Journal of Medical and Surgical
Research (JMSR)


...

Pages: 1144-1144

Date of Publication: 01-Mar-2023

Comparative analysis of her-2 clones in invasive breast cancer: a literature review.

Author: S. Nagib, M. Regragui, A.Mazti, S. Benayad, N. Bennani-Guebessi, F. Marnissi, M. Karkouri.

Category: JMSR Pathology

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Abstract:

Introduction: The human epidermal growth factor receptor 2 (HER2) gene is an important tumor marker in invasive breast carcinoma (IBC). From 12 to 20% of IBC exhibit HER2 overexpression. The American Society of Clinical Oncology (ASCO) Tumor Marker Guidelines Panel has recommended HER2 research since 2001 as a routine test for newly diagnosed and metastatic breast cancer. Today, it is a standard of care. HER2 status is screened using immunohistochemistry (scored 0 to 3+) and confirmed with in-situ hybridization (ISH) for equivocal (2+) cases. With the era of new therapeutic strategies, the role of pathologists is increasingly crucial, and specific training and special attention during HER2 tests are warranted.

Objective: Several preanalytic factors such as fixation, antigen recovery, antibody clones, enzyme activity, reaction time, temperature and substrate concentration can influence the intensity of HER2 staining. As well, false negative or false positive HER-2 status may lead to inappropriate treatment in IBC patients. The purpose of this work is to study the impact of the choice of the antibody clones on the interpretation of HER2.

Method: We were conducted a literature review, a total of 8 studies published between 2009 and 2022 were analysed (cf. Annex.1) to compare the performance of different HER-2 clones, in particular the interobserving reproducibility and concordance with results of fluorescence in situ hybridization.

Results: This review allowed us to find 2 main clones, HercecpTest and 4B5, which are equivalent, and their performance has been improved by automation. We also found other clones that are performing (CB11). Generally, choice of clone left to each laboratory and guidelines of professional societies do not impose a particular clone.

Conclusion: For quality assurance, supplier recommendations should be implemented, in-house blocks are to be developed and a monitor the positivity rate should also be set up as well as an adherence to an external quality assessment system.

Keywords: Invasive breast carcinoma, HER2 clone, HercepTest , 4B5

Full Text:

COMPARATIVE ANALYSIS OF HER-2 CLONES IN INVASIVE BREAST CANCER: A LITERATURE REVIEW.

S. Nagib, M. Regragui, A.Mazti , S. Benayad,N. Bennani-Guebessi, F. Marnissi , M. Karkouri

Pathology Department, Ibn Rochd University Hospital, Casablanca, Morocco.

Introduction: The human epidermal growth factor receptor 2 (HER2) gene is an important tumor marker in invasive breast carcinoma (IBC). From 12 to 20% of IBC exhibit HER2 overexpression. The American Society of Clinical Oncology (ASCO) Tumor Marker Guidelines Panel has recommended HER2 research since 2001 as a routine test for newly diagnosed and metastatic breast cancer. Today, it is a standard of care. HER2 status is screened using immunohistochemistry (scored 0 to 3+) and confirmed with in-situ hybridization (ISH) for equivocal (2+) cases. With the era of new therapeutic strategies, the role of pathologists is increasingly crucial, and specific training and special attention during HER2 tests are warranted.

Objective: Several preanalytic factors such as fixation, antigen recovery, antibody clones, enzyme activity, reaction time, temperature and substrate concentration can influence the intensity of HER2 staining. As well, false negative or false positive HER-2 status may lead to inappropriate treatment in IBC patients. The purpose of this work is to study the impact of the choice of the antibody clones on the interpretation of HER2.

Method: We were conducted a literature review, a total of 8 studies published between 2009 and 2022 were analysed (cf. Annex.1) to compare the performance of different HER-2 clones, in particular the interobserving reproducibility and concordance with results of fluorescence in situ hybridization.

Results: This review allowed us to find 2 main clones, HercecpTest and 4B5, which are equivalent, and their performance has been improved by automation. We also found other clones that are performing (CB11). Generally, choice of clone left to each laboratory and guidelines of professional societies do not impose a particular clone.

Conclusion: For quality assurance, supplier recommendations should be implemented, in-house blocks are to be developed and a monitor the positivity rate should also be set up as well as an adherence to an external quality assessment system.

