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NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Antiemesis Version 2.2015 NCCN.org Continue Version 2.2015, 09/22/15 © National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. Printed by Alexandre Ferreira on 10/25/2015 6:12:07 AM. For personal use only. Not approved for distribution. Copyright © 2015 National Comprehensive Cancer Network, Inc., All Rights Reserved. NCCN Guidelines Version 2.2015 Panel Members NCCN Guidelines Index Antiemesis Table of Contents Antiemesis Discussion David S. Ettinger, MD/Chair † Steve Kirkegaard, PharmD Σ Eric Roeland, MD The Sidney Kimmel Comprehensive Huntsman Cancer Institute UC San Diego Moores Cancer Cancer Center at Johns Hopkins at the University of Utah Center Michael J. Berger, PharmD/Vice Chair, BCOP Σ Dwight D. Kloth, PharmD, BCOP Σ Hope S. Rugo, MD † ‡ The Ohio State University Comprehensive Fox Chase Cancer Center UCSF Helen Diller Family Cancer Center - James Cancer Hospital Comprehensive Cancer Center and Solove Research Institute Ruth Lagman, MD £ Mayo Clinic Cancer Center Bridget Scullion, PharmD, BCOP Jonathan Aston, PharmD, BCOP, BCPS Σ Dana-Farber/Brigham and Women’s Vanderbilt-Ingram Cancer Center Dean Lim, MD † Cancer Center | Massachusetts City of Hope Comprehensive Cancer Center General Hospital Cancer Center Sally Barbour, PharmD, BCOP, CCP Σ Duke Cancer Institute Cynthia Ma, MD, PhD † John Timoney, PharmD, BCOP † Siteman Cancer Center at Barnes-Jewish Memorial Sloan Kettering Cancer Philip J. Bierman, MD † ‡ Hospital and Washington University School Center Fred & Pamela Buffet Cancer Center of Medicine Barbara Todaro, PharmD Σ Debra Brandt, DO Belinda Mandrell, PhD, RN † Roswell Park Cancer Institute Yale Cancer Center/Smilow Cancer Hospital St. Jude Children’s Research Hospital/ University of Tennessee Cancer Institute Susan G. Urba, MD † £ Dawn E. Dolan, PharmD, BCOP Σ University of Michigan Moffitt Cancer Center Laura Boehnke Michaud, PharmD, BCOP Σ Comprehensive Cancer Center The University of Texas Georgiana Ellis, MD † M.D. Anderson Cancer Center Fred Hutchinson Cancer Research Center/ Seattle Cancer Care Alliance Lisle M. Nabell, MD University of Alabama at Birmingham Eun Jeong Kim, PharmD, MS Σ Comprehensive Cancer Center Stanford Cancer Institute Kim Noonan, MS, RN, ANP, AOCN # Dana-Farber/Brigham and Women’s ‡ Hematology/hematology oncology Cancer Center | Massachusetts General Þ Internal medicine Hospital Cancer Center † Medical oncology # Nurse Σ Pharmacology NCCN Continue £ Supportive care including palliative, Miranda Hughes, PhD pain management, pastoral care, Dorothy A. Shead, MS and oncology social work NCCN Guidelines Panel Disclosures * Writing committee member Version 2.2015, 09/22/15 © National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. Printed by Alexandre Ferreira on 10/25/2015 6:12:07 AM. For personal use only. Not approved for distribution. Copyright © 2015 National Comprehensive Cancer Network, Inc., All Rights Reserved. NCCN Guidelines Version 2.2015 Table of Contents NCCN Guidelines Index Antiemesis Table of Contents Antiemesis Discussion NCCN Antiemesis Panel Members Clinical Trials: NCCN believes that Guidelines Updates the best management for any cancer Principles of Emesis Control for the Cancer Patient (AE-1) patient is in a clinical trial. Participation in clinical trials is especially encouraged. CHEMOTHERAPY-INDUCED EMESIS: To find clinical trials online at NCCN High Emetic Risk Intravenous Chemotherapy - member institutions, click here: Acute and Delayed Emesis Prevention (AE-2) nccn.org/clinical_trials/physician.html. Moderate Emetic Risk Intravenous Chemotherapy - Emesis Prevention (AE-3) NCCN Categories of Evidence and Low and Minimal Emetic Risk Intravenous Chemotherapy - Emesis Prevention (AE-4) Consensus: All recommendations Oral Chemotherapy - Emesis Prevention (AE-5) are Category 2A unless otherwise specified. Breakthrough Treatment for Chemotherapy-Induced Nausea/Vomiting (AE-6) Emetogenic Potential of Intravenous Antineoplastic Agents (AE-7) See NCCN Categories of Evidence and Consensus. Emetogenic Potential of Oral Antineoplastic Agents (AE-9) Principles of Managing Multiday Emetogenic Chemotherapy Regimens (AE-A) Principles for Managing Breakthrough Emesis (AE-B) RADIATION-INDUCED EMESIS: Radiation-Induced