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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 | 정현철 | - |
dc.date.accessioned | 2019-02-12T16:42:26Z | - |
dc.date.available | 2019-02-12T16:42:26Z | - |
dc.date.issued | 2018 | - |
dc.identifier.issn | 0140-6736 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/167098 | - |
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 gastro-oesophageal 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.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | LANCET | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adenocarcinoma/drug therapy* | - |
dc.subject.MESH | Adenocarcinoma/mortality | - |
dc.subject.MESH | Adenocarcinoma/pathology | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized/adverse effects | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized/therapeutic use* | - |
dc.subject.MESH | Esophageal Neoplasms/drug therapy* | - |
dc.subject.MESH | Esophageal Neoplasms/mortality | - |
dc.subject.MESH | Esophageal Neoplasms/pathology | - |
dc.subject.MESH | Esophagogastric Junction*/pathology | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Infusions, Intravenous | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Neoplasm Staging | - |
dc.subject.MESH | Paclitaxel/adverse effects | - |
dc.subject.MESH | Paclitaxel/therapeutic use* | - |
dc.subject.MESH | Stomach Neoplasms/drug therapy* | - |
dc.subject.MESH | Stomach Neoplasms/pathology | - |
dc.subject.MESH | Survival Rate | - |
dc.subject.MESH | Treatment Outcome | - |
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.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Kohei Shitara | - |
dc.contributor.googleauthor | Mustafa Özgüroğlu | - |
dc.contributor.googleauthor | Yung-Jue Bang | - |
dc.contributor.googleauthor | Maria Di Bartolomeo | - |
dc.contributor.googleauthor | Mario Mandalà | - |
dc.contributor.googleauthor | Min-Hee Ryu | - |
dc.contributor.googleauthor | Lorenzo Fornaro | - |
dc.contributor.googleauthor | Tomasz Olesiński | - |
dc.contributor.googleauthor | Christian Caglevic | - |
dc.contributor.googleauthor | Hyun C Chung | - |
dc.contributor.googleauthor | Kei Muro | - |
dc.contributor.googleauthor | Eray Goekkurt | - |
dc.contributor.googleauthor | Wasat Mansoor | - |
dc.contributor.googleauthor | Raymond S McDermott | - |
dc.contributor.googleauthor | Einat Shacham-Shmueli | - |
dc.contributor.googleauthor | Xinqun Chen | - |
dc.contributor.googleauthor | Carlos Mayo | - |
dc.contributor.googleauthor | S Peter Kang | - |
dc.contributor.googleauthor | Atsushi Ohtsu | - |
dc.contributor.googleauthor | Charles S Fuchs | - |
dc.contributor.googleauthor | Guillermo Lerzo | - |
dc.contributor.googleauthor | Juan Manuel O'Connor | - |
dc.contributor.googleauthor | Guillermo Ariel Mendez | - |
dc.contributor.googleauthor | James Lynam | - |
dc.contributor.googleauthor | Niall Tebbutt | - |
dc.contributor.googleauthor | Mark Wong | - |
dc.contributor.googleauthor | Andrew Strickland | - |
dc.contributor.googleauthor | Chris Karapetis | - |
dc.contributor.googleauthor | David Goldstein | - |
dc.contributor.googleauthor | Paul Vasey | - |
dc.contributor.googleauthor | Jean-Luc Van Laethem | - |
dc.contributor.googleauthor | Eric Van Cutsem | - |
dc.contributor.googleauthor | Scott Berry | - |
dc.contributor.googleauthor | Mark Vincent | - |
dc.contributor.googleauthor | Bettina Muller | - |
