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Cited by 1,762

The DOI matches its Crossref record; 90 of the 90 references it cites were found in a registry or an index.

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

Open access
Wolff, Antonio C., Hammond, M. Elizabeth H., Hicks, David G., Dowsett, Mitch, McShane, Lisa M., Allison, Kimberly H., Allred, Donald C., Bartlett, John M.S., Bilous, Michael, Fitzgibbons, Patrick, Hanna, Wedad, Jenkins, Robert B., Mangu, Pamela B., Paik, Soonmyung, Perez, Edith A., Press, Michael F., Spears, Patricia A., Vance, Gail H., Viale, Giuseppe, Hayes, Daniel F.·2014·Archives of Pathology and Laboratory Medicine

Abstract

Purpose. —To update the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for human epidermal growth factor receptor 2 (HER2) testing in breast cancer to improve the accuracy of HER2 testing and its utility as a predictive marker in invasive breast cancer. Methods. —ASCO/CAP convened an Update Committee that included coauthors of the 2007 guideline to conduct a systematic literature review and update recommendations for optimal HER2 testing. Results. —The Update Committee identified criteria and areas requiring clarification to improve the accuracy of HER2 testing by immunohistochemistry (IHC) or in situ hybridization (ISH). The guideline was reviewed and approved by both organizations. Recommendations. —The Update Committee recommends that HER2 status (HER2 negative or positive) be determined in all patients with invasive (early stage or recurrence) breast cancer on the basis of one or more HER2 test results (negative, equivocal, or positive). Testing criteria define HER2-positive status when (on observing within an area of tumor that amounts to >10% of contiguous and homogeneous tumor cells) there is evidence of protein overexpression (IHC) or gene amplification ( HER2 copy number or HER2 /CEP17 ratio by ISH based on counting at least 20 cells within the area). If results are equivocal (revised criteria), reflex testing should be performed using an alternative assay (IHC or ISH). Repeat testing should be considered if results seem discordant with other histopathologic findings. Laboratories should demonstrate high concordance with a validated HER2 test on a sufficiently large and representative set of specimens. Testing must be performed in a laboratory accredited by CAP or another accrediting entity. The Update Committee urges providers and health systems to cooperate to ensure the highest quality testing.

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Metadata

Authors
Wolff, A. C., Hammond, M. E. H., Hicks, D. G., Dowsett, M., McShane, L. M., Allison, K. H., Allred, D. C., Bartlett, J. M. S., Bilous, M., Fitzgibbons, P., Hanna, W., Jenkins, R. B., Mangu, P. B., Paik, S., Perez, E. A., Press, M. F., Spears, P. A., Vance, G. H., Viale, G., & Hayes, D. F.
Venue
Archives of Pathology and Laboratory Medicine
Published
2014-02
Volume
138
Issue
2
Pages
241-256
ISSN
  • 0003-9985 (ISSN-L)
  • 1543-2165
OpenAlex
W1974685860
Cited by
1,762
References
90
FWCI
76.52
Type
journal article
Language
en
Open access
bronze

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CoChat. (2026). Citation check: 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. https://app.cochat.ai/papers/10.5858/arpa.2013-0953-sa
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Wolff, A. C., Hammond, M. E. H., Hicks, D. G., Dowsett, M., McShane, L. M., Allison, K. H., Allred, D. C., Bartlett, J. M. S., Bilous, M., Fitzgibbons, P., Hanna, W., Jenkins, R. B., Mangu, P. B., Paik, S., Perez, E. A., Press, M. F., Spears, P. A., Vance, G. H., Viale, G., & Hayes, D. F. (2014). 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. Archives of Pathology and Laboratory Medicine. https://doi.org/10.5858/arpa.2013-0953-sa

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.