Accreditation/Credit Designation

Physicians’ Education Resource®, LLC, 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 Bayer HealthCare Pharmaceuticals, Eisai, Inc., and Merck & Co., Inc.

Medical Crossfire®: Linking Current Evidence to Treatment Planning for Hepatocellular Carcinoma: A Multidisciplinary Tumor Board

Release Date: October 31, 2019
Expiration Date: October 31, 2020
Media: Internet - based

Activity Overview

Following a decade-long paucity of new drug options for the management of hepatocellular carcinoma (HCC), the oncology community has seen an explosion of progress in novel strategies for patients with these tumors. Currently, surgical resection, local ablation, and liver transplantation represent curative options for patients with early-stage HCC. For transplant-ineligible patients with unresectable, more advanced disease, National Comprehensive Cancer Network Guidelines® recommend treatment management with transarterial chemoembolization, transarterial radioembolization, ablation, or radiation therapy or treatment with the small molecule tyrosine kinase inhibitors (TKIs) sorafenib and lenvatinib. Over the past 2 years, the FDA has approved next-generation TKIs (eg, regorafenib and cabozantinib) and immune checkpoint inhibitors (eg, nivolumab and pembrolizumab) for the second-line treatment of patients with advanced HCC. Furthermore, the monoclonal antibody ramucirumab is the first drug to be approved for advanced HCC based on the presence of high levels of the clinical biomarker α-fetoprotein, which is expressed in more than 40% of these patients. With the recent availability of these new agents, the sequencing of therapies for patients with advanced HCC has become far more promising but also far more complicated than in the past. Not only do clinicians need to understand the indications for these agents, but they must also be informed about common adverse events (AEs) associated with these drugs and management techniques to proactively mitigate predictable treatment-related AEs, to optimize outcomes and maintain patients on therapy whenever possible.

Because curative and palliative treatments are often used in combination for patients with all stages of HCC, effective management of this disease requires a multidisciplinary collaboration between hepatologists, pathologists, oncologists, interventional radiologists, and surgical oncologists. This educational activity was designed to provide expert guidance on the multidisciplinary approach to core concepts in HCC.

Benefits of Participating

  • Gain insights into the importance of proper staging and determination of liver functionality for patients with HCC, particularly because of underlying cirrhosis and other comorbidities often associated with this disease
  • Determine the appropriate criteria for choosing liver resection, liver transplantation, ablative therapy, and/or adjuvant systemic treatment for patients with early-stage HCC
  • Distinguish when to use specific locoregional treatment options (eg, ablation, arterially-directed therapy, radiation) for patients with intermediate-stage HCC
  • Improve clinical competence regarding the integration of newly approved systemic agents, including TKIs and immune checkpoint inhibitors, and management of treatment-related AEs for patients with advanced, unresectable HCC

Acknowledgement of Commercial Support

This activity is supported by educational grants from Bayer HealthCare Pharmaceuticals, Eisai, Inc., and Merck & Co., Inc.

Instructions for This Activity and Receiving Credit

  • You will need to log in 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/Videos” will be available for your reference.
  • In order to receive a CME Certificate, you 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.” You may immediately download a CME Certificate upon completion of these steps.

Target Audience

This educational program is directed toward medical oncologists, surgeons, and interventional radiologists interested in the treatment of HCC. Other allied healthcare professionals, including nurse practitioners, physician assistants, and nurses involved in the treatment and management of patients with HCC are also invited to participate.

