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HER2 assessment in urothelial carcinoma: standardization challenges and the path forward
Peipei Xie1, Yajie Wang1, Lei Lu2
1Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute, Beijing, 100142, China.
Abstract:
Human epidermal growth factor receptor 2 (HER2) is a crucial oncogenic factor, highly expressing in various cancers, with urothelial carcinoma (UC) showing one of the highest levels of HER2 overexpression. HER2 serves as an ideal therapeutic target in UC. Current HER2-targeted therapies primarily include tyrosine kinase inhibitors, monoclonal antibodies, and antibody-drug conjugates (ADCs). Among these, ADCs combined with immunotherapy have shown outstanding clinical potential, which have changed the treatment landscape in UC. However, the assessment of HER2 status in UC is still facing major challenges. There is no unified consensus on testing methods and the definition of HER2 positivity, accompanied by significant spatiotemporal expression heterogeneity. These challenges significantly making HER2 assessment difficult in UC, hindering the more precise clinical application of HER2-targeted therapies especially ADCs. In this review, we focus on analyzing the current challenges in standardizing HER2 detection and positivity definitions in UC, elaborating on the spatiotemporal heterogeneity of HER2 expression, and systematically summarizing new HER2 testing methods. It is aimed to provide theoretical insights and new perspectives for HER2 testing and assessment in UC. In order to adress the challenges in HER2 assessment in UC, future researches should concentrate on establishing a unified standard for UC-specific HER2 assessment algorithm, and exploring new HER2 testing methods tailored to clinical needs.
Insights
Human epidermal growth factor receptor 2 (HER2) is a key target in urothelial carcinoma (UC). Challenges in HER2 testing and defining positivity hinder effective treatment, especially with antibody-drug conjugates (ADCs).
Area of Science:
- Oncology
- Molecular Biology
- Diagnostic Pathology
Background:
- Human epidermal growth factor receptor 2 (HER2) is highly overexpressed in urothelial carcinoma (UC), making it a critical therapeutic target.
- Current HER2-targeted therapies, including antibody-drug conjugates (ADCs), show significant clinical potential in UC treatment.
Purpose of the Study:
- To analyze current challenges in standardizing HER2 detection and positivity definitions in UC.
- To elaborate on the spatiotemporal heterogeneity of HER2 expression.
- To systematically summarize novel HER2 testing methods for UC.
Main Methods:
- Review of current HER2 testing methodologies in urothelial carcinoma.
- Analysis of HER2 expression heterogeneity across different time points and locations within tumors.
- Systematic summary of emerging HER2 detection techniques.
Main Results:
- Significant challenges exist in standardizing HER2 assessment due to lack of consensus on testing methods and positivity definitions.
- Spatiotemporal heterogeneity of HER2 expression complicates accurate diagnosis and treatment selection.
- Existing assessment methods hinder precise clinical application of HER2-targeted therapies, particularly ADCs.
Conclusions:
- Establishing a unified standard for HER2 assessment algorithms specific to UC is crucial.
- Development of new HER2 testing methods tailored to clinical needs is essential for advancing targeted therapies in UC.
- Addressing assessment challenges will improve the efficacy of HER2-targeted treatments like ADCs in urothelial carcinoma.
