Cited 15 times in
A single arm phase Ib/II trial of first-line pembrolizumab, trastuzumab and chemotherapy for advanced HER2-positive gastric cancer
DC Field | Value | Language |
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dc.contributor.author | 김효송 | - |
dc.contributor.author | 남정모 | - |
dc.contributor.author | 신수진 | - |
dc.contributor.author | 이상길 | - |
dc.contributor.author | 정희철 | - |
dc.contributor.author | 정민규 | - |
dc.contributor.author | 정현철 | - |
dc.contributor.author | 이충근 | - |
dc.contributor.author | 라선영 | - |
dc.contributor.author | 김현기 | - |
dc.date.accessioned | 2022-12-22T04:53:10Z | - |
dc.date.available | 2022-12-22T04:53:10Z | - |
dc.date.issued | 2022-10 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/192246 | - |
dc.description.abstract | In this multi-center phase II trial, we evaluated the efficacy and safety of a quadruplet regimen (pembrolizumab, trastuzumab, and doublet chemotherapy) as first-line therapy for unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (AGC) (NCT02901301). The primary endpoints were recommended phase 2 dose (RP2D) for phase Ib and objective response rate (ORR) for phase II. The secondary endpoints included progression-free survival (PFS), overall survival (OS), duration of response, time to response and safety. Without dose-limiting or unexpected toxicities, the starting dose in the phase Ib trial was selected as RP2D. In 43 patients, the primary endpoint was achieved: the objective response rate was 76.7% (95% confidence interval [CI]: 61.4-88.2), with complete and partial responses in 14% and 62.8% of patients, respectively. The median progression-free survival, overall survival, and duration of response were 8.6 months, 19.3 months, and 10.8 months, respectively. No patients discontinued pembrolizumab because of immune-related adverse events. Programmed death ligand-1 status was not related to survival. Post hoc analyses of pretreatment tumor specimens via targeted sequencing indicated that ERBB2 amplification, RTK/RAS pathway alterations, and high neoantigen load corrected by HLA-B were positively related to survival. The current quadruplet regimen shows durable efficacy and safety for patients with HER2-positive AGC. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Nature Pub. Group | - |
dc.relation.isPartOf | NATURE COMMUNICATIONS | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized / therapeutic use | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols* / adverse effects | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Receptor, ErbB-2 / genetics | - |
dc.subject.MESH | Receptor, ErbB-2 / metabolism | - |
dc.subject.MESH | Stomach Neoplasms* / drug therapy | - |
dc.subject.MESH | Stomach Neoplasms* / genetics | - |
dc.subject.MESH | Trastuzumab / therapeutic use | - |
dc.title | A single arm phase Ib/II trial of first-line pembrolizumab, trastuzumab and chemotherapy for advanced HER2-positive gastric cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Choong-Kun Lee | - |
dc.contributor.googleauthor | Sun Young Rha | - |
dc.contributor.googleauthor | Hyo Song Kim | - |
dc.contributor.googleauthor | Minkyu Jung | - |
dc.contributor.googleauthor | Beodeul Kang | - |
dc.contributor.googleauthor | Jingmin Che | - |
dc.contributor.googleauthor | Woo Sun Kwon | - |
dc.contributor.googleauthor | Sejung Park | - |
dc.contributor.googleauthor | Woo Kyun Bae | - |
dc.contributor.googleauthor | Dong-Hoe Koo | - |
dc.contributor.googleauthor | Su-Jin Shin | - |
dc.contributor.googleauthor | Hyunki Kim | - |
dc.contributor.googleauthor | Hei-Cheul Jeung | - |
dc.contributor.googleauthor | Dae Young Zang | - |
dc.contributor.googleauthor | Sang Kil Lee | - |
dc.contributor.googleauthor | Chung Mo Nam | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.identifier.doi | 10.1038/s41467-022-33267-z | - |
dc.contributor.localId | A01202 | - |
dc.contributor.localId | A01264 | - |
dc.contributor.localId | A04596 | - |
dc.contributor.localId | A02812 | - |
dc.contributor.localId | A03794 | - |
dc.contributor.localId | A03606 | - |
dc.contributor.localId | A03773 | - |
dc.contributor.localId | A03259 | - |
dc.contributor.localId | A01316 | - |
dc.contributor.localId | A01108 | - |
dc.relation.journalcode | J02293 | - |
dc.identifier.eissn | 2041-1723 | - |
dc.identifier.pmid | 36224176 | - |
dc.contributor.alternativeName | Kim, Hyo Song | - |
dc.contributor.affiliatedAuthor | 김효송 | - |
dc.contributor.affiliatedAuthor | 남정모 | - |
dc.contributor.affiliatedAuthor | 신수진 | - |
dc.contributor.affiliatedAuthor | 이상길 | - |
dc.contributor.affiliatedAuthor | 정희철 | - |
dc.contributor.affiliatedAuthor | 정민규 | - |
dc.contributor.affiliatedAuthor | 정현철 | - |
dc.contributor.affiliatedAuthor | 이충근 | - |
dc.contributor.affiliatedAuthor | 라선영 | - |
dc.contributor.affiliatedAuthor | 김현기 | - |
dc.citation.volume | 13 | - |
dc.citation.number | 1 | - |
dc.citation.startPage | 6002 | - |
dc.identifier.bibliographicCitation | NATURE COMMUNICATIONS, Vol.13(1) : 6002, 2022-10 | - |
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