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자료유형
학술저널
저자정보
Min Chong Kim (Department of Pathology Yeungnam University College of Medicine Daegu Korea) Su Hwan Kang (Department of Breast Surgery Yeungnam University College of Medicine Daegu Korea) Jung Eun Choi (Department of Breast Surgery Yeungnam University College of Medicine Daegu Korea) Young Kyung Bae (Department of Pathology Yeungnam University College of Medicine Daegu Korea)
저널정보
한국유방암학회 Journal of Breast Cancer Journal of Breast Cancer Vol.23 No.5
발행연도
2020.1
수록면
484 - 497 (14page)

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Purpose: In 2007, the American Society of Clinical Oncology and the College of American Pathologists had established a human epidermal growth factor receptor 2 (HER2) testing guideline, which was updated in 2013 and subsequently in 2018. We assessed the clinical impact of the recent update by comparing the in situ hybridization (ISH) results based on the 2007, 2013, and 2018 guidelines. Methods: We assessed 2 cohorts. The first cohort included 1,161 primary invasive breast cancer (IBC) samples including 18 bilateral IBC cases, with both immunohistochemistry (IHC) and silver-enhanced ISH (SISH) results available for the HER2 status. The second cohort included 160 IBC cases with equivocal HER2 IHC, assessed using SISH. We retrospectively evaluated and compared the HER2 SISH results. Results: There were 22 (1.9%) and 20 (12.5%) cases with altered SISH results according to the 2013 guidelines in cohorts 1 and 2, respectively. As per the 2018 guidelines, final HER2 statuses of 16 (1.4%) and 14 (8.5%) cases changed in cohorts 1 and 2, respectively. The 2013 guidelines increased the positive rate compared to the 2007 guidelines, in both cohorts (0.6% and 6.2%, respectively). Most equivocal cases in cohorts 1 (92.3%) and 2 (100%) as per the 2013 guidelines were reclassified as HER2-negative according to the 2018 guidelines. The 2018 guidelines increased the negative rates (1.3% in cohort 1 and 8.7% in cohort 2) and slightly decreased the positive rates (−0.2% in cohort 1 and −3.1% in cohort 2), compared to the 2013 guidelines. With each update, minor changes in the positive and negative rates were observed in whole breast cancer samples (cohort 1). However, the 2018 guidelines affected previously defined HER2-positive IBC with equivocal IHC results. Conclusion: Under the 2013 guidelines, the positive and equivocal cases increased. However, the 2018 guidelines eliminated ambiguous cases by reclassifying them as HER2-negative.

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