Accreditation/Credit Designation

Physicians' Education Resource®, LLC, (PER®) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Physicians' Education Resource®, LLC, designates this enduring material for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Acknowledgment of Commercial Support

This activity is supported by educational grants from Eisai, Inc., and Exelixis, Inc.

Community Practice Connections™: Navigating New Sequencing Challenges for the Treatment of Hepatocellular Carcinoma


Release Date: August 30, 2018
Expiration Date: August 30, 2019
Media: Internet - based
 

Activity Overview

Community Practice Connections™: Navigating New Sequencing Challenges for the Treatment of Hepatocellular Carcinoma, is an online activity based on the live symposium held adjunct to the annual oncology meeting in Chicago.
 
Historically, hepatocellular carcinoma (HCC) has been associated with poor outcomes, in large part due to the few effective treatment options available to patients who are ineligible for curative therapy. However, recent approvals and emerging strategies for HCC are transforming patient care and improving patient outcomes. Within this online interactive activity, 2 internationally renowned experts in HCC will provide you with their insights on a number of clinically important questions regarding immunotherapy and other targeted therapies, treatment selection and sequencing, and adverse event management.
 
During this activity, you will learn about:
  • The biology and mechanisms of action of newer targeted agents for HCC
  • Key clinical trial data that are changing how patients with HCC are treated
  • Integrating new therapeutic options into your care plans for patients with HCC

Acknowledgment of Commercial Support

This activity is supported by educational grants from Eisai, Inc., and Exelixis, Inc.

Instructions for This Activity and Receiving Credit

  • You will need to login to participate in the activity.
  • Each presentation may contain an interactive question(s). You may move forward through the presentation; however, you may not go back to change answers or review videos/content until you finish the presentation.
  • At the end of the activity, “educational content/video files” will be available for your reference.
  • In order to receive a CME/CE certificate, participants must complete the activity.
  • Complete the posttest and pass with a score of 70% or higher, complete the evaluation and then click on request for credit. Participants may immediately download a CME/CE certificate upon completion of these steps.

Target Audience

This educational activity is directed toward medical, surgical, and radiation oncologists involved in the treatment of patients with hepatocellular carcinoma (HCC). Nurse practitioners, physician assistants, nurses, and other healthcare professionals interested in the treatment and management of patients with HCC also are invited to participate.

Learning Objectives

At the conclusion of this activity, participants should be better prepared to:

  1. Describe how the natural history of HCC is evolving, and the implications of these changes for patients and the practitioners who manage patients with these tumors
  2. Explain the biology and mechanistic rationale that underlie recent targeted drug development in HCC
  3. Evaluate efficacy and safety outcomes from practice-changing clinical trials conducted in patients with HCC
  4. Apply recent evidence and patient characteristics to inform optimized sequencing decisions in the management of patients with HCC

Chair

Alan P. Venook
Alan P. Venook, MD, FASCO
Madden Family Distinguished Professor in Medical Oncology and Translational Research
Shorenstein Associate Director, Program Development
Helen Diller Family Comprehensive Cancer Center
University of California, San Francisco
San Francisco, CA

Disclosure: Grant/Research Support: Genentech, Roche; Consultant: Halozyme

Faculty

Anthony El-Khoueiry
Anthony El-Khoueiry, MD
Associate Professor of Clinical Medicine
Norris Cancer Center CISO Chair
Keck School of Medicine
University of Southern California
Los Angeles, CA

Disclosure: Dr. El-Khoueiry reports no relevant financial relationships with commercial interests to disclose.

Jordi Bruix
Jordi Bruix, MD, PhD
Professor of Medicine
University of Barcelona
Director, Barcelona Clinic Liver Cancer (BCLC) Group
Liver Unit at the Hospital Clinic
Barcelona, Spain

Disclosure: Grant/Research Support: Bayer; Consultant: Daiichi Sankyo, ArQule, Bayer, AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, Lilly, Kowa, Novartis, Roche, Onxeo, Terumo, Sirtex; Advisory Boards: Bayer, AbbVie, Bristol-Myers Squibb, Novartis, Roche, Onxeo, Terumo, Sirtex, BTG

Ghassan K. Abou-Alfa
Ghassan K. Abou-Alfa, MD, MBA
Memorial Sloan Kettering Cancer Center
New York, NY

Disclosure: Grant/Research Support: Agios, Array, AstraZeneca, Bayer, BMS, Casi, Celgene, Exelixis, Genentech, Incyte, Lilly, MabVax, MedImmune, Momenta, Novartis, OncoMed Pharmaceuticals, Roche; Consultant: Agios, Amgen, Antengene, Aptus, Aslan, Astellas, AstraZeneca, Bayer, BMS, Boston Scientific, CARsgen, Celgene, Casi, CytomX, Daiichi, Debio, Delcath, Eisai, Exelixis, Gilead, Halozyme, Inovio, Ipsen, Merck, Onxeo, PCI Biotech, Roche, Sanofi, Servier, Silenseed, Sillajen, Sirtex, Yakult

The staff of Physicians’ Education Resource®, LLC have no relevant financial relationships with commercial interests to disclose.

