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

Antonia R. Sepulveda, Stanley R. Hamilton, Carmen J. Allegra, Wayne Grody, Allison M Cushman-Vokoun, William K. Funkhouser, Scott E. Kopetz, Christopher Lieu, Noralane M. Lindor, Bruce D. Minsky, Federico A. Monzon, Daniel J. Sargent, Veena M. Singh, Joseph Willis, Jennifer Clark, Carol Colasacco, R. Bryan Rumble, Robyn Temple-Smolkin, Christina B. Ventura, Jan A. Nowak

Research output: Contribution to journalReview article

30 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)187-225
Number of pages39
JournalJournal of Molecular Diagnostics
Volume19
Issue number2
DOIs
StatePublished - Mar 1 2017

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Molecular Pathology
Colorectal Neoplasms
Biomarkers
Epidermal Growth Factor Receptor
Guidelines
Therapeutics
Histology
Monoclonal Antibodies
Drug Therapy
Mutation
Pathologists
Genes

ASJC Scopus subject areas

  • Pathology and Forensic Medicine
  • Molecular Medicine

Cite this

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. / Sepulveda, Antonia R.; Hamilton, Stanley R.; Allegra, Carmen J.; Grody, Wayne; Cushman-Vokoun, Allison M; Funkhouser, William K.; Kopetz, Scott E.; Lieu, Christopher; Lindor, Noralane M.; Minsky, Bruce D.; Monzon, Federico A.; Sargent, Daniel J.; Singh, Veena M.; Willis, Joseph; Clark, Jennifer; Colasacco, Carol; Rumble, R. Bryan; Temple-Smolkin, Robyn; Ventura, Christina B.; Nowak, Jan A.

In: Journal of Molecular Diagnostics, Vol. 19, No. 2, 01.03.2017, p. 187-225.

Research output: Contribution to journalReview article

Sepulveda, AR, Hamilton, SR, Allegra, CJ, Grody, W, Cushman-Vokoun, AM, Funkhouser, WK, Kopetz, SE, Lieu, C, Lindor, NM, Minsky, BD, Monzon, FA, Sargent, DJ, Singh, VM, Willis, J, Clark, J, Colasacco, C, Rumble, RB, Temple-Smolkin, R, Ventura, CB & Nowak, JA 2017, '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', Journal of Molecular Diagnostics, vol. 19, no. 2, pp. 187-225. https://doi.org/10.1016/j.jmoldx.2016.11.001
Sepulveda, Antonia R. ; Hamilton, Stanley R. ; Allegra, Carmen J. ; Grody, Wayne ; Cushman-Vokoun, Allison M ; Funkhouser, William K. ; Kopetz, Scott E. ; Lieu, Christopher ; Lindor, Noralane M. ; Minsky, Bruce D. ; Monzon, Federico A. ; Sargent, Daniel J. ; Singh, Veena M. ; Willis, Joseph ; Clark, Jennifer ; Colasacco, Carol ; Rumble, R. Bryan ; Temple-Smolkin, Robyn ; Ventura, Christina B. ; Nowak, Jan A. / 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. In: Journal of Molecular Diagnostics. 2017 ; Vol. 19, No. 2. pp. 187-225.
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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.",
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AU - Sepulveda, Antonia R.

AU - Hamilton, Stanley R.

AU - Allegra, Carmen J.

AU - Grody, Wayne

AU - Cushman-Vokoun, Allison M

AU - Funkhouser, William K.

AU - Kopetz, Scott E.

AU - Lieu, Christopher

AU - Lindor, Noralane M.

AU - Minsky, Bruce D.

AU - Monzon, Federico A.

AU - Sargent, Daniel J.

AU - Singh, Veena M.

AU - Willis, Joseph

AU - Clark, Jennifer

AU - Colasacco, Carol

AU - Rumble, R. Bryan

AU - Temple-Smolkin, Robyn

AU - Ventura, Christina B.

AU - Nowak, Jan A.

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N2 - 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.

AB - 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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