Cited 95 times in
Safety and Efficacy of Durvalumab and Tremelimumab Alone or in Combination in Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
DC Field | Value | Language |
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dc.contributor.author | 정현철 | - |
dc.date.accessioned | 2020-04-13T16:56:08Z | - |
dc.date.available | 2020-04-13T16:56:08Z | - |
dc.date.issued | 2020 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/175571 | - |
dc.description.abstract | PURPOSE: This randomized, multicenter, open-label, phase Ib/II study assessed durvalumab and tremelimumab in combination or as monotherapy for chemotherapy-refractory gastric cancer or gastroesophageal junction (GEJ) cancer. PATIENTS AND METHODS: Second-line patients were randomized 2:2:1 to receive durvalumab plus tremelimumab (arm A), or durvalumab (arm B) or tremelimumab monotherapy (arm C), and third-line patients received durvalumab plus tremelimumab (arm D). A tumor-based IFNγ gene signature was prospectively evaluated as a potential predictive biomarker in second- and third-line patients receiving the combination (arm E). The coprimary endpoints were objective response rate and progression-free survival (PFS) rate at 6 months. RESULTS: A total of 113 patients were treated: 6 in phase Ib and 107 (arm A, 27; arm B, 24; arm C, 12; arm D, 25; arm E, 19) in phase II. Overall response rates were 7.4%, 0%, 8.3%, 4.0%, and 15.8% in the five arms, respectively. PFS rates at 6 months were 6.1%, 0%, 20%, 15%, and 0%, and 12-month overall survival rates were 37.0%, 4.6%, 22.9%, 38.8%, and NA, respectively. Treatment-related grade 3/4 adverse events were reported in 17%, 4%, 42%, 16%, and 11% of patients, respectively. CONCLUSIONS: Response rates were low regardless of monotherapy or combination strategies. No new safety signals were identified. Including use of a tumor-based IFNγ signature and change in baseline and on-treatment circulating tumor DNA are clinically feasible and may be novel strategies to improve treatment response in this difficult-to-treat population. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | American Association for Cancer Research | - |
dc.relation.isPartOf | CLINICAL CANCER RESEARCH | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.title | Safety and Efficacy of Durvalumab and Tremelimumab Alone or in Combination in Patients with Advanced Gastric and Gastroesophageal Junction Adenocarcinoma | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Ronan J. Kelly | - |
dc.contributor.googleauthor | Jeeyun Lee | - |
dc.contributor.googleauthor | Yung-Jue Bang | - |
dc.contributor.googleauthor | Khaldoun Almhanna | - |
dc.contributor.googleauthor | Mariela Blum-Murphy | - |
dc.contributor.googleauthor | Daniel V.T. Catenacci | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.contributor.googleauthor | Zev A. Wainberg | - |
dc.contributor.googleauthor | Michael K. Gibson | - |
dc.contributor.googleauthor | Keun-Wook Lee | - |
dc.contributor.googleauthor | Johanna C. Bendell | - |
dc.contributor.googleauthor | Crystal S. Denlinger | - |
dc.contributor.googleauthor | Cheng Ean Chee | - |
dc.contributor.googleauthor | Takeshi Omori | - |
dc.contributor.googleauthor | Rom Leidner | - |
dc.contributor.googleauthor | Heinz-Josef Lenz | - |
dc.contributor.googleauthor | Yee Chao | - |
dc.contributor.googleauthor | Marlon C. Rebelatto | - |
dc.contributor.googleauthor | Philip Z. Brohawn | - |
dc.contributor.googleauthor | Peng He | - |
dc.contributor.googleauthor | Jennifer McDevitt | - |
dc.contributor.googleauthor | Siddharth Sheth | - |
dc.contributor.googleauthor | Judson M. Englert | - |
dc.contributor.googleauthor | Geoffrey Y. Ku | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-19-2443 | - |
dc.contributor.localId | A03773 | - |
dc.relation.journalcode | J00564 | - |
dc.identifier.pmid | 31676670 | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | 정현철 | - |
dc.citation.volume | 26 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 846 | - |
dc.citation.endPage | 854 | - |
dc.identifier.bibliographicCitation | CLINICAL CANCER RESEARCH, Vol.26(4) : 846-854, 2020 | - |
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