{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,18]],"date-time":"2026-08-18T03:21:22Z","timestamp":1787023282796,"version":"build-2736575974"},"reference-count":38,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,11,30]],"date-time":"2021-11-30T00:00:00Z","timestamp":1638230400000},"content-version":"vor","delay-in-days":466,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,1,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>For the prevention of chemotherapy-induced nausea and vomiting (CINV) during the delayed phase (24\u2013120 hours) after moderately emetogenic chemotherapy (MEC), the use of 3-day dexamethasone (DEX) is often recommended. This study compared the efficacy and safety of two DEX-sparing regimens with 3-day DEX, focusing on delayed nausea.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>This open-label, randomized, phase III study was designed to demonstrate noninferiority of two DEX-sparing regimens: ondansetron + DEX on day 1 + metoclopramide on days 2\u20133 (MCP arm), and palonosetron + DEX on day 1 (PAL arm) versus ondansetron on day 1 + DEX on days 1\u20133 (DEX arm) in chemotherapy-na\u00efve patients receiving MEC. Primary efficacy endpoint was total control (TC; no emetic episodes, no use of rescue medication, no nausea) in the delayed phase. Noninferiority was defined as a lower 95% CI greater than the noninferiority margin set at \u221220%. Secondary endpoints included no vomiting, no rescue medication, no (significant) nausea, impact of CINV on quality of life, and antiemetics-associated side effects.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Treatment arms were comparable for 189 patients analyzed: predominantly male (55.7%), median age 65.0\u2009years, colorectal cancer (85.7%), and oxaliplatin-based chemotherapy (81.5%). MCP demonstrated noninferiority to DEX for delayed TC (MCP 56.1% vs. DEX 50.0%; 95% CI, \u221211.3%, 23.5%). PAL also demonstrated noninferiority to DEX (PAL 55.6% vs. DEX 50.0%; 95% CI, \u221212.0%, 23.2%). There were no statistically significant differences for all secondary endpoints between treatment arms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study showed that DEX-sparing regimens are noninferior to multiple-day DEX in terms of delayed TC rate in patients undergoing MEC. ClinicalTrials.gov \u00a0identifier. NCT02135510.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Implications for Practice<\/jats:title>\n                    <jats:p>Chemotherapy-induced nausea and vomiting (CINV) in the delayed phase (24\u2013120 hours after chemotherapy) remains one of the most troublesome adverse effects associated with cancer treatment. In particular, delayed nausea is often poorly controlled. The role of dexamethasone (DEX) in the prevention of delayed nausea after moderately emetogenic chemotherapy (MEC) is controversial. This study is the first to include nausea assessment as a part of the primary study outcome to better gauge the effectiveness of CINV control and patients\u2019 experience. Results show that a DEX-sparing strategy does not result in any significant loss of overall antiemetic control: DEX-sparing strategies incorporating palonosetron or multiple-day metoclopramide are safe and at least as effective as standard treatment with a 3-day DEX regimen with ondansetron in controlling delayed CINV\u2014and nausea in particular\u2014following MEC.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1634\/theoncologist.2020-0305","type":"journal-article","created":{"date-parts":[[2020,7,31]],"date-time":"2020-07-31T08:14:10Z","timestamp":1596183250000},"page":"e173-e181","source":"Crossref","is-referenced-by-count":17,"title":["Metoclopramide, Dexamethasone, or Palonosetron for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting After Moderately Emetogenic Chemotherapy (MEDEA): A Randomized, Phase III, Noninferiority Trial"],"prefix":"10.1093","volume":"26","author":[{"given":"Maurice J.D.L.","family":"van der Vorst","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"},{"name":"Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elisa C.","family":"Toffoli","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marlien","family":"Beusink","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Myra E.","family":"van Linde","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Theo","family":"van Voorthuizen","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saskia","family":"Brouwer","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Rijnstate Hospital, Arnhem, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annette A.","family":"van Zweeden","sequence":"additional","affiliation":[{"name":"Amstelland Hospital, Amstelveen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzan","family":"Vrijaldenhoven","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Noordwest Ziekenhuisgroep, Alkmaar, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johan C.","family":"Berends","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Noordwest Ziekenhuisgroep, Den Helder, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes","family":"Berkhof","sequence":"additional","affiliation":[{"name":"Department of Epidemiology and Biostatistics, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henk M.W.","family":"Verheul","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands"},{"name":"Department of Medical Oncology, Radboudumc, Nijmegen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2020,8,21]]},"reference":[{"key":"2021122511445554900_onco13464-bib-0001","doi-asserted-by":"crossref","first-page":"4472","DOI":"10.1200\/JCO.2006.05.6382","article-title":"Delayed nausea and vomiting continue to reduce patients\u2019 quality of life after highly and moderately emetogenic chemotherapy despite antiemetic treatment","volume":"24","author":"Bloechl-Daum","year":"2006","journal-title":"J Clin Oncol"},{"key":"2021122511445554900_onco13464-bib-0002","doi-asserted-by":"crossref","first-page":"735","DOI":"10.1007\/s00520-012-1574-9","article-title":"Nausea still the poor relation in antiemetic therapy? 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