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Updated: Jul 11, 2026
Optimization of a Multiplex RNA-based Expression Assay Using Breast Cancer Archival Material
Published on: August 1, 2018
Analysis of surrogate markers for target-specific therapy in breast carcinomas using archival materials
Hironobu Sasano1, Takashi Suzuki, Takuya Moriya
1Department of Pathology, Tohoku University School of Medicine and Tohoku University Hospital, 2-1 Seiryou-machi, Sendai 980-8575, Japan. hsasano@patholo2.med.tohoku.ac.jp
Abstract:
Recent development of target-specific therapy may have the potential to revolutionize cancer therapy. Target-specific therapy such as trastuzumab or imatinib requires the presence of its specific target in cancer cells. Therefore, it has become very important to identify these targets as a surrogate marker such as HER2/neu for trastuzumab in breast cancer or c-kit for imatinib in gastrointesitinal stromal tumor for these treatments to exert maximum clinical benefits on the patients with these malignancies. Archival or 10% formalin-fixed and paraffin-embedded materials could be the most accessible materials available for examining these surrogate markers for therapy, especially in patients with breast carcinoma. In addition, correlation of the findings with histological features that are pivotal in an evaluation of the findings obtained and retrospective analysis are both possible in these analyses. Immunohistochemistry or FISH for HER2/neu have been widely performed in numerous institutions and provide the gold standard for the treatment of trastuzumab in patients with breast carcinoma. In addition, an analysis of potential surrogate markers at DNA, mRNA and protein levels has become possible using archival materials of human breast carcinoma. However, it is very important to make these analyses widely available or possible to perform in any of the regular diagnostic laboratories without technical difficulties and financial burden on the patients. In addition, it is necessary to standardize the following when using surgical pathology materials for the analysis of these markers, especially in terms of quality control or reproducibility of the results obtained by the analysis: (1) fixation or specimens preparation, (2) methodology to be used and (3) interpretation and/or assessment of the findings.
Insights
Identifying cancer therapy targets like HER2/neu is crucial for effective treatment. Standardizing analysis of archival tissue samples ensures reliable results for personalized medicine, benefiting patients with breast carcinoma.
Area of Science:
- Oncology
- Molecular Pathology
- Cancer Biomarkers
Background:
- Target-specific cancer therapies, such as trastuzumab and imatinib, require identification of specific molecular targets (e.g., HER2/neu, c-kit) in tumor cells.
- Archival formalin-fixed, paraffin-embedded (FFPE) tissues are valuable resources for examining these surrogate markers, particularly in breast carcinoma.
- Retrospective analysis allows correlation of marker status with histological features for comprehensive evaluation.
Purpose of the Study:
- To highlight the importance of identifying surrogate markers for target-specific cancer therapies.
- To emphasize the utility of archival FFPE tissues for biomarker analysis in breast cancer.
- To underscore the need for standardization in analyzing biomarkers from surgical pathology specimens.
Main Methods:
- Utilizing archival FFPE materials for analysis of potential surrogate markers at DNA, mRNA, and protein levels.
- Performing immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) for HER2/neu in breast carcinoma.
- Correlating biomarker findings with histological features through retrospective analysis.
Main Results:
- Archival FFPE tissues are accessible for examining surrogate markers crucial for targeted therapies.
- IHC and FISH for HER2/neu are established methods for guiding trastuzumab treatment in breast cancer.
- Analysis of biomarkers at multiple molecular levels (DNA, mRNA, protein) is feasible using archival samples.
Conclusions:
- Accurate identification of surrogate markers is essential for maximizing the clinical benefit of target-specific cancer therapies.
- Standardization of fixation, preparation, methodology, and interpretation is critical for reproducible biomarker analysis in routine diagnostics.
- Making these analyses widely accessible in diagnostic laboratories without technical or financial barriers is necessary for broader patient benefit.
