The impact of 2018 ASCO-CAP HER2 testing guidelines on breast cancer HER2 results. An audit of 2132 consecutive cases evaluated by immunohistochemistry and in situ hybridization

Farshid, Gelareh; Dhatrak, Deepak; Gilhotra, Amardeep; Koszyca, Barbara; Nolan, James P.

doi:10.1038/s41379-020-0555-7

Cited by 12 publications

(7 citation statements)

References 17 publications

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“…HER2 gene amplification seems to be very constant in different tumor regions, as opposed to greater variability observed with protein expression as assessed by IHC staining. This in turn is reflected in lower concordance rates between IHC and FISH [54][55][56]. As HER2-ICC also evaluates HER2 protein expression similar to IHC, it is subject to this observed variability, which may be the cause of decreased sensitivity as compared to HER2-FISH in our assay.…”

Section: Discussionmentioning

confidence: 97%

Circulating tumor cell assay to non-invasively evaluate PD-L1 and other therapeutic targets in multiple cancers

et al. 2022

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Biomarker directed selection of targeted anti-neoplastic agents such as immune checkpoint inhibitors, small molecule inhibitors and monoclonal antibodies form an important aspect of cancer treatment. Immunohistochemistry (IHC) analysis of the tumor tissue is the method of choice to evaluate the presence of these biomarkers. However, a significant barrier to biomarker testing on tissue is the availability of an adequate amount of tissue and need for repetitive sampling due to tumor evolution. Also, tumor tissue testing is not immune to inter- and intra-tumor heterogeneity. We describe the analytical and clinical validation of a Circulating Tumor Cell (CTC) assay to accurately assess the presence of PD-L1 22C3 and PD-L1 28.8, ER, PR and HER2, from patients with solid tumors to guide the choice of suitable targeted therapies. Analytically, the test has high sensitivity, specificity, linearity and precision. Based on a blinded case control study, the clinical sensitivity and specificity for PD-L1 (22C3 and 28.8) was determined to be 90% and 100% respectively. The clinical sensitivity and specificity was 83% and 89% for ER; 80% and 94% for PR; 63% and 89% for HER2 (by ICC); and 100% and 92% for HER2 (by FISH), respectively. The performance characteristics of the test support its suitability and adaptability for routine clinical use.

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Section: Discussionmentioning

confidence: 97%

Circulating tumor cell assay to non-invasively evaluate PD-L1 and other therapeutic targets in multiple cancers

et al. 2022

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“…For many years bright field alternatives to FISH, including chromogenic in situ hybridization (CISH) and SISH, have been utilized by us and others for assessing HER2 amplification in breast and gastroesophageal carcinomas. 15,16 CISH has been studied in 2 prior reports for MDM2 amplification, 17,18 and a SISH probe is available commercially for this purpose. CISH and SISH are similar in producing stable signals, detectable by light microscopy.…”

Section: Discussionmentioning

confidence: 99%

Silver In Situ Hybridization for the Rapid Assessment of MDM2 Amplification in Soft Tissue and Bone Tumors. Validation Based on an Audit of 192 Consecutive Cases Evaluated by Silver In Situ Hybridization and Fluorescence In Situ Hybridization