dc.contributor.googleauthor | Felipe Rey | - |
dc.contributor.googleauthor | Angela Zambrano | - |
dc.contributor.googleauthor | Joaquin Guerra | - |
dc.contributor.googleauthor | Merete Krogh | - |
dc.contributor.googleauthor | Lene Baeksgaard | - |
dc.contributor.googleauthor | Mette Yilmaz | - |
dc.contributor.googleauthor | Anneli Elme | - |
dc.contributor.googleauthor | Andrus Magi | - |
dc.contributor.googleauthor | Paivi Auvinen | - |
dc.contributor.googleauthor | Tuomo Alanko | - |
dc.contributor.googleauthor | Markus Moehler | - |
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dc.contributor.googleauthor | Peter Thuss-Patience | - |
dc.contributor.googleauthor | Eray Goekkurt | - |
dc.contributor.googleauthor | Thomas Hoehler | - |
dc.contributor.googleauthor | Georg Haag | - |
dc.contributor.googleauthor | Salah-Eddin Al-Batran | - |
dc.contributor.googleauthor | Hugo Castro | - |
dc.contributor.googleauthor | Karla Lopez | - |
dc.contributor.googleauthor | Mynor Aguilar Vasquez | - |
dc.contributor.googleauthor | Mario Sandoval | - |
dc.contributor.googleauthor | Ka On Lam | - |
dc.contributor.googleauthor | Sinead Cuffe | - |
dc.contributor.googleauthor | Cathy Kelly | - |
dc.contributor.googleauthor | Ravit Geva | - |
dc.contributor.googleauthor | Einat Shacham-Shmueli | - |
dc.contributor.googleauthor | Ayala Hubert | - |
dc.contributor.googleauthor | Alex Beny | - |
dc.contributor.googleauthor | Baruch Brenner | - |
dc.contributor.googleauthor | Aprile Giuseppe | - |
dc.contributor.googleauthor | Alfredo Falcone | - |
dc.contributor.googleauthor | Evaristo Maiello | - |
dc.contributor.googleauthor | Rodolfo Passalacqua | - |
dc.contributor.googleauthor | Vincenzo Montesarchio | - |
dc.contributor.googleauthor | Hiroki Hara | - |
dc.contributor.googleauthor | Keisho Chin | - |
dc.contributor.googleauthor | Tomohiro Nishina | - |
dc.contributor.googleauthor | Yoshito Komatsu | - |
dc.contributor.googleauthor | Nozumo Machida | - |
dc.contributor.googleauthor | Shuichi Hironaka | - |
dc.contributor.googleauthor | Taroh Satoh | - |
dc.contributor.googleauthor | Takao Tamura | - |
dc.contributor.googleauthor | Naotaoshi Sugimoto | - |
dc.contributor.googleauthor | Haruhiko Cho | - |
dc.contributor.googleauthor | Yashushi Omuro | - |
dc.contributor.googleauthor | Ken Kato | - |
dc.contributor.googleauthor | Masahiro Goto | - |
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dc.contributor.googleauthor | Kazuhiro Yoshida | - |
dc.contributor.googleauthor | Hideo Baba | - |
dc.contributor.googleauthor | Taito Esaki | - |
dc.contributor.googleauthor | Junji Furuse | - |
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dc.contributor.googleauthor | Carlos Hernandez Hernandez | - |
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dc.contributor.googleauthor | Adriana Dominguez Andrade | - |
dc.contributor.googleauthor | Katriona Clarke | - |
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dc.contributor.googleauthor | Nils Glenjen | - |
dc.contributor.googleauthor | Tomasz Kubiatowski | - |
dc.contributor.googleauthor | Jassem Jacek | - |
dc.contributor.googleauthor | Marek Wojtukiewicz | - |
dc.contributor.googleauthor | Sergey Lazarev | - |
dc.contributor.googleauthor | Yuri Lancukhay | - |
dc.contributor.googleauthor | Sergey Afanasayev | - |
dc.contributor.googleauthor | Vladimir Moiseyenko | - |
