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ASCP, CAP, AMP, and ASCO Issue Draft Colorectal Cancer Molecular Marker Testing Guideline, Announce Opening of Public Comment Period

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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) today released a draft of a clinical practice guideline on the use of molecular marker testing for patients with primary or metastatic colorectal carcinoma. This evidence-based guideline will help establish standard molecular marker testing, guide targeted therapies, and advance personalized care for these patients. The draft guidance document, “Guideline on the Evaluation of Molecular Markers for Colorectal Cancer Workgroup Draft Recommendations Summary,” is now available online for public comment through April 22, 2015.

The draft guidance is designed to identify opportunities for improving patient outcomes. “By bringing together four key organizations, all with substantial interest in treatment of colorectal cancer, we have addressed multiple elements of the patient care continuum,” said Wayne W. Grody, MD, PhD, UCLA School of Medicine, Project Co-Chair on behalf of ASCP. “While we didn’t focus on a selected set of molecular markers, we considered the overall plan of care from collection of tissue samples to diagnostics, treatment, and follow-up.”

Multidisciplinary Approach

The co-chairs, one from each of the four organizations, utilized the expertise of more than 25 specialists in a variety of disciplines, including pathologists and oncologists as well as patient advocates, to draft the guidance document. The multidisciplinary perspective has resulted in a thorough set of draft recommendations that streamline processes and contribute to improving patient outcomes.

“While other colorectal cancer biomarker guidelines have been published, they tend to focus on one marker or a small panel of markers for one specific clinical use, unlike the collaborative multidisciplinary approach for this guideline,” said Stanley R. Hamilton, MD, FCAP, AGAF, The University of Texas MD Anderson Cancer Center, Project Co-Chair on behalf of CAP. “This guideline addresses all current molecular markers that can impact treatment decisions for patients with colorectal cancer. To date, there isn’t an evidence-based guideline that’s quite as all-encompassing and patient-centered as this one.”

Input from stakeholders, including scientists, clinicians, government agencies, other nonprofit organizations, patients, patient advocates, and members of the public, is critical to the release of a final set of recommendations for the care of patients with colorectal cancer. “Anyone who may be affected by or play a role in the application of the guideline is encouraged to provide comments,” said Antonia R. Sepulveda, MD, PhD, FASCP, FCAP, Columbia University, Project Co-Chair on behalf of AMP. “From the onset, we have adhered to the Institute of Medicine’s Standards for Developing Trustworthy Clinical Practice Guidelines, which includes a dedicated external review period.”

The final guidance document is targeted for publication later this year. “Given the rapid evolution of the field, we have ‘future proofed’ the document with a research section that acknowledges molecular markers and tests on the horizon,” said Carmen Allegra, MD, University of Florida Health Cancer Center, Project Co-Chair on behalf of ASCO. “We intend to review these recommendations regularly and will update the guidance document as necessary.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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