Learning Objectives

Upon successful completion of this educational activity, you should be better prepared to:

  • Describe the mechanistic rationales underlying recent targeted drug development in HCC and how they relate to HCC biology
  • Discuss the selection and timing of appropriate locoregional treatment options for patients with HCC, including surgery, ablation, arterially-directed therapies, and radiation therapy
  • Evaluate recent clinical trial evidence and patient characteristics to inform optimized sequencing decisions in the management of patients with advanced HCC
  • Outline strategies to mitigate the treatment-related toxicities of current and emerging therapies for the management of HCC

Faculty, Staff, and Planners’ Disclosures

Faculty

Ghassan Abou-Alfa
Ghassan Abou-Alfa, MD, MBA
Professor of Medicine
Memorial Sloan Kettering Cancer Center
Weill Medical College at Cornell University
New York, NY

Disclosures: Grant/Research Support: ActaBiologica, Agios, Array, AstraZeneca, Bayer, BeiGene, Bristol-Myers Squibb, CASI, Celgene, Exelixis, Genentech, Halozyme, Incyte, Lilly, MabVax, Novartis, OncoQuest, Polaris, Puma, QED, Roche; Consultant: 3DMedcare, Agios, Alignmed, Amgen, Antengene, Aptus, ASLAN, Astellas, AstraZeneca, Bayer, BeiGene, Bioline, Bristol-Myers Squibb, Boston Scientific, Bridgebio, CARsgen, Celgene, CASI, Cipla, CytomX, Daiichi, Debio, Delcath, Eisai, Exelixis, Flatiron, Genoscience, Halozyme, Hengrui, Incyte, Inovio, Ipsen, Jansen, Jazz, KLUS, Kyowa Kirin, LAM, Lilly, Loxo, Merck, Mina, Novella, Onxeo, PCI Biotech, Pfizer, Pieris, QED, RedHill, Sanofi, Servier, Silenseed, SillaJen, Sobi, Targovax, Tekmira, twoXAR, Vicus, Yakult, Yiviva.

Aiwu Ruth He
Aiwu Ruth He, MD, PhD
Associate Professor
Division of Hematology and Oncology
Department of Medicine
Georgetown University
Washington, DC

Disclosures: Grant/Research Support: Genentech, Merck; Consultant: Bristol-Myers Squibb, Eisai, Genentech, Merck; Speaker’s Bureau: Bayer, Bristol-Myers Squibb, Eisai, Exelixis.

Bachir Taouli
Bachir Taouli, MD, MHA
Professor of Radiology
Vice-chair of Translational Research
Director of Body MRI
Director of Cancer Imaging Program
Department of Radiology and Translational and Molecular Imaging Institute Icahn School of Medicine at Mount Sinai
New York, NY

Disclosures: Grant Research Support: Bayer HealthCare; Consultant: Bayer HealthCare.

Alice C. Wei
Alice C. Wei, MDCM, MSc, FRCSC, FACS
Associate Attending Surgeon
Hepatopancreatobiliary Service
Department of Surgery
Memorial Sloan Kettering Cancer Center
Co-Director of Surgical Initiatives
David M. Rubenstein Center for Pancreatic Cancer Research
Memorial Sloan Kettering Cancer Center
New York, NY

Disclosures: Speaker’s Bureau: Celgene; Other Support: Bayer (travel).

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

Disclosure Policy and Resolution of Conflicts of Interest (COI)

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. The ACCME defines “relevant financial relationships” as financial relationships in any amount occurring within the past 12 months that creates a 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 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 education purposes only and is not meant to substitute for the independent clinical judgment of a physician relative to diagnostic or treatment 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® or the company that provided commercial support.

PER Pulse™ Recaps

1 of 3

Medical Crossfire®: Linking Current Evidence to Treatment Planning for Hepatocellular Carcinoma: A Multidisciplinary Tumor Board is a continuing medical education (CME)-certified program. For this program, chair Ghassan Abou-Alfa, MD, MBA, was joined by expert faculty Aiwu Ruth He, MD, PhD; Bachir Taouli, MD, MHA; and Alice C. Wei, MD, MSc, to provide expert guidance on the multidisciplinary approach to hepatocellular carcinoma (HCC) management.

