Antonia R Sepulveda1, Stanley R Hamilton2, Carmen J Allegra3, Wayne Grody4, Allison M Cushman-Vokoun5, William K Funkhouser6, Scott E Kopetz7, Christopher Lieu8, Noralane M Lindor9, Bruce D Minsky10, Federico A Monzon11, Daniel J Sargent12, Veena M Singh13, Joseph Willis14, Jennifer Clark15, Carol Colasacco16, R Bryan Rumble17, Robyn Temple-Smolkin18, Christina B Ventura16, Jan A Nowak19. 1. Department of Pathology and Cell Biology, Columbia University, New York, NY. Electronic address: as4400@cumc.columbia.edu. 2. Department of Pathology, University of Texas MD Anderson Cancer Center, Houston. 3. Division of Hematology and Oncology, University of Florida Medical Center, Gainesville. 4. Departments of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics, UCLA Medical Center, Los Angeles, CA. 5. Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha. 6. Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill. 7. Department of Gastrointestinal (GI) Medical Oncology, University of Texas MD Anderson Cancer Center, Houston. 8. Division of Medical Oncology, University of Colorado Denver School of Medicine, Denver. 9. Department of Medical Genetics, Mayo Clinic, Scottsdale, AZ. 10. Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston. 11. Castle Biosciences, Friendswood, TX. 12. Department of Health Sciences Research, Mayo Clinic, Rochester, MN. 13. Biocept, San Diego, CA. 14. Department of Pathology, Case Western Reserve University, Cleveland, OH. 15. ASCP Institute for Science, Technology, and Policy, American Society for Clinical Pathology, Washington, DC. 16. Laboratory and Pathology Quality Center, College of American Pathologists, Northfield, IL. 17. American Society of Clinical Oncology, Alexandria, VA. 18. Association for Molecular Pathology, Bethesda, MD. 19. Department of Pathology and Laboratory Medicine, Roswell Park Cancer Institute, Buffalo, NY.
Abstract
OBJECTIVES: To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. METHODS: The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. RESULTS: Twenty-one guideline statements were established. CONCLUSIONS: Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented. Key Words: Molecular diagnostics; Gastrointestinal; Histology; Genetics; Oncology.
OBJECTIVES: To develop evidence-based guideline recommendations through a systematic review of the literature to establish standard molecular biomarker testing of colorectal cancer (CRC) tissues to guide epidermal growth factor receptor (EGFR) therapies and conventional chemotherapy regimens. METHODS: The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology convened an expert panel to develop an evidence-based guideline to establish standard molecular biomarker testing and guide therapies for patients with CRC. A comprehensive literature search that included more than 4,000 articles was conducted. RESULTS: Twenty-one guideline statements were established. CONCLUSIONS: Evidence supports mutational testing for EGFR signaling pathway genes, since they provide clinically actionable information as negative predictors of benefit to anti-EGFR monoclonal antibody therapies for targeted therapy of CRC. Mutations in several of the biomarkers have clear prognostic value. Laboratory approaches to operationalize CRC molecular testing are presented. Key Words: Molecular diagnostics; Gastrointestinal; Histology; Genetics; Oncology.
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