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, Antonio C.; Hammond, M. Elizabeth; Allison, Kimberly H.; Harvey, Brittany E.; Mangu, Pamela B.; Bartlett, John M.S.; Bilous, Michael; Ellis, Ian O.; Fitzgibbons, Patrick L.; Hanna, Wedad; Jenkins, Robert B.; Press, Michael F.; Spears, Patricia A.; Vance, Gail H.; Viale, Giuseppe; McShane, Lisa M.; Dowsett, Mitchell

doi:10.5858/arpa.2018-0902-sa

Cited by 852 publications

(783 citation statements)

References 48 publications

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“…The benefit from anti‐HER2 target therapy for these cases is uncertain . HER2 IHC 2+ cases with HER2 copy numbers of <4 and ISH ratios ≥2 in the reflex ISH test were regarded as HER2‐negative by the 2018 updated ASCO/CAP guidelines . The present study including 202 IHC 2+ cases did not disclose significant survival differences between HER2 copy numbers of ≥4 and HER2 copy numbers of <4 cases (Table ).…”

Section: Discussionmentioning

confidence: 66%

“…If the HER2 test result is ultimately deemed to be equivocal, the oncologists may consider anti‐HER2 target therapy . The 2018 updated ASCO/CAP guideline recommendations suggest that the formerly ISH‐equivocal cases with concurrent IHC scored 2+ are defined as HER2‐negative . The benefit from anti‐HER2 target therapy for these cases is uncertain .…”

Section: Discussionmentioning

confidence: 99%

“…The 2018 updated ASCO/CAP guideline recommendations suggest that the formerly ISH‐equivocal cases with concurrent IHC scored 2+ are defined as HER2‐negative . The benefit from anti‐HER2 target therapy for these cases is uncertain . HER2 IHC 2+ cases with HER2 copy numbers of <4 and ISH ratios ≥2 in the reflex ISH test were regarded as HER2‐negative by the 2018 updated ASCO/CAP guidelines .…”

Section: Discussionmentioning

confidence: 99%

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HER2 immunohistochemical scores provide prognostic information for patients with HER2‐type invasive breast cancer

et al. 2019

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Aims Invasive breast cancer patients with human epidermal growth factor receptor 2 (HER2) immunohistochemical (IHC) scores of 3+ or 2+ with reflex in‐situ hybridisation (ISH) positivity are suitable for anti‐HER2 therapies. The aim of this study is to investigate whether the prognoses between IHC 3+ patients and IHC 2+/ISH+ patients are different. Methods and results We analysed the clinicopathological information of 886 consecutive cases of HER2‐positive early breast cancer. The influences of the patients’ age, cancer stage, hormone receptor status and anti‐HER2 treatment were adjusted using a multivariate Cox regression model. Both HER2 copy numbers and HER2 ISH ratios of the IHC 3+ group were significantly higher than those of the IHC 2+/ISH+ group. The outcomes of IHC 3+ patients were significantly better than those of IHC 2+/ISH+ patients in the univariate and multivariate analyses. HER2 copy numbers of ≥8 represented the best prognostic value, and it was chosen to be the cut‐off value. The reflex ISH for IHC 2+ patients with high HER2 copy numbers (≥8) predicted a better overall survival than that for those with low HER2 copy numbers. Conclusion HER2 IHC scores and HER2 copy numbers can provide prognostic information for patients with HER2‐positive invasive breast cancer. Both IHC 3+ and IHC 2+ patients with high HER2 copy numbers had a better prognosis.

