HER2 Testing in Breast Cancer

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Author: Kathryn R. Perkinson, BS, HTL(ASCP)
Reviewers: Jim Burchette, HT(ASCP); Carla Shoffeitt, MSM, HT(ASCP)

HER2/neu is a useful tumor marker for therapeutic decision making in patients with breast cancer. This course includes a review current breast cancer statistics, a comparison of methods used for HER2/neu testing, proper interpretation of HER2/neu fluorescence in situ hybridization (FISH), and the College of American Pathologists (CAP) guidelines for HER2/neu FISH testing.

Continuing Education Credits

Objectives

  • Review current breast cancer statistics.
  • Compare methods for HER2 testing.
  • Explain the College of American Pathologists (CAP) guidelines for HER2 fluorescence in situ hybridization (FISH) testing.
  • Outline the method for HER2 FISH assay.
  • Demonstrate proper interpretation of HER2 FISH assay.

Course Outline

  • Introduction
      • Overview
  • Theoretical Background
      • HER2: The Protein and the Gene
      • HER2 Protein Overexpression and Gene Amplification
      • HER2 is overexpressed in over 50% of breast tumors.
      • HER2 is a member of the epidermal growth factor receptor (EGFR) family of oncogenes.
      • HER2 is located on the long arm of chromosome 20.
  • Clinical Utility of HER2/neu Testing
      • Clinical Utility of HER2 Testing
      • Herceptin® (Trastuzumab)
      • Herceptin® (Trastuzumab): Additional Information
      • Testing for HER2: Sensitivity Versus Specificity
      • Herceptin® is a drug that is used to treat patients with HER2-positive breast tumors.
      • Herceptin® is associated with LOW cost and cardiac toxicity.
      • Herceptin® (Trastuzumab) Response
  • Clinical Testing for HER2/neu
      • Testing Methodologies
      • History of Testing for HER2: Timeline
      • History of Testing for HER2: Early Trials used Immunohistochemistry (IHC) testing
      • Testing Algorithms
      • HER2 by Immunohistochemistry (IHC)
      • HER2 by In Situ Hybridization (ISH) Methods
      • Additional Testing Methods for HER2
  • Methods to Assess HER2/neu Status
      • Fluorescence in Situ Hybridization (FISH) Versus Immunohistochemistry (IHC)
      • Which of the following are the two primary methods used to assess HER2 status is clinical laboratories?
      • What are the benefits of using immunohistochemistry (IHC) as a marker for HER2 gene amplification? (Choose all that apply.)
  • Immunohistochemical (IHC) methods
      • Summary of HER2 Immunohistochemical (IHC) Method
      • Patients with Immunohistochemistry (IHC) 2+ Tumors
      • Interpretation of HER2 Immunohistochemistry (IHC)
      • Interpretation of HER2 Immunohistochemistry (IHC): Agilent Dako HercepTest™
  • FISH TESTING
      • Fluorescence In Situ Hybridization (FISH)
      • Fluorescence In Situ Hybridization (FISH): Definitions
      • Need for Hematoxylin and Eosin (H&E) Slide
      • Breast Cancer Sample - Normal for HER2 Gene Copy Number
      • Polysomy of Chromosome 17 in Breast Cancer
      • HER2 Fluorescence in Situ Hybridization (FISH) Slide - Positive for Gene Amplification
      • HER2 Fluorescence in Situ Hybridization (FISH) Interpretation
      • Fluorescence in Situ Hybridization (FISH): Equivocal Results
      • Test Systems Without a Chromosome 17 Centromere Signal to Enumerate
      • FISH staining results with an average HER2 signals/tumor cell of >4.0 and <6.0 with the HER2/CEP17 ratio of <2.0 are considered equivocal res...
  • Testing Inaccuracies - Discordant Results between IHC and FISH
      • Discordant Results between Immunohistochemistry (IHC) and Fluorescence in Situ Hybridization (FISH)
      • Test Inaccuracies
      • Pre-Analytical Causes of Test Inaccuracies
      • Analytical Causes of Test Inaccuracies
      • Use of Image Analysis to Reduce Analytical Phase Testing Inaccuracies
      • Post-Analytical Causes of Test Inaccuracies
      • HER2 immunohistochemistry (IHC) scores of 1+, 2+, and 3+ are ALL considered positive for HER2.
  • HER2/NEU TESTING GUIDELINES
      • College of American Pathologists' (CAP) Guidelines for HER2
      • Pre-Analytic Guidelines: Specimen Handling Requirements
      • Analytic Guidelines: Assays
      • Analytic Guidelines: Interpretation
      • Post Analytic Guideline: Pathologist Competency
      • Quality Management
      • Validation Criteria
      • What is the Gold Standard?
      • Fluorescence in situ hybridization (FISH) is the gold standard for HER2 testing.
      • Which of the following is the range for optimal fixation times for HER2 FISH testing?
  • References
      • References

Additional Information

Level of instruction: Beginning to intermediate
Intended audience:  Clinical laboratory histotechnologists, histotechnicians, and other medical laboratory personnel who have an interest in this subject matter. This course is also appropriate for histology and clinical laboratory science students, pathology residents, and practicing pathologists.  
Author information: Kathryn R. Perkinson, BS, HTL(ASCP) has been the manager of the Molecular Pathology Department of Duke University Health System in Durham, North Carolina since 1998.  She holds a Bachelor of Science degree in biochemistry from North Carolina State University. Kathryn has over 25 years of experience in molecular biology in both the research and clinical healthcare fields at Duke University. The Molecular Pathology Department, under her leadership, has tripled in size over the past 15 years. 
Reviewer information: Jim Burchette, HT(ASCP) is retired from Duke University Medical Center, Durham, North Carolina as an Immunopathology Analytical Specialist in Molecular Pathology. He has over 38 years of experience in surgical pathology histotechnology with 33 years of immunopathology specialty. Jim has authored numerous peer-reviewed publications, (www.pubmed.com; search burchette j), two book chapters, and many abstracts, posters, and technical acknowledgments in peer reviewed scientific articles. Jim served as a consultant for Triangle Biomedical Sciences (TBS), Dako North America, Leica Microsystems, and Polysciences.
Reviewer information: Carla J. Shoffeitt, MSM, HT(ASCP) is the Manager of the Pathology Department of Emory St. Joseph’s Hospital of Emory Healthcare in Atlanta, Georgia. She holds a Master of Science Degree in Healthcare Management as well as a Bachelor of Science degree in Biology from Troy University, Troy, Alabama. She is certified as a Histotechnician and has 25 years of experience in the field of Histology.
Course description: HER2 is a useful tumor marker for therapeutic decision making in patients with breast cancer. This course includes a review of current breast cancer statistics and compares various methods for HER2 testing. Information is based on the current ASCO/CAP HER2 Test Guid

This course is part of:
Histology CE
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