ctDNA analysis are confirmed as valuable tools for HER2 detection and patient selection.
- Standardization of HER2 detection methods and diagnostic criteria is crucial.
Conclusions:
- Targeting HER2 in CRC, despite its rarity, offers significant therapeutic opportunities.
- Further high-quality, randomized evidence is needed to support regulatory approval and routine clinical use of anti-HER2 agents.
- Standardization of diagnostic approaches is a key challenge for advancing HER2-targeted therapy in CRC.
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