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Section: Discussionmentioning

confidence: 66%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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HER2 immunohistochemical scores provide prognostic information for patients with HER2‐type invasive breast cancer

et al. 2019

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“…Antigen retrieval was as follows: for SMA, none; for CK7, Cam5.2, CK5/6, MUC4, mammaglobin, GCDFP‐15, p63 and SMM, Bond epitope retrieval solution 1 (Leica Biosystems); for calponin, Bond epitope retrieval solution 2 (Leica Biosystems); and for GATA3, MUC5AC, ER, PR, HER2 and AR, cell conditioning solution 1 (Ventana). For ER, PR and HER2, positive staining was defined according to ASCO/CAP guidelines . For the two breast MEC, immunohistochemistry was performed and evaluated on standard sections, whereas TMA was applied for MEC of salivary gland origin.…”

Section: Methodsmentioning

confidence: 99%

CRTC1–MAML2 fusion in mucoepidermoid carcinoma of the breast

et al. 2018

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Aims Mucoepidermoid carcinomas (MEC) are the most common malignant neoplasms of salivary glands, but are uncommon in other sites. Salivary gland MEC are most frequently associated with CRTC1–MAML2 translocations. Exceedingly rare MEC of the breast demonstrate a basal‐like and often triple (oestrogen and progesterone receptor, HER2)‐negative immunophenotype, with a single case previously reported to show MAML2 rearrangement, although the fusion partner was not known. Comprehensive genomic studies of breast MEC are lacking. In this study, we analysed the immunophenotype and molecular landscape of two breast MEC to elucidate the pathogenesis of these rare tumours. Methods and results Two breast MEC were subjected to capture‐based next‐generation DNA sequencing of 479 cancer‐related genes. The presence of the CRTC1–MAML2 fusion transcript was interrogated by reverse transcriptase–polymerase chain reaction. In addition, the immunoprofiles of breast MEC were compared to salivary gland MEC. Both breast MEC harboured CRTC1–MAML2 fusions. In contrast to most triple‐negative breast carcinomas of no special type, the mutational burden of MEC was very low, with one case demonstrating only an inactivating SETD2 mutation, and the other harbouring no somatic variants in genes on the panel. No copy number alterations were identified. The immunoprofiles of breast and salivary gland MEC were overlapping, but not identical. Conclusions The findings highlight MEC as a breast cancer subtype more closely related to its salivary gland counterpart than to basal‐like/triple‐negative breast cancers of no special type.

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“…5). HER2 should be tested in cell blocks because these allow protocols that are standardized for FFPE tissue [43-45]. Immunostaining for HER2 on direct smear or liquid-based preparations is not standardized and is insufficiently reliable for clinical use [14, 30, 43, 46].…”

Section: Evaluation Of Prognostic/predictive Markers Of Breast Cancermentioning

confidence: 99%

Ancillary Tests in Breast Cytology: A Practical Guide

Beça

Schmitt

2019

Acta Cytologica

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Utilization of fine-needle aspiration biopsy (FNAB) cytology for the diagnosis of diseases of the breast has been met with both excitement and uncertainty during the last couple of decades. Presently, FNAB for the diagnosis of primary and metastatic breast lesions is on the rise again. This is probably due to its fast turnaround time, cost efficiency, and minimal invasiveness, characteristics of this sampling modality which are particularly crucial for patients requiring frequent repeat biopsy in the setting of metastatic lesions. In this article, we will briefly review the main modern applications of FNAB of the breast when coupled with contemporary ancillary techniques. Such contemporary ancillary techniques range from classic immunocytochemistry (ICC) to the most modern molecular techniques, particularly next-generation sequencing. Coupled with contemporary ICC and molecular methods, FNAB of the breast can be used for several applications. The applications reviewed in this article include the primary diagnosis of a breast lesion, the identification of the breast as a primary source of a metastatic lesion, the evaluation of breast prognostic/predictive markers, and the tracking of tumor evolution. In our opinion, FNAB of the breast is an ideal sampling method, sharing many of the advantages of truly liquid and of tissue biopsies. Ultimately, we aim at demystifying the complexity of many of the challenges traditionally associated with the application of ancillary techniques to FNAB of the breast and provide insights into some of the most cutting-edge and clinically useful application scenarios.

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

Cited by 852 publications

References 48 publications

HER2 immunohistochemical scores provide prognostic information for patients with HER2‐type invasive breast cancer

HER2 immunohistochemical scores provide prognostic information for patients with HER2‐type invasive breast cancer

CRTC1–MAML2 fusion in mucoepidermoid carcinoma of the breast

Ancillary Tests in Breast Cytology: A Practical Guide

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