New clinical practice guideline addresses testing of molecular biomarkers in colorectal cancer patients

A new, evidenced-based clinical practice guideline on molecular biomarker testing for patients with colorectal cancer identifies opportunities for improving patient outcomes.

The American Society for Clinical Pathology (ASCP), the College of American Pathologists (CAP), the Association for Molecular Pathology (AMP), and the American Society of Clinical Oncology (ASCO) collaborated to develop the Molecular Biomarkers for the Evaluation of Colorectal Cancer guideline. The guideline will be published online on Feb. 6, 2017, in AJCP/American Journal of Clinical Pathology, Archives of Pathology & Laboratory Medicine, JMD/Journal of Molecular Diagnostics and JCO/Journal of Clinical Oncology, from each collaborating organization, respectively.

This pivotal guideline addresses testing a wide range of molecular biomarkers in patients with early and advanced colorectal cancer. It will help establish standard molecular biomarker testing, guide targeted therapy decisions, and advance personalized care for patients with colorectal cancer, which is the second leading cause of cancer-related death in the U.S. for women and men combined*.

"Realizing that molecular diagnostics is a rapidly evolving field of medicine, the collaborating organizations of CAP, ASCP, AMP, and ASCO are committed to updating this guideline routinely in order to capture and make recommendations for new discoveries in the field," said Stanley R. Hamilton, MD, FCAP, AGAF, the University of Texas MD Anderson Cancer Center, project co-chair on behalf of the CAP.

A multi-disciplinary panel of experts, appointed by each of the organizations, included pathologists, oncologists, methodologists, and patient representatives, who worked collaboratively to develop the guideline through an evidence-based process following the Institute of Medicine standards for guideline development.

"The evidence-based recommendations for this guideline focused on molecular biomarkers identified as the most useful in patients with colorectal cancer, in order to select patients who can benefit from enhanced treatment with targeted therapies," said Antonia R. Sepulveda, MD, PhD, FASCP, FCAP, Columbia University, project co-chair on behalf of AMP.

"This guideline was created to offer physicians and patients guidance concerning the value of each of the new biomarkers relevant to colorectal cancer," said Carmen Allegra, MD, University of Florida Health Cancer Center, project co-chair on behalf of ASCO. "Hopefully, the widespread application of these recommendations will result in improved outcomes for all patients with colorectal cancer."

"While many existing recommendations cover the application of individual molecular biomarkers in colorectal cancer, this guideline fills the need for an overarching set of recommendations spanning the breadth of current knowledge," said Wayne W. Grody, MD, PhD, FASCP, FCAP, UCLA School of Medicine, project co-chair on behalf of ASCP. "This comprehensive guideline will prove useful for pathologists and oncologists to support decision-making on what molecular tests to order for patients with colorectal cancer."

Twenty-one guideline statements were established (eight recommendations, 10 expert consensus opinions, and three "no recommendation") based on evidence from a comprehensive literature review, which included over 4,000 articles. The guideline supports mutational testing for genes in the epidermal growth factor receptor (EGFR) pathway to inform targeted therapy decisions. Additional recommendations are intended to streamline molecular testing processes and contribute to improving patient outcomes.

An ongoing communication and information dissemination campaign to the professionals and the public will be launched for awareness and to assist in the integration of guideline recommendations into pathology, laboratory, and clinical practice. The guideline will be reviewed every four years, or earlier in the event of publication of substantive and high-quality evidence that could potentially alter the original guideline recommendations.