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CC BY-NC-ND 4.0 · South Asian J Cancer 2022; 11(04): 281-286
DOI: 10.1055/s-0042-1751052
Original Article
Breast Cancer

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

B. R. Nagarjun
1   Department of Oncopathology, Gujarat Cancer and Research Institute, Ahmedabad, Gujarat, India
,
Biren Parikh
1   Department of Oncopathology, Gujarat Cancer and Research Institute, Ahmedabad, Gujarat, India
,
Manaswi Nareshkumar Patel
3   Former Fellow in Oncopathology, Gujarat Cancer and Research Institute, Ahmedabad, Gujarat, India
,
Pina J. Trivedi
2   Department of Cytogenetics, Gujarat Cancer and Research Institute, Ahmedabad, Gujarat, India
,
Dharmesh M. Patel
2   Department of Cytogenetics, Gujarat Cancer and Research Institute, Ahmedabad, Gujarat, India
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Abstract

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Biren Parikh

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.

Keywords

ASCO/CAP guidelines 2018 - equivocal - FISH - HER2 - invasive breast cancer

Note

Institutional review was obtained for the study.




Publication History

Article published online:
23 August 2022

© 2022. MedIntel Services Pvt Ltd. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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  • References

  • 1 Malvia S, Bagadi SA, Dubey US, Saxena S. Epidemiology of breast cancer in Indian women. Asia Pac J Clin Oncol 2017; 13 (04) 289-295
    CrossrefPubMedGoogle Scholar
  • 2 Wolff AC, Hammond ME, Schwartz JN. et al; American Society of Clinical Oncology/College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med 2007; 131 (01) 18-43
    CrossrefPubMedGoogle Scholar
  • 3 Wolff AC, Hammond ME, Hicks DG. et al; American Society of Clinical Oncology, College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol 2013; 31 (31) 3997-4013
    CrossrefPubMedGoogle Scholar
  • 4 Wolff AC, Hammond MEH, Allison KH. et al. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. Arch Pathol Lab Med 2018; 142 (11) 1364-1382
    CrossrefPubMedGoogle Scholar
  • 5 Liu ZH, Wang K, Lin DY. et al. Impact of the updated 2018 ASCO/CAP guidelines on HER2 FISH testing in invasive breast cancer: a retrospective study of HER2 fish results of 2233 cases. Breast Cancer Res Treat 2019; 175 (01) 51-57
    CrossrefPubMedGoogle Scholar
  • 6 Wang B, Ding W, Sun K, Wang X, Xu L, Teng X. Impact of the 2018 ASCO/CAP guidelines on HER2 fluorescence in situ hybridization interpretation in invasive breast cancers with immunohistochemically equivocal results. Sci Rep 2019; 9 (01) 16726
    CrossrefPubMedGoogle Scholar
  • 7 Perez EA, Reinholz MM, Hillman DW. et al. HER2 and chromosome 17 effect on patient outcome in the N9831 adjuvant trastuzumab trial. J Clin Oncol 2010; 28 (28) 4307-4315
    CrossrefPubMedGoogle Scholar
  • 8 Adamczyk A, Kruczak A, Harazin-Lechowska A. et al. Relationship between HER2 gene status and selected potential biological features related to trastuzumab resistance and its influence on survival of breast cancer patients undergoing trastuzumab adjuvant treatment. OncoTargets Ther 2018; 11: 4525-4535
    CrossrefPubMedGoogle Scholar
  • 9 Stocker A, Hilbers ML, Gauthier C. et al. HER2/CEP17 ratios and clinical outcome in HER2-positive early breast cancer undergoing trastuzumab-containing therapy. PLoS One 2016; 11 (07) e0159176
    CrossrefPubMedGoogle Scholar
  • 10 Patil Okaly GV, Panwar D, Lingappa KB. et al. FISH and HER2/neu equivocal immunohistochemistry in breast carcinoma. Indian J Cancer 2019; 56 (02) 119-123
    CrossrefPubMedGoogle Scholar
  • 11 Lin L, Sirohi D, Coleman JF, Gulbahce HE. American Society of Clinical Oncology/College of American Pathologists 2018 Focused Update of Breast Cancer HER2 FISH Testing Guidelines Results from a National Reference Laboratory. Am J Clin Pathol 2019; 152 (04) 479-485
    CrossrefPubMedGoogle Scholar
  • 12 Press MF, Sauter G, Buyse M. et al. HER2 Gene Amplification Testing by Fluorescent In Situ Hybridization (FISH): comparison of the ASCO-College of American Pathologists Guidelines with FISH scores used for enrollment in Breast Cancer International Research Group clinical trials. J Clin Oncol 2016; 34 (29) 3518-3528
    CrossrefPubMedGoogle Scholar
  • 13 Press MF, Villalobos I, Santiago A. et al. Assessing the New American Society of Clinical Oncology/College of American Pathologists guidelines for HER2 testing by fluorescence in situ hybridization: experience of an academic consultation practice. Arch Pathol Lab Med 2016; 140 (11) 1250-1258
    CrossrefPubMedGoogle Scholar
  • 14 Ballard M, Jalikis F, Krings G. et al. ‘Non-classical’ HER2 FISH results in breast cancer: a multi-institutional study. Mod Pathol 2017; 30 (02) 227-235
    CrossrefPubMedGoogle Scholar
  • 15 Long TH, Lawce H, Durum C. et al. The new equivocal: changes to HER2 FISH results when applying the 2013 ASCO/CAP guidelines. Am J Clin Pathol 2015; 144 (02) 253-262
    CrossrefPubMedGoogle Scholar
  • 16 Hanna WM, Rüschoff J, Bilous M. et al. HER2 in situ hybridization in breast cancer: clinical implications of polysomy 17 and genetic heterogeneity. Mod Pathol 2014; 27 (01) 4-18
    CrossrefPubMedGoogle Scholar
  • 17 Ahn S, Woo JW, Lee K, Park SY. HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation. J Pathol Transl Med 2020; 54 (01) 34-44
    CrossrefPubMedGoogle Scholar
  • 18 Valent A, Penault-Llorca F, Cayre A, Kroemer G. Change in HER2 (ERBB2) gene status after taxane-based chemotherapy for breast cancer: polyploidization can lead to diagnostic pitfalls with potential impact for clinical management. Cancer Genet 2013; 206 (1-2): 37-41
    CrossrefPubMedGoogle Scholar
  • 19 Kong H, Bai Q, Li A, Zhou X, Yang W. Characteristics of HER2-negative breast cancers with FISH-equivocal status according to 2018 ASCO/CAP guideline. Diagn Pathol 2022; 17 (01) 5
    CrossrefPubMedGoogle Scholar
  • 20 Pasricha S, Menon V, Gupta G. et al. Impact of 2018 ASCO/CAP guidelines on HER-2 reporting categories of IHC and reflex FISH in breast cancer. Breast J 2020; 26 (11) 2213-2216
    CrossrefPubMedGoogle Scholar
  • 21 Wang J, Xu B. Targeted therapeutic options and future perspectives for HER2-positive breast cancer. Signal Transduct Target Ther 2019; 4: 34
    CrossrefPubMedGoogle Scholar
  • 22 Xu B, Shen J, Guo W, Zhao W, Zhuang Y, Wang L. Impact of the 2018 ASCO/CAP HER2 guidelines update for HER2 testing by FISH in breast cancer. Pathol Res Pract 2019; 215 (02) 251-255
    CrossrefPubMedGoogle Scholar