Cited 24 times in
A non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer
DC Field | Value | Language |
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dc.contributor.author | 정현철 | - |
dc.date.accessioned | 2018-07-20T12:00:21Z | - |
dc.date.available | 2018-07-20T12:00:21Z | - |
dc.date.issued | 2017 | - |
dc.identifier.issn | 0344-5704 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/161626 | - |
dc.description.abstract | PURPOSE: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Springer Verlag | - |
dc.relation.isPartOf | CANCER CHEMOTHERAPY AND PHARMACOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antibodies, Bispecific/therapeutic use* | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized/therapeutic use* | - |
dc.subject.MESH | Asian Continental Ancestry Group | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Stomach Neoplasms/drug therapy* | - |
dc.subject.MESH | Stomach Neoplasms/pathology | - |
dc.title | A non-randomized, open-label, single-arm, Phase 2 study of emibetuzumab in Asian patients with MET diagnostic positive, advanced gastric cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine | - |
dc.contributor.department | Dept. of Internal Medicine | - |
dc.contributor.googleauthor | Daisuke Sakai | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.contributor.googleauthor | Do-Youn Oh | - |
dc.contributor.googleauthor | Se Hoon Park | - |
dc.contributor.googleauthor | Shigenori Kadowaki | - |
dc.contributor.googleauthor | Yeul Hong Kim | - |
dc.contributor.googleauthor | Akihito Tsuji | - |
dc.contributor.googleauthor | Yoshito Komatsu | - |
dc.contributor.googleauthor | Yoon-Koo Kang | - |
dc.contributor.googleauthor | Kazunori Uenaka | - |
dc.contributor.googleauthor | Sameera R. Wijayawardana | - |
dc.contributor.googleauthor | Volker Wacheck | - |
dc.contributor.googleauthor | Xuejing Wang | - |
dc.contributor.googleauthor | Ayuko Yamamura | - |
dc.contributor.googleauthor | Toshihiko Doi | - |
dc.identifier.doi | 10.1007/s00280-017-3445-z | - |
dc.contributor.localId | A03773 | - |
dc.relation.journalcode | J00437 | - |
dc.identifier.eissn | 1432-0843 | - |
dc.identifier.pmid | 29071414 | - |
dc.subject.keyword | Antibodies, monoclonal, humanized | - |
dc.subject.keyword | Clinical trial | - |
dc.subject.keyword | LY2875358 | - |
dc.subject.keyword | MET protein, human | - |
dc.subject.keyword | Phase II | - |
dc.subject.keyword | Stomach neoplasms | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | Chung, Hyun Cheol | - |
dc.citation.volume | 80 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 1197 | - |
dc.citation.endPage | 1207 | - |
dc.identifier.bibliographicCitation | CANCER CHEMOTHERAPY AND PHARMACOLOGY, Vol.80(6) : 1197-1207, 2017 | - |
dc.identifier.rimsid | 61649 | - |
dc.type.rims | ART | - |
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