Quantitative Impact of the 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Practice Guideline Update on Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: A Systematic Analysis

Wei, Christina; Garcia, Lino; Murata-Collins, Joyce; Schmolze, Daniel; Apple, Sophia K.

doi:10.5858/arpa.2020-0378-oa

Cited by 5 publications

(8 citation statements)

References 13 publications

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“…Fifteen (6.4%) of our cases were reclassified when the 2018 HER2 ASCO/CAP criteria were applied. Similarly, Wei et al showed, in their systematic analysis, that 7.1% of HER2 FISH results were reclassified using the 2018 ASCO/CAP criteria 13 . Reclassification rates of other studies are shown in Table 3 14–18 .…”

Section: Discussionmentioning

confidence: 87%

HER2 Equivocal (Score = 2+) Breast Carcinoma Cases Identified by Immunohistochemistry at a South African Hospital. What is the Impact of Fluorescent In Situ Hybridization Testing?

Mohanlal

Bouwer

Willem

2023

Applied Immunohistochemistry &Amp; Molecular Morphology

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The American Society of Clinical Oncology and the College of American Pathologists (ASCO/CAP) guidelines are used for human epidermal growth factor receptor 2 (HER2) reporting in breast carcinoma. Cases that demonstrate weak to moderate complete membrane immunohistochemical staining in >10% of the tumor are scored as 2+ (equivocal). This study aimed to determine what proportion of HER2 immunohistochemistry (IHC) score = 2+ breast carcinomas were confirmed to be positive by HER2 fluorescent in situ hybridization (FISH). There were 241 HER2 IHC score = 2+ breast carcinomas included. Most (74.3%) carcinomas were estrogen and progesterone receptor-positive. Invasive breast carcinoma of no special type (89.2%) was the commonest histologic subtype. Most tumors were grade 2 (64.3%). As per the FISH report, at the time of diagnosis, 27 cases (11.2%) were HER2 FISH positive. All HER2 FISH equivocal cases and one FISH positive case assessed using the 2013 ASCO/CAP HER2 criteria were reclassified to HER2 FISH negative when the 2018 criteria were applied. There was a high level of agreement (κ = 0.979) between HER2 FISH results obtained using the 2013 and the 2018 criteria. This study provides insight into the frequency of HER2 FISH positivity (11.2%) among HER2 IHC score = 2+ breast carcinomas and the impact of modifications to the ASCO/CAP HER2 guidelines. Elimination of the HER2 FISH equivocal category by the 2018 guidelines has reduced the need for repeat testing and simplified clinical management. Reclassification of previous HER2 FISH positive to negative has resulted in some patients being ineligible for costly anti-HER therapy.

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Section: Discussionmentioning

confidence: 87%

HER2 Equivocal (Score = 2+) Breast Carcinoma Cases Identified by Immunohistochemistry at a South African Hospital. What is the Impact of Fluorescent In Situ Hybridization Testing?

Mohanlal

Bouwer

Willem

2023

Applied Immunohistochemistry &Amp; Molecular Morphology

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“…For each antibody, positive and negative controls were included in each slide run. ER, PgR, and HER2 status were assessed according to the latest breast biomarker reporting guidelines published by the College of American Pathologists (CAP) in June 2021 23,24 . According to the updated recommendations from the International Ki67 Breast Cancer Working Group, a cut‐off value of ≥30% was used to define the high proliferation group 25 .…”