Disclosure Policy and Resolution of Conflicts of Interest

As a sponsor accredited by the ACCME, it is the policy of PER® to ensure fair balance, independence, objectivity, and scientific rigor in all of its CME activities. In compliance with ACCME guidelines, PER® requires everyone who is in a position to control the content of a CME activity to disclose all relevant financial relationships with commercial interests. ACCME defines relevant financial relationships as financial relationships in any amount occurring within the past 12 months that create a conflict of interest (COI).
 
Additionally, PER® is required by ACCME to resolve all COI. PER® has identified and resolved all COI prior to the start of this activity by using a multistep process.

Off-Label Disclosure and Disclaimer

This CME/CE activity may or may not discuss investigational, unapproved, or off-label use of drugs. Participants are advised to consult prescribing information for any products discussed. The information provided in this CME activity is for continuing medical and nursing education purposes only, and is not meant to substitute for the independent clinical judgment of a physician or nurse relative to diagnostic, treatment, or management options for a specific patient’s medical condition. The opinions expressed in the content are solely those of the individual faculty members and do not reflect those of PER®.

PER Pulse™ Recaps

1 of 3
First-Line Therapy for Advanced Hepatocellular Carcinoma

The online continuing medical education (CME) activity, Community Practice Connections™: Navigating New Sequencing Challenges for the Treatment of Hepatocellular Carcinoma, featured 3 experts in hepatocellular carcinoma (HCC) who provided their insights on a number of clinically important questions regarding immunotherapy and other targeted therapies, treatment selection and sequencing, and adverse event management: Alan P. Venook, MD, FASCO, Madden Family Distinguished Professor in Medical Oncology and Translational Research, and Shorenstein Associate Director for Program Development at the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco; Anthony El-Khoueiry, MD, Associate Professor of Clinical Medicine, Norris Cancer Center CISO Chair at the Keck School of Medicine, and Director of the Phase I Drug Development Clinical Program, University of Southern California, Los Angeles; and Ghassan K. Abou-Alfa, MD, MBA, Attending Physician in the Department of Medicine, Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY.

This first of 3 PER Pulse™ Recaps reviews first-line therapy for advanced HCC. Below are some highlights from the activity, featuring video clips from Dr. Venook and Dr. Abou-Alfa:

  • Sorafenib was granted approval from the US Food and Drug Administration (FDA) for patients with advanced HCC on the basis of the pivotal SHARP trial, in which sorafenib demonstrated a 2.8-month improvement in median overall survival (OS) over placebo (10.7 vs 7.9 months). Dr. Venook discussed some challenges associated with sorafenib use, citing the low frequency of tumor shrinkage and the fact that it is frequently not well tolerated, particularly in patients with compromised liver function.
  • The multitargeted tyrosine kinase inhibitor lenvatinib has been examined in a phase III noninferiority trial called REFLECT, where it was compared with sorafenib in the frontline, unresectable HCC setting. In that trial, survival in the lenvatinib arm was noninferior to that in the sorafenib arm (median OS, 13.6 vs 12.3 months, respectively). Lenvatinib was granted approval from the FDA as first-line treatment of unresectable HCC on August 16, 2018.
  • Dr. Abou-Alfa shared his thoughts regarding how to choose between lenvatinib and sorafenib:
    • He pointed out that both progression-free survival (7.4 vs 3.7 months) and response rate (24.1% vs 9.2%) were superior for lenvatinib compared with sorafenib.
    • However, he reminded participants that in the RESORCE trial, patients who received sorafenib first had a survival advantage in the second-line setting with regorafenib, which is specifically indicated to be used after sorafenib.
    • He called the toxicity profile of lenvatinib “inviting,” but he also cautioned that more data are needed to determine which treatment option may be preferred.

2 of 3
Second-Line Therapy for Advanced Hepatocellular Carcinoma

The online continuing medical education (CME) activity, Community Practice Connections™: Navigating New Sequencing Challenges for the Treatment of Hepatocellular Carcinoma, featured 3 experts in hepatocellular carcinoma (HCC) who provided their insights on a number of clinically important questions regarding immunotherapy and other targeted therapies, treatment selection and sequencing, and adverse event management: Alan P. Venook, MD, FASCO, Madden Family Distinguished Professor in Medical Oncology and Translational Research, and Shorenstein Associate Director for Program Development at the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco; Anthony El-Khoueiry, MD, Associate Professor of Clinical Medicine, Norris Cancer Center CISO Chair at the Keck School of Medicine, and Director of the Phase I Drug Development Clinical Program, University of Southern California, Los Angeles; and Ghassan K. Abou-Alfa, MD, MBA, Attending Physician in the Department of Medicine, Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY.

