American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer.

By Antonio C. Wolff, M. Hammond, Jared N. Schwartz, K. Hagerty, D. Allred, Richard J. Cote, Mitchell Dowsett, P. Fitzgibbons, Wedad M. Hanna, A. Langer and 13 more. Archives of Pathology & Laboratory Medicine, 2006

5,113 citations recorded by the source corpus.

PURPOSE To develop a guideline to improve the accuracy of human epidermal growth factor receptor 2(HER2) testing in invasive breast cancer and its utility as a predictive marker. METHODS The American Society of Clinical Oncology and the College of American Pathologists convened an expert panel, which conducted a systematic review of the literature and developed recommendations for optimal HER2 testing performance. The guideline was reviewed by selected experts and approved by the board of directors for both organizations. RESULTS Approximately 20% of current HER2 testing may be inaccurate. When carefully validated testing is performed, available data do not clearly demonstrate the superiority of either immunohistochemistry(IHC) or in situ hybridization (ISH) as a predictor of benefit from anti-HER2 therapy. RECOMMENDATIONS The panel recommends that HER2 status should be determined for all invasive breast cancer. A testing algorithm that relies on accurate, reproducible assay performance, including newly available types of brightfield ISH, is proposed. Elements to reliably reduce assay variation (for example, specimen handling, assay exclusion, and reporting criteria) are specified. An algorithm defining positive, equivocal, and negative values for both HER2 protein expression and gene amplification is recommended: a positive HER2 result is IHC staining of 3 + (uniform, intense membrane staining of 30% of invasive tumor cells), a fluorescent in situ hybridization (FISH) result of more than six HER2 gene copies per nucleus or a FISH ratio (HER2 gene signals to chromosome 17 signals) of more than 2.2; a negative result is an IHC staining of 0 or 1 +, a FISH result of less than 4.0 HER2 gene copies per nucleus, or FISH ratio of less than 1.8. Equivocal results require additional action for final determination. It is recommended that to perform HER2 testing, laboratories show 95% concordance with another validated test for positive and negative assay values. The panel strongly recommends validation of laboratory assay or modifications, use of standardized operating procedures, and compliance with new testing criteria to be monitored with the use of stringent laboratory accreditation standards, proficiency testing, and competency assessment. The panel recommends that HER2 testing be done in a CAP-accredited laboratory or in a laboratory that meets the accreditation and proficiency testing requirements set out by this document.

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1. E. Senkus
2. A. Goldhirsch
3. J. Reis-Filho
4. Pankaj Kumar
5. S. Kyriakides
6. F. Cardoso
7. Mitchell Dowsett
8. Rupali Aggarwal

Citations in the corpus

• Human Epidermal Growth Factor Receptor 2 (HER2) in Cancers: Overexpression and Therapeutic Implications (2014, unknown): “Breast cancer specimens should initially undergo HER2 testing by a validated immunohistochemistry (IHC) assay for HER2 protein expression [58].”
• American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer. (2007, methodology): “Trastuzumab is a humanized monoclonal antibody that binds to the extracellular domain of HER2.”
• An overview of triple-negative breast cancer (2016, methodology): “This will optimize the pre-analytic and analytic phases of the testing procedures and the interpretation and scoring of the test results [30, 31].”
• Breast Cancer Histopathology Image Analysis: A Review (2014, unknown): “consistency of the interpretation [8], [9].”
• Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. (2007, background): “2) or CISH (chromogenic in situ hybridization: more than six HER2 signals per cell) [77] is sufficient.”
• Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. (2013, methodology): “Inclusion and Exclusion Criteria Articles were selected for inclusion in the systematic review of the evidence if they met the following criteria : (1) the study compared, prospectively or retrospectively, fluorescent ISH (FISH) and immunohistochemistry (IHC) results or other tests; described techni”
• Basal-like and triple-negative breast cancers: a critical review with an emphasis on the implications for pathologists and oncologists (2011, methodology): “Future studies are likely to produce slightly different prevalence rates for triple-negative breast cancers given the change in the definition of HER2 and hormone receptor positivity according to the ASCOsCAP guidelines”
• PD‐L1 Immunohistochemistry Assays for Lung Cancer: Results from Phase 1 of the Blueprint PD‐L1 IHC Assay Comparison Project (2017, background): “Far more uncertain in terms of technical and clinical performance will be the outcomes from the use of nonstandard LDTs (scenario D, Table 3), as has been demonstrated for other IHC biomarkers.(32,33)”