Interobserver Concordance in Implementing the 2010 ASCO/CAP Recommendations for Reporting ER in Breast Carcinomas

Reisenbichler, Emily; Lester, Susan C.; Richardson, Andrea L.; Dillon, Deborah; Ly, Amy; Brock, Jane E.

doi:10.1309/ajcp1rf9fuizrdpi

Cited by 48 publications

(18 citation statements)

References 20 publications

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“…Therefore, the true differences in tumor genomics can be confounded by these two factors. However, a review of the prior literature [37, 38] shows that heterogeneity found in our study is notably higher than found in the studies related to observer variability. Therefore, a minor part of the variability comes from the interobserver/technique induced variability and the majority of the differences are from inter-sample variability.…”

Section: Discussioncontrasting

confidence: 88%

“…Therefore, a minor part of the variability comes from the interobserver/technique induced variability and the majority of the differences are from inter-sample variability. For example, in our study, 8.78% of average discordance between a pair of samples for the patients was observed using positivity/negativity for ER percentage staining which is greater than the discordance (<5%) seen between the observers in the study by Reisenbichler et al [38]. Moreover, using ER Allred score, a difference of more than 1 point in 20.62% percent of the cases was found whereas Reisenbichler et al found that occurring in less than 10% of their cases.…”

Section: Discussioncontrasting

confidence: 72%

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Intra-tumor molecular heterogeneity in breast cancer: definitions of measures and association with distant recurrence-free survival

Saha

Harowicz

Cain

et al. 2018

Breast Cancer Res Treat

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Section: Discussioncontrasting

confidence: 88%

Section: Discussioncontrasting

confidence: 72%

Intra-tumor molecular heterogeneity in breast cancer: definitions of measures and association with distant recurrence-free survival

Saha

Harowicz

Cain

et al. 2018

Breast Cancer Res Treat

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“…These results are comparable with other groups that have evaluated inter-observer agreement for estrogen receptor immunohistochemical assays. 24,25 To our knowledge, ours is the only study that also evaluated intra-observer agreement. Three months after initial review, Observers 1 and 3 rescored the tissue microarray slides and we found strong agreement across all platforms (κ ≥ 0.91).…”

Section: Discussionmentioning

confidence: 98%

A systematic comparison of three commercial estrogen receptor assays in a single clinical outcome breast cancer cohort

et al. 2016

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Breast cancers are routinely assessed for estrogen receptor status using immunohistochemical assays to assist in patient prognosis and clinical management. Specific assays vary between laboratories, and several antibodies have been validated and recommended for clinical use. As numerous factors can influence assay performance, many laboratories have opted for ready-to-use assays using automated stainers to improve reproducibility and consistency. Three commonly used autostainer vendors-Dako, Leica, and Ventana-all offer such estrogen receptor assays; however, they have never been directly compared. Here, we present a systematic comparison of three platform-specific estrogen receptor ready-to-use assays using a retrospective, tamoxifen-treated, breast cancer cohort from patients who were treated in Calgary, Alberta, Canada from 1985 to 2000. We found all assays showed good intra-observer agreement. Inter-observer pathological scoring showed some variability: Ventana had the strongest agreement followed closely by Dako, whereas Leica only showed substantial agreement. We also analyzed each estrogen receptor assay with respect to 5-year disease-free survival, and found that all performed similarly in univariate and multivariate models. Determination of measures of test performance found that the Leica assay had a lower negative predictive value than Dako or Ventana, compared with the original ligand-binding assay, while other measures-sensitivity, specificity, positive predictive value, and accuracywere comparable between the three ready-to-use assays. When comparing against disease-free survival, the difference in negative predictive value between the vendor assays were not as extreme, but Dako and Ventana still performed slightly better than Leica. Despite some discordance, we found that all ready-to-use assays were comparable with or superior to the ligand-binding assay, endorsing their continued use. Our analysis also allowed for exploration of estrogen receptor-negative, progesterone receptor-positive cases, and we discovered that this phenotype was not consistent across the assays, suggesting this might be an artifact. Endocrine therapy is standard treatment for hormone receptor-positive breast cancers that can improve patient survival. 1-3 Estrogen receptor and progesterone receptor analysis is routinely performed by immunohistochemical assays on breast cancer specimens to classify hormone receptor status and determine patient prognosis and management. [1][2][3][4] Eventually, immunohistochemical-based testing replaced the ligand-binding assay as the standard method for determining hormone receptor status. 5 The switch from ligand-binding assay to immunohistochemistry did not occur at a specific time point, and varied by location and laboratories between the mid-90s and early 2000s. Although estrogen and progesterone receptor are both routinely evaluated, patient management decisions are typically made on the basis of estrogen receptor results alone as the role of progesterone receptor in breast cancer patie...

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“…Beside different scoring systems interobserver variability can also occur. Tumors with low levels of ER expression are often difficult to classify and can lead to observer discordance [24]. In our study the scoring results of the central lab using the Allred scoring method and those of the participating lab using their proper scoring system were significantly positive correlated for ER and PR.…”

Section: Discussionmentioning

confidence: 47%

Study Assessing the Quality of Quantification of Estrogen Receptor Protein Expression by Immunohistochemistry and Gene Expression in Breast Cancer

Sas

Steven

Marie

et al. 2014

Pathology Research International

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Although immunohistochemistry (IHC) is a widely used technique to classify tumors in ER-positive versus ER-negative ones, interlab variabilities can occur. This study aims to investigate the influences of preanalytical and analytical factors on IHC results. For this purpose, the different steps of the preparation of IHC sections and scoring procedures were compared between two participating laboratories and a central lab. There was a significant positive correlation between the IHC results of the participating laboratories and those of the central lab (correlation coefficient > 0.600; P<0.05). Nevertheless, some discordant cases for immunostaining (5.3% for ER and 5.6% for PR) and for scoring (10.5% for PR) occur at site 1. Comparing IHC results with ESR1 gene expression results revealed a significant positive correlation (correlation coefficients > 0.769; P<0.05). PCR results of ER target genes showed some heterogeneity in the ER-signalling pathway. These results suggest that differences in the IHC procedure between these laboratories did not have a big influence on the end result. Nevertheless, discordant cases caused by preanalytical and analytical lab-specific procedures have been identified.

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Interobserver Concordance in Implementing the 2010 ASCO/CAP Recommendations for Reporting ER in Breast Carcinomas

Abstract: Discordance overwhelmingly reflected differing opinions recording the proportion of tumor cells positive with low levels of expression (<10% staining; 12/13 cases).

Cited by 48 publications

References 20 publications

Intra-tumor molecular heterogeneity in breast cancer: definitions of measures and association with distant recurrence-free survival

Intra-tumor molecular heterogeneity in breast cancer: definitions of measures and association with distant recurrence-free survival

A systematic comparison of three commercial estrogen receptor assays in a single clinical outcome breast cancer cohort

Study Assessing the Quality of Quantification of Estrogen Receptor Protein Expression by Immunohistochemistry and Gene Expression in Breast Cancer

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