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Beyond the Guidelines: Clinical Investigator Perspectives on the Management of Hepatobiliary Cancers
Released March 2020

Proceedings from a CME symposium held at the 2020 Gastrointestinal Cancers Symposium. Featuring perspectives from Dr Ghassan Abou-Alfa, Dr Anthony El-Khoueiry, Dr Richard S Finn, Professor Dr Peter R Galle and Dr Andrew X Zhu. (Video Program)

CE Disclosures and Faculty Information

  • TARGET AUDIENCE
    This activity is intended for medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers involved in the treatment of gastrointestinal cancers.

    OVERVIEW OF ACTIVITY
    Hepatocellular carcinoma (HCC), the most common form of liver cancer, is a major cause of mortality globally, resulting in an estimated 600,000 deaths per year. The incidence rate of liver cancer in the United States has increased sharply, and it is estimated that approximately 42,810 new cases will be diagnosed in 2020 in this country and 30,160 individuals will die of the disease. By contrast, biliary tract cancers — gallbladder cancer, intrahepatic cholangiocarcinoma, perihilar cholangiocarcinoma and extrahepatic cholangiocarcinoma — are a relatively rare, heterogeneous group of gastrointestinal tumors. In both cases, many patients are either diagnosed with advanced disease or experience disease progression after local and/or adjuvant therapy and are thus no longer be amenable to potential cure. As such, palliative therapy intended to increase duration of life has become a mainstay of treatment. For this reason, it is widely recognized that an urgent need exists for the development of new and better therapeutic options, and this has driven a spate of investigational efforts within these fields.

    Several consensus- and evidence-based treatment guidelines are available and aim to assist clinicians with making management decisions in this dynamic environment. However, in situations in which multiple acceptable therapeutic options exist, such guidelines may not be particularly helpful at the time of decision-making. By exploring the perspectives of leading investigators regarding a number of clinical scenarios and reviewing key data sets, this activity will assist medical oncologists, hematology-oncology fellows, surgeons and other healthcare providers in the development of evidence-based strategies for the treatment of HCC and biliary tract cancers.

    LEARNING OBJECTIVES

    • Develop evidence-based strategies to properly diagnose and stage HCC, and use this information to counsel patients regarding long-term prognosis.
    • Consider age, performance status, degree of liver function and other clinical factors in the selection of up-front therapy for patients with newly diagnosed unresectable or metastatic HCC.
    • Acknowledge the available Phase III data with and the FDA approvals of regorafenib and cabozantinib for progressive HCC, and discern how these agents can be optimally integrated into the clinical care of patients.
    • Develop an understanding of the biologic rationale for, available clinical data with and FDA approvals of nivolumab and pembrolizumab for the treatment of progressive HCC, and identify patients appropriate for therapy with these agents.
    • Understand published Phase III data with and the rationale for investigation of ramucirumab for patients with advanced HCC and elevated alpha-fetoprotein who have experienced disease progression after treatment with sorafenib, and use this information to appropriately integrate ramucirumab into current treatment algorithms.
    • Counsel patients regarding the incidence and manifestation of side effects and toxicities associated with existing and emerging targeted agents and immunotherapeutic approaches in the management of advanced HCC.
    • Recall available and emerging data with other investigational agents and strategies currently in clinical testing for HCC, and where applicable, refer eligible patients for trial participation or other expanded access programs.
    • Consider available clinical research findings and the perspectives of gastrointestinal cancer investigators on the formation of evidence-based therapeutic algorithms for the management of unresectable and metastatic biliary tract cancers.
    • Recognize the molecular heterogeneity of biliary tract cancers, appreciate the biologic rationale for efforts to exploit documented abnormalities, and use this information to identify patients who may be eligible for studies evaluating novel targeted agents.

    ACCREDITATION STATEMENT
    Research To Practice is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

    CREDIT DESIGNATION STATEMENT
    Research To Practice designates this enduring material for a maximum of 2.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    AMERICAN BOARD OF INTERNAL MEDICINE (ABIM) — MAINTENANCE OF CERTIFICATION (MOC)
    Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 2.5 Medical Knowledge MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credit.

