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      Tuesday, May 30, 2023
      News & Perspective Drugs & Diseases CME & Education Academy Video Decision Point
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      CME

      HER2 Testing in 2023: Case Studies for Pathologists

      • Authors: Giuseppe Viale, MD, FRCPath; Peter A. Fasching, MD
      • CME Released: 3/14/2023
      • Valid for credit through: 3/14/2024
      Start Activity

      • Credits Available

        Physicians - maximum of 1.00 AMA PRA Category 1 Credit(s)™

        You Are Eligible For

        • Letter of Completion

      Target Audience and Goal Statement

      This educational activity is intended for an international audience of non-US pathologists, hematology/oncology specialists, and obstetricians/gynecologists.

      The goal of this activity is to enable learners to increase their knowledge and confidence on HER2 testing considering the recent clinical trial data for HER2-low breast cancer.

      Upon completion of this activity, participants will:

      • Have increased knowledge regarding the
        • HER2 testing guidelines and recommendations for breast cancer
        • Definition of HER2-low in breast cancer
      • Have greater competence related to
        • Selecting patients for HER2 testing
      • Demonstrate greater confidence in their ability to
        • Use HER2 testing to drive treatment decisions in advanced breast cancer

      Disclosures

      Medscape, LLC requires every individual in a position to control educational content to disclose all financial relationships with ineligible companies that have occurred within the past 24 months. Ineligible companies are organizations whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.

      All relevant financial relationships for anyone with the ability to control the content of this educational activity are listed below and have been mitigated. Others involved in the planning of this activity have no relevant financial relationships.

      Disclosures for additional planners can be found here.

      Faculty

      • Giuseppe Viale, MD, FRCPath

        Chairman, Department of Pathology & Laboratory Medicine
        European Institute of Oncology
        Milan, Italy

        Disclosures

        Guiseppe Viale, MD, FRCPath, has the following relevant financial relationships:
        Consultant or advisor for: Agilent; AstraZeneca; Bayer; Daiichi Sankyo, Inc.; Dako; Menarini; Merck Sharp & Dohme; Novartis; Pfizer, Inc.; Roche; Ventana Medical Systems
        Speaker or member of speakers bureau for: Agilent; Cepheid; Dako; Roche; Ventana Medical Systems
        Research funding from: Roche

      • Peter A. Fasching, MD

        Associate Professor of Gynecology and Obstetrics Translational Medicine
        University Hospital Erlangen
        Comprehensive Cancer Center Erlangen-EMN
        Erlangen, Germany

        Disclosures

        Peter A. Fasching, MD, has the following relevant financial relationships:
        Consultant or advisor for: Agendia; AstraZeneca; Daiichi Sankyo, Inc.; Eisai, Inc.; Eli Lilly and Company; Gilead Sciences, Inc.; Merck Sharp & Dohme; Novartis; Pfizer, Inc.; Pierre Fabre; Rocha; Sanofi Aventis; Seagen, Inc.
        Speaker or member of speakers bureau for: AstraZeneca; Daiichi Sankyo, Inc.; Eisai, Inc.; Eli Lilly and Company; Gilead Sciences, Inc.; Merck Sharp & Dohme; Novartis; Pfizer, Inc.; Roche; Seagen, Inc.
        Research funding from: Biontech; Cepheid; Pfizer, Inc.

      Editors

      • Mihai Surducan, PhD

        Medical Education Director, Medscape, LLC

        Disclosures

        Mihai Surducan, PhD, has no relevant financial relationships.

      • Jason Luis Quiñones, PhD

        Associate Medical Writer, Medscape, LLC

        Disclosures

        Jason Luis Quiñones, PhD, has no relevant financial relationships.

      Compliance Reviewer

      • Esther Nyarko, PharmD

        Director, Accreditation and Compliance, Medscape, LLC

        Disclosures

        Esther Nyarko, PharmD, has no relevant financial relationships.

      Peer Reviewer

      This activity has been peer reviewed and the reviewer has no relevant financial relationships.

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        For Physicians

      • Medscape, LLC designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit(s)™ . Physicians should claim only the credit commensurate with the extent of their participation in the activity.

        Contact This Provider

      For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact [email protected]

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      This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. To receive AMA PRA Category 1 Credit™, you must receive a minimum score of 70% on the post-test.

      Follow these steps to earn CME/CE credit*:

      1. Read about the target audience, learning objectives, and author disclosures.
      2. Study the educational content online or print it out.
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      You may now view or print the certificate from your CME/CE Tracker. You may print the certificate, but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period, you can print out the tally as well as the certificates from the CME/CE Tracker.

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      < Clinical Advances in The Future Directions Across the Spectrum of Breast Cancer
      From Medscape Education
      CME

      HER2 Testing in 2023: Case Studies for Pathologists

      Authors: Giuseppe Viale, MD, FRCPath; Peter A. Fasching, MDFaculty and Disclosures

      CME Released: 3/14/2023

      Valid for credit through: 3/14/2024

      processing....

