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.
OBJECTIVE
- 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.
From the 1 Department of Pathology and Cell Biology, Columbia University, New York, NY.
Antonia R
AR
Sepulveda
2 Department of Pathology.
Stanley R
SR
Hamilton
5 Division of Hematology and Oncology, University of Florida Medical Center, Gainesville.
Carmen J
CJ
Allegra
6 Departments of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics, UCLA Medical Center, Los Angeles, CA.
Wayne
W
Grody
7 Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha.
Allison M
AM
Cushman-Vokoun
8 Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill.
William K
WK
Funkhouser
3 Department of Gastrointestinal (GI) Medical Oncology.
Scott E
SE
Kopetz
9 Division of Medical Oncology, University of Colorado Denver School of Medicine, Denver.
Christopher
C
Lieu
10 Department of Medical Genetics, Mayo Clinic, Scottsdale, AZ.
Noralane M
NM
Lindor
4 Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston.
Bruce D
BD
Minsky
11 Castle Biosciences, Friendswood, TX.
Federico A
FA
Monzon
12 Department of Health Sciences Research, Mayo Clinic, Rochester, MN.
Daniel J
DJ
Sargent
13 Biocept, San Diego, CA.
Veena M
VM
Singh
14 Department of Pathology, Case Western Reserve University, Cleveland, OH.
Joseph
J
Willis
15 ASCP Institute for Science, Technology, and Policy, American Society for Clinical Pathology, Washington, DC.
Jennifer
J
Clark
16 Laboratory and Pathology Quality Center, College of American Pathologists, Northfield, IL.
Carol
C
Colasacco
17 American Society of Clinical Oncology, Alexandria, VA.
R
R
Bryan Rumble
18 Association for Molecular Pathology, Bethesda, MD.
Robyn
R
Temple-Smolkin
16 Laboratory and Pathology Quality Center, College of American Pathologists, Northfield, IL.
Christina
C
B Ventura
From the 1 Department of Pathology and Cell Biology, Columbia University, New York, NY.|2 Department of Pathology.|3 Department of Gastrointestinal (GI) Medical Oncology.|4 Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston.|5 Division of Hematology and Oncology, University of Florida Medical Center, Gainesville.|6 Departments of Pathology and Laboratory Medicine, Pediatrics, and Human Genetics, UCLA Medical Center, Los Angeles, CA.|7 Department of Pathology and Microbiology, University of Nebraska Medical Center, Omaha.|8 Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill.|9 Division of Medical Oncology, University of Colorado Denver School of Medicine, Denver.|10 Department of Medical Genetics, Mayo Clinic, Scottsdale, AZ.|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.
Jan A
JA
Nowak
D006801:Humans; D000574:American Medical Association; D014408:Biomarkers, Tumor / Q000235:genetics; D015179:Colorectal Neoplasms / Q000175:diagnosis / Q000235:genetics / Q000473:pathology; D004252:DNA Mutational Analysis; D066246:ErbB Receptors / Q000235:genetics; D019317:Evidence-Based Medicine; D005820:Genetic Testing; D009154:Mutation; D010338:Pathology, Clinical; D057089:Pathology, Molecular; D011379:Prognosis; D014481:United States; D000078202:Systematic Reviews as Topic
D014408:Biomarkers, Tumor; C512478:EGFR protein, human; D066246:ErbB Receptors