Institutional quality assurance for breast cancer HER2 immunohistochemical testing: identification of outlier results and impact of simultaneous fluorescence in situ hybridization cotesting

Green, Ian F.; Zynger, Debra L.

doi:10.1016/j.humpath.2015.08.001

Cited by 6 publications

(3 citation statements)

References 26 publications

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“…Guidelines for FISH processing, testing, and data interpretation were released by the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) years ago (Wolff et al., 2007) and have been updated since, e.g., in 2013 and 2018 (Wolff et al., 2013; Wolff et al., 2018). However, multiannual experience with HER2 testing in breast cancer made it apparent that the immunohistochemical approach is subject to certain variabilities for intra‐ and inter‐laboratory technical reasons and, to some extent, due to variation in observer‐dependent data interpretation (Green & Zynger, 2015). In contrast, the preparation of FISH specimens turned out to be more robust, and the spot counting of FISH specimens occurred more objectively because it is basically a user‐independent and particularly quantitative approach.…”

Section: Introductionmentioning

confidence: 99%

Complementary Tumor Diagnosis by Single Cell–Based Cytogenetics Using Multi‐marker Fluorescence In Situ Hybridization (mFISH)

Brockhoff

2023

Current Protocols

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Multi‐color (or multi‐marker) fluorescence in situ hybridization (mFISH) is a well‐established, valuable, complementary tool for prenatal and pathological (tumor) diagnosis. A variety of chromosomal abnormalities, such as partial or total chromosomal gains, losses, inversions, or translocations, which are considered to cause genetic syndromes, can relatively easily be detected on a cell‐by‐cell basis. Individual cells either in suspension (e.g., in the form of a cytological specimen derived from body fluids) or within a tissue (e.g., a solid tumor specimen or biopsy) can be quantitatively evaluated with respect to the chromosomal hybridization markers of interest (e.g., a gene or centromeric region) and with due consideration of cellular heterogeneity. FISH is helpful or even essential for the (sub‐)classification, stratification, and unambiguous diagnosis of a number of malignant diseases and contributes to treatment decision in many cases. Here, the diagnostic power and limitations of typical FISH and mFISH approaches (except chromosome painting and RNA hybridization) are discussed, with special emphasis on tumor and single‐cell diagnostics. Well‐established and novel FISH protocols, the latter addressed to accelerate and flexibilize the preparation and hybridization of formalin‐fixed and paraffin‐embedded tissues, are provided. Moreover, guidelines and molecular aspects important for data interpretation are discussed. Finally, sophisticated multiplexed approaches and those that analyze very rare single‐cell events, which are not yet implemented in diagnostic procedures, will be touched upon. © 2023 The Authors. Current Protocols published by Wiley Periodicals LLC.This article was corrected on 21 December 2023. See the end of the full text for details.Basic Protocol 1: (m)FISH applied to formaldehyde‐fixed paraffin‐embedded tissuesBasic Protocol 2: (m)FISH applied to cytological specimens

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Section: Introductionmentioning

confidence: 99%

Complementary Tumor Diagnosis by Single Cell–Based Cytogenetics Using Multi‐marker Fluorescence In Situ Hybridization (mFISH)

Brockhoff

2023

Current Protocols

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“…In one study, the overall concordance between observers for equivocal HER2neu results was low (55.8%) but for negative and positive results it was very high 15 . A unique trend of reporting was observed; pathologist with 100 per cent IHC and FISH concordance, usually had a tendency to play safe and reported a high number of equivocal cases while pathologists who reported clear cut results (positive or negative) had lesser concordance with FISH 15 . We observed that pathologist reporting both HER2neu IHC and FISH at our institute had better concordance with the FISH results 71 .…”

Section: Issues Plaguing Hormone Receptor and Her2neu Testingmentioning

confidence: 94%

“…Globally, hormone receptor-positive cancers are the most common subtype of breast cancer, accounting for 78-80 per cent of all cases 1 2 3 7 12 13 . The global HER2neu IHC-based positivity rates range from 11 to 20 per cent 2 3 14 15 . The problem of erroneous results of ER/PR and HER2neu testing is universal and not confined to countries with low resources 5 .…”

Section: Learning From Global Experiencementioning

confidence: 99%

Improving accuracy of breast cancer biomarker testing in India

Shet

2017

Indian Journal of Medical Research

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There is a global mandate even in countries with low resources to improve the accuracy of testing biomarkers in breast cancer viz. oestrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2neu) given their critical impact in the management of patients. The steps taken include compulsory participation in an external quality assurance (EQA) programme, centralized testing, and regular performance audits for laboratories. This review addresses the status of ER/PR and HER2neu testing in India and possible reasons for the delay in development of guidelines and mandate for testing in the country. The chief cause of erroneous ER and PR testing in India continues to be easily correctable issues such as fixation and antigen retrieval, while for HER2neu testing, it is the use of low-cost non-validated antibodies and interpretative errors. These deficiencies can however, be rectified by (i) distributing the accountability and responsibility to surgeons and oncologist, (ii) certification of centres for testing in oncology, and (iii) initiation of a national EQA system (EQAS) programme that will help with economical solutions and identifying the centres of excellence and instill a system for reprimand of poorly performing laboratories.

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Impact of the 2013 ASCO/CAP HER2 revised guidelines on HER2 results in breast core biopsies with invasive breast carcinoma: a retrospective study

et al. 2016

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Institutional quality assurance for breast cancer HER2 immunohistochemical testing: identification of outlier results and impact of simultaneous fluorescence in situ hybridization cotesting

Cited by 6 publications

References 26 publications

Complementary Tumor Diagnosis by Single Cell–Based Cytogenetics Using Multi‐marker Fluorescence In Situ Hybridization (mFISH)

Complementary Tumor Diagnosis by Single Cell–Based Cytogenetics Using Multi‐marker Fluorescence In Situ Hybridization (mFISH)

Improving accuracy of breast cancer biomarker testing in India

Impact of the 2013 ASCO/CAP HER2 revised guidelines on HER2 results in breast core biopsies with invasive breast carcinoma: a retrospective study

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