{"@context":{"@vocab":"https://cir.nii.ac.jp/schema/1.0/","rdfs":"http://www.w3.org/2000/01/rdf-schema#","dc":"http://purl.org/dc/elements/1.1/","dcterms":"http://purl.org/dc/terms/","foaf":"http://xmlns.com/foaf/0.1/","prism":"http://prismstandard.org/namespaces/basic/2.0/","cinii":"http://ci.nii.ac.jp/ns/1.0/","datacite":"https://schema.datacite.org/meta/kernel-4/","ndl":"http://ndl.go.jp/dcndl/terms/","jpcoar":"https://github.com/JPCOAR/schema/blob/master/2.0/"},"@id":"https://cir.nii.ac.jp/crid/1361981471093473280.json","@type":"Article","productIdentifier":[{"identifier":{"@type":"DOI","@value":"10.1210/jc.2015-3989"}},{"identifier":{"@type":"URI","@value":"http://academic.oup.com/jcem/article-pdf/101/11/4103/20287783/jcem4103.pdf"}},{"identifier":{"@type":"PMID","@value":"27548104"}}],"dc:title":[{"@value":"Characterization of Tumor Size Changes Over Time From the Phase 3 Study of Lenvatinib in Thyroid Cancer"}],"description":[{"type":"abstract","notation":[{"@value":"<jats:sec>\n                  <jats:title>Context:</jats:title>\n                  <jats:p>Lenvatinib improved the progression-free survival (PFS) and overall response rate of patients with radioiodine-refractory differentiated thyroid cancer vs placebo in the Phase 3 Study of (E7080) Lenvatinib in Differentiated Cancer of the Thyroid (SELECT).</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Objective:</jats:title>\n                  <jats:p>The objective of the study was to characterize tumor size changes with lenvatinib treatment.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Design:</jats:title>\n                  <jats:p>SELECT was a phase 3, randomized, double-blind, multicenter study.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Setting:</jats:title>\n                  <jats:p>In this clinical trial, tumor assessments of lenvatinib (n = 261) and placebo-treated (n = 131) patients were performed by independent radiological review per Response Evaluation Criteria in Solid Tumors version, 1.1 at 8-week intervals.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Patients:</jats:title>\n                  <jats:p>Patients with complete or partial response were defined as responders to lenvatinib (n = 169). Of the 92 nonresponders, 76 had at least one postbaseline tumor assessment and were included in this analysis.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Interventions:</jats:title>\n                  <jats:p>Lenvatinib (24 mg once daily) or placebo in 28-day cycles until unacceptable toxicity, disease progression, or death.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Main Outcome Measures:</jats:title>\n                  <jats:p>This was an exploratory analysis of key end points from SELECT, including PFS, overall response rate, and tumor reduction.</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Results:</jats:title>\n                  <jats:p>The median maximum percentage change in tumor size was −42.9% for patients receiving lenvatinib (responders, −51.9%; nonresponders, −20.2%). Tumor size reduction was most pronounced at first assessment (median, −24.7% at 8 wk after randomization); thereafter, the rate of change was slower but continuous (−1.3% per mo). In a multivariate model, percentage change in tumor size at the first assessment was a marginally significant positive predictor for PFS (P = .06).</jats:p>\n               </jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions:</jats:title>\n                  <jats:p>The change in tumor size conferred by lenvatinib was characterized by two phases: an initial, rapid decline, followed by slower, continuous shrinkage.</jats:p>\n               </jats:sec>"}]}],"creator":[{"@id":"https://cir.nii.ac.jp/crid/1381981471093473290","@type":"Researcher","foaf:name":[{"@value":"Bruce Robinson"}],"jpcoar:affiliationName":[{"@value":"Kolling Institute of Medical Research (B.R.), University of Sydney, New South Wales 2006, Australia;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473285","@type":"Researcher","foaf:name":[{"@value":"Martin Schlumberger"}],"jpcoar:affiliationName":[{"@value":"Department of Nuclear Medicine and Endocrine Oncology (M.S.), Gustave Roussy and University Paris-Sud, 94805 Villejuif, France;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473280","@type":"Researcher","foaf:name":[{"@value":"Lori J. Wirth"}],"jpcoar:affiliationName":[{"@value":"Department of Medicine (L.J.W.), Massachusetts General Hospital, Boston, Massachusetts 02114;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473284","@type":"Researcher","foaf:name":[{"@value":"Corina E. Dutcus"}],"jpcoar:affiliationName":[{"@value":"Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473287","@type":"Researcher","foaf:name":[{"@value":"James Song"}],"jpcoar:affiliationName":[{"@value":"Eisai Inc (C.E.D., J.S.), Woodcliff Lake, New Jersey 07677;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473288","@type":"Researcher","foaf:name":[{"@value":"Matthew H. Taylor"}],"jpcoar:affiliationName":[{"@value":"Knight Cancer Institute (M.H.T.), Oregon Health and Science University, Portland, Oregon 97239;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473282","@type":"Researcher","foaf:name":[{"@value":"Sung-Bae Kim"}],"jpcoar:affiliationName":[{"@value":"Department of Oncology (S.-B.K.), Asan Medical Center, University of Ulsan College of Medicine, Seoul, 138-736, Republic of South Korea;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473286","@type":"Researcher","foaf:name":[{"@value":"Monika K. Krzyzanowska"}],"jpcoar:affiliationName":[{"@value":"Division of Medical Oncology and Hematology (M.K.K.), Princess Margaret Cancer Centre, Toronto, Ontario, Canada M5G 2M9;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473281","@type":"Researcher","foaf:name":[{"@value":"Jaume Capdevila"}],"jpcoar:affiliationName":[{"@value":"Department of Medical Oncology (J.C.), Vall d’Hebron University Hospital, Vall Hebron Institute of Oncology, 08035 Barcelona, Spain;"}]},{"@id":"https://cir.nii.ac.jp/crid/1381981471093473289","@type":"Researcher","foaf:name":[{"@value":"Steven I. Sherman"}],"jpcoar:affiliationName":[{"@value":"Department of Endocrine Neoplasia and Hormonal Disorders (S.I.S.), Division of Internal Medicine, The University of Texas M. D. 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