In 2010, results of a phase 3 randomized controlled trial showed that targeted therapy directed against HER2 statistically significantly prolonged overall survival compared with chemotherapy alone in patients with HER2–positive advanced GEA. Because there are important differences in HER2 expression, scoring, and outcomes in GEA relative to breast carcinoma, the need for guideline recommendations for HER2 testing specific to GEA was recognized. In response to this need, the College of American Pathologists, American Society for Clinical Pathology, and the American Society of Clinical Oncology convened an international expert panel to systematically review published documents and to develop an evidence-based guideline to establish recommendations for HER2 testing in GEA.
This session will present this evidence-based guideline and recommendations for the use of HER2 testing in GEA, including use and interpretation of immunohistochemistry and in situ hybridization for determination of HER2 protein expression and amplification status. The presentation will address laboratory test performance primarily, but also clinical applications related to oncology, surgery, gastroenterology, and genetics. Two overarching questions will be addressed:
• What is the optimal testing algorithm for the assessment of HER2 status in patients with GEA?
• What strategies can help ensure optimal performance, interpretation, and reporting of established assays in patients with GEA?
• Describe current guideline recommendations for HER2 testing in GEA to determine prognosis and prediction of response to therapies
• Understand recommended laboratory practice guidelines for the use and performance of HER2 testing in the evaluation of GEA to determine prognosis and prediction of response to therapies
• Apply recommendations for HER2 testing in GEA
Mary Kay Washington, MD, PhD, FASCP, FCAP
Jaffer A. Ajani, MD, FASCO
Category: Anatomic Pathology, Clinical Laboratories, Clinical Pathology, Current Affairs, Education, General Healthcare News, Genetics, Histology, Laboratory Compliance, Laboratory Management & Operations, Medical Research, Pathology News, Reports, Science, Training, Webinars