      References

      1. Cancer.net Breast cancer statistics. Accessed February 28, 2022. https://www.cancer.net/cancer-types/breast-cancer/statistics
      2. International Agency for Research on Cancer, World Health Organization. Globocan 2020: Europe Fact Sheets. Accessed February 28, 2023. Available at: https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf
      3. Slamon DJ, et al. Human breast cancer: correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science. 1987;235:177-182.
      4. Slamon DJ, et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science. 1989;244:707-712.
      5. Slamon DJ, et al. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001;344:783-792.
      6. Cronin KA, et al. Population-based estimate of the prevalence of HER-2 positive breast cancer tumors for early stage patients in the US. Cancer Invest. 2010;28:963-968.
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      8. Chia S, et al. Human epidermal growth factor receptor 2 overexpression as a prognostic factor in a large tissue microarray series of node negative breast cancers. J Clin Oncol. 2008;26:5697-5704.
      9. Redig AJ, et al. Breast cancer as a systemic disease: a view of metastasis. J Inter Med. 2013;274:113-126.
      10. Kennecke H, et al. Metastatic behavior of breast cancer subtypes. J Clin Oncol. 2010;28:3271-3277.
      11. Wang, H. et al. The prognosis analysis of different metastasis pattern in patients with different breast cancer subtypes: a SEER based study. Oncotarget. 2016;8:26368-26379.
      12. Wu Q. et al. Breast cancer subtypes predict the preferential site of distant metastases: a SEER based study. Oncotarget. 2017;8:27990-27996.
      13. Zimmer AS, et al. HER2‐positive breast cancer brain metastasis: A new and exciting landscape. Cancer Reports. 2022;5.
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      16. Wolff AC, et al. 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;31:3997-4013.
      17. Wolff AC, et al. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med. 2014;138:241-256.
      18. Wolff AC, 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. J Clin Oncol. 2018;36:2105-2122.
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      20. Myers MB. Targeted therapies with companion diagnostics in the management of breast cancer: current perspectives. Pharmgenomics Pers Med. 2016;22:7-16.
      21. Food and Drug Administration (FDA). HER2 FISH pharmDx Kit labeling information. Accessed December 7, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf4/P040005C.pdf
      22. Food and Drug Administration (FDA). VENTANA HER2 dual ISH DNA probe cocktail. Accessed December 7, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190031C.pdf
      23. Food and Drug Administration (FDA). HercepTest for the dako autostainer code K5207HER2. Accessed December 7, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf/p980018s010c.pdf
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      25. Food and Drug Administration (FDA). PATHWAY anti-HER-2/neu (4B5) rabbit monoclonal primary antibody interpretation guide for breast cancer. Accessed December 7, 2022. https://www.accessdata.fda.gov/cdrh_docs/pdf/P990081S047D.pdf
      26. Cardoso F, et al. Early breast cancer: ESMO Cinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2019;30:1194-1220.
      27. Cardoso F, et al. 4th ESO-ESMO International Consensus Guidelines for Advanced Breast Cancer (ABC 4). Ann Oncol. 2018;29:1634-1657.
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      31. Zhang H, et al. HER2-low breast cancers: current insights and future directions. Semin Diagn Pathol. 2022;39:305-312.
      32. Curigliano G. HER2 low: a separate entity? PRO. Presented at: the San Antonio Breast Cancer Symposium; December 6-10, 2022; San Antonio, Texas. Special session 3.
      33. McMahon L, et al. HER2 FISH analysis on a skeletal metastasis: a case report and technical review. J Histotechnol. 2015;38:135-139.
      34. Penault-Llorca F, et al. Experts’ opinion: recommendations for retesting breast cancer metastases for HER2 and hormone receptor status. Breast. 2013;22:200-202.
      35. National Comprehensive Cancer Network (NCCN). Breast cancer (Version 4.2022). 2022. Accessed September 16, 2022. https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
      36. Gennari A, et al. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021;32:1475-1495.
      37. Tarantino P, et al. Evolution of low HER2 expression between early and advanced-stage breast cancer. Eur J Cancer. 2022;163:35-43.
      38. Miglietta F, et al. Evolution of HER2-low expression from primary to recurrent breast cancer. NPJ Breast Cancer. 2021;7:1-8. doi: 10.1038/s41523-021-00343-4. Erratum in: NPJ Breast Cancer. 2021;7:1-8.
      39. Aurilio G, et al. Discordant hormone receptor and human epidermal growth factor receptor 2 status in bone metastases compared to primary breast cancer. Acta Oncol. 2013;52:1649-1656.
