Impact of 2018 ASCO/CAP guidelines on HER‐2 reporting categories of IHC and reflex FISH in breast cancer

Pasricha, Sunil; Menon, Vidya; Gupta, Gurudutt; Kamboj, Meenakshi; Sharma, Abhimanyu; Durga, Garima; Tripathi, Rupal; Batra, Ullas; Jajodia, Ankush; Koyyala, Venkata Pradeep Babu; Agrawal, Chaturbhuj; Doval, D.C.; Mehta, Anurag

doi:10.1111/tbj.14031

Cited by 5 publications

(4 citation statements)

References 17 publications

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“…Variation in HER2 status reported in other studies is around 5 to 10%. 20 These findings explain the impact of the revised guidelines in identifying more patients with HER2 negative status in whom anti-HER2 targeted agents is avoided. The patients in group 2 and 4 categories are associated with low HER-2 protein expression, and there has been no strong evidence of treatment benefit in these two groups; hence, the updated 2018 guidelines identifies the false positive FISH cases to avoid unwarranted treatment.…”

Section: Discussionmentioning

confidence: 91%

Indian Data on HER2 Fluorescence In Situ Hybridization in Invasive Breast Cancer with Immunohistochemically Equivocal Results As Per 2018 ASCO/CAP Guidelines

Nagarjun

Parikh

Patel

et al. 2022

South Asian J Cancer

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Introduction Hormonal status and HER2 expression are valuable biomarkers and dictate the management of the patients diagnosed with invasive breast cancer (IBC). It is crucial to identify the patients who truly respond to anti-HER2 targeted therapy. Updated 2018 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines has recommended certain modifications in HER2 interpretation by fluorescence in situ hybridization (FISH) with concomitant immunohistochemistry (IHC). Objectives We aimed to evaluate HER2 FISH interpretation in IBC with equivocal IHC results as per 2018 ASCO/CAP recommendations and compare FISH results with hormonal receptor status. Materials and Methods FISH results of 502 cases of IBC with equivocal IHC report between January 2016 to January 2022 were reviewed retrospectively. FISH results were categorized according to ASCO/CAP guidelines 2018 into five respective groups. Results FISH testing in IHC equivocal cases showed 219 (43.6%) cases were classic amplified (positive) belonged to group 1, 217(43.2%) cases were classic nonamplified (negative) fell into group 5, 39 (7.8%) and 02 (0.4%) patients were in group 2 (negative) and group 3 (positive), and 25 (5.0%) cases were in group 4 (negative). About 52.1 and 49.3% of cases with estrogen receptor and progesterone receptor positivity were reported as HER2 positive. Among 502 cases, 25 equivocal cases according to the 2013 guidelines were redefined as HER2 negative and 02 (0.4%) cases reported positive were classified negative as per updated 2018 guidelines. Conclusion Revised 2018 guidelines is helpful in accurate identification of HER2 status and in avoiding targeted therapy in unwarranted cases. Updated 2018 guidelines has removed equivocal HER2-FISH category that has eliminated management dilemma in these cases. Only long-term clinical follow-up will establish the validity of the updated guidelines.

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Section: Discussionmentioning

confidence: 91%

Indian Data on HER2 Fluorescence In Situ Hybridization in Invasive Breast Cancer with Immunohistochemically Equivocal Results As Per 2018 ASCO/CAP Guidelines

Nagarjun

Parikh

Patel

et al. 2022

South Asian J Cancer

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“…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%

“…Many studies have carried out the significant positive result improvement of IHC stain, compared with ISH [ 9 , 10 ] based on the updated ASCO/CAP 2018 guidelines. However, in Thailand, the confirmation of the ISH test is recommended for all equivocal (2+) or positive (3+) IHC testing because of reimbursement issues.…”

Section: Introductionmentioning

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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“…Reflex FISH testing in the setting of an IHC HER2 equivocal status has diagnosed a significant number of HER2 positive patients. 14 However, the current guidelines do not recommend reflex FISH testing in the setting of a negative initial IHC staining. 15 , 16 These guidelines are based on literature suggesting a concordance as high as 96% between IHC protein overexpression and FISH gene amplification.…”

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confidence: 99%

Are There More HER2 FISH in the Sea? An Institution’s Experience in Identifying HER2 Positivity Using Fluorescent In Situ Hybridization in Patients with HER2 Negative Immunohistochemistry

Suydam,

Chibane,

Brown

et al. 2023

Ann Surg Oncol

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Background Approximately 20% of breast cancers express HER2-positive receptors in the USA. HER2 receptor immunohistochemistry (IHC) staining with equivocal (2+) results commonly undergoes fluorescence in-situ hybridization (FISH) for further classification. Current guidelines do not recommend routine FISH testing in IHC-negative (0 or 1+) cases. This study investigates an institution that performs both IHC and FISH testing on all cases to identify the true HER2-positive rate. Patients and Methods A retrospective chart review from 2015 to 2021 was conducted at an institution where both HER2 IHC and FISH testing were performed at the time of diagnosis for all invasive breast cancers. The rate of true HER2-positive patients was determined, and patient and tumor characteristics were further explored. Results A total of 1835 invasive breast cancer cases were primarily treated at this institution. A total of 289 cases were HER2 positive on IHC and FISH testing (15.7%). An additional 38 cases were identified as HER2 negative on IHC, but reclassified as HER2 positive on reflex FISH testing. Total HER2 positive cases increased from 289 (15.7%) to 327 cases (17.8%) with reflex FISH testing. Conclusions The additional HER2-positive cases after completing FISH testing on IHC-negative tumors suggests there may be a role for routine FISH testing in addition to standard IHC staining to determine HER2 status for breast cancer. The ethical, prognostic and even benefits of a correct diagnosis outweigh the added expense of FISH testing.

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Impact of 2018 ASCO/CAP guidelines on HER‐2 reporting categories of IHC and reflex FISH in breast cancer

Cited by 5 publications

References 17 publications

Indian Data on HER2 Fluorescence In Situ Hybridization in Invasive Breast Cancer with Immunohistochemically Equivocal Results As Per 2018 ASCO/CAP Guidelines

Indian Data on HER2 Fluorescence In Situ Hybridization in Invasive Breast Cancer with Immunohistochemically Equivocal Results As Per 2018 ASCO/CAP Guidelines

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

Are There More HER2 FISH in the Sea? An Institution’s Experience in Identifying HER2 Positivity Using Fluorescent In Situ Hybridization in Patients with HER2 Negative Immunohistochemistry

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