TY - JOUR
T1 - Human epidermal growth factor receptor 2 testing in breast cancer
T2 - American society of clinical oncology/ college of American pathologists clinical practice guideline focused update
AU - Wolff, Antonio C.
AU - Elizabeth Hale Hammond, M.
AU - Allison, Kimberly H.
AU - Harvey, Brittany E.
AU - Mangu, Pamela B.
AU - Bartlett, John M.S.
AU - Bilous, Michael
AU - Ellis, Ian O.
AU - Fitzgibbons, Patrick
AU - Hanna, Wedad
AU - Jenkins, Robert B.
AU - Press, Michael F.
AU - Spears, Patricia A.
AU - Vance, Gail H.
AU - Viale, Giuseppe
AU - McShane, Lisa M.
AU - Dowsett, Mitchell
N1 - Funding Information:
The Expert Panel thanks Gary Lyman, Cynthia Anderson, the Clinical Practice Guidelines Committee, and the CAP Advisory and Independent Review Panels for their thoughtful reviews and insightful comments on this guideline. The Expert Panel also wishes to thank Neil Goldstein, Allen Gown, Erin Grimm, Christine Houston, Loralee McMahon, Dylan Miller, Bill Wyatt, and Hadi Yaziji for sharing their routine clinical experience with HER2 testing in breast cancer through the research survey and open session of the meeting, and those who participated in the online open comment period for providing feedback and suggestions for improving the guideline recommendations.
Funding Information:
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Intermountain Healthcare and University of Utah School of Medicine Stanford University School of Medicine Ontario Institute for Cancer Research Western Sydney University and Australian Clinical Laboratories The University of Nottingham St Jude Medical Center Sunnybrook Health Sciences Centre and Women’s College Hospital Mayo Clinic University of Southern California Cancer Information and Support Network Indiana University School of Medicine University of Milan and Istituto Europeo di Oncologia National Cancer Institute The Royal Marsden NHS Foundation Trust American Society of Clinical Oncology American Society of Clinical Oncology Abbreviation: HER2, human epidermal growth factor receptor 2. *Steering Committee member.
Publisher Copyright:
© 2018 by American Society of Clinical Oncology and College of American Pathologists.
PY - 2018/7/10
Y1 - 2018/7/10
N2 - Purpose To update key recommendations of the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guideline. Methods Based on the signals approach, an Expert Panel reviewed published literature and research survey results on the observed frequency of less common in situ hybridization (ISH) patterns to update the recommendations. Recommendations Two recommendations addressed via correspondence in 2015 are included. First, immunohistochemistry (IHC) 2+ is defined as invasive breast cancer with weak to moderate complete membrane staining observed in . 10% of tumor cells. Second, if the initial HER2 test result in a core needle biopsy specimen of a primary breast cancer is negative, a new HER2 test may (not “must”) be ordered on the excision specimen based on specific clinical criteria. The HER2 testing algorithm for breast cancer is updated to address the recommended work-up for less common clinical scenarios (approximately 5% of cases) observed when using a dual-probe ISH assay. These scenarios are described as ISH group 2 (HER2/chromosome enumeration probe 17 [CEP17] ratio $ 2.0; average HER2 copy number, 4.0 signals per cell), ISH group 3 (HER2/CEP17 ratio, 2.0; average HER2 copy number $ 6.0 signals per cell), and ISH group 4 (HER2/CEP17 ratio, 2.0; average HER2 copy number $ 4.0 and, 6.0 signals per cell). The diagnostic approach includes more rigorous interpretation criteria for ISH and requires concomitant IHC review for dual-probe ISH groups 2 to 4 to arrive at the most accurate HER2 status designation (positive or negative) based on combined interpretation of the ISH and IHC assays. The Expert Panel recommends that laboratories using single-probe ISH assays include concomitant IHC review as part of the interpretation of all single-probe ISH assay results.
AB - Purpose To update key recommendations of the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guideline. Methods Based on the signals approach, an Expert Panel reviewed published literature and research survey results on the observed frequency of less common in situ hybridization (ISH) patterns to update the recommendations. Recommendations Two recommendations addressed via correspondence in 2015 are included. First, immunohistochemistry (IHC) 2+ is defined as invasive breast cancer with weak to moderate complete membrane staining observed in . 10% of tumor cells. Second, if the initial HER2 test result in a core needle biopsy specimen of a primary breast cancer is negative, a new HER2 test may (not “must”) be ordered on the excision specimen based on specific clinical criteria. The HER2 testing algorithm for breast cancer is updated to address the recommended work-up for less common clinical scenarios (approximately 5% of cases) observed when using a dual-probe ISH assay. These scenarios are described as ISH group 2 (HER2/chromosome enumeration probe 17 [CEP17] ratio $ 2.0; average HER2 copy number, 4.0 signals per cell), ISH group 3 (HER2/CEP17 ratio, 2.0; average HER2 copy number $ 6.0 signals per cell), and ISH group 4 (HER2/CEP17 ratio, 2.0; average HER2 copy number $ 4.0 and, 6.0 signals per cell). The diagnostic approach includes more rigorous interpretation criteria for ISH and requires concomitant IHC review for dual-probe ISH groups 2 to 4 to arrive at the most accurate HER2 status designation (positive or negative) based on combined interpretation of the ISH and IHC assays. The Expert Panel recommends that laboratories using single-probe ISH assays include concomitant IHC review as part of the interpretation of all single-probe ISH assay results.
UR - http://www.scopus.com/inward/record.url?scp=85049596746&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85049596746&partnerID=8YFLogxK
U2 - 10.1200/JCO.2018.77.8738
DO - 10.1200/JCO.2018.77.8738
M3 - Article
C2 - 29846122
AN - SCOPUS:85049596746
SN - 0732-183X
VL - 36
SP - 2105
EP - 2122
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 20
ER -