Methodology of antiemetic trials: response assessment, evaluation of new agents and definition of chemotherapy emetogenicity

Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer
Paul J HeskethM Tonato

Abstract

Establishing appropriate and practical methodology is a key to progress in the investigation of chemotherapy-induced nausea and vomiting. Critical issues include patient response assessment, proper trial design for evaluating new agents, and the definition of chemotherapy emetogenicity. In assessing antiemetic response, the primary end-point should be complete control of emesis and nausea. Emesis and nausea should be independently assessed with the period of observation defined (acute, delayed, anticipatory). Emesis can be evaluated by measuring the number of emetic episodes either by direct observation or by patient self-report using patient-completed diaries. Nausea should be measured by patient self-report with the standard parameters, including frequency and intensity. New antiemetic drug development should proceed in an orderly progression from open-label phase I-II trials defining tolerance and minimally fully effective dose to phase III comparative trials. A randomized, parallel, double-blind study is the preferred design for the latter, and the comparator arm should always include the current best available treatment. Antiemetic placebos are no longer acceptable with chemotherapy regimens known to produce emesis in a ma...Continue Reading

Citations

Jun 14, 2008·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Sarah G BrearleyAlex Molassiotis
Dec 21, 2000·Paediatric Anaesthesia·R DrakeJ M Thompson
Jun 6, 2008·The New England Journal of Medicine·Paul J Hesketh
Mar 22, 2014·Journal of Comparative Effectiveness Research·Jacqueline Flank, L Lee Dupuis
May 9, 2014·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Ian N OlverBogda Koczwara
Sep 4, 2015·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Helen VolL Lee Dupuis
Sep 24, 2005·Internal Medicine Journal·I N Olver
Sep 5, 2006·Autonomic Neuroscience : Basic & Clinical·Konrad StreitbergerAntonius Schneider
Jun 26, 2015·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Catalina Hernandez TorresMark Clemons
Jun 21, 2016·Expert Opinion on Pharmacotherapy·Christina H Ruhlmann, Jørn Herrstedt
Oct 2, 2008·Journal of the American Pharmacists Association : JAPhA·Cindy L O'Bryant, Brian C Crandell
Mar 29, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Wilson C MertensPeter K Lindenauer
Sep 30, 2005·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Jeanette EzzoGrant Zhang
Nov 22, 2014·The Cochrane Database of Systematic Reviews·Jeanette EzzoEric Manheimer
Sep 2, 2017·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Karin JordanFranziska Jahn
Jun 18, 2002·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Rolf KaiserJürgen Brockmöller
Feb 24, 2001·American Journal of Clinical Oncology·S BosnjakL Mitrović
Apr 2, 2017·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Kristopher DennisEdward Chow
Oct 10, 2003·Cancer Investigation·Victor T Chang, Jane Ingham
Aug 10, 2016·Supportive Care in Cancer : Official Journal of the Multinational Association of Supportive Care in Cancer·Karin JordanPaul J Hesketh
Oct 3, 2000·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·J P IoannidisJ Lau
Aug 28, 2019·Global Advances in Health and Medicine : Improving Healthcare Outcomes Worldwide·E Anne LownFrederick M Hecht
Apr 16, 2021·Hispanic Health Care International : the Official Journal of the National Association of Hispanic Nurses·Erica Garcia FraustoL Lee Dupuis

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