Reliability of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry in Breast Core Needle Biopsies

Lebeau, Annette; Turzynski, Andreas; Braun, Susanne; Behrhof, Wera; Fleige, Barbara; Schmitt, Wolfgang; Grob, Tobias; Burkhardt, Lia; Hölzel, Dieter; Jackisch, Christian; Thomssen, Christoph; Müller, Volkmar; Untch, Michael

doi:10.1200/jco.2009.25.9366

Cited by 58 publications

(43 citation statements)

References 43 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…28,31,32 Middleton et al 33 demonstrated that adherence to the ASCO/CAP guidelines resulted in greater IHC-FISH concordance, although the improvement was only 0.5%. Our data showed a significant improvement in concordance rates after implementation of the guidelines.…”

Section: Commentmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of HER2/neu Status by Immunohistochemistry Using Computer-Based Image Analysis and Correlation With Gene Amplification by Fluorescence In Situ Hybridization Assay: A 10-Year Experience and Impact of Test Standardization on Concordance Rate

Sarode¹,

Xiang²,

Christie³

et al. 2015

Archives of Pathology &Amp; Laboratory Medicine

View full text Add to dashboard Cite

College of American Pathologists proposed several recommendations for human epidermal growth factor receptor 2 (HER2) test standardization. One suggestion was that image analysis (IA) could be useful for scoring of HER2/ neu immunohistochemistry. The utilization of IA in a realworld practice in a large cohort of cases has not been previously reported.Objectives.-To compare HER2/neu quantification by IA with gene amplification by fluorescence in situ hybridization (FISH); to determine sensitivity, specificity, and concordance rates with the FISH assay; and to determine association between HER2 status with estrogen receptor (ER), progesterone receptor (PR), and Ki-67 expression.Design.-We evaluated HER2 results performed by immunohistochemistry and FISH in conjunction with ER, PR, and Ki-67 in 3093 invasive breast cancer cases from 2002 to 2011.Results.-The overall concordance between immunohistochemistry and FISH was 87.3% (1768 of 2026). When analyzed by year, there was an improvement in the positive concordance rate from 49.4% (44 of 89) to 95.0% (57 of 60) (P , .001). The negative concordance rate was at least 95% with a median false-negative rate of 1.5%. In the FISHþ group, amplification ratio showed significant correlation with IA scores (P , .001). Positive versus negative HER2 status was associated with lower ER and PR levels (P , .001) and higher Ki-67 expression (P , .001).Conclusion.-Scoring of HER2/neu by IA was associated with high false-positive rates before 2008. Improvement in concordance rate after 2008 may be due to proper tissue handling, improved HER2/neu scoring by IA, and assay standardization.

show abstract

Section: Commentmentioning

confidence: 99%

“…Crushed tumor cells and nonspecific staining at the edges are frequently seen in small biopsy specimens. 27,32 These artifacts may result in higher reading by the machine. Based on our experience, scoring of small biopsy specimens is more problematic than for excision specimens, because of limited tissue and overlapping fields.…”

Section: Commentmentioning

confidence: 99%

Evaluation of HER2/neu Status by Immunohistochemistry Using Computer-Based Image Analysis and Correlation With Gene Amplification by Fluorescence In Situ Hybridization Assay: A 10-Year Experience and Impact of Test Standardization on Concordance Rate

Sarode¹,

Xiang²,

Christie³

et al. 2015

Archives of Pathology &Amp; Laboratory Medicine

View full text Add to dashboard Cite

show abstract

“…However, the application of ASCO/CAP guidelines as well as proficiency tests have improved the accuracy of HER2 determination in the last few years [34].…”

Section: Pathological Complete Response (Pcr) Following Neoadjuvant Cmentioning

confidence: 99%

Comparison of different approaches for assessment of HER2 expression on protein and mRNA level: prediction of chemotherapy response in the neoadjuvant GeparTrio trial (NCT00544765)

