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Clinical Roundtable Monograph Clinical Advances in Hematology & Oncology October 2015 Advances in the Management of Chemotherapy-Induced Nausea and Vomiting: New Data From Recent and Ongoing Trials Discussants Eric Roeland, MD Director of Clinical Research in Symptom Intervention Assistant Clinical Professor of Medicine University of California, San Diego Moores Cancer Center La Jolla, California Matti S. Aapro, MD Dean of the Multidisciplinary Oncology Institute A CME Activity Clinique de Genolier Approved for Genolier, Switzerland 1.25 AMA PRA Category 1 Credit(s) TM Lee S. Schwartzberg, MD Professor of Medicine Chief, Division of Hematology & Oncology Release Date: October 2015 The University of Tennessee Health Science Center Expiration Date: October 31, 2016 Memphis, Tennessee Estimated time to complete activity: 1.25 hours Project ID: 11026 Abstract: Chemotherapy-induced nausea and vomiting (CINV) is among the most feared and debilitating adverse events experienced by cancer patients. Left unaddressed, CINV symptoms not only decrease quality of life, but may also affect patients’ willingness to continue chemotherapy treatment. Detailed guidelines are available that outline best practices for prophylaxis of acute and delayed CINV. However, adherence to guideline recommendations continues to be suboptimal, and many patients still suffer unnecessarily from CINV. In addition, breakthrough/refractory CINV continues to present particular challenges. The development of effective CINV treatments with diverse mechanisms of action has expanded the options available for preventing symptoms. The US Food and Drug Administration has recently approved several new therapies for the management of CINV. NEPA is a fixed-dose combination of netupitant (300 mg) plus palonosetron (0.5 mg). In combination with dexamethasone, NEPA has demonstrated superior efficacy to palonosetron alone in patients receiving highly or moderately emetogenic chemotherapy. Rolapitant is a next- generation neurokinin 1 (NK1) receptor antagonist. Both palonosetron and rolapitant have proven particularly effective in controlling delayed CINV. Regimens that combine a serotonin 5-hydroxytryptamine–3 receptor antagonist, an NK1 receptor antagonist, and a corticosteroid now represent the standard of care for managing both acute and delayed CINV in patients receiving highly emetogenic chemotherapy. This activity is supported by an independent Jointly provided by Postgraduate Institute for educational grant from Eisai Inc. Medicine and Millennium Medical Publishing Target Audience Eric Roeland, MD—Speakers bureau: Teva and Eisai; Data Safety Monitor- This activity has been designed to meet the educational needs of oncologists, ing Board: Cellceutix; Advisory board: Eisai, Inform Genomics, and Helsinn. hematologists, and oncology nurses involved in the management of cancer pa- Consulting: Eisai tients receiving chemotherapy. Lee S. Schwartzberg, MD—Consultant: Eisai, Helsinn, Merck, and Tesaro Matti S. Aapro, MD—Study grants: Helsinn, Eisai, Merck, Roche, and Statement of Need/Program Overview Chemotherapy-induced nausea and vomiting (CINV) is among the most feared Janssen; Consultant or speaker: Helsinn, Eisai, Merck, Roche, and Janssen and debilitating adverse events experienced by cancer patients. Symptoms not only decrease quality of life, but may also lead patients to delay or postpone chemo- The planners and managers reported the following financial relationships or rela- therapy. Patients must be educated regarding CINV management before they begin tionships to products or devices they or their spouse/life partner have with com- chemotherapy and then asked about specific symptoms after treatment. Options for mercial interests related to the content of this CME activity: prevention and treatment of CINV are based on the emetogenic risk of the chemo- therapy and the type of CINV (acute, delayed, anticipatory, or breakthrough/refrac- The following PIM planners and managers, Trace Hutchison, PharmD; Samantha tory). The US Food and Drug Administration has recently approved new therapies Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, RN, BSN, and Jan Schultz, for the management of CINV. NEPA is a fixed-dose combination of netupitant RN, MSN, CHCP hereby state that they or their spouse/life partner do not have plus palonosetron. In combination with dexamethasone, NEPA has demonstrated any financial relationships or relationships to products or devices with any com- superior efficacy over palonosetron alone in patients receiving highly or moderately mercial interest related to the content of this activity of any amount during the past emetogenic chemotherapy. Rolapitant is a next-generation neurokinin 1 receptor 12 months. Jacquelyn Matos: No real or apparent conflicts of interest to report. antagonist. Both palonosetron and rolapitant have proven particularly effective in Maggie Merchant, PhD: No real or apparent conflicts of interest to report. controlling delayed CINV. Detailed management guidelines, with recommenda- tions based on data from phase 3 clinical trials, provide effective approaches for pre- Method of Participation vention and treatment. Adherence to guidelines is suboptimal but can be improved There are no fees for participating in and receiving CME credit for this activity. with the use of programs incorporating provider education sessions, monthly audit- During the period October 2015 through October 31, 2016, participants must feedback sessions, and risk assessment tools. 1) read the learning objectives and faculty disclosures; 2) study the educational activity; 3) complete the post-test by recording the best answer to each question Educational Objectives in the answer key on the evaluation form; 4) complete the evaluation form; and After completing this activity, the participant should be better able to: 5) mail or fax the evaluation form with answer key to Postgraduate Institute for Medicine. You may also complete the post-test online at www.cmeuniversity. • Describe the impact, incidence, and risk factors of CINV com. On the navigation menu, click on “Find Post-test/Evaluation by Course” • Distinguish chemotherapy regimens with high, moderate, and low emeto- and search by course ID 11026. Upon registering and successfully completing genic risk the post-test with a score of 75% or better and submitting the activity evaluation, • Implement strategies for CINV prevention and management based on rec- your certificate will be made available immediately. Processing credit requests ommendations from guidelines online will reduce the amount of paper used by nearly 100,000 sheets per year. • Evaluate the efficacy and safety data supporting the use of approved anti- emetic agents in the prevention of CINV A statement of credit will be issued only upon receipt of a completed activity • Assess results from recent and ongoing clinical trials in CINV management evaluation form and a completed post-test with a score of 75% or better. Your statement will be emailed to you within three weeks. Accreditation Statement This activity has been planned and implemented in accordance with the ac- Media creditation requirements and policies of the Accreditation Council for Monograph Continuing Medical Education (ACCME) through the joint provider- ship of Postgraduate Institute for Medicine and Millennium Medical Pub- Disclosure of Unlabeled Use lishing, Inc. The Postgraduate Institute for Medicine is accredited by the This educational activity may contain discussion of published and/or inves- ACCME to provide continuing medical education for physicians. tigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled Credit Designation indications. PIM, Millennium Medical Publishing, Inc., and Eisai Inc. do not The Postgraduate Institute for Medicine designates this enduring material for a recommend the use of any agent outside of the labeled indications. maximum of 1.25 AMA PRA Category 1 Credit(s)TM. Physicians should claim only the credit commensurate with the extent of their participation in the activity. The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the Disclosure of Conflicts of Interest official prescribing information for each product for discussion of approved Postgraduate Institute for Medicine (PIM) requires instructors, planners, man- indications, contraindications, and warnings. agers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may Disclaimer have as related to the content of this activity. All identified COI are thoroughly Participants have an implied responsibility to use the newly acquired informa- vetted and resolved according to PIM policy. PIM is committed to provid- tion to enhance patient outcomes and their own professional development. The ing its learners with high-quality CME activities and related materials that information presented in this activity is not meant to serve as a guideline for pa- promote improvements or quality in healthcare and not a specific proprietary tient management. Any procedures, medications, or other courses of diagnosis or business interest of a commercial interest. treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications
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