    Please note, this program has been specifically designed for the following ABIM specialty: medical oncology.

    Personal information and data sharing: Research To Practice aggregates deidentified user data for program-use analysis, program development, activity planning and site improvement. We may provide aggregate and deidentified data to third parties, including commercial supporters. We do not share or sell personally identifiable information to any unaffiliated third parties or commercial supporters. Please see our privacy policy at ResearchToPractice.com/Privacy-Policy for more information.

    HOW TO USE THIS CME ACTIVITY
    This CME activity consists of a video component. To receive credit, the participant should review the CME information, watch the video, complete the Post-test with a score of 80% or better and fill out the Educational Assessment and Credit Form located at ResearchToPractice.com/GICancers20/Hepatobiliary/CME.

    CONTENT VALIDATION AND DISCLOSURES
    Research To Practice (RTP) is committed to providing its participants with high-quality, unbiased and state-of-the-art education. We assess conflicts of interest with faculty, planners and managers of CME activities. Conflicts of interest are identified and resolved through a conflict of interest resolution process. In addition, all activity content is reviewed by both a member of the RTP scientific staff and an external, independent physician reviewer for fair balance, scientific objectivity of studies referenced and patient care recommendations.

    FACULTY — The following faculty (and their spouses/partners) reported relevant conflicts of interest, which have been resolved through a conflict of interest resolution process:

    Ghassan Abou-Alfa, MD
    Professor
    Memorial Sloan Kettering Cancer Center
    New York, New York

    Consulting Agreements: Agios Pharmaceuticals Inc, AI Therapeutics, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene, BioLineRx, Bristol-Myers Squibb Company, Celgene Corporation, CytomX Therapeutics, Debiopharm Group, Eisai Inc, Exelixis Inc, Flatiron Health, Genoscience Pharma, Incyte Corporation, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Minapharm Pharmaceuticals, Pfizer Inc, QED Therapeutics, RedHill Biopharma Ltd, Sanofi Genzyme, Silenseed Ltd, SillaJen, Sobi, Targovax, twoXAR, Vicus Therapeutics, Yiviva; Contracted Research: Acta Biologica, Agios Pharmaceuticals Inc, Array BioPharma Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, BeiGene, Bristol-Myers Squibb Company, CASI Pharmaceuticals Inc, Celgene Corporation, Exelixis Inc, Genentech, Halozyme Inc, Incyte Corporation, Lilly, MabVax Therapeutics, Novartis, Polaris Group, Puma Biotechnology Inc, QED Therapeutics, Roche Laboratories Inc.

    Anthony El-Khoueiry, MD
    Associate Professor of Clinical Medicine
    Medical Director of Clinical Investigations Support Office
    Phase I Program Director
    USC Norris Comprehensive Cancer Center
    Los Angeles, California

    Advisory Committee: Agenus Inc, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Exelixis Inc, Genentech, Merck, Roche Laboratories Inc; Contracted Research: Astex Pharmaceuticals, AstraZeneca Pharmaceuticals LP, Merck.

    Richard S Finn, MD
    Professor of Clinical Medicine
    Division of Hematology/Oncology
    David Geffen School of Medicine at UCLA
    Director, Signal Transduction and Therapeutics Program
    Jonsson Comprehensive Cancer Center at UCLA
    Los Angeles, California

    Consulting Agreements: AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Eisai Inc, Genentech, Lilly, Merck, Novartis, Pfizer Inc, Roche Laboratories Inc; Contracted Research: Bristol-Myers Squibb Company, Eisai Inc, Genentech, Merck, Pfizer Inc, Roche Laboratories Inc; Data and Safety Monitoring Board/Committee: AstraZeneca Pharmaceuticals LP.

    Professor Dr Peter R Galle, PhD
    Director
    Department of Internal Medicine I
    University Medical Center Mainz
    Mainz, Germany

    Advisory Committee and Consulting Agreements: Agios Pharmaceuticals Inc, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Genentech, Ipsen Biopharmaceuticals Inc, Lilly, Merck, Novartis, Roche Laboratories Inc, Sirtex Medical Ltd; Data and Safety Monitoring Board/Committee: Novartis; Speakers Bureau: Agios Pharmaceuticals Inc, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Ipsen Biopharmaceuticals Inc, Lilly, Merck, Roche Laboratories Inc, Sirtex Medical Ltd.