Noske

Loibl

Darb‐Esfahani

et al. 2010

Breast Cancer Res Treat

View full text Add to dashboard Cite

show abstract

“…Reliable, high-quality HER2 testing for clinical use is of paramount importance for the correct identification of patients who would benefit from HER2-targeted therapies. 1,[14][15][16][17][18] False-negative HER2 assessments could result in denial of an effective treatment, while false-positive assessments may lead to inappropriate administration of a potentially harmful, costly, and ineffective HER2-targeted therapy, or exclusion from treatment with other targeted therapies in the HER2-negative setting. 1,8,11,19,20 Despite 410 years of routine HER2 testing, studies have demonstrated variability in HER2 positivity assessments between local pathology laboratories and central testing centers, posing a challenge for clinicians.…”

mentioning

confidence: 99%

Assessing HER2 testing quality in breast cancer: variables that influence HER2 positivity rate from a large, multicenter, observational study in Germany

Rüschoff¹,

Lebeau

Kreipe

et al. 2017

Modern Pathology

Self Cite

View full text Add to dashboard Cite

Despite 410 years of routine human epidermal growth factor receptor 2 (HER2) testing in breast cancer, testing quality is still an issue. Guidelines recommend assessing HER2 positivity rates as a quality indicator; however, the extent to which patient-or tumor-related factors influence HER2 positivity is still unknown. The present study analyzed these influences to identify pathology centers with HER2 positivity rates unexplained by patient-or tumor-related factors. This observational, prospective study monitored routine HER2 testing at 57 institutes of pathology in Germany (January 2013-August 2014). Data collected included HER2 test result, patient-and tumorrelated factors, sample source, and method of sample retrieval. Factors influencing HER2 positivity rates were identified by multiple logistic regression. Individual center effects were assessed in an extended multiple logistic regression model by their statistical significance after adjusting for the combined effect of patient-or tumorrelated covariates and multiple testing. Analyses included 15 332 invasive breast cancer samples. Histologic grade showed the strongest influence on HER2 positivity, followed by hormone receptor status, histologic subtype, age, and nodal status (all Po 0.0001). The overall HER2 positivity rate across centers was 14.4% (range 7.1-27.3%). A statistically significant center effect on the HER2 positivity rate was identified for three centers (Po 0.05), with a trend toward a center effect for a further three (P o0.2). This study, the first of its kind, highlights that assessing HER2 testing quality with HER2 positivity rates should include standardized assessment of patient-or tumor-related characteristics to identify centers with HER2 testing quality issues more effectively. As treatment options for HER2-positive breast cancer continue to evolve, identifying the right patients is key. Overexpression of the human epidermal growth factor receptor 2 (HER2) protein or amplification of the HER2 gene occurs in~15-20% of all breast cancers. 1 HER2-positive breast cancer has a worse prognosis than HER2-negative disease, having an increased risk of recurrence and a more aggressive disease course. 2-4 HER2 is a prognostic biomarker predictive for the response to HER2-targeted therapies including the recombinant monoclonal antibodies trastuzumab and pertuzumab, and the antibody-drug conjugate ado-trastuzumab emtansine, all of which specifically target HER2 and are effective treatments for HER2-positive breast Correspondence: Professor J

show abstract

Reliability of Human Epidermal Growth Factor Receptor 2 Immunohistochemistry in Breast Core Needle Biopsies

Cited by 58 publications

References 43 publications

Evaluation of HER2/neu Status by Immunohistochemistry Using Computer-Based Image Analysis and Correlation With Gene Amplification by Fluorescence In Situ Hybridization Assay: A 10-Year Experience and Impact of Test Standardization on Concordance Rate

Evaluation of HER2/neu Status by Immunohistochemistry Using Computer-Based Image Analysis and Correlation With Gene Amplification by Fluorescence In Situ Hybridization Assay: A 10-Year Experience and Impact of Test Standardization on Concordance Rate

Comparison of different approaches for assessment of HER2 expression on protein and mRNA level: prediction of chemotherapy response in the neoadjuvant GeparTrio trial (NCT00544765)

Assessing HER2 testing quality in breast cancer: variables that influence HER2 positivity rate from a large, multicenter, observational study in Germany

Contact Info

Product

Resources

About