      40. Schrijver WA, et al. Receptor conversion in distant breast cancer metastases: a systematic review and meta-analysis, J Natl Cancer Inst. 2018;110:568-580.
      41. Payandeh M, et al. Is there any concordance between of IHC with FISH in HER2-positive breast cancer patients? Int J Hematol Oncol Stem Cell Res. 2015;11:1-6.
      42. Liwski CR, et al. HER2 testing in metastatic breast cancer – Is reflex ISH testing necessary on HER2 IHC-equivocal (2+) cases? Ann Diagn Pathol. 2022;59:1-7.
      43. Memon R, et al. Discordance between immunohistochemistry and in situ hybridization to detect HER2 overexpression/gene amplification in breast cancer in the modern age: a single institution experience and pooled literature review study. Clin Breast Cancer. 2022;22:e123-e133.
      44. Pala EE, et al. Problems in determining HER2 status in breast carcinoma. J Breast Health. 2015;11:10-16.
      45. Orlandi A, et al. To treat or not to treat: HER2 equivocal is the matter! Transl Cancer Res. 2018;S433-S435.
      46. Scheel AH, et al. Physical basis of the ‘magnification rule’ for standardized Immunohistochemical scoring of HER2 in breast and gastric cancer. Diagn Pathol. 2018;13:1-7.
      47. Vance GH, et al. Genetic heterogeneity in HER2 testing in breast cancer. Arch Pathol Lab Med. 2009;133:611-612.
      48. Ahn S, et al. HER2 status in breast cancer: changes in guidelines and complicating factors for interpretation. J Pathology Transl Medicine. 2020;54:34-44.
      49. Fehrenbacher L, et al. NSABP B-47/NRG Oncology phase III randomized trial comparing adjuvant chemotherapy with or without trastuzumab in high-risk invasive breast cancer negative for HER2 by FISH and with IHC 1+ or 2. J Clin Oncol. 2020;38:444-453.
      50. Yazaki S, et al. Lower response to trastuzumab emtansine in metastatic breast cancer patients with human epidermal growth factor receptor 2 immunohistochemistry score of 2 and fluorescence in situ hybridization positive compared with immunohistochemistry score of 3: a retrospective study. Anticancer Drugs. 2020;31:973-978.
      51. Marchiò C, et al. Evolving concepts in HER2 evaluation in breast cancer: heterogeneity, HER2-low carcinomas and beyond. Sem Cancer Bio. 2021;72:123-135.
      52. Sapino A, et al. Current challenges for HER2 testing in diagnostic pathology: state of the art and controversial issues. Front Oncol. 2013;3:1-9.
      53. Venetis K, et al. HER2 low, ultra-low, and novel complementary biomarkers: expanding the spectrum of HER2 positivity in breast cancer. Front Mol Biosci. 2022;9:1-12.
      54. Viale G, et al. Retrospective study to estimate the prevalence and describe the clinicopathological characteristics, treatment patterns, and outcomes of HER2-low breast cancer. Presented at: the San Antonio Breast Cancer Symposium 2022 meeting; December 6-10, 2022; San Antonio, Texas. Poster HER2-15.
      55. Diéras V, et al. Trastuzumab deruxtecan (T-DXd) for advanced breast cancer patients (ABC), regardless HER2 status: a phase II study with biomarkers analysis (DAISY). Cancer Res. 2022;82(Suppl_4): Abstract PD8-02.
      56. ClinicalTrials.gov. Study of trastuzumab deruxtecan (T-DXd) vs investigator’s choice chemotherapy in HER2-low, hormone receptor positive, metastatic breast cancer (DB-06). Accessed December 5, 2022. https://clinicaltrials.gov/ct2/show/NCT04494425
      57. Modi S, et al. Trastuzumab deruxtecan in previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387:9-20.
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      60. Rugo HS, et al. TROPiCS-02: a phase III study investigating sacituzumab govitecan in the treatment of HR+/HER2- metastatic breast cancer. Future Oncol. 2020;16:705-715.
      61. Schmid P, et al. Sacituzumab govitecan efficacy in HR+/HER2- metastatic breast cancer by HER2 immunohistochemistry status in the phase 3 TROPiCS-02 study. Presented at: the 2022 annual ESMO Congress; Paris, France. Abstract FPN 214MO.
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      65. Hurvitz SA, et al. Safety and unique pharmacokinetic profile of ARX788, a site-specific ADC, in heavily pretreated patients with HER2-overexpresing solid tumors: Results from two phase 1 clinical trials. J Clin Oncol. 2021;39(suppl 15): Abstract 1038.
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      67. Moutafi M, et al. Quantitative measurement of HER2 expression to subclassify ERBB2 unamplified breast cancer. Lab Investig. 2022;102:1101-1108.
      68. Moy B, et al. Chemotherapy and targeted therapy for human epidermal growth factor receptor 2–negative metastatic breast cancer that is either endocrine-pretreated or hormone receptor–negative: ASCO Guideline rapid recommendation update. J Clin Oncol. 2022;40:3088-3090.
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