This first of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for choosing among diverse therapies for patients with early-stage HCC. Below are some highlights from the activity featuring Dr Alice C. Wei:

  • Patients with HCC have the best chance for survival when they are diagnosed and treated early, before any symptoms arise. Routine screening of patients at high risk (including Asians 40 years or older and any individuals with cirrhosis, hepatitis B or C, history of alcoholism, or nonalcoholic fatty liver disease [NAFLD]) using ultrasound every 6 months with or without testing alpha-fetoprotein (AFP) levels can help identify early lesions that should be further investigated with additional diagnostic imaging.1
  • Potentially curative radical therapies include resection, liver transplantation, or local ablation with either radiofrequency or percutaneous ethanol injection.1 A randomized trial of patients with early-stage HCC randomized to hepatic resection or radiofrequency ablation (RFA) showed no differences in terms of 10-year overall survival (47.6% vs 41.8%; P = .531), 10-year disease-free survival (31.9% vs 18.6%; P = .072), or overall recurrence (71.3% vs 81.7%), indicating that RFA is an effective modality with a decreased complication rate for treating this patient population.2
  • Neoadjuvant strategies to make resection feasible or easier are also being investigated for treatment of early-stage HCC. The phase II BIOSHARE trial demonstrated that preoperative sorafenib twice daily for 4 weeks allowed for R0 resections in 22 of 25 patients (88%) with early-stage HCC.3 Additional studies are ongoing to determine the role of neoadjuvant treatment for patients with early-stage, resectable HCC.

“At the moment, the interest is not anymore only on tyrosine kinase inhibitors, but also on checkpoint inhibitors [in the adjuvant setting for resectable HCC].”
—Ghassan Abou-Alfa, MD, MBA

References

  1. NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers, version 3.2019. National Comprehensive Cancer Network website. nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Published August 1, 2019. Accessed November 13, 2019.
  2. Ng KKC, Chok KSH, Chan ACY, et al. Randomized clinical trial of hepatic resection versus radiofrequency ablation for early-stage hepatocellular carcinoma. Br J Surg. 2017;104(13):1775-1784. doi: 10.1002/bjs.10677.
  3. Bouattour M, Fartoux L, Rosmorduc O, et al. BIOSHARE multicenter neoadjuvant phase 2 study: results of pre-operative sorafenib in patients with resectable hepatocellular carcinoma (HCC)—from GERCOR IRC. J Clin Oncol. 2016;34(4 suppl; abstr 252). doi: 10.1200/jco.2016.34.4_suppl.252.

2 of 3

Medical Crossfire®: Linking Current Evidence to Treatment Planning for Hepatocellular Carcinoma: A Multidisciplinary Tumor Board is a continuing medical education (CME)-certified program. For this program, chair Ghassan Abou-Alfa, MD, MBA, was joined by expert faculty Aiwu Ruth He, MD, PhD; Bachir Taouli, MD, MHA; and Alice C. Wei, MD, MSc, to provide expert guidance on the multidisciplinary approach to hepatocellular carcinoma (HCC) management.

This second of 3 PER Pulse™ Recaps summarizing the online activity focuses on strategies for individualizing decision-making for patients with intermediate-stage HCC. Below are some highlights from the activity featuring Dr Taouli:

  • Hepatic resection is potentially curative treatment for qualifying patients, which include those with adequate liver function (eg, Child-Pugh class A and selected Child-Pugh class B patients without portal hypertension), no major vascular invasion, adequate liver remnant, and no extrahepatic metastases.1
  • Locoregional approaches for patients with unresectable HCC include ablative techniques (eg, radiofrequency ablation, microwave ablation, radiation therapy) and catheter-directed therapies (eg, transarterial chemoembolization [TACE], transarterial radioembolization [TARE], hepatic artery infusion).1
  • TARE with yttrium-90 microspheres has a favorable toxicity profile,2 which may be an alternative treatment for TACE in patients with liver-limited, unresectable HCC.1

“At Mount Sinai, we’ve been doing more and more radiation therapy [as locoregional treatment for these patients], and it’s been really effective in certain situations that are difficult to treat or access for ablation.”
—Bachir Taouli, MD, MBA

References

  1. NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers, version 3.2019. National Comprehensive Cancer Network website. nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Published August 1, 2019. Accessed November 13, 2019.
  2. Kulik LM, Carr BI, Mulcahy MF, et al. Safety and efficacy of 90Y radiotherapy for hepatocellular carcinoma with and without portal vein thrombosis. Hepatology. 2008;47(1):71-81. doi: 10.1002/hep.21980.