This second of 3 PER Pulse™ Recaps reviews second-line therapy for advanced HCC. Below are some highlights from the activity, featuring a video clip from Dr. Abou-Alfa:

  • In the RESORCE trial of patients with HCC who had tolerated and progressed on sorafenib, regorafenib produced a 2.8-month survival advantage compared with placebo.
  • In the phase I/II CheckMate 040 trial of patients with advanced HCC, nivolumab administered as second-line therapy produced responses in 20% of patients, with a median duration of response of 9.9 months.
  • Dr. Abou-Alfa shared his insights about the results from the placebo-controlled CELESTIAL trial of cabozantinib in patients with HCC who had received prior sorafenib, pointing out the 2.2-month improvement in overall survival (10.2 vs 8.0 months). In his experience, cabozantinib has shown attractive tolerability. He reminded participants that unlike an earlier tivantinib trial (another c-MET inhibitor) that restricted patient eligibility to those with c-MET–positive disease, the CELESTIAL trial was open to patients with advanced HCC, regardless of c-MET expression.
  • The placebo-controlled REACH-2 trial is examining ramucirumab, an anti-VEGFR2 monoclonal antibody as second-line treatment for patients with advanced HCC and elevated baseline alpha-fetoprotein, which has been associated with poor prognosis and aggressive disease. In the REACH-2 trial, patients receiving ramucirumab had a 1.2-month improvement in median survival (8.5 vs 7.3 months).
  • At the time this CME activity was released, only regorafenib and nivolumab were approved by the US Food and Drug Administration (FDA) for patients with HCC that has already been treated with sorafenib. Since that time, cabozantinib was approved on January 14, 2019, on the basis of the CELESTIAL data, and pembrolizumab, an immune checkpoint inhibitor, received accelerated approval on November 9, 2018, on the basis of a 17% overall response rate in the phase II KEYNOTE-224 trial. This highlights how rapidly the field of HCC management is evolving.

3 of 3
Managing Treatment-Related Toxicities in Advanced Hepatocellular Carcinoma

The online continuing medical education (CME) activity, Community Practice Connections™: Navigating New Sequencing Challenges for the Treatment of Hepatocellular Carcinoma, featured 3 experts in hepatocellular carcinoma (HCC) who provided their insights on a number of clinically important questions regarding immunotherapy and other targeted therapies, treatment selection and sequencing, and adverse event management: Alan P. Venook, MD, FASCO, Madden Family Distinguished Professor in Medical Oncology and Translational Research, and Shorenstein Associate Director of Program Development at the Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco; Anthony El-Khoueiry, MD, Associate Professor of Clinical Medicine, Norris Cancer Center CISO Chair at the Keck School of Medicine, and Director of the Phase I Drug Development Clinical Program, University of Southern California, Los Angeles; and Ghassan K. Abou-Alfa, MD, MBA, Attending Physician in the Department of Medicine, Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, New York, NY.

This third of 3 PER Pulse™ Recaps reviews management strategies for treatment-related toxicities in advanced HCC. Below are some highlights from the activity, featuring a video clip from Dr. Abou-Alfa:

  • For patients with HCC receiving tyrosine kinase inhibitors (TKIs), dermatologic toxicities (including hand-foot skin reaction [HFSR]), hypertension, and fatigue are among the most common treatment-related toxicities.
    • For patients with grade 2 HFSR, topical steroid cream and topical anesthetic/analgesic may be prescribed. A decrease in the TKI dosage is warranted with the appearance of grade 2 toxicity, and treatment interruption is warranted with grade 3 toxicity, with resumption at a reduced dosage after improvement to grade 2 or better. In his video, Dr. Abou-Alfa recommends considering consultation with a dermatologist to manage this toxicity.
    • Management of hypertension should follow the Joint National Committee Guideline for the Management of High Blood Pressure in Adults.
    • Fatigue is generally managed by searching for and assessing contributing factors to fatigue, such as pain, emotional distress, sleep disturbance, anemia, and nutritional deficiencies.
  • For patients receiving immune checkpoint inhibitors (ICPis), immune-related adverse events (irAEs) have been well characterized. Disruption of the ICP molecules’ role in the maintenance of immunologic homeostasis is believed to promote autoimmune-like, T-cell–mediated toxicities that affect various organ systems, including dermatologic, gastrointestinal, pulmonary, and endocrine systems. In his video, Dr. Abou-Alfa reminds participants that although ICPis tend to be well tolerated in patients with HCC, irAEs can be serious.
    • irAEs are generally reversible with proper management.
    • For most grade 2 irAEs, the ICPi is interrupted until the toxicity is grade ≤1, whereas grade 3 irAEs typically require the addition of a corticosteroid to treatment interruption.
    • Grade 4 irAEs warrant permanent treatment discontinuation.

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