Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update.
Antonio C. Wolff,M. Elizabeth H. Hammond,Kimberly H. Allison,Brittany E. Harvey,Pamela B. Mangu,John M. S. Bartlett,Michael Bilous,Ian O. Ellis,Patrick L. Fitzgibbons,Wedad Hanna,Robert B. Jenkins,Michael F. Press,Patricia A. Spears,Gail H. Vance,Giuseppe Viale,Lisa M. McShane,Mitchell Dowsett +16 more
TLDR
The HER2 testing algorithm for breast cancer is updated 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.Abstract:
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. Find additional information at www.asco.org/breast-cancer-guidelines .read more
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Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
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Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer.
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Pertuzumab plus trastuzumab for HER2-amplified metastatic colorectal cancer (MyPathway): an updated report from a multicentre, open-label, phase 2a, multiple basket study.
Funda Meric-Bernstam,Herbert Hurwitz,Kanwal Pratap Singh Raghav,Robert R. McWilliams,Marwan Fakih,Ari M. Vanderwalde,Charles Swanton,Razelle Kurzrock,Howard A. Burris,Christopher Sweeney,Ron Bose,David R. Spigel,Mary Beattie,Steven Blotner,Alyssa Stone,Katja Schulze,Vaikunth Cuchelkar,John D. Hainsworth +17 more
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Primary results from IMpassion131, a double-blind, placebo-controlled, randomised phase III trial of first-line paclitaxel with or without atezolizumab for unresectable locally advanced/metastatic triple-negative breast cancer
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TL;DR: In the phase III IMpassion130 trial, combining atezolizumab with first-line nanoparticle albumin-bound-paclitaxel for advanced triple-negative breast cancer (aTNBC) showed a statistically significant progression-free survival (PFS) benefit in the intention-to-treat (ITT) and programmed death-ligand 1 (PD-L1)-positive populations, and a clinically meaningful overall survival (OS) effect in PD-L 1-positive aTNBC as discussed by the authors.
References
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Journal ArticleDOI
HER2 in situ hybridization in breast cancer: clinical implications of polysomy 17 and genetic heterogeneity
Wedad Hanna,Josef Rüschoff,Michael Bilous,Renata A. Coudry,Mitch Dowsett,Robert Yoshiyuki Osamura,Frédérique Penault-Llorca,Marc J. van de Vijver,Giuseppe Viale +8 more
TL;DR: Recommendations are highlighted that the use of mean HER2 copy number rather than HER2:CEP17 ratio to define HER2 positivity in cases where coamplification of the centromere might mask HER2 amplification, and a need to harmonize in situ hybridization scoring methodology to support accurate HER2 status determination.
Journal ArticleDOI
Updated UK Recommendations for HER2 assessment in breast cancer
Emad A. Rakha,Sarah E Pinder,John M. S. Bartlett,Merdol Ibrahim,Jane Starczynski,Pauline J Carder,Elena Provenzano,Andrew M Hanby,Sarah Hales,Andrew H S Lee,Ian O. Ellis +10 more
TL;DR: This paper provides an update of the guidelines for HER2 testing in the UK by providing guidelines of test performance parameters, and recommendations on the postanalytical interpretation of test results.
Journal ArticleDOI
Does chromosome 17 centromere copy number predict polysomy in breast cancer? A fluorescence in situ hybridization and microarray-based CGH analysis†
Caterina Marchiò,Maryou B K Lambros,Patrizia Gugliotta,Ludovica Verdun di Cantogno,Cristina Botta,Barbara Pasini,David S.P. Tan,Alan Mackay,Kerry Fenwick,Narinder Tamber,Gianni Bussolati,Alan Ashworth,Jorge S. Reis-Filho,Anna Sapino +13 more
TL;DR: The results suggest that true chromosome 17 polysomy is likely to be a rare event in breast cancer and that CEP17 copy number greater than 3.0 in FISH analysis is frequently related to gain or amplification of the centromeric region.
Journal ArticleDOI
Discordance between core needle biopsy (CNB) and excisional biopsy (EB) for estrogen receptor (ER), progesterone receptor (PgR) and HER2 status in early breast cancer (EBC)
TL;DR: CNB can be used with confidence for ER and HER2 determination, but for PgR, due to a substantial discordance between CNB and EB, results from CNB should be use with caution.
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