Σάββατο 10 Ιουνίου 2017

[Internal quality control on HER2 status determination in breast cancers: Experience of a cancer center].

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[Internal quality control on HER2 status determination in breast cancers: Experience of a cancer center].

Bull Cancer. 2017 Jun 05;:

Authors: Ngo C, Laé M, Ratour J, Hamel F, Taris C, Caly M, Le Cunff A, Reyal F, Kirova Y, Pierga JY, Vincent-Salomon A

Abstract
INTRODUCTION: The implementation of an internal quality control is mandatory to guarantee the accuracy of HER2 status in invasive breast cancers.
OBJECTIVES: To evaluate the impact of our quality control assurance on HER2 status results in invasive breast carcinomas from 2008 to 2014.
METHODS: HER2 status was determined by immunohistochemistry as the first-line indication, completed by fluorescence in situ hybridization (FISH) for scores 2+ by immunohistochemistry. Internal quality control of HER2 status relied on the standardization of pre-analytical phases, the use of external controls with a known number of HER2 gene copies determined by FISH and continued monitoring of concordance between immunohistochemistry and FISH.
RESULTS: The proportion of HER2-positive cases corresponding to scores 3+ by immunohistochemistry and 2+ amplified by FISH varied from 10.6% to 13.8% (median of 11.3%). The proportion of scores 2+ amplified by FISH varied from 13.3% to 32.7% during period of study. The rate of concordance between FISH and immunohistochemistry for score 0/1+ and 3+ cases were≥97%. Eight among 12 discordant cases were false positive resulting from errors in interpretation of immunohistochemistry (score 2+ instead of 3+).
DISCUSSION: Calibration of immunohistochemistry on FISH for HER2 status contributes to limit variability of immunohistochemistry results due to technical issues or interpretation. The implementation of an external control of score 3+ on each slide enables accurate interpretation of score 2+ and 3+ by immunohistochemistry.

PMID: 28595742 [PubMed - as supplied by publisher]



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