Highly reproducible results of breast cancer biomarkers when analysed in accordance with national guidelines-a Swedish survey with central re-assessment

Maria Ekholm, Dorthe Grabau, Pär Ola Bendahl, Jonas Bergh, Göran Elmberger, Hans Olsson, Leila Russo, Giuseppe Viale, Mårten Fernö

Research output: Contribution to journalArticle

12 Citations (Scopus)

Abstract

Background: Biomarkers are crucial for decisions regarding adjuvant therapy in primary breast cancer, and their correct assessment is therefore of the utmost importance. Aims: To investigate the concordance between Swedish pathology departments and a reference laboratory, for routine analysis of oestrogen receptor (ER), progesterone receptor (PR), Ki67, and human epidermal growth factor receptor 2 (HER2), alone, and in combination (St Gallen subtypes). Methods: This survey included 27 of the 28 pathology laboratories in Sweden, covering 98% of cases of primary breast cancer surgery in Sweden. Paraffin-embedded tumour blocks (n = 270) were collected and sent to the central reference laboratory, together with the originally stained slides, for re-analysis. The primary evaluations were previously performed according to national Swedish guidelines, without any knowledge of the subsequent central assessment. Results: The agreement for ER, PR, and Ki67 was 99% [kappa value (κ) = 0.95], 95% (κ = 0.85), and 85% (κ = 0.70), respectively. The agreement for HER2 (0/1 + vs. 2+/3+) was 85% (κ = 0.64), but when equivocal tumours were further analysed with in situ hybridisation, only one discrepancy was observed. Discrepancies between results for ER and PR seem to be explained by analytical differences, whereas the interpretation of staining seems to be more critical for Ki67 and HER2 immunohistochemistry. The agreement between the results from the Swedish laboratories and the reference laboratory, based on the St Gallen subtypes, was 88% (κ = 0.81). Conclusions: When applying national guidelines, highly reproducible results were obtained in routine assessment of breast cancer biomarkers, and the results of this study confirm the clinical utility of these markers for decisions regarding the treatment of primary breast cancer.

Original languageEnglish
Pages (from-to)1040-1048
Number of pages9
JournalActa Oncologica
Volume54
Issue number7
DOIs
Publication statusPublished - Jul 1 2015

Fingerprint

Tumor Biomarkers
Guidelines
Breast Neoplasms
Progesterone Receptors
Sweden
Biomarkers
Pathology
Estrogen Receptors
Paraffin
In Situ Hybridization
Neoplasms
Immunohistochemistry
Surveys and Questionnaires
Staining and Labeling
Therapeutics
human ERBB2 protein

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Hematology

Cite this

Highly reproducible results of breast cancer biomarkers when analysed in accordance with national guidelines-a Swedish survey with central re-assessment. / Ekholm, Maria; Grabau, Dorthe; Bendahl, Pär Ola; Bergh, Jonas; Elmberger, Göran; Olsson, Hans; Russo, Leila; Viale, Giuseppe; Fernö, Mårten.

In: Acta Oncologica, Vol. 54, No. 7, 01.07.2015, p. 1040-1048.

Research output: Contribution to journalArticle

Ekholm, Maria ; Grabau, Dorthe ; Bendahl, Pär Ola ; Bergh, Jonas ; Elmberger, Göran ; Olsson, Hans ; Russo, Leila ; Viale, Giuseppe ; Fernö, Mårten. / Highly reproducible results of breast cancer biomarkers when analysed in accordance with national guidelines-a Swedish survey with central re-assessment. In: Acta Oncologica. 2015 ; Vol. 54, No. 7. pp. 1040-1048.
@article{07e813bd18514b3e993cc83d4e54b9eb,
title = "Highly reproducible results of breast cancer biomarkers when analysed in accordance with national guidelines-a Swedish survey with central re-assessment",
abstract = "Background: Biomarkers are crucial for decisions regarding adjuvant therapy in primary breast cancer, and their correct assessment is therefore of the utmost importance. Aims: To investigate the concordance between Swedish pathology departments and a reference laboratory, for routine analysis of oestrogen receptor (ER), progesterone receptor (PR), Ki67, and human epidermal growth factor receptor 2 (HER2), alone, and in combination (St Gallen subtypes). Methods: This survey included 27 of the 28 pathology laboratories in Sweden, covering 98{\%} of cases of primary breast cancer surgery in Sweden. Paraffin-embedded tumour blocks (n = 270) were collected and sent to the central reference laboratory, together with the originally stained slides, for re-analysis. The primary evaluations were previously performed according to national Swedish guidelines, without any knowledge of the subsequent central assessment. Results: The agreement for ER, PR, and Ki67 was 99{\%} [kappa value (κ) = 0.95], 95{\%} (κ = 0.85), and 85{\%} (κ = 0.70), respectively. The agreement for HER2 (0/1 + vs. 2+/3+) was 85{\%} (κ = 0.64), but when equivocal tumours were further analysed with in situ hybridisation, only one discrepancy was observed. Discrepancies between results for ER and PR seem to be explained by analytical differences, whereas the interpretation of staining seems to be more critical for Ki67 and HER2 immunohistochemistry. The agreement between the results from the Swedish laboratories and the reference laboratory, based on the St Gallen subtypes, was 88{\%} (κ = 0.81). Conclusions: When applying national guidelines, highly reproducible results were obtained in routine assessment of breast cancer biomarkers, and the results of this study confirm the clinical utility of these markers for decisions regarding the treatment of primary breast cancer.",
author = "Maria Ekholm and Dorthe Grabau and Bendahl, {P{\"a}r Ola} and Jonas Bergh and G{\"o}ran Elmberger and Hans Olsson and Leila Russo and Giuseppe Viale and M{\aa}rten Fern{\"o}",
year = "2015",
month = "7",
day = "1",
doi = "10.3109/0284186X.2015.1037012",
language = "English",
volume = "54",
pages = "1040--1048",
journal = "Acta Oncologica",
issn = "0284-186X",
publisher = "Informa Healthcare",
number = "7",

