Breast Cancer Predictive Markers

(based on 131 customer ratings)

Author: Joelle Weaver MAOM, HTL(ASCP), QIHC
Reviewer: Carla Shoffeitt, MSM, HT(ASCP)

Toxicity, side effects, and unpredictable effectiveness have been the hallmark of anti-cancer therapies used in the past to treat breast and other primary cancers. Targeted therapies have been developed which reduce patient risk and provide remarkable improvement in patient outcomes. This course will discuss how predictive markers/testing are used to select patients who are most likely to respond positively to a specific breast cancer treatment, including current testing methodologies and compliance standards.

Continuing Education Credits

Objectives

  • Recognize the value of predictive test results to clinical treatment decisions in human breast cancer.
  • Identify the main types of predictive testing performed in the histology laboratory.
  • Determine test methodologies used to identify the expression and amplification of human epidermal growth factor receptor 2 (HER2).
  • Examine current test methodologies used to identify the expression and amplification of HER2.
  • Identify compliance standards for validation, correlation, and proficiency testing under the guidelines set by the College of American Pathologists (CAP).

Course Outline

  • Introduction
      • Predictive Testing is the Basis of Personalized Treatment
      • Predictive versus Prognostic
      • Response Rates to Common Therapies
      • True or False: A prognostic factor is information concerning the patient used to help the clinician select the appropriate individuals for treatment w...
      • True or False: Researchers have determined that only patients with tumors that demonstrate more significant than 70% estrogen receptor (ER) positive c...
  • Types of Breast Cancer
      • Incidence and Risk Factors
      • Breast Cancer Classification
      • Tumor Staging
      • Use of Immunohistochemistry for Breast Tumor Classification
      • True or False: Adenocarcinoma is a very rare type of human breast cancer.
      • True or False: Obesity, alcohol, and tobacco use are believed to have an impact on the risk of developing breast cancer.
  • Regulation and Compliance with Predictive Markers
      • Validation, Quality Control, Regulations...Why?
      • Regulation
      • Validation Purpose
      • Compliance Documentation
      • Mandatory Proficiency Testing
      • True or False: Laboratories accredited by the College of American Pathologists (CAP) that perform HER2 testing are not required to participate in prof...
      • True or False: Test method verification or validation is required for all new test systems used in the laboratory before they are used in patient test...
  • Theoretical Basis of Immunohistochemical Testing
      • Basics of Immunohistochemistry
      • Variables Affecting IHC
      • Types of Antibodies
      • Staining Patterns
      • Which factors may impact staining by IHC techniques?
      • True or False: IHC alone is used to determine a primary diagnosis.
  • Hormone Receptor Testing
      • Introduction to Estrogen Receptors and Progesterone Receptors
      • Hormonal Factors in Breast Cancer
      • Clinical Application of Estrogen Receptor and Progesterone Receptor Testing
      • Use of Immunohistochemistry for Determining Estrogen Receptor and Progesterone Receptor Status
      • Scoring and Reporting of Estrogen Receptor and Progesterone Receptor Testing
      • Response Rates to Targeted Therapy
      • The pattern for estrogen receptor (ER) staining by IHC is localized within which part of the cell?
  • Human Epidermal Growth Factor Receptor 2
      • Introduction to Human Epidermal Growth Factor Receptor 2
      • Immunohistochemistry Testing Options For HER2
      • Complimentary Testing Helps Assess HER2 Status
      • Targeted Treatment Based on HER2 Status
      • Impact of Variation in Test Results
      • IHC Scoring Criteria
      • True or False: HER2 over-expression in breast cancer is localized to chromosome 17.
      • True or False: Only patients who overexpress HER2 (e.g., those with positive IHC, CISH, or FISH scores) are candidates to receive Herceptin® (tra...
  • HER2 Testing by In Situ Hybridization
      • Introduction
      • Specimen Handling and Fixation for Molecular and In Situ Methods
      • Introduction to HER2 Methods Using In Situ Hybridization
      • Introduction to Fluorescent In Situ Hybridization Methods
      • Fluorescence
      • Details of Fluorescent In Situ Hybridization
      • Chromogenic In Situ Hybridization Method for HER2
      • HER2 Test Method: Advantages and Disadvantages
      • CISH and FISH Scoring Criteria
      • Using chromogenic in situ hybridization (CISH), a single copy of HER2 amplification appears under the light microscope as which of the following?
      • What is the most commonly used, rapid, and cost-effective method to assess HER2 status in clinical histology?
  • References
      • References

Additional Information

Level of Instruction: Intermediate
Intended Audience: This course is intended for histology bench technicians and technologists, supervisors, and administrators.
Author Information: Joelle Weaver MAOM, HTL(ASCP), QIHC, is a certified histotechnologist with a broad range of practical histology experience in clinical histopathology. She has received qualification in immunohistochemistry (IHC) from the American Society for Clinical Pathology and Green Belt certification from Purdue University, West Lafayette, Indiana. Joelle's bachelor's degree was received from Bowling Green State University in Bowling Green, Ohio, and her Master's Degree was awarded from Bluffton University in Bluffton, Ohio. She graduated from a NAACLS-accredited histotechnology program and has held positions as an adjunct professor, education coordinator, and program director at Columbus State Community College in Columbus, Ohio (2002-2011). Joelle is a histotechnologist and technical consultant in Louisville, Kentucky, specializing in IHC.
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 in Healthcare Management and a Bachelor of Science 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: Toxicity, side effects, and unpredictable effectiveness have been the hallmarks of anti-cancer therapies used in the past to treat breast and other primary cancers. Targeted therapies have been developed to reduce patient risk and improve patient outcomes. This course will discuss how predictive markers/testing select patients most likely to respond positively to a specific breast cancer treatment, including current testing methodologies and compliance standards.

This course is part of:
Histology CE
Metastatic breast cancer
Female white tech uses microscope (computer in background)
DAB (brown) chromogen localized to cell membrane in HER2 stain using clone CB11. Counterstain is hematoxylin.
Adenovirus infected liver demonstrated with mouse IgG1 monoclonal antibody cocktail of clones 2/6 and 20/11. DAB chromogen.
HER2/<i>neu</i> gene FISH
3+ HER2 breast cancer detected with the Dako HercepTest. Image courtesy of Jim Burchette.