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Robin K. Kelley, Grace Wang and Alan P. Venook

Biomarkers reflective of the molecular and genetic heterogeneity in colorectal cancers now guide certain aspects of clinical management and offer great potential for enrichment, stratification, and identification of novel therapeutic targets in drug development. Using case-based examples, this article reviews biomarkers that have an established role in the clinical management of colorectal cancer: mismatch repair protein testing and KRAS and BRAF mutational analysis. A selection of biomarkers undergoing validation for future clinical application is presented, and the dynamic and challenging interface between biomarkers in research and clinical practice is discussed.

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Robin K. Kelley, Chloe Atreya, Alan P. Venook and Phillip G. Febbo

Because of a surge in molecular testing capabilities concurrent with the rising numbers of targeted therapies in clinical development, the commercial use of predictive biomarkers before clinical validation is available is a topic of growing relevance to medical oncologists. Increasingly, patients will present questions about, requests for, and results from commercial biomarker tests for their oncologists to address. The sheer numbers of tests reaching the market, along with forecasted American Medical Association reforms in current procedural terminology coding and increasing FDA oversight of in vitro companion diagnostic device development, are likely to draw intense scrutiny to the regulation of commercial molecular testing in the near future, which will also require clinicians to remain abreast of the level of clinical validation of the biomarker tests available in practice. In addition to the direct risks of novel biomarker testing, including financial cost and ethical issues, the indirect risks encompass those associated with any clinical decision based on the biomarker test results. A great need exists for comprehensive and dynamic practice guidelines for all types of biomarker testing according to tumor type.

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Robin K. Kelley, Stephanie L. Van Bebber, Kathryn A. Phillips and Alan P. Venook

Predictive and prognostic biomarkers offer a potential means to personalize cancer medicine, although many reach the market-place before they have been validated, and their adoption is often hindered by variable clinical evidence. Because of this variability in supporting evidence, clinical practice guidelines formulated by panels of subspecialty experts may be particularly important in guiding stakeholders' acceptance and use of new personalized medicine biomarker tests and other nascent technologies. This article provides a structured review of the clinical evidence supporting 4 contemporary biomarker tests in colorectal cancer: K-ras and B-raf mutation analyses, mismatch repair protein testing, and the Oncotype DX Colon Cancer Assay. All 4 tests have been evaluated for guideline inclusion by the NCCN Guidelines Panel for Colon Cancer. This case study shows significant variability in the level of clinical evidence associated with these tests. In the cases of B-raf and mismatch repair protein testing, the available evidence is also inconsistent as it pertains to the specific NCCN Guideline recommendation. Based on this uncertainty in the evidence base, the authors conclude that expert clinical judgment, experience, and consensus may be more heavily weighted than published clinical trial data in the evaluation of new personalized medicine biomarker tests. Potential implications of this conclusion and future directions for research are discussed.

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Al B. Benson III, Michael I. D'Angelica, Daniel E. Abbott, Thomas A. Abrams, Steven R. Alberts, Daniel A. Anaya, Chandrakanth Are, Daniel B. Brown, Daniel T. Chang, Anne M. Covey, William Hawkins, Renuka Iyer, Rojymon Jacob, Andrea Karachristos, R. Kate Kelley, Robin Kim, Manisha Palta, James O. Park, Vaibhav Sahai, Tracey Schefter, Carl Schmidt, Jason K. Sicklick, Gagandeep Singh, Davendra Sohal, Stacey Stein, G. Gary Tian, Jean-Nicolas Vauthey, Alan P. Venook, Andrew X. Zhu, Karin G. Hoffmann and Susan Darlow

The NCCN Guidelines for Hepatobiliary Cancers provide treatment recommendations for cancers of the liver, gallbladder, and bile ducts. The NCCN Hepatobiliary Cancers Panel meets at least annually to review comments from reviewers within their institutions, examine relevant new data from publications and abstracts, and reevaluate and update their recommendations. These NCCN Guidelines Insights summarize the panel's discussion and most recent recommendations regarding locoregional therapy for treatment of patients with hepatocellular carcinoma.

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NCCN Guidelines Insights: Hepatobiliary Cancers, Version 2.2019

Featured Updates to the NCCN Guidelines

Al B. Benson III, Michael I. D’Angelica, Daniel E. Abbott, Thomas A. Abrams, Steven R. Alberts, Daniel A. Anaya, Robert Anders, Chandrakanth Are, Daniel Brown, Daniel T. Chang, Jordan Cloyd, Anne M. Covey, William Hawkins, Renuka Iyer, Rojymon Jacob, Andreas Karachristos, R. Kate Kelley, Robin Kim, Manisha Palta, James O. Park, Vaibhav Sahai, Tracey Schefter, Jason K. Sicklick, Gagandeep Singh, Davendra Sohal, Stacey Stein, G. Gary Tian, Jean-Nicolas Vauthey, Alan P. Venook, Lydia J. Hammond and Susan D. Darlow

The NCCN Guidelines for Hepatobiliary Cancers provide treatment recommendations for cancers of the liver, gallbladder, and bile ducts. The NCCN Hepatobiliary Cancers Panel meets at least annually to review comments from reviewers within their institutions, examine relevant new data from publications and abstracts, and reevaluate and update their recommendations. These NCCN Guidelines Insights summarize the panel’s discussion and updated recommendations regarding systemic therapy for first-line and subsequent-line treatment of patients with hepatocellular carcinoma.