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Phase I/II study of first-line combination therapy with sorafenib plus resminostat, an oral HDAC inhibitor, versus sorafenib monotherapy for advanced hepatocellular carcinoma in east Asian patients

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dc.contributor.authorTak, Won Young-
dc.contributor.authorRyoo, Baek-Yeol-
dc.contributor.authorLim, Ho Yeong-
dc.contributor.authorKim, Do-Young-
dc.contributor.authorOkusaka, Takuji-
dc.contributor.authorIkeda, Masafumi-
dc.contributor.authorHidaka, Hisashi-
dc.contributor.authorYeon, Jong-Eun-
dc.contributor.authorMizukoshi, Eishiro-
dc.contributor.authorMorimoto, Manabu-
dc.contributor.authorLee, Myung-Ah-
dc.contributor.authorYasui, Kohichiroh-
dc.contributor.authorKawaguchi, Yasunori-
dc.contributor.authorHeo, Jeong-
dc.contributor.authorMorita, Sojiro-
dc.contributor.authorKim, Tae-You-
dc.contributor.authorFuruse, Junji-
dc.contributor.authorKatayama, Kazuhiro-
dc.contributor.authorAramaki, Takeshi-
dc.contributor.authorHara, Rina-
dc.contributor.authorKimura, Takuya-
dc.contributor.authorNakamura, Osamu-
dc.contributor.authorKudo, Masatoshi-
dc.date.available2020-11-02T06:50:23Z-
dc.date.issued2018-12-
dc.identifier.issn0167-6997-
dc.identifier.issn1573-0646-
dc.identifier.urihttps://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/2860-
dc.description.abstractPurpose: Resminostat is an oral inhibitor of class I, IIB, and IV histone deacetylases. This phase I/II study compared the safety and efficacy of resminostat plus sorafenib versus sorafenib monotherapy as first-line therapy for advanced hepatocellular carcinoma (HCC). Experimental design: In phase I, resminostat (400mg or 600mg/day on days 1 to 5 every 14days) was administered with sorafenib (800mg/day for 14days) to determine the recommended dose for phase II. In phase II, patients were randomized (1:1) to sorafenib monotherapy or resminostat plus sorafenib. The primary endpoint was time-to-progression (TTP). Results: Nine patients (3: 400mg, 6: 600mg) were enrolled in phase I, and the recommended dose of resminostat was determined to be 400mg/day. Then 170 patients were enrolled in phase II. Median TTP/overall survival (OS) were 2.8/14.1months with monotherapy versus 2.8/11.8months with combination therapy (Hazard Ratio [HR]: 0.984, p=0.925/HR: 1.046, p=0.824). The overall incidence of adverse events was similar in both groups (98.8% versus 100.0%). However, thrombocytopenia Grade 3 was significantly more frequent in the combination therapy group (34.5% versus 2.4%, p<0.001). Subgroup analysis revealed that median TTP/OS was 1.5/6.9months for monotherapy versus 2.8/13.1months for combination therapy (HR: 0.795, p=0.392/HR: 0.567, p=0.065) among patients with a normal-to-high baseline platelet count ( 150x10(3)/mm(3)). Conclusions: In patients with advanced HCC, first-line therapy with resminostat at the recommended dose plus sorafenib showed no significant efficacy advantage over sorafenib monotherapy.-
dc.format.extent13-
dc.language영어-
dc.language.isoENG-
dc.publisherKluwer Academic Publishers-
dc.titlePhase I/II study of first-line combination therapy with sorafenib plus resminostat, an oral HDAC inhibitor, versus sorafenib monotherapy for advanced hepatocellular carcinoma in east Asian patients-
dc.typeArticle-
dc.publisher.location네델란드-
dc.identifier.doi10.1007/s10637-018-0658-x-
dc.identifier.scopusid2-s2.0-85053437981-
dc.identifier.wosid000450005200011-
dc.identifier.bibliographicCitationInvestigational New Drugs, v.36, no.6, pp 1072 - 1084-
dc.citation.titleInvestigational New Drugs-
dc.citation.volume36-
dc.citation.number6-
dc.citation.startPage1072-
dc.citation.endPage1084-
dc.type.docTypeArticle-
dc.description.isOpenAccessN-
dc.description.journalRegisteredClasssci-
dc.description.journalRegisteredClassscie-
dc.description.journalRegisteredClassscopus-
dc.relation.journalResearchAreaOncology-
dc.relation.journalResearchAreaPharmacology & Pharmacy-
dc.relation.journalWebOfScienceCategoryOncology-
dc.relation.journalWebOfScienceCategoryPharmacology & Pharmacy-
dc.subject.keywordPlusADVANCED SOLID TUMORS-
dc.subject.keywordPlusJAPANESE PATIENTS-
dc.subject.keywordPlusCANCER-
dc.subject.keywordPlusTRIALS-
dc.subject.keywordAuthorHepatocellular carcinoma-
dc.subject.keywordAuthorHDAC-
dc.subject.keywordAuthorResminostat-
dc.subject.keywordAuthorSorafenib-
dc.subject.keywordAuthorSystemic chemotherapy-
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