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 the 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 journalArticle

87 Citations (Scopus)

Abstract

Purpose: Molecular testing of colorectal cancers (CRCs) to improve patient care and outcomes of targeted and conventional therapies has been the center of many recent studies, including clinical trials. Evidencebased recommendations for the molecular testing of CRC tissues to guide epidermal growth factor receptor (EGFR) -targeted therapies and conventional chemotherapy regimens are warranted in clinical practice. The purpose of this guideline is to develop evidence-based recommendations to help establish standard molecular biomarker testing for CRC through a systematic review of the literature. Methods: The American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to develop an evidence-based guideline to help establish standard molecular biomarker testing, guide targeted therapies, and advance personalized care for patients with CRC. A comprehensive literature search that included over 4,000 articles was conducted to gather data to inform this guideline. Results: Twenty-one guideline statements (eight recommendations, 10 expert consensus opinions and three no recommendations) were established. Recommendations: Evidence supports mutational testing for genes in the EGFR signaling pathway, 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 molecular testing for predictive and prognostic molecular biomarkers involve selection of assays, type of specimens to be tested, timing of ordering of tests and turnaround time for testing results.

Original languageEnglish (US)
Pages (from-to)1453-1496
Number of pages44
JournalJournal of Clinical Oncology
Volume35
Issue number13
DOIs
StatePublished - May 1 2017

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Molecular Pathology
Colorectal Neoplasms
Biomarkers
Guidelines
Epidermal Growth Factor Receptor
Patient Care
erbB-1 Genes
Therapeutics
Expert Testimony
Monoclonal Antibodies
Pathologists
Clinical Trials
Drug Therapy
Mutation

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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 the 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 Clinical Oncology, Vol. 35, No. 13, 01.05.2017, p. 1453-1496.

Research output: Contribution to journalArticle

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 the American Society of Clinical Oncology', Journal of Clinical Oncology, vol. 35, no. 13, pp. 1453-1496. https://doi.org/10.1200/JCO.2016.71.9807
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 the American Society of Clinical Oncology. In: Journal of Clinical Oncology. 2017 ; Vol. 35, No. 13. pp. 1453-1496.
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abstract = "Purpose: Molecular testing of colorectal cancers (CRCs) to improve patient care and outcomes of targeted and conventional therapies has been the center of many recent studies, including clinical trials. Evidencebased recommendations for the molecular testing of CRC tissues to guide epidermal growth factor receptor (EGFR) -targeted therapies and conventional chemotherapy regimens are warranted in clinical practice. The purpose of this guideline is to develop evidence-based recommendations to help establish standard molecular biomarker testing for CRC through a systematic review of the literature. Methods: The American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to develop an evidence-based guideline to help establish standard molecular biomarker testing, guide targeted therapies, and advance personalized care for patients with CRC. A comprehensive literature search that included over 4,000 articles was conducted to gather data to inform this guideline. Results: Twenty-one guideline statements (eight recommendations, 10 expert consensus opinions and three no recommendations) were established. Recommendations: Evidence supports mutational testing for genes in the EGFR signaling pathway, 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 molecular testing for predictive and prognostic molecular biomarkers involve selection of assays, type of specimens to be tested, timing of ordering of tests and turnaround time for testing results.",
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T2 - Guideline from The American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology

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.

PY - 2017/5/1

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N2 - Purpose: Molecular testing of colorectal cancers (CRCs) to improve patient care and outcomes of targeted and conventional therapies has been the center of many recent studies, including clinical trials. Evidencebased recommendations for the molecular testing of CRC tissues to guide epidermal growth factor receptor (EGFR) -targeted therapies and conventional chemotherapy regimens are warranted in clinical practice. The purpose of this guideline is to develop evidence-based recommendations to help establish standard molecular biomarker testing for CRC through a systematic review of the literature. Methods: The American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) convened an Expert Panel to develop an evidence-based guideline to help establish standard molecular biomarker testing, guide targeted therapies, and advance personalized care for patients with CRC. A comprehensive literature search that included over 4,000 articles was conducted to gather data to inform this guideline. Results: Twenty-one guideline statements (eight recommendations, 10 expert consensus opinions and three no recommendations) were established. Recommendations: Evidence supports mutational testing for genes in the EGFR signaling pathway, 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 molecular testing for predictive and prognostic molecular biomarkers involve selection of assays, type of specimens to be tested, timing of ordering of tests and turnaround time for testing results.

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