Cited 10 times in
Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study
DC Field | Value | Language |
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dc.contributor.author | 신상준 | - |
dc.date.accessioned | 2024-03-22T06:18:46Z | - |
dc.date.available | 2024-03-22T06:18:46Z | - |
dc.date.issued | 2023-12 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/198514 | - |
dc.description.abstract | Purpose: To evaluate the efficacy and safety of tucatinib and trastuzumab in patients with previously treated human epidermal growth factor receptor 2-positive (HER2+) metastatic biliary tract cancer (mBTC). Methods: SGNTUC-019 (ClinicalTrials.gov identifier: NCT04579380) is an open-label phase II basket study evaluating the efficacy and safety of tucatinib and trastuzumab in patients with HER2-altered solid tumors. In the biliary tract cancer cohort, patients had previously treated HER2 overexpressing or amplified (HER2+) tumors (identified with local testing) with no prior HER2-directed therapy. The primary end point was confirmed objective response rate (cORR) per investigator assessment. Patients were treated on a 21-day cycle with tucatinib (300 mg orally twice daily) and trastuzumab (8 mg/kg intravenously followed by 6 mg/kg every 3 weeks). Results: Thirty patients were enrolled. As of data cutoff (January 30, 2023), the median duration of follow-up was 10.8 months. The cORR was 46.7% (90% CI, 30.8 to 63.0), with a disease control rate of 76.7% (90% CI, 60.6 to 88.5). The median duration of response and progression-free survival were 6.0 months (90% CI, 5.5 to 6.9) and 5.5 months (90% CI, 3.9 to 8.1), respectively. At data cutoff, 15 patients (50.0%) had died, and the estimated 12-month overall survival rate was 53.6% (90% CI, 36.8 to 67.8). The two most common treatment-emergent adverse events (TEAEs) were pyrexia (43.3%) and diarrhea (40.0%). Grade ≥3 TEAEs were reported in 18 patients (60.0%), with the most common being cholangitis, decreased appetite, and nausea (all 10.0%), which were generally not treatment related. TEAEs led to treatment regimen discontinuation in one patient, and there were no deaths due to TEAEs. Conclusion: Tucatinib combined with trastuzumab had clinically significant antitumor activity and was well tolerated in patients with previously treated HER2+ mBTC. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
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.subject.MESH | Antibodies, Monoclonal, Humanized* / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Neoplasms* / drug therapy | - |
dc.subject.MESH | Receptor, ErbB-2 / metabolism | - |
dc.subject.MESH | Trastuzumab / adverse effects | - |
dc.title | Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Yoshiaki Nakamura | - |
dc.contributor.googleauthor | Nobumasa Mizuno | - |
dc.contributor.googleauthor | Yu Sunakawa | - |
dc.contributor.googleauthor | Jean-Luc Canon | - |
dc.contributor.googleauthor | Matthew D Galsky | - |
dc.contributor.googleauthor | Erika Hamilton | - |
dc.contributor.googleauthor | Hidetoshi Hayashi | - |
dc.contributor.googleauthor | Guy Jerusalem | - |
dc.contributor.googleauthor | Seung Tae Kim | - |
dc.contributor.googleauthor | Keun-Wook Lee | - |
dc.contributor.googleauthor | Lionel Aurelien Kankeu Fonkoua | - |
dc.contributor.googleauthor | Bradley J Monk | - |
dc.contributor.googleauthor | Danny Nguyen | - |
dc.contributor.googleauthor | Do-Youn Oh | - |
dc.contributor.googleauthor | Alicia Okines | - |
dc.contributor.googleauthor | David M O'Malley | - |
dc.contributor.googleauthor | Paula Pohlmann | - |
dc.contributor.googleauthor | Martin Reck | - |
dc.contributor.googleauthor | Sang Joon Shin | - |
dc.contributor.googleauthor | Kazuki Sudo | - |
dc.contributor.googleauthor | Shunji Takahashi | - |
dc.contributor.googleauthor | Cedric Van Marcke | - |
dc.contributor.googleauthor | Evan Y Yu | - |
dc.contributor.googleauthor | Roman Groisberg | - |
dc.contributor.googleauthor | Jorge Ramos | - |
dc.contributor.googleauthor | Sherry Tan | - |
dc.contributor.googleauthor | Thomas E Stinchcombe | - |
dc.contributor.googleauthor | Tanios Bekaii-Saab | - |
dc.identifier.doi | 10.1200/jco.23.00606 | - |
dc.contributor.localId | A02105 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 37751561 | - |
dc.contributor.alternativeName | Shin, Sang Joon | - |
dc.contributor.affiliatedAuthor | 신상준 | - |
dc.citation.volume | 41 | - |
dc.citation.number | 36 | - |
dc.citation.startPage | 5569 | - |
dc.citation.endPage | 5578 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.41(36) : 5569-5578, 2023-12 | - |
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