}

TY - JOUR

T1 - Highly reproducible results of breast cancer biomarkers when analysed in accordance with national guidelines-a Swedish survey with central re-assessment

AU - Ekholm, Maria

AU - Grabau, Dorthe

AU - Bendahl, Pär Ola

AU - Bergh, Jonas

AU - Elmberger, Göran

AU - Olsson, Hans

AU - Russo, Leila

AU - Viale, Giuseppe

AU - Fernö, Mårten

PY - 2015/7/1

Y1 - 2015/7/1

N2 - Background: Biomarkers are crucial for decisions regarding adjuvant therapy in primary breast cancer, and their correct assessment is therefore of the utmost importance. Aims: To investigate the concordance between Swedish pathology departments and a reference laboratory, for routine analysis of oestrogen receptor (ER), progesterone receptor (PR), Ki67, and human epidermal growth factor receptor 2 (HER2), alone, and in combination (St Gallen subtypes). Methods: This survey included 27 of the 28 pathology laboratories in Sweden, covering 98% of cases of primary breast cancer surgery in Sweden. Paraffin-embedded tumour blocks (n = 270) were collected and sent to the central reference laboratory, together with the originally stained slides, for re-analysis. The primary evaluations were previously performed according to national Swedish guidelines, without any knowledge of the subsequent central assessment. Results: The agreement for ER, PR, and Ki67 was 99% [kappa value (κ) = 0.95], 95% (κ = 0.85), and 85% (κ = 0.70), respectively. The agreement for HER2 (0/1 + vs. 2+/3+) was 85% (κ = 0.64), but when equivocal tumours were further analysed with in situ hybridisation, only one discrepancy was observed. Discrepancies between results for ER and PR seem to be explained by analytical differences, whereas the interpretation of staining seems to be more critical for Ki67 and HER2 immunohistochemistry. The agreement between the results from the Swedish laboratories and the reference laboratory, based on the St Gallen subtypes, was 88% (κ = 0.81). Conclusions: When applying national guidelines, highly reproducible results were obtained in routine assessment of breast cancer biomarkers, and the results of this study confirm the clinical utility of these markers for decisions regarding the treatment of primary breast cancer.

AB - Background: Biomarkers are crucial for decisions regarding adjuvant therapy in primary breast cancer, and their correct assessment is therefore of the utmost importance. Aims: To investigate the concordance between Swedish pathology departments and a reference laboratory, for routine analysis of oestrogen receptor (ER), progesterone receptor (PR), Ki67, and human epidermal growth factor receptor 2 (HER2), alone, and in combination (St Gallen subtypes). Methods: This survey included 27 of the 28 pathology laboratories in Sweden, covering 98% of cases of primary breast cancer surgery in Sweden. Paraffin-embedded tumour blocks (n = 270) were collected and sent to the central reference laboratory, together with the originally stained slides, for re-analysis. The primary evaluations were previously performed according to national Swedish guidelines, without any knowledge of the subsequent central assessment. Results: The agreement for ER, PR, and Ki67 was 99% [kappa value (κ) = 0.95], 95% (κ = 0.85), and 85% (κ = 0.70), respectively. The agreement for HER2 (0/1 + vs. 2+/3+) was 85% (κ = 0.64), but when equivocal tumours were further analysed with in situ hybridisation, only one discrepancy was observed. Discrepancies between results for ER and PR seem to be explained by analytical differences, whereas the interpretation of staining seems to be more critical for Ki67 and HER2 immunohistochemistry. The agreement between the results from the Swedish laboratories and the reference laboratory, based on the St Gallen subtypes, was 88% (κ = 0.81). Conclusions: When applying national guidelines, highly reproducible results were obtained in routine assessment of breast cancer biomarkers, and the results of this study confirm the clinical utility of these markers for decisions regarding the treatment of primary breast cancer.

UR - http://www.scopus.com/inward/record.url?scp=84930920262&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84930920262&partnerID=8YFLogxK

U2 - 10.3109/0284186X.2015.1037012

DO - 10.3109/0284186X.2015.1037012

M3 - Article

VL - 54

SP - 1040

EP - 1048

JO - Acta Oncologica

JF - Acta Oncologica

SN - 0284-186X

IS - 7

ER -