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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 | Kelly, Ronan J. | - |
dc.contributor.author | Lee, Jeeyun | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Almhanna, Khaldoun | - |
dc.contributor.author | Blum-Murphy, Mariela | - |
dc.contributor.author | Catenacci, Daniel V. T. | - |
dc.contributor.author | Hyun Cheol Chung | - |
dc.contributor.author | Wainberg, Zev A. | - |
dc.contributor.author | Gibson, Michael K. | - |
dc.contributor.author | Lee, Keun-Wook | - |
dc.contributor.author | Bendell, Johanna C. | - |
dc.contributor.author | Denlinger, Crystal S. | - |
dc.contributor.author | Chee, Cheng Ean | - |
dc.contributor.author | Omori, Takeshi | - |
dc.contributor.author | Leidner, Rom | - |
dc.contributor.author | Lenz, Heinz-Josef | - |
dc.contributor.author | Chao, Yee | - |
dc.contributor.author | Rebelatto, Marlon C. | - |
dc.contributor.author | Brohawn, Philip Z. | - |
dc.contributor.author | He, Peng | - |
dc.contributor.author | McDevitt, Jennifer | - |
dc.contributor.author | Sheth, Siddharth | - |
dc.contributor.author | Englert, Judson M. | - |
dc.contributor.author | Ku, Geoffrey Y. | - |
dc.date.accessioned | 2021-01-31T11:08:17Z | - |
dc.date.available | 2021-01-31T11:08:17Z | - |
dc.date.created | 2020-05-22 | - |
dc.date.issued | 2020-02 | - |
dc.identifier.citation | Clinical Cancer Research, Vol.26 No.4, pp.846-854 | - |
dc.identifier.issn | 1078-0432 | - |
dc.identifier.other | 101359 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173049 | - |
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 IFN gamma 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 IFNg 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.language | 영어 | - |
dc.publisher | American Association for Cancer Research | - |
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.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1158/1078-0432.CCR-19-2443 | - |
dc.citation.journaltitle | Clinical Cancer Research | - |
dc.identifier.wosid | 000514157200011 | - |
dc.identifier.scopusid | 2-s2.0-85079410465 | - |
dc.citation.endpage | 854 | - |
dc.citation.number | 4 | - |
dc.citation.startpage | 846 | - |
dc.citation.volume | 26 | - |
dc.identifier.sci | 000514157200011 | - |
dc.description.isOpenAccess | Y | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.contributor.affiliatedAuthor | Lee, Keun-Wook | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | MICROSATELLITE INSTABILITY | - |
dc.subject.keywordPlus | PROSPECTIVE VALIDATION | - |
dc.subject.keywordPlus | PROGNOSTIC SCORE | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | CANCER | - |
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