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Trastuzumab Deruxtecan in Anti-Human Epidermal Growth Factor Receptor 2 Treatment-Naive Patients With Human Epidermal Growth Factor Receptor 2-Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial
DC Field | Value | Language |
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dc.contributor.author | 정현철 | - |
dc.date.accessioned | 2024-05-30T07:14:20Z | - |
dc.date.available | 2024-05-30T07:14:20Z | - |
dc.date.issued | 2023-02 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/199657 | - |
dc.description.abstract | PURPOSETo investigate efficacy and safety of trastuzumab deruxtecan (T-DXd) in human epidermal growth factor receptor 2 (HER2)-low gastric or gastroesophageal junction (GEJ) adenocarcinoma.METHODSPatients with locally advanced or metastatic HER2-low (cohort 1, immunohistochemistry 2+/in situ hybridization-negative; cohort 2, immunohistochemistry 1+) gastric/GEJ adenocarcinoma treated with at least two prior regimens, including fluoropyrimidine and platinum, but anti-HER2 therapy naive, received T-DXd 6.4 mg/kg intravenously once every 3 weeks. The primary end point was confirmed objective response rate by independent central review.RESULTSAmong 21 patients enrolled in cohort 1 and 24 enrolled in cohort 2, 19 and 21 patients, respectively, had central HER2 confirmation, received T-DXd, and had measurable tumors at baseline. The confirmed objective response rate was 26.3% (95% CI, 9.1 to 51.2) from five partial responses in cohort 1 and 9.5% (95% CI, 1.2 to 30.4) from two partial responses in cohort 2. Thirteen patients (68.4%) in cohort 1 and 12 (60.0%) in cohort 2 experienced reduced tumor size. The median overall survival was 7.8 months (95% CI, 4.7 to nonevaluable) in cohort 1 and 8.5 months (95% CI, 4.3 to 10.9) in cohort 2; the median progression-free survival was 4.4 months (95% CI, 2.7 to 7.1) and 2.8 months (95% CI, 1.5 to 4.3), respectively. The most common grade >= 3 treatment-emergent adverse events in cohorts 1 and 2 were anemia (30.0% and 29.2%), decreased neutrophil count (25.0% and 29.2%), and decreased appetite (20.0% and 20.8%). Drug-related interstitial lung disease/pneumonitis occurred in one patient in each cohort (grade 1 or 2). No drug-related deaths occurred.CONCLUSIONThis study provides preliminary evidence that T-DXd has clinical activity in patients with heavily pretreated HER2-low gastric/GEJ adenocarcinoma. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Trastuzumab Deruxtecan in Anti-Human Epidermal Growth Factor Receptor 2 Treatment-Naive Patients With Human Epidermal Growth Factor Receptor 2-Low Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Cohort Results in a Phase II Trial | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Kensei Yamaguchi | - |
dc.contributor.googleauthor | Yung-Jue Bang | - |
dc.contributor.googleauthor | Satoru Iwasa | - |
dc.contributor.googleauthor | Naotoshi Sugimoto | - |
dc.contributor.googleauthor | Min-Hee Ryu | - |
dc.contributor.googleauthor | Daisuke Sakai | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.contributor.googleauthor | Hisato Kawakami | - |
dc.contributor.googleauthor | Hiroshi Yabusaki | - |
dc.contributor.googleauthor | Jeeyun Lee | - |
dc.contributor.googleauthor | Tatsu Shimoyama | - |
dc.contributor.googleauthor | Keun-Wook Lee | - |
dc.contributor.googleauthor | Kaku Saito | - |
dc.contributor.googleauthor | Yoshinori Kawaguchi | - |
dc.contributor.googleauthor | Takahiro Kamio | - |
dc.contributor.googleauthor | Akihito Kojima | - |
dc.contributor.googleauthor | Masahiro Sugihara | - |
dc.contributor.googleauthor | Kohei Shitara | - |
dc.identifier.doi | 10.1200/JCO.22.00575 | - |
dc.contributor.localId | A03773 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 36379002 | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | 정현철 | - |
dc.citation.volume | 41 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 816 | - |
dc.citation.endPage | 825 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.41(4) : 816-825, 2023-02 | - |
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