ArticlePloS one2015
Impact of Modified 2013 ASCO/CAP Guidelines on HER2 Testing in Breast Cancer. One Year Experience.
Article in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
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Who cites it
24 citing papers in PubMed.
- HER2 testing: evolution and update for a companion diagnostic assay.Nature reviews. Clinical oncology · 2025Review
- Extratumoral signs on mammography as a novel prognostic indicator for breast cancer: evidence from malignant nonspiculate and noncalcified masses.American journal of translational research · 2025Article
- ERBB2-amplified lobular breast carcinoma exhibits concomitant CDK12 co-amplification associated with poor prognostic features.The journal of pathology. Clinical research · 2024Article
- Biomarker dynamics and prognosis in breast cancer after neoadjuvant chemotherapy.Scientific reports · 2022Article
- Combining Neratinib with CDK4/6, mTOR, and MEK Inhibitors in Models of HER2-positive Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2021Article
- A study of HER2 expression in endometrial carcinoma: a single centre experience.The Pan African medical journal · 2021Article
- Impact of the Updated Guidelines on Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Breast Cancer.Journal of breast cancer · 2020Article
- Clinicopathologic features of breast cancer reclassified as HER2-amplified by fluorescence in situ hybridization with alternative chromosome 17 probes.Annals of diagnostic pathology · 2020Article
- Review
- PET imaging of aThe British journal of radiology · 2019Article
- Variability of predictive markers (hormone receptors, Her2, Ki67) and intrinsic subtypes of breast cancer in four consecutive years 2015-2018.Journal of cancer research and clinical oncology · 2019Article
- What to expect from the 2018 ASCO/CAP HER2 guideline in the reflex in situ hybridization test of immunohistochemically equivocal 2+ cases?Virchows Archiv : an international journal of pathology · 2019Article
- Assessment of ERBB2/HER2 Status in HER2-Equivocal Breast Cancers by FISH and 2013/2014 ASCO-CAP Guidelines.JAMA oncology · 2019Article
- HER2 overexpression and correlation with other significant clinicopathologic parameters in Ivorian breast cancer women.BMC clinical pathology · 2019Article
- Deciphering HER2 Breast Cancer Disease: Biological and Clinical Implications.Frontiers in oncology · 2019Review
- Single molecule localization microscopy coupled with touch preparation for the quantification of trastuzumab-bound HER2.Scientific reports · 2018Article
- Protein biomarkers for subtyping breast cancer and implications for future research.Expert review of proteomics · 2018Review
- Challenges and future of biomarker tests in the era of precision oncology: Can we rely on immunohistochemistry (IHC) or fluorescenceOncotarget · 2017Review
- Review
- Direct estrogen receptor (ER) / HER family crosstalk mediating sensitivity to lumretuzumab and pertuzumab in ER+ breast cancer.PloS one · 2017Article
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Abstract
introductionThe latest guidelines of the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) to test Human Epidermal Growth Factor Receptor 2 (HER2) in breast cancer after being revised in 2008 underwent a second modification in October 2013. The modification includes changes in cut-offs: 10% strong membranous staining for score 3+ on immunohistochemistry (IHC) (previously 30%) and using the ratio of >2 or absolute gene-copy-number (6 or more) alone or in combination with each other by in-situ-hybridisation technology (previously >2.2 and average copy-number of 6 or more). Hereby we addressed the question, which impact the modified cut-offs had on overall HER2-positivity in a single institution.
methodsWe prospectively analysed 617 consecutive diagnostic breast-cancer cases which underwent double HER2 testing by immunohistochemistry and fluorescent in-situ hybridisation (FISH), using the modified 2013 ASCO/CAP-guidelines for one year (October 2013-October 2014). Results were compared with HER2-test results on 1,528 consecutive diagnostic breast-cancer cases from two previous years (2011-2012), using the 2008 ASCO/CAP guidelines, also tested with IHC and FISH in each case.
resultsBetween October 2013 and October 2014, overall HER2-positivity was 15.8% (98 of 617 cases were either IHC 3+ or FISH amplified). 79 of 617 cases (13%) were IHC 3+, 96 of 617 cases (15.5%) were FISH amplified. Equivocal cases were seen in 25 of 617 cases (4.1%). 22 of 25 equivocal cases (88%) in 2013-2014 were IHC 1+ or 2+. In 13 equivocal cases, there was a repeated IHC/FISH testing: 2 of 13 cases (15%) became FISH amplified, 1 of 13 cases (7.5%) became IHC 3+. In 2011-2012, overall HER2-positivity (IHC/FISH) was 13.8% (211 of 1,528 cases). 185 of 1,528 cases (12%) were 3+ on IHC, 181 of 1,522 cases (12%) were amplified by FISH. Six of 1,528 cases were equivocal by FISH, and interpreted as non-amplified (0.3%).
conclusionsApplying the modified ASCO/CAP guidelines from 2013 resulted in an increase (2%) in overall HER2-positivity rate compared to overall-HER2-positivity rate using the 2008 ASCO/CAP guidelines. The increased positivity rate was mainly due to more FISH-positive cases (3.5% more than until 2013). The high rate of equivocal cases (4.1%) did not contribute to increase in overall HER2-positivity, but resulted in delay in definitive HER2-status.
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