dc.contributor.googleauthor | Vladimir Kostorov | - |
dc.contributor.googleauthor | Svetlana Protsenko | - |
dc.contributor.googleauthor | Vadim Shirinkin | - |
dc.contributor.googleauthor | Dina Sakaeva | - |
dc.contributor.googleauthor | Natalia Fadeeva | - |
dc.contributor.googleauthor | Wei Peng Yong | - |
dc.contributor.googleauthor | Chau Hsien Matthew Ng | - |
dc.contributor.googleauthor | Barbara Robertson | - |
dc.contributor.googleauthor | Bernardo Rapaport | - |
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dc.contributor.googleauthor | Conrad Jacobs | - |
dc.contributor.googleauthor | Gregory Landers | - |
dc.contributor.googleauthor | Waldemar Szpak | - |
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dc.contributor.googleauthor | Yeul Hong Kim | - |
dc.contributor.googleauthor | Yung-Jue Bang | - |
dc.contributor.googleauthor | Hyun Cheol Chung | - |
dc.contributor.googleauthor | Min-Hee Ryu | - |
dc.contributor.googleauthor | Maria Alsina Maqueda | - |
dc.contributor.googleauthor | Federico Longo Munoz | - |
dc.contributor.googleauthor | Andres Cervantes Aguilar | - |
dc.contributor.googleauthor | Enrique Aranda Aguilar | - |
dc.contributor.googleauthor | Pilar Garcia Alfonso | - |
dc.contributor.googleauthor | Fernando Rivera | - |
dc.contributor.googleauthor | Jaime Feliu Batle | - |
dc.contributor.googleauthor | Roberto Pazo Cid | - |
dc.contributor.googleauthor | Kun-Huei Yeh | - |
dc.contributor.googleauthor | Jen-Shi Chen | - |
dc.contributor.googleauthor | Yee Chao | - |
dc.contributor.googleauthor | Chia-Jui Yen | - |
dc.contributor.googleauthor | Mustafa Özgüroğlu | - |
dc.contributor.googleauthor | Oguz Kara | - |
dc.contributor.googleauthor | Suayib Yalcin | - |
dc.contributor.googleauthor | Daniel Hochhauser | - |
dc.contributor.googleauthor | Ian Chau | - |
dc.contributor.googleauthor | Al Benson | - |
dc.contributor.googleauthor | Veena Shankaran | - |
dc.contributor.googleauthor | Walid Shaib | - |
dc.contributor.googleauthor | Philip Philip | - |
dc.contributor.googleauthor | Vivek Sharma | - |
dc.contributor.googleauthor | Robert Siegel | - |
dc.contributor.googleauthor | Weijing Sun | - |
dc.contributor.googleauthor | Zev Wainberg | - |
dc.contributor.googleauthor | Ben George | - |
dc.contributor.googleauthor | Andrea Bullock | - |
dc.contributor.googleauthor | Samuel Myrick | - |
dc.contributor.googleauthor | Josephine Faruol | - |
dc.contributor.googleauthor | Richard Siegel | - |
dc.contributor.googleauthor | Timothy Larson | - |
dc.contributor.googleauthor | Carlos Becerra | - |
dc.contributor.googleauthor | Suresh Ratnam | - |
dc.contributor.googleauthor | Donald A. Richards | - |
dc.contributor.googleauthor | Stephen L. Riche | - |
dc.identifier.doi | 10.1016/S0140-6736(18)31257-1 | - |
dc.contributor.localId | A03773 | - |
dc.relation.journalcode | J02152 | - |
dc.identifier.eissn | 1474-547X | - |
dc.identifier.pmid | 29880231 | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S0140673618312571 | - |
dc.contributor.alternativeName | Chung, Hyun Cheol | - |
dc.contributor.affiliatedAuthor | 정현철 | - |
dc.citation.volume | 392 | - |
dc.citation.number | 10142 | - |
dc.citation.startPage | 123 | - |
dc.citation.endPage | 133 | - |
dc.identifier.bibliographicCitation | LANCET, Vol.392(10142) : 123-133, 2018 | - |
dc.identifier.rimsid | 58079 | - |
dc.type.rims | ART | - |
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