Emesis Prevention/Treatment (AE-10) ANTICIPATORY EMESIS: Anticipatory Emesis Prevention/Treatment (AE-11) The NCCN Guidelines® are a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment. Any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment. The National Comprehensive Cancer Network® (NCCN®) makes no representations or warranties of any kind regarding their content, use or application and disclaims any responsibility for their application or use in any way. The NCCN Guidelines are copyrighted by National Comprehensive Cancer Network®. All rights reserved. The NCCN Guidelines and the illustrations herein may not be reproduced in any form without the express written permission of NCCN. ©2015. Version 2.2015, 09/22/15 © National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. Printed by Alexandre Ferreira on 10/25/2015 6:12:07 AM. For personal use only. Not approved for distribution. Copyright © 2015 National Comprehensive Cancer Network, Inc., All Rights Reserved. NCCN Guidelines Version 2.2015 Updates NCCN Guidelines Index Antiemesis Table of Contents Antiemesis Discussion Updates in Version 2.2015 of the NCCN Guidelines for Antiemesis from Version 1.2015 include: AE-2 AE-3 • High emetic risk intravenous chemotherapy - acute and delayed • Moderate emetic risk intravenous chemotherapy - emesis emesis prevention: prevention: Day 1 added: Day 1 added: ◊ Rolapitant 180 mg PO once (category 1). ◊ Rolapitant 180 mg PO once (category 1). ◊ If rolapitant given: Dexamethasone 20 mg PO/IV once ◊ Schwartzberg LS, et al. Lancet Oncol 2015;16:1071-1078. ◊ Rapoport BL, et al. Lancet Oncol 2015;16:1079-1089. Day 2 and 3 added: Day 2, 3, 4 added: ◊ Rolapitant used day 1: ± dexamethasone 8 mg PO/IV daily on ◊ If rolapitant is given on day 1, dexamethasone 8 mg PO/IV twice daily days 2, 3 days 2, 3, 4 Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged. UPDATES Version 2.2015, 09/22/15 © National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. 1 OF 2 Printed by Alexandre Ferreira on 10/25/2015 6:12:07 AM. For personal use only. Not approved for distribution. Copyright © 2015 National Comprehensive Cancer Network, Inc., All Rights Reserved. NCCN Guidelines® Version 2.2015 Updates NCCN Guidelines Index Antiemesis Table of Contents Antiemesis Discussion Updates in Version 1.2015 of the NCCN Guidelines for Antiemesis from Version 2.2014 include: AE-2 AE-5 • The information on this page has been reformatted for clarity and • Oral chemotherapy - emesis prevention: consistency. High to moderate emetic risk, clarified ondansetron 16-24 mg(total dose) • High emetic risk intravenous chemotherapy - acute and delayed emesis PO daily. prevention: Low to minimal emetic risk, clarified Removed “Preferred” from palonosetron 0.25 mg IV day 1 ◊ Dolasetron 100 mg PO daily added “PRN” Day 1, added the following netupitant-containing regimen: ◊ Granisetron 1-2 mg (total dose) PO added “PRN” ◊ Netupitant 300 mg/palonosetron 0.5 mg PO once ◊ Ondansetron 8-16 mg (total dose) PO daily added “PRN” ◊ Dexamethasone 12 mg PO day 1 AE-8 ◊ Hesketh P, Rossi G, Rizzi G et al. Efficacy and safety of NEPA, an • Emetogenic potential of Intravenous antineoplastic agents oral combination of netupitant and palonosetron, for prevention Added the following agents to low emetic risk: of chemotherapy-induced nausea and vomiting following highly ◊ Belinostat emetogenic chemotherapy: a randomized dose ranging pivotal study. ◊ Blinatumomab Ann Oncol 2014; 25: 1340–1346 Added the following agents to minimal emetic risk: Changed lorazepam from every 4-6 h to every 6 h. (also applies to AE-3 ◊ Nivolumab and AE-6) ◊ Obinutuzumab Added a new footnote, “If neither aprepitant nor fosaprepitant are given ◊ Pembrolizumab on day 1, then dexamethasone 20 mg PO/IV once on day 1, followed by 8 ◊ Ramucirumab mg BID PO/IV on days 2, 3, 4. ◊ Siltuximab AE-3 AE-9 • Moderate emetic risk intravenous chemotherapy - emesis prevention: • Emetogenic potential of oral antineoplastic agents Day 1, added the following netupitant-containing regimen: Added the following agents to moderate to high emetic risk: ◊ Netupitant 300 mg/palonosetron 0.5 mg PO once ◊ Ceritinib ◊ Dexamethasone 12 mg PO day 1 ◊ Lenvatinib ◊ Aapro M, Rugo H, Rossi G, et al. A randomized phase III study ◊ Olaparib evaluating the efficacy and safety of NEPA, a fixed-dose