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Phase II trial of dacomitinib in patients with HER2-positive gastric cancer

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dc.contributor.author조재용-
dc.date.accessioned2018-01-23T05:53:16Z-
dc.date.available2018-01-23T05:53:16Z-
dc.date.issued2016-
dc.identifier.issn1436-3291-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/155778-
dc.description.abstractBACKGROUND: Dacomitinib, an irreversible panHER inhibitor, shows significant preclinical antitumor activity in human epidermal growth factor receptor 2 (HER2)-positive gastric cancer (GC). The aim of this study was to evaluate the clinical activity of dacomitinib and discover potential biomarkers in HER2-positive GC patients. METHODS: We enrolled previously treated advanced HER2-positive GC [HER2 FISH (+) or HER2 IHC 3+] patients. The patients received dacomitinib 45 mg once daily. RESULTS: A total of 27 patients were enrolled. The number of prior chemotherapy regimens was 1 in 7 patients (26 %), 2 in 9 patients (33 %), and more than 2 in 11 patients (41 %). Seven patients had received prior anti-HER2 therapy. The 4-month progression-free survival (PFS) rate was 22.2 % and median PFS was 2.1 months (95 % CI, 2.3-3.4) There were 2 partial response (PRs) and 9 stable disease (SDs), resulting in 7.4 % (95 % CI, 0-17.5 %) of response rate (RR) and 40.7 % (95 % CI, 21.9-59.6 %) of disease control rate (DCR). Eleven patients (41 %) showed some degree of tumor shrinkage. Overall survival was 7.1 months (95 % CI, 4.4-9.8). The most common toxicities were skin rash, diarrhea, and fatigue, most of which were grade 1 or 2. The Ctrough of dacomitinib was lower in gastrectomy patients than nongastrectomy patients. Higher serum levels of HER2 extracellular domain (ECD) and lower levels of soluble E-cadherin (sECAD) correlated with higher dacomitinib activity. CONCLUSIONS: Dacomitinib functions as a single agent in HER2-positive GC patients with a tolerable safety profile. HER2 ECD and sECAD have the potential to be biomarkers for patient selection in a panHER inhibition strategy for HER2-positive GC. (ClinicalTrials.gov: NCT01152853).-
dc.description.statementOfResponsibilityrestriction-
dc.relation.isPartOfGASTRIC CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.titlePhase II trial of dacomitinib in patients with HER2-positive gastric cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorDo-Youn Oh-
dc.contributor.googleauthorKewn-Wook Lee-
dc.contributor.googleauthorJae Yong Cho-
dc.contributor.googleauthorWon Ki Kang-
dc.contributor.googleauthorSeock-Ah Im-
dc.contributor.googleauthorJin Won Kim-
dc.contributor.googleauthorYung-Jue Bang-
dc.identifier.doi10.1007/s10120-015-0567-z-
dc.contributor.localIdA03899-
dc.relation.journalcodeJ00916-
dc.identifier.eissn1436-3305-
dc.identifier.pmid26581547-
dc.identifier.urlhttps://link.springer.com/article/10.1007/s10120-015-0567-z-
dc.contributor.alternativeNameCho, Jae Yong-
dc.contributor.affiliatedAuthorCho, Jae Yong-
dc.citation.volume19-
dc.citation.number4-
dc.citation.startPage1095-
dc.citation.endPage1103-
dc.identifier.bibliographicCitationGASTRIC CANCER, Vol.19(4) : 1095-1103, 2016-
dc.identifier.rimsid48811-
dc.type.rimsART-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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