Keywords : Invasive breast carcinoma, HER2 clone, HercepTest , 4B5

References

  1. R__ampersandsignuuml;schoff J, and all. G. Comparison of HercepTest™ mAb pharmDx (Dako Omnis, GE001) with Ventana PATHWAY anti-HER-2/neu (4B5) in breast cancer: correlation with HER2 amplification and HER2 low status.Virchows Arch. 2022 Nov;481(5):685-694.
  2. Seema Jabbar, an all.219 Comparison of Two FDA-Approved Her2 Immunohistochemical Assays for Breast Carcinoma: HercepTest and Pathway Her2 (4B5);American Journal of Clinical Pathology, Volume 149, Issue suppl_1, January 2018, Pages S93–S94,
  3. Lucas E, and all . Comparison of Dako HercepTest and Ventana PATHWAY Anti-HER2 (4B5) Tests and Their Correlation With Fluorescent In Situ Hybridization in Breast Carcinoma. Appl Immunohistochem Mol Morphol. 2019 Jul;27(6):403-409..
  4. Layfield LJ, Frazier S, Esebua M, Schmidt RL. Interobserver reproducibility for HER2/neu immunohistochemistry: A comparison of reproducibility for the HercepTest™ and the 4B5 antibody clone. Pathol. Res. Pr. 2016;212(3):190–195 – PubMed
  5. NordiQC (06-DEC-2021). HER2 IHC assessments in the NordiQC (Aalborg, Denmark) breast cancer module. Available: https://www.nordiqc.org/downloads/assessments/149_11.pdf. Accessed 03.01.2022
  6. Doris Mayr 1, and all. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest (Dako) for manual testing and Her-2/neuTest 4B5 (Ventana) for Ventana BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Arch. 2009 Mar;454(3):241-8.
  7. Chantal Farra and all. The Impact of Partial Weak Staining in Normal Breast Epithelium on the Reliability of Immunohistochemistry Results in HercepTest-positive Breast Cancer. Clin Breast Cancer. 2019 Oct;19(5):340-344.
  8. Anne-Sofie Schrohl , and all. Human epidermal growth factor receptor 2 (HER2) immunoreactivity: specificity of three pharmacodiagnostic antibodies. Histopathology. 2011 Nov;59(5):975-83.

References:

  1. Rüschoff J, and all. G. Comparison of HercepTest™ mAb pharmDx (Dako Omnis, GE001) with Ventana PATHWAY anti-HER-2/neu (4B5) in breast cancer: correlation with HER2 amplification and HER2 low status.Virchows Arch. 2022 Nov;481(5):685-694.
  2. Seema Jabbar, an all.219 Comparison of Two FDA-Approved Her2 Immunohistochemical Assays for Breast Carcinoma: HercepTest and Pathway Her2 (4B5);American Journal of Clinical Pathology, Volume 149, Issue suppl_1, January 2018, Pages S93–S94,
  3. Lucas E, and all . Comparison of Dako HercepTest and Ventana PATHWAY Anti-HER2 (4B5) Tests and Their Correlation With Fluorescent In Situ Hybridization in Breast Carcinoma. Appl Immunohistochem Mol Morphol. 2019 Jul;27(6):403-409..
  4. Layfield LJ, Frazier S, Esebua M, Schmidt RL. Interobserver reproducibility for HER2/neu immunohistochemistry: A comparison of reproducibility for the HercepTest™ and the 4B5 antibody clone. Pathol. Res. Pr. 2016;212(3):190–195 – PubMed
  5. NordiQC (06-DEC-2021). HER2 IHC assessments in the NordiQC (Aalborg, Denmark) breast cancer module. Available: https://www.nordiqc.org/downloads/assessments/149_11.pdf. Accessed 03.01.2022
  6. Doris Mayr 1, and all. Comprehensive immunohistochemical analysis of Her-2/neu oncoprotein overexpression in breast cancer: HercepTest (Dako) for manual testing and Her-2/neuTest 4B5 (Ventana) for Ventana BenchMark automatic staining system with correlation to results of fluorescence in situ hybridization (FISH). Virchows Arch. 2009 Mar;454(3):241-8.
  7. Chantal Farra and all. The Impact of Partial Weak Staining in Normal Breast Epithelium on the Reliability of Immunohistochemistry Results in HercepTest-positive Breast Cancer. Clin Breast Cancer. 2019 Oct;19(5):340-344.
  8. Anne-Sofie Schrohl , and all. Human epidermal growth factor receptor 2 (HER2) immunoreactivity: specificity of three pharmacodiagnostic antibodies. Histopathology. 2011 Nov;59(5):975-83