Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology

Author:

Sepulveda Antonia R.1,Hamilton Stanley R.2,Allegra Carmen J.3,Grody Wayne4,Cushman-Vokoun Allison M.5,Funkhouser William K.6,Kopetz Scott E.7,Lieu Christopher8,Lindor Noralane M.9,Minsky Bruce D.10,Monzon Federico A.11,Sargent Daniel J.12,Singh Veena M.13,Willis Joseph14,Clark Jennifer15,Colasacco Carol16,Bryan Rumble R.17,Temple-Smolkin Robyn18,B. Ventura Christina16,Nowak Jan A.1912710

Affiliation:

1. From theDepartment of Pathology and Cell Biology, Columbia University, New York, NY

2. Department of Pathology,

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

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.

Publisher

Archives of Pathology and Laboratory Medicine

Subject

Medical Laboratory Technology,General Medicine,Pathology and Forensic Medicine

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