OVERVIEW OF ACTIVITY

It is estimated that approximately 180,000 new invasive breast cancer cases will be diagnosed in 2008, and 41,000 individuals will die as a result of the disease. A major breakthrough in the individualized management of breast cancer has stemmed from the clinician’s ability to segment the disease based on tumor-specific prognostic and predictive variables or biomarkers — specifically, cellular expression of ER, PR and/or HER2 and amplification of these and other genes representative of invasion or proliferation — that correlate both with long-term outcome and response to various treatments. The future of targeted and personalized breast cancer treatment algorithms will likely rely upon the incorporation of many additional relevant tumor-specific biomarkers. The utility of these molecular expressions may ultimately reside in the culmination of a signature or profile rather than in the presence of a single upregulated receptor. Additionally, the contributory roles of genetic-based assays that enable quantitative measurements versus historical IHC assays delivering largely qualitative findings have yet to be elucidated. Tools such as the Oncotype DX^® assay have already begun to enable the tailoring of treatment algorithms in the setting of controversial clinical situations, and further efforts to enhance the precision of therapeutic decision-making are underway. A thorough understanding of the evidence-based validation of such tools, in addition to knowledge of the specific populations likely to benefit from their use, is essential to ensuring best-practice patient outcomes. The primary goal of this activity is to provide medical oncologists with the information they need for optimal utilization of these biomarkers and genomic assays in up-to-date patient care strategies.

LEARNING OBJECTIVES

• Compare and contrast the qualitative and quantitative molecular assays currently used to measure ER/PR and HER2 tumor expression, and describe the clinical application and challenges that accompany each method.
• Describe the evidence to support global standardization of ER/PR and HER2 testing, and provide examples of how this consistency may improve patient care.
• Summarize the objectives and recommendations of the ASCO/College of American Pathologists guidelines for HER2 testing.
• Design a clinical algorithm for resolving inconclusive IHC and/or FISH HER2 testing in your practice.
• Appraise the relationship between quantitative ER/PR measurements and response to hormonal therapy.
• Discriminate between the Oncotype DX and MammaPrint^® genomic assays in terms of the tissue requirements, development and validation, and prognostic and predictive capabilities of each.
• Assess the clinical value of biopsying metastases for diagnostic confirmation of disease and/or assessment of biomarker concordance with the primary lesion.

ACCREDITATION STATEMENT

Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

CREDIT DESIGNATION STATEMENT

Research To Practice designates this educational activity for a maximum of 3 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

HOW TO USE THIS CME ACTIVITY

This CME activity contains both audio and print components. To receive credit, the participant should review the CME information, listen to the CDs and complete the Post-test and Educational Assessment and Credit Form located in our website at ResearchToPractice.com/BreastBiomarkers. ResearchToPractice.com/BreastBiomarkers includes an easy-to-use, interactive version of this monograph with links to relevant full-text articles, abstracts, trial information and other web resources indicated here in blue underlined text.

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This program is supported by educational grants from Genentech BioOncology, Genomic Health Inc and Novartis Pharmaceuticals Corporation.

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TOPICS

Challenges in HER2 Testing and Interpretation
- Select publications

Assessment of Estrogen Receptor Status
- Select publications

Evolving Role of Genomic Assays in Breast Cancer
- Select publications

Tissue Biomarkers in the Management of Breast Cancer:
A CME Audio Series and Activity

Faculty Disclosures

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