{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,4]],"date-time":"2026-10-04T06:07:11Z","timestamp":1791094031679,"version":"4.1.0"},"reference-count":37,"publisher":"Wiley","issue":"11","license":[{"start":{"date-parts":[[2014,4,16]],"date-time":"2014-04-16T00:00:00Z","timestamp":1397606400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Aliment Pharmacol Ther"],"published-print":{"date-parts":[[2014,6]]},"abstract":"<jats:title>Summary<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>A phase I dose\u2010escalation trial of transarterial chemoembolisation (<jats:styled-content style=\"fixed-case\">TACE<\/jats:styled-content>) with idarubicin\u2010loaded beads was performed in cirrhotic patients with hepatocellular carcinoma (<jats:styled-content style=\"fixed-case\">HCC<\/jats:styled-content>).<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To estimate the maximum\u2010tolerated dose (<jats:styled-content style=\"fixed-case\">MTD<\/jats:styled-content>) and to assess safety, efficacy, pharmacokinetics and quality of life.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Patients received a single TACE session with injection of 2\u00a0mL drug\u2010eluting beads (DEBs; DC Bead 300\u2013500\u00a0\u03bcm) loaded with idarubicin. The idarubicin dose was escalated according to a modified continuous reassessment method. MTD was defined as the dose level closest to that causing dose\u2010limiting toxicity (DLT) in 20% of patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Twenty\u2010one patients were enrolled, including nine patients at 5\u00a0mg, six patients at 10\u00a0mg, and six patients at 15\u00a0mg. One patient at each dose level experienced<jats:styled-content style=\"fixed-case\">DLT<\/jats:styled-content>(acute myocardial infarction, hyperbilirubinaemia and elevated aspartate aminotransferase (<jats:styled-content style=\"fixed-case\">AST<\/jats:styled-content>) at 5\u2010, 10\u2010 and 15\u2010mg, respectively). The calculated<jats:styled-content style=\"fixed-case\">MTD<\/jats:styled-content>of idarubicin was 10\u00a0mg. The most frequent grade \u22653 adverse events were pain, elevated<jats:styled-content style=\"fixed-case\">AST<\/jats:styled-content>, elevated \u03b3\u2010glutamyltranspeptidase and thrombocytopenia. At 2\u00a0months, the objective response rate was 52% (complete response, 28%, and partial response, 24%) by modified Response Evaluation Criteria in Solid Tumours. The median time to progression was 12.1\u00a0months (95%<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>7.4\u00a0months \u2013 not reached); the median overall survival was 24.5\u00a0months (95%<jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>14.7\u00a0months \u2013 not reached). Pharmacokinetic analysis demonstrated the ability of<jats:styled-content style=\"fixed-case\">DEB<\/jats:styled-content>s to release idarubicin slowly.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Using drug\u2010eluting beads, the maximum\u2010tolerated dose of idarubicin was 10\u00a0mg per<jats:styled-content style=\"fixed-case\">TACE<\/jats:styled-content>session. Encouraging responses and median time to progression were observed. Further clinical investigations are warranted (<jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>01040559).<\/jats:p><\/jats:sec>","DOI":"10.1111\/apt.12746","type":"journal-article","created":{"date-parts":[[2014,4,17]],"date-time":"2014-04-17T02:41:05Z","timestamp":1397702465000},"page":"1301-1313","source":"Crossref","is-referenced-by-count":59,"title":["Idarubicin\u2010loaded beads for chemoembolisation of hepatocellular carcinoma: results of the<scp>IDASPHERE<\/scp>phase I trial"],"prefix":"10.1111","volume":"39","author":[{"given":"M.","family":"Boulin","sequence":"first","affiliation":[{"name":"INSERM U866 University of Burgundy Dijon France"},{"name":"Department of Pharmacy University Hospital Dijon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"P.","family":"Hillon","sequence":"additional","affiliation":[{"name":"INSERM U866 University of Burgundy Dijon France"},{"name":"Department of Hepatogastroenterology University Hospital Dijon France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J. 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