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Assessment of dual-probe Her-2 fluorescent in situ hybridization in breast cancer by the 2013 ASCO/CAP guidelines produces more equivocal results than that by the 2007 ASCO/CAP guidelines

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Abstract

Dual-probe fluorescence in situ hybridization (D-FISH) is a widely accepted method to determine the gene amplification status of human epidermal growth factor receptor 2 (Her-2). In 2013, the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) updated the guidelines on the Her-2 testing for invasive breast cancer (BCa). The interpretation criteria for D-FISH changed accordingly. In this study, we compared the Her-2 FISH statuses based on the 2013 and 2007 ASCO/CAP guidelines in 1931 cases of BCa with Her-2 D-FISH testing at our hospital. We analyzed the clinicopathologic features of cases with equivocal results by the 2013 ASCO/CAP guidelines. Although the guideline update significantly improved the detection rate of Her-2 amplification, it also significantly increased the rate of equivocal results, posing a dilemma for clinical management. The equivocal results had a good reproducibility. The distribution of D-FISH-equivocal cases did not correlate with Her-2 status by immunohistochemistry, suggesting that Her-2 D-FISH equivocality may not reflect Her-2 overexpression. Compared with Her-2-negative cases by D-FISH, Her-2 D-FISH-equivocal cases had higher Ki67 expression, higher histological grade, more frequent lymph node metastasis, and lower estrogen receptor α expression, indicating a group of BCa with worse prognosis. The clinical significance of Her-2-equivocal results by D-FISH warrants further investigation.

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Acknowledgments

This work was supported by grants from the National Natural Science Foundation of China (81302292, 30930038, 81302294, 81272358, 81172531, and 81202101); the National Natural Science Foundation of Tianjin City, China (15JCQNJC45300).

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Authors and Affiliations

  1. Department of Breast Pathology and Lab, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer; Key Laboratory of Cancer Prevention and Therapy, Tianjin, 300060, China

    Xiao-Long Qian, Yi-Ling Yang, Feng Gu, Xiao-Jing Guo, Fang-Fang Liu & Li Fu

  2. Key Laboratory of Breast Cancer Prevention and Therapy, Tianjin Medical University, Ministry of Education, Tianjin, 300060, China

    Xiao-Long Qian, Yi-Ling Yang, Feng Gu, Xiao-Jing Guo, Fang-Fang Liu & Li Fu

  3. Memorial Sloan Kettering Cancer Center, 1275 York Avenue, New York, NY, 10065, USA

    Hannah Y. Wen

  4. Department of Pathology, University Medical Center of Princeton, Plainsboro, NJ, USA

    Lanjing Zhang

  5. Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA

    Lanjing Zhang

  6. Department of Chemical Biology, Ernest Mario School of Pharmacy, Rutgers University, Piscataway, NJ, USA

    Lanjing Zhang

  7. Department of Pathology, Robert Wood Johnson Medical School, Rutgers University, Piscataway, NJ, USA

    Lanjing Zhang

  8. Department of Pathology, Cooper University Hospital, Cooper Medical School of Rowan University, One Cooper Plaza, Camden, NJ, 08103, USA

    Xin-Min Zhang

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  1. Xiao-Long Qian
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  2. Hannah Y. Wen
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  3. Yi-Ling Yang
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  4. Feng Gu
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  6. Fang-Fang Liu
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  7. Lanjing Zhang
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  8. Xin-Min Zhang
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  9. Li Fu
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Corresponding author

Correspondence to Li Fu.

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The authors declare no conflict of interest.

Ethics statement

All BCa samples were collected with written consent from the patients prior to participation in the study. The protocols for collection and analysis of the samples were approved by the Institutional Review Board of Tianjin Medical University Cancer Institute and Hospital, in accordance with the revision of the Declaration of Helsinki.

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Qian, XL., Wen, H.Y., Yang, YL. et al. Assessment of dual-probe Her-2 fluorescent in situ hybridization in breast cancer by the 2013 ASCO/CAP guidelines produces more equivocal results than that by the 2007 ASCO/CAP guidelines. Breast Cancer Res Treat 159, 31–39 (2016). https://doi.org/10.1007/s10549-016-3917-6

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  • DOI: https://doi.org/10.1007/s10549-016-3917-6

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