Recommendations for human epidermal growth factor receptor 2 testing in breast

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

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)3997-4013
Number of pages17
JournalJournal of Clinical Oncology
Volume31
Issue number31
DOIs
StatePublished - Nov 1 2013

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Breast
In Situ Hybridization
Immunohistochemistry
Guidelines
Breast Neoplasms
human ERBB2 protein
Medical Oncology
Gene Amplification
Reflex
Neoplasms
Recurrence
Health

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

Cite this

Wolff, A. C., Hammond, M. E. H., Hicks, D. G., Dowsett, M., McShane, L. M., Allison, K. H., ... Hayes, D. F. (2013). Recommendations for human epidermal growth factor receptor 2 testing in breast. Journal of Clinical Oncology, 31(31), 3997-4013. https://doi.org/10.1200/JCO.2013.50.9984

Recommendations for human epidermal growth factor receptor 2 testing in breast. / 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 Brian; Mangu, Pamela B.; Paik, Soonmyung; Perez, Edith A.; Press, Michael F.; Spears, Patricia A.; Vance, Gail H.; Viale, Giuseppe; Hayes, Daniel F.

In: Journal of Clinical Oncology, Vol. 31, No. 31, 01.11.2013, p. 3997-4013.

Research output: Contribution to journalArticle

Wolff, AC, Hammond, MEH, Hicks, DG, Dowsett, M, McShane, LM, Allison, KH, Allred, DC, Bartlett, JMS, Bilous, M, Fitzgibbons, P, Hanna, W, Jenkins, RB, Mangu, PB, Paik, S, Perez, EA, Press, MF, Spears, PA, Vance, GH, Viale, G & Hayes, DF 2013, 'Recommendations for human epidermal growth factor receptor 2 testing in breast', Journal of Clinical Oncology, vol. 31, no. 31, pp. 3997-4013. https://doi.org/10.1200/JCO.2013.50.9984
Wolff AC, Hammond MEH, Hicks DG, Dowsett M, McShane LM, Allison KH et al. Recommendations for human epidermal growth factor receptor 2 testing in breast. Journal of Clinical Oncology. 2013 Nov 1;31(31):3997-4013. https://doi.org/10.1200/JCO.2013.50.9984
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 Brian ; Mangu, Pamela B. ; Paik, Soonmyung ; Perez, Edith A. ; Press, Michael F. ; Spears, Patricia A. ; Vance, Gail H. ; Viale, Giuseppe ; Hayes, Daniel F. / Recommendations for human epidermal growth factor receptor 2 testing in breast. In: Journal of Clinical Oncology. 2013 ; Vol. 31, No. 31. pp. 3997-4013.
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