Impact of the 2013 ASCO/CAP <i>HER2</i> Guideline Updates at an Academic Medical Center That Performs Primary <i>HER2</i> FISH Testing

Muller, Kristen E.; Marotti, Jonathan D.; Memoli, Vincent A.; Wells, Wendy A.; Tafe, Laura J.

doi:10.1309/ajcpe5nchwpsmr5d

Cited by 51 publications

(43 citation statements)

References 17 publications

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“…A recent study also showed that the percentage of Her-2 D-FISH equivocal cases was as high as 9.4% according to the ASCO/CAP 2013 guidelines [16], similar to our results. Several other studies also demonstarted a significant increase in the D-FISH equivocal cases after the ASCO/CAP 2013 guideline update [12,14,15,17,18]. In addition, our assay revealed the interpretation of D-FISH equivocal results with good reproducibility.…”

Section: Discussionsupporting

confidence: 63%

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

Qian

Wen

Yang

et al. 2016

Breast Cancer Res Treat

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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 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 Ki-67 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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Section: Discussionsupporting

confidence: 63%

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

Qian

Wen

Yang

et al. 2016

Breast Cancer Res Treat

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“…1,4 The number of such cases within a laboratory varies based on the patient population referred for ISH testing, but it seems to be approximately 5% of cases (range, 1% to 16%). 15,[19][20][21][32][33][34][35][36][37][38][39][40][41][42] The use of alternative probes to adjudicate these cases has also increased since 2013.…”

Section: Clinical Questionmentioning

confidence: 99%

Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update

Wolff

Hammond

Allison

et al. 2018

Archives of Pathology &Amp; Laboratory Medicine

944

840

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Purpose.-To update key recommendations of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) human epidermal growth factor receptor 2 (HER2) testing in breast cancer guideline.Methods.-Based on the signals approach, an Expert Panel reviewed published literature and research survey results on the observed frequency of less common in situ hybridization (ISH) patterns to update the recommendations.Recommendations.-Two recommendations addressed via correspondence in 2015 are included. First, immunohistochemistry (IHC) 2þ is defined as invasive breast cancer with weak to moderate complete membrane staining observed in .10% of tumor cells. Second, if the initial HER2 test result in a core needle biopsy specimen of a primary breast cancer is negative, a new HER2 test may (not ''must'') be ordered on the excision specimen based on specific clinical criteria. The HER2 testing algorithm for breast cancer is updated to address the recommended workup for less common clinical scenarios (approximately 5% of cases) observed when using a dual-probe ISH assay. These scenarios are described as ISH group 2 (HER2/ chromosome enumeration probe 17 [CEP17] ratio 2.0; average HER2 copy number ,4.0 signals per cell), ISH group 3 (HER2/CEP17 ratio ,2.0; average HER2 copy number 6.0 signals per cell), and ISH group 4 (HER2/ CEP17 ratio ,2.0; average HER2 copy number 4.0 and ,6.0 signals per cell). The diagnostic approach includes more rigorous interpretation criteria for ISH and requires concomitant IHC review for dual-probe ISH groups 2 to 4 to arrive at the most accurate HER2 status designation (positive or negative) based on combined interpretation of the ISH and IHC assays. The Expert Panel recommends that laboratories using single-probe ISH assays include concomitant IHC review as part of the interpretation of all single-probe ISH assay results.

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“…In a laboratory using FISH for first-line testing, reflex HER2 IHC provided a clear positive or negative result in only 5 of 17 FISH-equivocal cases (29%). 17 In contrast, in a laboratory using first-line IHC, reflex FISH for 2þ IHC yielded a clear amplified or nonamplified result in 43 of 50 cases (86%). 18 It should be recognized that both IHC and FISH represent an attempt to convert a continuous biologic variable into a dichotomous category, an exercise that is clearly dependent on reproducible application of a validated cutoff.…”

Section: Test Methodologymentioning

confidence: 90%

Molecular Testing in Breast Cancer: A Guide to Current Practices

Hagemann

2016

Archives of Pathology &Amp; Laboratory Medicine

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Context.-Molecular diagnostics play a role in the management of many cancers, including breast cancer.Objective.-To provide an update on molecular testing in current clinical practice, targeted at practicing pathologists who are not breast cancer specialists.Data Sources.-This study is a narrative literature review.Conclusions.-In addition to routine hormone (estrogen and progesterone) receptor testing, new and recurrent tumors are tested for HER2 amplification by in situ hybridization or overexpression by immunohistochemistry. Intrinsic subtyping of tumors represents a fundamental advance in our understanding of breast cancer biology, but currently it has an indirect role in patient management. Clinical next-generation sequencing (tumor profiling) is increasingly used to identify potentially actionable mutations in tumor tissue. Multianalyte assays with algorithmic analysis, including MammaPrint, Oncotype DX, and Prosigna, play a larger role in breast cancer than in many other malignancies. Given that a proportion of breast cancers are familial, testing of nontumor tissue for cancer predisposition mutations also plays a role in breast cancer care.

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Impact of the 2013 ASCO/CAP HER2 Guideline Updates at an Academic Medical Center That Performs Primary HER2 FISH Testing

Cited by 51 publications

References 17 publications

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

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

Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update

Molecular Testing in Breast Cancer: A Guide to Current Practices

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