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A non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer

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dc.contributor.author정현철-
dc.date.accessioned2018-07-20T12:00:21Z-
dc.date.available2018-07-20T12:00:21Z-
dc.date.issued2017-
dc.identifier.issn0344-5704-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/161626-
dc.description.abstractPURPOSE: Mesenchymal-epithelial transition factor (MET) is expressed in gastric cancer and associated with poor clinical outcomes. We assessed activity, safety, and pharmacokinetics of emibetuzumab, a bivalent monoclonal anti-MET antibody that blocks ligand-dependent and ligand-independent MET signaling. METHODS: This non-randomized, single-arm, Phase 2 study enrolled Asian patients with MET diagnostic positive advanced gastric adenocarcinoma. Emibetuzumab (2000 mg, intravenous) was given on days 1 and 15 (28-day cycle). The primary endpoint was 8-week progression-free survival rate. Secondary objectives included safety, pharmacokinetics, overall survival, and change in tumor size. RESULTS: Tumors from 65 patients were immunohistochemically screened to enroll 15 MET diagnostic positive patients (23% positivity; 8 Japanese, 7 Korean; 10 male). Eight-week progression-free survival rate was 0.47 (70% CI, 0.33-0.59). Disease control rate was 40% (target lesion decreases, three patients; no complete/partial responses according to RECIST). Median overall survival was 17.1 weeks (95% CI, 6.3-not achievable). No serious emibetuzumab-related adverse events or new safety signals emerged. Grade ≥ 3 possibly drug-related adverse events were hyperkalemia, hyponatremia, and hyperuricemia (one each). Emibetuzumab's pharmacokinetics profile was similar to that observed previously. MET expression and clinical outcomes were not obviously associated. CONCLUSION: Emibetuzumab was well tolerated with limited single-agent activity in advanced gastric adenocarcinoma.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherSpringer Verlag-
dc.relation.isPartOfCANCER CHEMOTHERAPY AND PHARMACOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAntibodies, Bispecific/therapeutic use*-
dc.subject.MESHAntibodies, Monoclonal, Humanized/therapeutic use*-
dc.subject.MESHAsian Continental Ancestry Group-
dc.subject.MESHDisease-Free Survival-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHStomach Neoplasms/drug therapy*-
dc.subject.MESHStomach Neoplasms/pathology-
dc.titleA non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorDaisuke Sakai-
dc.contributor.googleauthorHyun Cheol Chung-
dc.contributor.googleauthorDo-Youn Oh-
dc.contributor.googleauthorSe Hoon Park-
dc.contributor.googleauthorShigenori Kadowaki-
dc.contributor.googleauthorYeul Hong Kim-
dc.contributor.googleauthorAkihito Tsuji-
dc.contributor.googleauthorYoshito Komatsu-
dc.contributor.googleauthorYoon-Koo Kang-
dc.contributor.googleauthorKazunori Uenaka-
dc.contributor.googleauthorSameera R. Wijayawardana-
dc.contributor.googleauthorVolker Wacheck-
dc.contributor.googleauthorXuejing Wang-
dc.contributor.googleauthorAyuko Yamamura-
dc.contributor.googleauthorToshihiko Doi-
dc.identifier.doi10.1007/s00280-017-3445-z-
dc.contributor.localIdA03773-
dc.relation.journalcodeJ00437-
dc.identifier.eissn1432-0843-
dc.identifier.pmid29071414-
dc.subject.keywordAntibodies, monoclonal, humanized-
dc.subject.keywordClinical trial-
dc.subject.keywordLY2875358-
dc.subject.keywordMET protein, human-
dc.subject.keywordPhase II-
dc.subject.keywordStomach neoplasms-
dc.contributor.alternativeNameChung, Hyun Cheol-
dc.contributor.affiliatedAuthorChung, Hyun Cheol-
dc.citation.volume80-
dc.citation.number6-
dc.citation.startPage1197-
dc.citation.endPage1207-
dc.identifier.bibliographicCitationCANCER CHEMOTHERAPY AND PHARMACOLOGY, Vol.80(6) : 1197-1207, 2017-
dc.identifier.rimsid61649-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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