{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,23]],"date-time":"2026-09-23T16:10:26Z","timestamp":1790179826923,"version":"4.1.0"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"8","license":[{"start":{"date-parts":[[2021,5,21]],"date-time":"2021-05-21T00:00:00Z","timestamp":1621555200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"DOI":"10.13039\/100009954","name":"Taiho Pharmaceutical Co.","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009954","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Palonosetron has demonstrated non-inferiority to ondansetron for prevention of chemotherapy-induced nausea and vomiting in pediatric patients in the United States and Europe. We conducted a single-arm registration study to evaluate the efficacy, safety and pharmacokinetics of palonosetron in pediatric patients in Japan.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Key inclusion criteria were age of 28\u00a0days to 18\u00a0years and malignant disease for which initial highly emetogenic chemotherapy or moderately emetogenic chemotherapy was planned. Patients received palonosetron at 20\u00a0\u03bcg\/kg over at least 30\u00a0s intravenously before the start of highly emetogenic chemotherapy or moderately emetogenic chemotherapy and received dexamethasone on Days 1\u20133. The primary endpoint was the proportion of patients achieving a complete response in the overall phase (0\u2013120\u00a0h) in Course 1, and its threshold was set at 30%.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>From December 2016 to June 2019, 60 patients were enrolled, and 58 received at least one dose of palonosetron. The proportion of patients achieving a complete response during the overall phase was 58.6% (95% confidence interval, 44.9%\u201371.4%), showing the primary endpoint was met (P\u00a0&amp;lt;\u00a00.0001). Treatment-related adverse events occurred in two patients (3.4%). Regarding the pharmacokinetics of palonosetron, neither the plasma concentration immediately after administration nor the area under the plasma concentration\u2013time curve from time 0 to infinity differed significantly among the age groups.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>We demonstrated the efficacy of palonosetron in pediatric patients receiving highly emetogenic chemotherapy or moderately emetogenic chemotherapy and confirmed the appropriateness of the 20\u00a0\u03bcg\/kg dose, regardless of age, considering the safety and pharmacokinetic profiles.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration<\/jats:title>\n                  <jats:p>JapicCTI-163305, registered 6 June 2016.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jjco\/hyab079","type":"journal-article","created":{"date-parts":[[2021,5,17]],"date-time":"2021-05-17T11:08:46Z","timestamp":1621249726000},"page":"1204-1211","source":"Crossref","is-referenced-by-count":2,"title":["Phase III study of palonosetron for prevention of chemotherapy-induced nausea and vomiting in pediatric patients"],"prefix":"10.1093","volume":"51","author":[{"given":"Junichi","family":"Hara","sequence":"first","affiliation":[{"name":"Department of Pediatric Hematology and Oncology, Osaka City General Hospital, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshiyuki","family":"Kosaka","sequence":"additional","affiliation":[{"name":"Department of Hematology and Oncology, Kobe Children\u2019s Hospital, Kobe, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsuyoshi","family":"Koh","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology, Saitama Children\u2019s Medical Center, Saitama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimikazu","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Children\u2019s Cancer Center, National Center for Child Health and Development, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadashi","family":"Kumamoto","sequence":"additional","affiliation":[{"name":"Department of Pediatric Oncology, National Cancer Center Hospital, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Fujisaki","sequence":"additional","affiliation":[{"name":"Department of Pediatric Hematology and Oncology, Osaka City General Hospital, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuji","family":"Ishida","sequence":"additional","affiliation":[{"name":"Department of Pediatric Oncology, Shizuoka Cancer Center, Shizuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryoko","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Department of Child Health, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinji","family":"Mochizuki","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Graduate School of Institute of Biomedical & Health Sciences, Hiroshima University, Hiroshima, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Goto","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, Kanagawa Children\u2019s Medical Center, Yokohama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuki","family":"Yuza","sequence":"additional","affiliation":[{"name":"Department of Hematology\/Oncology, Tokyo Metropolitan Children\u2019s Medical Center, Tokyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuhki","family":"Koga","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Kyushu University, Fukuoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2021,5,21]]},"reference":[{"key":"2021080204311784700_ref1","doi-asserted-by":"publisher","first-page":"183","DOI":"10.1016\/j.paed.2018.02.002","article-title":"Principles of chemotherapy","volume":"28","author":"Makin","year":"2018","journal-title":"Paediatr Child Health"},{"key":"2021080204311784700_ref2","doi-asserted-by":"publisher","first-page":"S37","DOI":"10.1007\/s00520-010-0994-7","article-title":"Antiemetics in children receiving chemotherapy. 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