    Andrew X Zhu, MD, PhD
    Director, Jiahui International Cancer Center
    Shanghai, China
    Director Emeritus, Liver Cancer Research
    Massachusetts General Hospital Cancer Center
    Boston, Massachusetts

    Advisory Committee: Bayer HealthCare Pharmaceuticals, Eisai Inc, Exelixis Inc, Lilly, Merck, Roche Laboratories Inc, Sanofi Genzyme.

    MODERATOR — Dr Love is president and CEO of Research To Practice. Research To Practice receives funds in the form of educational grants to develop CME activities from the following commercial interests: AbbVie Inc, Acerta Pharma — A member of the AstraZeneca Group, Adaptive Biotechnologies, Agendia Inc, Agios Pharmaceuticals Inc, Amgen Inc, Ariad Pharmaceuticals Inc, Array BioPharma Inc, Astellas, AstraZeneca Pharmaceuticals LP, Bayer HealthCare Pharmaceuticals, Biodesix Inc, bioTheranostics Inc, Blueprint Medicines, Boehringer Ingelheim Pharmaceuticals Inc, Boston Biomedical Inc, Bristol-Myers Squibb Company, Celgene Corporation, Clovis Oncology, Daiichi Sankyo Inc, Dendreon Pharmaceuticals Inc, Eisai Inc, EMD Serono Inc, Exelixis Inc, Foundation Medicine, Genentech, Genmab, Genomic Health Inc, Gilead Sciences Inc, Guardant Health, Halozyme Inc, ImmunoGen Inc, Incyte Corporation, Infinity Pharmaceuticals Inc, Ipsen Biopharmaceuticals Inc, Janssen Biotech Inc, administered by Janssen Scientific Affairs LLC, Jazz Pharmaceuticals Inc, Kite Pharma Inc, Lexicon Pharmaceuticals Inc, Lilly, Loxo Oncology Inc, a wholly owned subsidiary of Eli Lilly & Company, Merck, Merrimack Pharmaceuticals Inc, Myriad Genetic Laboratories Inc, Natera Inc, Novartis, Oncopeptides, Pfizer Inc, Pharmacyclics LLC, an AbbVie Company, Prometheus Laboratories Inc, Puma Biotechnology Inc, Regeneron Pharmaceuticals Inc, Sandoz Inc, a Novartis Division, Sanofi Genzyme, Seattle Genetics, Sirtex Medical Ltd, Spectrum Pharmaceuticals Inc, Taiho Oncology Inc, Takeda Oncology, Tesaro, A GSK Company, Teva Oncology, Tokai Pharmaceuticals Inc and Tolero Pharmaceuticals.

    RESEARCH TO PRACTICE CME PLANNING COMMITTEE MEMBERS, STAFF AND REVIEWERS — Planners, scientific staff and independent reviewers for Research To Practice have no relevant conflicts of interest to disclose.

    This educational activity contains discussion of published and/or investigational uses of agents that are not indicated by the Food and Drug Administration. Research To Practice does not recommend the use of any agent outside of the labeled indications. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications and warnings. The opinions expressed are those of the presenters and are not to be construed as those of the publisher or grantors.

    This activity is supported by educational grants from Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb Company, Exelixis Inc, Genentech, Incyte Corporation and Lilly.

    Hardware/Software Requirements:
    A high-speed Internet connection
    A monitor set to 1280 x 1024 pixels or more
    Internet Explorer 11 or later, Firefox 56 or later, Chrome 61 or later, Safari 11 or later, Opera 48 or later
    Adobe Flash Player 27 plug-in or later
    Adobe Acrobat Reader
    (Optional) Sound card and speakers for audio

    Release date: March 2020
    Expiration date: March 2021

    After completing the Post-test, learners may download and review the answers here in order to identify further areas of study.

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