3 of 3

Medical Crossfire®: Linking Current Evidence to Treatment Planning for Hepatocellular Carcinoma: A Multidisciplinary Tumor Board is a continuing medical education (CME)-certified program. For this program, chair Ghassan Abou-Alfa, MD, MBA, was joined by expert faculty Aiwu Ruth He, MD, PhD; Bachir Taouli, MD, MHA; and Alice C. Wei, MD, MSc, to provide expert guidance on the multidisciplinary approach to hepatocellular carcinoma (HCC) management.

This third of 3 PER Pulse™ Recaps summarizing the online activity focuses on how to assess the impact of changing treatment paradigms for patients with advanced-stage HCC. Below are some highlights from the activity featuring Dr He:

  • Since 2017, 6 new drugs have been approved for systemic treatment of advanced HCC: 3 tyrosine kinase inhibitors (TKIs; lenvatinib, cabozantinib, and regorafenib), 2 checkpoint inhibitors (nivolumab and pembrolizumab), and 1 VEGFR2 antagonist (ramucirumab). This evolution in choices has changed the treatment landscape for both frontline and subsequent lines of therapy.1
  • Oncologists treating patients with advanced HCC know well that TKI therapy is associated with hypertension, cardiotoxicity, diarrhea, and hemorrhage. General adverse event (AE) management for this class of drugs includes hypertension screening and management, cardiac risk assessment, consideration of wound-healing issues associated with surgery, and dose reductions to lessen toxicity.2-5 TKIs have short half-lives, so temporarily discontinuing treatment should cause symptoms to abate.
  • Checkpoint inhibitors are associated with immune-related AEs (eg, pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, skin reactions) that require different management strategies, such as thyroid function monitoring, dermatologic and gastrointestinal toxicity monitoring, and pneumonitis mitigation.6-7 Most patients tolerate immunotherapies well, but AE symptoms can linger even after treatment is complete.

“There is a lot of excitement in immunotherapy [as second-line therapy for advanced HCC]. We’re also very excited about it, but I think it’s still too early to know what the role is going to be for HCC.”
—Alice C. Wei, MD, MSc

References

  1. NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers, version 3.2019. National Comprehensive Cancer Network website. nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Published August 1, 2019. Accessed November 13, 2019.
  2. Nexavar (sorafenib) [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2005; updated 2018. labeling.bayerhealthcare.com/html/products/pi/Nexavar_PI.pdf. Accessed November 13, 2019.
  3. Lenvima (lenvatinib) [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2015; updated 2019. lenvima.com/pdfs/prescribing-information.pdf. Accessed November 13, 2019.
  4. Stivarga (regorafenib) [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2012; updated 2019. labeling.bayerhealthcare.com/html/products/pi/Stivarga_PI.pdf. Accessed November 13, 2019.
  5. Cabometyx (cabozantinib) [package insert]. Alameda, CA: Exelixis, Inc; 2012; updated 2019. cabometyxhcp.com/pi/. Accessed November 13, 2019.
  6. Opdivo (nivolumab) [package insert]. Princeton, NJ: Bristol-Myers Squibb Co; 2014; updated 2019. packageinserts.bms.com/pi/pi_opdivo.pdf. Accessed November 13, 2019.
  7. Keytruda (pembrolizumab) [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2014; updated 2019. merck.com/product/usa/pi_circulars/k/keytruda/keytruda_pi.pdf. Accessed November 13, 2019.

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