{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T10:17:26Z","timestamp":1787912246661,"version":"build-2784847793"},"reference-count":24,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2018,11,13]],"date-time":"2018-11-13T00:00:00Z","timestamp":1542067200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Cancer Institute"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Blood &amp; Cancer"],"published-print":{"date-parts":[[2019,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Fosaprepitant is a neurokinin\u20101 receptor antagonist, approved for the prevention of chemotherapy\u2010induced nausea and vomiting. The data on the use of fosaprepitant in children are limited and therefore we conducted a phase III randomized controlled trial.<\/jats:p><\/jats:sec><jats:sec><jats:title>Procedure<\/jats:title><jats:p>Children aged 1\u201012\u00a0years scheduled to receive moderately or highly emetogenic chemotherapy were randomly assigned to arm\u2010A (fosaprepitant) or arm\u2010B (placebo). Children recruited to arm\u2010A received intravenous ondansetron plus dexamethasone followed by fosaprepitant infusion. Children recruited to arm\u2010B received the same drugs as those given to children in arm\u2010A, except that fosaprepitant was substituted with a placebo. Ondansetron and dexamethasone were continued for 48 hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a complete response (CR), defined as no vomiting, no retching, and no use of rescue medication, during the 24\u2010120\u00a0hours (delayed phase) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the acute phase (0\u201024\u00a0hours) and overall after administration of the last dose of chemotherapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One\u2010hundred\u2010sixty\u2010three patients were analyzed (81 in the fosaprepitant arm and 82 in the placebo arm). CR rates were significantly higher in the fosaprepitant arm compared to those in the placebo arm during the acute phase (86% vs 60%, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001), delayed phase (79% vs 51%, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001), and overall phase (70% vs 41%, <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001). Three (4%) patients in the fosaprepitant arm and sixteen (20%) in the placebo arm required rescue anti\u2010emetics (<jats:italic>P<\/jats:italic>\u00a0=\u00a00.0017).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Addition of fosaprepitant to ondansetron and dexamethasone improved chemotherapy\u2010induced vomiting control in children treated with moderately or highly emetogenic chemotherapy.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pbc.27551","type":"journal-article","created":{"date-parts":[[2018,11,14]],"date-time":"2018-11-14T04:24:31Z","timestamp":1542169471000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":29,"title":["Intravenous fosaprepitant for the prevention of chemotherapy\u2010induced vomiting in children: A double\u2010blind, placebo\u2010controlled, phase III randomized trial"],"prefix":"10.1002","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7557-5816","authenticated-orcid":false,"given":"Venkatraman","family":"Radhakrishnan","sequence":"first","affiliation":[{"name":"Department of Medical Oncology (Pediatric Oncology Division) Cancer Institute (WIA)  Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Archit","family":"Joshi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology (Pediatric Oncology Division) Cancer Institute (WIA)  Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0446-7260","authenticated-orcid":false,"given":"Jaikumar","family":"Ramamoorthy","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology (Pediatric Oncology Division) Cancer Institute (WIA)  Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Swaminathan","family":"Rajaraman","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Cancer Institute (WIA)  Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prasanth","family":"Ganesan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology (Pediatric Oncology Division) Cancer Institute (WIA)  Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trivadi S.","family":"Ganesan","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology (Pediatric Oncology Division) Cancer Institute (WIA)  Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Manikandan","family":"Dhanushkodi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology (Pediatric Oncology Division) Cancer Institute (WIA)  Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tenali G.","family":"Sagar","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology (Pediatric Oncology Division) Cancer Institute (WIA)  Chennai India"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,11,13]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1007\/s40272-017-0228-2"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.74.4789"},{"key":"e_1_2_8_4_1","unstructured":"NCCN.NCCN clinical practice guidelines in oncology (NCCN Guidelines\u00ae) antiemesis antiemesis.pdf.2018.http:\/\/www.nccn.org\/professionals\/physician_gls\/pdf\/antiemesis.pdf."},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.26542"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-008-0539-5"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.25955"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.21631"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdv482"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/pbc.23114"},{"key":"e_1_2_8_11_1","unstructured":"European Medicines Agency.Assessment report for paediatric studies submitted according to Article 46 of the Regulation (EC) No 1901\/2006\u2010Emend\/Ivemend\u2014Merck Sharp & Dohme Limited\u2014PK\/PD study.http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/EPAR_-Assessment_Report_-_Variation\/human\/000743\/WC500186694.pdf. 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