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Phase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer

DC Field Value Language
dc.contributor.authorLee, K. -W.-
dc.contributor.authorPark, S. R.-
dc.contributor.authorOh, D. -Y.-
dc.contributor.authorPark, Y. -I.-
dc.contributor.authorKhosravan, R.-
dc.contributor.authorLin, X.-
dc.contributor.authorLee, S. -Y.-
dc.contributor.authorRoh, E. -J.-
dc.contributor.authorValota, O.-
dc.contributor.authorLechuga, M. J.-
dc.contributor.authorBang, Y. -J.-
dc.date.accessioned2021-01-31T11:55:20Z-
dc.date.available2021-01-31T11:55:20Z-
dc.date.created2020-12-21-
dc.date.issued2013-12-
dc.identifier.citationInvestigational New Drugs, Vol.31 No.6, pp.1547-1558-
dc.identifier.issn0167-6997-
dc.identifier.other119335-
dc.identifier.urihttps://hdl.handle.net/10371/173136-
dc.description.abstractBackground We evaluated the maximum tolerated dose (MTD) and safety of sunitinib plus capecitabine/cisplatin (XP) or capecitabine/oxaliplatin (XELOX) in Korean patients with advanced gastric cancer (GC). Methods Sunitinib (37.5 or 25 mg/day) was administered on a 2-week-on/1-week-off schedule with chemotherapy. Assessments included dose-limiting toxicity (DLT), safety, pharmacokinetics, and antitumor activity. Results Twenty-eight patients received sunitinib/XP; 48 received sunitinib/XELOX. The MTDs were: sunitinib 25 mg/day, cisplatin 80 mg/m(2), and capecitabine 1,000 mg/m(2); sunitinib 37.5 mg/day, oxaliplatin 110 mg/m(2), and capecitabine 800 mg/m(2); and sunitinib 25 mg/day, oxaliplatin 110 mg/m(2), and capecitabine 1,000 mg/m(2). DLTs at the MTDs comprised grade (G) 4 febrile neutropenia plus G3 diarrhea (n = 1; sunitinib/XP), dose delays due to hematologic toxicity (n = 2; both sunitinib/XP), G3 bleeding (menorrhagia; n = 1; sunitinib/XELOX), and G3 increased alanine aminotransferase levels (n = 1; sunitinib/XELOX). There was a high frequency of G3/4 hematologic adverse events observed with both treatment regimens, particularly with sunitinib/XP. Frequent non-hematologic, G3/4 adverse events were nausea, stomatitis, and hypophosphatemia with sunitinib/XP and hypophosphatemia and pulmonary embolism with sunitinib/XELOX. No drug-drug interactions were apparent. At the MTDs, median progression-free survival was 6.4 months and 5.5-8.0 months for sunitinib/XP and sunitinib/XELOX, respectively; and the objective response rate was 46.7 % and 43.5-45.5 % for sunitinib/XP and sunitinib/XELOX, respectively. Conclusions At the MTD, sunitinib/XELOX had an acceptable safety profile in patients with advanced GC.-
dc.language영어-
dc.publisherKluwer Academic Publishers-
dc.titlePhase I study of sunitinib plus capecitabine/cisplatin or capecitabine/oxaliplatin in advanced gastric cancer-
dc.typeArticle-
dc.contributor.AlternativeAuthor방영주-
dc.identifier.doi10.1007/s10637-013-0032-y-
dc.citation.journaltitleInvestigational New Drugs-
dc.identifier.wosid000326602500016-
dc.identifier.scopusid2-s2.0-84888588300-
dc.citation.endpage1558-
dc.citation.number6-
dc.citation.startpage1547-
dc.citation.volume31-
dc.identifier.sci000326602500016-
dc.description.isOpenAccessN-
dc.contributor.affiliatedAuthorBang, Y. -J.-
dc.type.docTypeArticle-
dc.description.journalClass1-
dc.subject.keywordPlusENDOTHELIAL GROWTH-FACTOR-
dc.subject.keywordPlusEXPRESSION-
dc.subject.keywordPlusCARCINOMA-
dc.subject.keywordPlusTRIAL-
dc.subject.keywordPlusCHEMOTHERAPY-
dc.subject.keywordPlusOXALIPLATIN-
dc.subject.keywordPlusRECEPTORS-
dc.subject.keywordPlusCISPLATIN-
dc.subject.keywordPlusSU11248-
dc.subject.keywordPlusPLACEBO-
dc.subject.keywordAuthorAdvanced gastric cancer-
dc.subject.keywordAuthorCapecitabine-
dc.subject.keywordAuthorCisplatin-
dc.subject.keywordAuthorOxaliplatin-
dc.subject.keywordAuthorPhase I-
dc.subject.keywordAuthorSunitinib-
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