Impact of the 2018 ASCO/CAP HER2 guidelines update for HER2 testing by FISH in breast cancer

Xu, Baojun; Shen, Jianguo; Guo, Wenhao; Zhao, Wenqiang; Zhuang, Yiyu; Wang, Linbo

doi:10.1016/j.prp.2018.10.035

Cited by 35 publications

(18 citation statements)

References 23 publications

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“…Other previous studies also reported that the number of cases in the negative group was significantly increased by applying the 2018 criteria (range 8.2%–10.4%) [ 11 19 20 ]. Similarly, previous studies on IHC 2+ cases showed a decrease in positive cases (range 0%–3.6%) and an increase in the negative cases (range 3.0%–15.5%), using the 2018 guidelines [ 21 22 23 ].…”

Section: Discussionsupporting

confidence: 69%

Impact of the Updated Guidelines on Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Breast Cancer

et al. 2020

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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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Section: Discussionsupporting

confidence: 69%

Impact of the Updated Guidelines on Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Breast Cancer

et al. 2020

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“…Recent studies on implementation of the updated 2018 ASCO/CAP guidelines have shown significant increases of HER2 negative rates through reclassification of ISH equivocal cases by the 2013 guidelines [15][16][17]. The updated guidelines seem to provide much clearer instructions for HER2 status designation by using concomitant IHC review in ISH groups 2, 3 and 4, and eliminating ISH equivocal category [15].…”

Section: Changes In Guidelines On Interpretation Of Her2 Statusmentioning

confidence: 99%

HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation

Ahn

Woo

Lee

et al. 2020

J Pathol Transl Med

133

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This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/ by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.Human epidermal growth factor receptor 2 (HER2) is a protooncogene that encodes epidermal growth factor receptor with tyrosine kinase activity, located on chromosome 17 at q21. In breast cancers, HER2 gene is amplified in 15%-20% of invasive breast cancers and its amplification is closely linked to HER2 protein overexpression [1,2]. HER2 amplification is a poor prognostic factor associated with a high rate of recurrence and mortality, and is a predictive factor for response to anthracyclinebased chemotherapies in patients with breast cancer [1,2]. Most importantly, it is a sole predictive marker for treatment benefits from HER2-targeting agents such as trastuzumab, lapatinib, and pertuzumab. As HER2-targeted therapy is exclusively effective in HER2-overexpressed and/or HER2-amplified breast cancers, precise assessment of HER2 status is an essential step for treatment of breast cancer. In this review, we focused on changes in the American Society of Clinical Oncology (ASCO)/ College of American Pathologists (CAP) guidelines on HER2 interpretation and some pitfalls in the interpretation of HER2 status in breast cancers. METHODS OF HER2 TESTINGCurrently, immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and chromogenic in situ hybridization (CISH) including silver in situ hybridization (SISH) are regarded as standard methods for determination of HER2 status in breast cancer, and some of them have been approved by the U.S. Food and Drug Administration (FDA) for HER2 testing in breast cancer since 1998.Although HER2 status can be directly tested by in situ hybridization (ISH), many laboratories have adopted IHC as a screening test, and FISH as a confirmation test for HER2 IHC equivocal cases, considering higher failure rate, longer procedure time and higher reagent cost of FISH, compared to that of IHC. Moreover, Human epidermal growth factor receptor 2 (HER2) protein overexpression and/or HER2 gene amplification is found in about 20% of invasive breast cancers. It is a sole predictive marker for treatment benefits from HER2 targeted therapy and thus, HER2 testing is a routine practice for newly diagnosed breast cancer in pathology. Currently, HER2 immunohistochemistry (IHC) is used for a screening test, and in situ hybridization is used as a confirmation test for HER2 IHC equivocal cases. Since the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines on HER2 testing was first released in 2007, it has been updated to provide clear instructions for HER2 testing and accurate determination of HER2 status in breast cancer. During HER2 interpretation, some pitfalls such as intratumoral HER2 heterogeneity and increase in chromosome enumeration probe 17 signals m...

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“…In our published meta-analysis 5 The frequency of HER-2 positivity for reflex FISH in our study was 33.06%, which is in contrast with the frequency reported by others. Murray et al, 13 Li et al, 14 Liu et al, 10 Xu et al, 12 and Hoda et al 15 focused on identifying the false-positive FISH cases to avoid unwarranted HDT. 10,16,17 The 2018 updated ASCO/CAP guidelines have eliminated the equivocal HER-2 FISH results and the subsequent dilemma for the medical oncologist and patients for HDT.…”

Section: Discussionmentioning

confidence: 99%

“…8 Although few studies have assiduously evaluated the impact of these 2018 updated ASCO/CAP guidelines, the implications of the same in the clinical practice are still enigmatic. [9][10][11][12][13][14][15] In this presented study, we evaluated the impact of 2018 ASCO/ CAP guidelines for HER-2 testing in IBC on various HER-2 scoring categories by up-front IHC testing and reflex FISH testing for equivocal cases.…”

Section: Introductionmentioning

confidence: 99%

Impact of 2018 ASCO/CAP guidelines on HER‐2 reporting categories of IHC and reflex FISH in breast cancer

et al. 2020

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Human epidermal growth factor receptor 2 (HER-2) is an established prognostic and predictive biomarker for breast cancer. To ensure accuracy and uniformity for HER-2 testing, ASCO/CAP published guidelines in 2007 which were updated in 2013 and recently in 2018. In this first study from Indian Oncology center, we evaluated the impact of 2018 ASCO/CAP guidelines. We found a substantial decrease in equivocal IHC cases (P-value < .00001). On reclassification, a total of 5.6% cases from equivocal and positive categories (2013 guidelines) shifted to the negative FISH result category (P-value < .0001), with adoption of 2018 guidelines and eliminated the double equivocal cases.

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Impact of the 2018 ASCO/CAP HER2 guidelines update for HER2 testing by FISH in breast cancer

Cited by 35 publications

References 23 publications

Impact of the Updated Guidelines on Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Breast Cancer

Impact of the Updated Guidelines on Human Epidermal Growth Factor Receptor 2 (HER2) Testing in Breast Cancer

HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation

Impact of 2018 ASCO/CAP guidelines on HER‐2 reporting categories of IHC and reflex FISH in breast cancer

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