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Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): A randomised, open-label, controlled, phase 3 trial
DC Field | Value | Language |
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dc.contributor.author | Shitara, Kohei | - |
dc.contributor.author | Ozguroglu, Mustafa | - |
dc.contributor.author | Bang, Yung-Jue | - |
dc.contributor.author | Di Bartolomeo, Maria | - |
dc.contributor.author | Mandala, Mario | - |
dc.contributor.author | Ryu, Min-Hee | - |
dc.contributor.author | Fornaro, Lorenzo | - |
dc.contributor.author | Olesinski, Tomasz | - |
dc.contributor.author | Caglevic, Christian | - |
dc.contributor.author | Chung, Hyun C. | - |
dc.contributor.author | Muro, Kei | - |
dc.contributor.author | Goekkurt, Eray | - |
dc.contributor.author | Mansoor, Wasat | - |
dc.contributor.author | McDermott, Raymond S. | - |
dc.contributor.author | Shacham-Shmueli, Einat | - |
dc.contributor.author | Chen, Xinqun | - |
dc.contributor.author | Mayo, Carlos | - |
dc.contributor.author | Kang, S. Peter | - |
dc.contributor.author | Ohtsu, Atsushi | - |
dc.contributor.author | Fuchs, Charles S. | - |
dc.date.accessioned | 2021-01-31T12:05:23Z | - |
dc.date.available | 2021-01-31T12:05:23Z | - |
dc.date.created | 2019-03-19 | - |
dc.date.issued | 2018-07-14 | - |
dc.identifier.citation | The Lancet, Vol.392 No.10142, pp.123-133 | - |
dc.identifier.issn | 0140-6736 | - |
dc.identifier.other | 72873 | - |
dc.identifier.uri | https://hdl.handle.net/10371/173265 | - |
dc.description.abstract | Background Patients with advanced gastric or gastro-oesophageal junction cancer that progresses on chemotherapy have poor outcomes. We compared pembrolizumab with paclitaxel in patients with advanced gastric or gastrooesophageal junction cancer that progressed on first-line chemotherapy with a platinum and fluoropyrimidine. Methods This randomised, open-label, phase 3 study was done at 148 medical centres in 30 countries. Eligible patients were randomised (1: 1) in blocks of four per stratum with an interactive voice-response and integrated web-response system to receive either pembrolizumab 200 mg every 3 weeks for up to 2 years or standard-dose paclitaxel. Primary endpoints were overall survival and progression-free survival in patients with a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) of 1 or higher. Safety was assessed in all patients, irrespective of CPS. The significance threshold for overall survival was p=0.0135 (one-sided). This trial is registered at ClinicalTrials.gov, number NCT02370498. Findings Between June 4, 2015, and July 26, 2016, 592 patients were enrolled. Of the 395 patients who had a PD-L1 CPS of 1 or higher, 196 patients were assigned to receive pembrolizumab and 199 patients were assigned to receive paclitaxel. As of Oct 26, 2017, 326 patients in the population with CPS of 1 or higher had died (151 [77%] of 196 patients in the pembrolizumab group and 175 [88%] of 199 patients in the paclitaxel group). Median overall survival was 9.1 months (95% CI 6.2-10.7) with pembrolizumab and 8.3 months (7.6-9.0) with paclitaxel (hazard ratio [HR] 0.82, 95% CI 0.66-1.03; one-sided p=0.0421). Median progression-free survival was 1.5 months (95% CI 1.4-2.0) with pembrolizumab and 4.1 months (3.1-4.2) with paclitaxel (HR 1.27, 95% CI 1.03-1.57). In the total population, grade 3-5 treatment-related adverse events occurred in 42 (14%) of the 294 patients treated with pembrolizumab and 96 (35%) of the 276 patients treated with paclitaxel. Interpretation Pembrolizumab did not significantly improve overall survival compared with paclitaxel as second-line therapy for advanced gastric or gastro-oesophageal junction cancer with PD-L1 CPS of 1 or higher. Pembrolizumab had a better safety profile than paclitaxel. Additional trials of pembrolizumab in gastric and gastro-oesophageal cancer are ongoing. | - |
dc.language | 영어 | - |
dc.publisher | The Lancet Publishing Group | - |
dc.title | Pembrolizumab versus paclitaxel for previously treated, advanced gastric or gastro-oesophageal junction cancer (KEYNOTE-061): A randomised, open-label, controlled, phase 3 trial | - |
dc.type | Article | - |
dc.contributor.AlternativeAuthor | 방영주 | - |
dc.identifier.doi | 10.1016/S0140-6736(18)31257-1 | - |
dc.citation.journaltitle | The Lancet | - |
dc.identifier.wosid | 000438501300027 | - |
dc.identifier.scopusid | 2-s2.0-85048592368 | - |
dc.citation.endpage | 133 | - |
dc.citation.number | 10142 | - |
dc.citation.startpage | 123 | - |
dc.citation.volume | 392 | - |
dc.identifier.sci | 000438501300027 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Bang, Yung-Jue | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | MISMATCH-REPAIR DEFICIENCY | - |
dc.subject.keywordPlus | CELL LUNG-CANCER | - |
dc.subject.keywordPlus | PD-1 BLOCKADE | - |
dc.subject.keywordPlus | SOLID TUMORS | - |
dc.subject.keywordPlus | DOUBLE-BLIND | - |
dc.subject.keywordPlus | CARCINOMA | - |
dc.subject.keywordPlus | NIVOLUMAB | - |
dc.subject.keywordPlus | ADENOCARCINOMA | - |
dc.subject.keywordPlus | MULTICENTER | - |
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