Section: Methodsmentioning

confidence: 99%

The molecular landscape of breast mucoepidermoid carcinoma

et al. 2023

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Mucoepidermoid carcinoma (MEC) of the breast is an extremely rare salivary gland‐type tumor characterized by epidermoid, basaloid, intermediate, and/or mucinous cells arranged in solid and cystic patterns. Despite their triple‐negative phenotype, breast MECs are generally considered low‐risk malignancies but their biology is largely unexplored; therefore, guidelines for clinical management are lacking. Here, we sought to characterize the molecular landscape of breast MECs. Thirteen cases were histologically reviewed, characterized for tumor‐infiltrating lymphocytes (TILs), and were subjected to immunohistochemistry for programmed death‐ligand 1 (PD‐L1, clone 22C3), EGFR, and amphiregulin (AREG). Rearrangements in MAML2 and EWSR1 were investigated by fluorescent in situ hybridization. Targeted next‐generation sequencing of 161 genes was performed on eight cases. Most MECs had low histological grade (n = 10, 77%), with the presence of TILs (n = 9/12; 75%) and PD‐L1 combined positive score ranging from 10 to 20 (n = 4/6; 67%). All cases showed EGFR and AREG overexpression and were fusion negative. Enrichment of genetic alterations was observed in PI3K/AKT/mTOR and cell cycle regulation pathways, while only one case harbored TP53 mutations. This is the first study providing extensive molecular data on breast MECs and the largest collection of cases available to date in the literature. Breast MECs lack TP53 mutations found in high‐grade forms of triple‐negative breast cancers and MAML2 or EWSR1 rearrangements pathognomonic of salivary MECs. Triple‐negativity and PD‐L1 positivity suggest a window of opportunity for immunotherapy in these patients. The EGFR/AREG axis activation, coupled with the mutational patterns in PI3K/AKT/mTOR and cell cycle pathways warrants caution in considering MECs as low‐risk neoplasms.

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“…Hormone receptors (HR) (i.e., estrogen receptor (ER), progesterone receptor (PgR)), Ki67, and HER2 status were updated to the breast biomarker reporting guidelines v1.4.1.1 published by the College of American Pathologists in November 2021 [ 29 , 30 , 31 ]. Then, lymphocyte subtyping was performed by immunohistochemistry (IHC) using antibodies against PD-L1 (clone 22C3), forkhead box P3 (FOXP3), CD4, and CD8 on an automated staining platform (i.e., Dako Omnis, Agilent, Santa Clara, CA, USA) on 4 µm-thick TMA sections, as previously described [ 32 , 33 , 34 ].…”

Section: Methodsmentioning

confidence: 99%

Breast Cancer during Pregnancy as a Special Type of Early-Onset Breast Cancer: Analysis of the Tumor Immune Microenvironment and Risk Profiles

Sajjadi

Venetis

Noale

et al. 2022

Cells

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Breast cancer during pregnancy (PrBC) is a rare tumor with only a little information on its immune landscape. Here, we sought to characterize the cellular composition of the tumor microenvironment (TME) of PrBC and identify its differences from early-onset breast cancer (EOBC) in non-pregnant women. A total of 83 PrBC and 89 EOBC were selected from our Institutional registry and subjected to tumor-infiltrating lymphocytes (TILs) profiling and immunohistochemistry for CD4, CD8, forkhead box P3 (FOXP3), and programmed death-ligand 1 (PD-L1) (clone 22C3). A significantly lower frequency of hormone receptor (HR)-positive tumors was observed in PrBC. The prevalence of low/null PD-L1 and CD8+TILs was higher in PrBC than in the controls, specifically in HR+/HER2– breast cancers. PrBC had a significantly higher risk of relapse and disease-related death, compared to EOBC. The presence of TILs and each TIL subpopulation were significantly associated with disease relapse. Moreover, the death rate was higher in PrBC with CD8+ TILs. The TME of PrBC is characterized by specific patterns of TIL subpopulations with significant biological and prognostic roles. Routine assessment of TILs and TILs subtyping in these patients would be a valid addition to the pathology report that might help identify clinically relevant subsets of women with PrBC.

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Quantitative Impact of the 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) Practice Guideline Update on Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: A Systematic Analysis

Cited by 5 publications

References 13 publications

HER2 Equivocal (Score = 2+) Breast Carcinoma Cases Identified by Immunohistochemistry at a South African Hospital. What is the Impact of Fluorescent In Situ Hybridization Testing?

HER2 Equivocal (Score = 2+) Breast Carcinoma Cases Identified by Immunohistochemistry at a South African Hospital. What is the Impact of Fluorescent In Situ Hybridization Testing?

The molecular landscape of breast mucoepidermoid carcinoma

Breast Cancer during Pregnancy as a Special Type of Early-Onset Breast Cancer: Analysis of the Tumor Immune Microenvironment and Risk Profiles

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