Impact of the 2013 <scp>A</scp>merican <scp>S</scp>ociety of <scp>C</scp>linical <scp>O</scp>ncology/<scp>C</scp>ollege of <scp>A</scp>merican <scp>P</scp>athologists guideline recommendations for human epidermal growth factor receptor 2 (<scp>HER</scp>2) testing of invasive breast carcinoma: a focus on tumours assessed as ‘equivocal’ for <scp>HER</scp>2 gene amplification by fluorescence <i>in‐situ</i> hybridization

Bethune, Gillian C.; Zanten, Daniel Veldhuijzen van; MacIntosh, Rebecca F.; Rayson, Daniel; Younis, Tallal; Thompson, Kara; Barnes, Penny J.

doi:10.1111/his.12723

Cited by 62 publications

(52 citation statements)

References 25 publications

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“…In our study, the equivocal cases by D-FISH accounted for 12.9% in the group of 255 consecutive BCa and 9.5% in 1266 Her-2 IHC 2+ cases. 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].…”

Section: Discussionsupporting

confidence: 92%

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: 92%

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

950

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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“…HER2 gene amplification was determined by staining of the centromeres of the corresponding chromosome 17 with a staining kit for HER2 (ZytoDot, 2C SPEC HER2/CEN17, Zyto Vision Ltd., Bremerhaven, Germany). HER2 positivity was defined as IHC score 3+ alone or 2+ with positive HER2 CISH [34]. Proliferation was assessed with the proliferation marker Ki67.…”

Section: Histopathological Assessmentmentioning

confidence: 99%

TILGen: A Program to Investigate Immune Targets in Breast Cancer Patients - First Results on the Influence of Tumor-Infiltrating Lymphocytes

et al. 2018

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Background: Despite advancements in the treatment of primary and metastatic breast cancer, many patients lack a durable response to these treatments. Patients with triple-negative breast cancer (TNBC) and human epidermal growth factor receptor 2(HER2)-positive breast cancer who do not have a pathological complete response (pCR) after neoadjuvant chemotherapy (NACT) have a very poor prognosis. Tumor-infiltrating lymphocytes (TILs) have been identified as a predictive marker for pCR after NACT in TNBC and HER2-positive breast cancer. These patient populations could also be suitable for novel treatment strategies including neoepitope-based therapies. This work analyses the effect of TILs on the pCR in neoadjuvantly treated patients in the TILGen study and presents the procedures aimed at establishing neoepitope-based therapies in this study. Methods: Neoadjuvantly treated HER2-positive and TNBC patients were eligible for the presented analysis concerning the association between TILs and pCR. A total of 146 patients could be identified within the TILGen study. TILs were evaluated as percentage of stromal tumor tissue in core biopsies at primary diagnosis. The phenotype ‘lymphocyte-predominant breast cancer' (LPBC) was associated with pCR by logistic regression adjusted for estrogen receptor status, progesterone receptor status, HER2 status, age at diagnosis, and grading. Results: LPBC was seen in 24 (16.4%) patients. In this patient group, 66.7% achieved a pCR, while the pCR rate was 32.8% in patients with a low TIL count. The adjusted odds ratio was 6.60 (95% confidence interval 2.02-21.56; p < 0.01). Conclusion: TILs are a strong predictor of pCR in TNBC and HER2-positive breast cancer patients. Implications for the use of this information including the effect on prognosis might help to identify patients most likely to benefit from a neoepitope-based therapy approach.

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Cited by 62 publications

References 25 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

TILGen: A Program to Investigate Immune Targets in Breast Cancer Patients - First Results on the Influence of Tumor-Infiltrating Lymphocytes

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