Farshid

Otto

Collis

et al. 2023

Applied Immunohistochemistry &Amp; Molecular Morphology

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The discovery of almost invariable mouse double minute 2 (MDM2) amplification among atypical lipomatous tumors (ALT)/well-differentiated liposarcoma and dedifferentiated liposarcoma is incorporated into the contemporary diagnostic workup of fatty lesions. MDM2 amplifications are also found frequently in intimal sarcomas and in low-grade osteogenic sarcoma. At present, fluorescence in situ hybridization (FISH) is the reference test for MDM2 assessment. We are interested in evaluating silver in situ hybridization (SISH) for this purpose. Between October 2016 and May 2020, in 192 consecutive cases requiring MDM2 FISH, SISH was also performed concurrently, including 77 (40.1%) core biopsies and 115 (58.9%) surgical specimens. The mean patient age was 61.0 years. SISH results were available overnight or within 48 hours if repeat testing was required. FISH results were available within 2 to 5 weeks. The cost of SISH was one third of FISH. FISH demonstrated MDM2 amplification in 44 cases (23.6%), was negative in 144 cases (74.4%) and nondiagnostic in 4 decalcified cases (2.0%). SISH showed MDM2 amplification in 33 cases (17.2%), no amplification in 119 cases (62.0%), and indeterminate results because of poor signal in 40 (20.8%) cases. All 33 (100%) SISH-amplified tumors and 113 of 119 (95.0%) nonamplified results were confirmed by FISH. There were no clear differences in the performance of SISH on NCB versus surgical specimens. The overall performance indices of SISH are sensitivity 75%, specificity 78.5%, positive predictive value 100%, and negative predictive value 95.8%. FISH is not required when SISH is clearly amplified. This is clinically useful and improves efficiency. Nonamplified SISH results provide early indications of the likely FISH findings, but there is a 4.2% chance of FISH being positive. At present, the main drawback of SISH is the high rate of nondiagnostic tests. Optimization of SISH signal detection to reduce the proportion of indeterminate results is our current focus.

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“…Compared with the 2013 ASCO/CAP guidelines, the 2018 ASCO/CAP guidelines refined the HER-2 evaluation algorithms by defining uncommon HER-2 ISH amplification patterns that cause uncertain biological and clinical significance. They increased the emphasis on coordinating ISH and IHC results [ 11 ], refining the criteria for HER-2-positive patients with monosomy chromosome 17 and co-amplification of HER-2 incorporation with HER-2 protein expression by IHC. These resulted in significantly decreased equivocal results and increased truly negative results in HER-2 IHC stains [ 9 , 12 ].…”

Section: Discussionmentioning

confidence: 99%

The concordance between IHC and ISH for HER-2 testing in breast cancer in Nakhon Pathom Hospital, Thailand, based on the ASCO/CAP 2018 guidelines: a retrospective study

Thambamroong¹

2022

ecancer

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Human epidermal growth factor receptor 2 (HER-2) is the prognostic and predictive biomarker for breast cancer found in a quarter of all breast cancer cases. Precise testing of HER-2 will impact treatment response.Based on the updated American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) HER-2 testing guidelines, we report 141 cases of positive concordance rate between HER-2 IHC stain and dual-probe ISH for HER-2 testing classified in equivocal (2+) and positive (3+) IHC groups in Nakhon Pathom Hospital, Thailand. Our study showed statistical significance in the relationship between positive (3+) IHC and dual-probe ISH for HER-2 testing with a correlation rate of 91.76% ( r s = 0.38031, p < 0.0001) and 37.50% in equivocal (2+) IHC groups.This is the first report of a positive concordance rate between equivocal and positive HER-2 IHC and dual-probe ISH for HER-2 based on the ASCO/CAP 2018 guidelines in Thailand. Our study confirmed a statistically significant relationship in the positive IHC (3+) group. In addition, we suggested reflexing ISH testing only in equivocal IHC (2+) cases to decrease the waiting time and economical approach.

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The impact of 2018 ASCO-CAP HER2 testing guidelines on breast cancer HER2 results. An audit of 2132 consecutive cases evaluated by immunohistochemistry and in situ hybridization

Cited by 12 publications

References 17 publications

Circulating tumor cell assay to non-invasively evaluate PD-L1 and other therapeutic targets in multiple cancers

Circulating tumor cell assay to non-invasively evaluate PD-L1 and other therapeutic targets in multiple cancers

Silver In Situ Hybridization for the Rapid Assessment of MDM2 Amplification in Soft Tissue and Bone Tumors. Validation Based on an Audit of 192 Consecutive Cases Evaluated by Silver In Situ Hybridization and Fluorescence In Situ Hybridization

The concordance between IHC and ISH for HER-2 testing in breast cancer in Nakhon Pathom Hospital, Thailand, based on the ASCO/CAP 2018 guidelines: a retrospective study

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