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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

Authors
 Kohei Shitara  ;  Mustafa Özgüroğlu  ;  Yung-Jue Bang  ;  Maria Di Bartolomeo  ;  Mario Mandalà  ;  Min-Hee Ryu  ;  Lorenzo Fornaro  ;  Tomasz Olesiński  ;  Christian Caglevic  ;  Hyun C Chung  ;  Kei Muro  ;  Eray Goekkurt  ;  Wasat Mansoor  ;  Raymond S McDermott  ;  Einat Shacham-Shmueli  ;  Xinqun Chen  ;  Carlos Mayo  ;  S Peter Kang  ;  Atsushi Ohtsu  ;  Charles S Fuchs  ;  Guillermo Lerzo  ;  Juan Manuel O'Connor  ;  Guillermo Ariel Mendez  ;  James Lynam  ;  Niall Tebbutt  ;  Mark Wong  ;  Andrew Strickland  ;  Chris Karapetis  ;  David Goldstein  ;  Paul Vasey  ;  Jean-Luc Van Laethem  ;  Eric Van Cutsem  ;  Scott Berry  ;  Mark Vincent  ;  Bettina Muller  ;  Felipe Rey  ;  Angela Zambrano  ;  Joaquin Guerra  ;  Merete Krogh  ;  Lene Baeksgaard  ;  Mette Yilmaz  ;  Anneli Elme  ;  Andrus Magi  ;  Paivi Auvinen  ;  Tuomo Alanko  ;  Markus Moehler  ;  Volker Kunzmann  ;  Thomas Seufferlein  ;  Peter Thuss-Patience  ;  Eray Goekkurt  ;  Thomas Hoehler  ;  Georg Haag  ;  Salah-Eddin Al-Batran  ;  Hugo Castro  ;  Karla Lopez  ;  Mynor Aguilar Vasquez  ;  Mario Sandoval  ;  Ka On Lam  ;  Sinead Cuffe  ;  Cathy Kelly  ;  Ravit Geva  ;  Einat Shacham-Shmueli  ;  Ayala Hubert  ;  Alex Beny  ;  Baruch Brenner  ;  Aprile Giuseppe  ;  Alfredo Falcone  ;  Evaristo Maiello  ;  Rodolfo Passalacqua  ;  Vincenzo Montesarchio  ;  Hiroki Hara  ;  Keisho Chin  ;  Tomohiro Nishina  ;  Yoshito Komatsu  ;  Nozumo Machida  ;  Shuichi Hironaka  ;  Taroh Satoh  ;  Takao Tamura  ;  Naotaoshi Sugimoto  ;  Haruhiko Cho  ;  Yashushi Omuro  ;  Ken Kato  ;  Masahiro Goto  ;  Ichinosuke Hyodo  ;  Kazuhiro Yoshida  ;  Hideo Baba  ;  Taito Esaki  ;  Junji Furuse  ;  Wan Zamaniah Wan Mohammed  ;  Carlos Hernandez Hernandez  ;  Juan Casas Garcia  ;  Adriana Dominguez Andrade  ;  Katriona Clarke  ;  Geir Hjortland  ;  Nils Glenjen  ;  Tomasz Kubiatowski  ;  Jassem Jacek  ;  Marek Wojtukiewicz  ;  Sergey Lazarev  ;  Yuri Lancukhay  ;  Sergey Afanasayev  ;  Vladimir Moiseyenko  ;  Vladimir Kostorov  ;  Svetlana Protsenko  ;  Vadim Shirinkin  ;  Dina Sakaeva  ;  Natalia Fadeeva  ;  Wei Peng Yong  ;  Chau Hsien Matthew Ng  ;  Barbara Robertson  ;  Bernardo Rapaport  ;  Graham Cohen  ;  Lydia Dreosti  ;  Paul Ruff  ;  Conrad Jacobs  ;  Gregory Landers  ;  Waldemar Szpak  ;  Sang-Young Roh  ;  Jeeyun Lee  ;  Yeul Hong Kim  ;  Yung-Jue Bang  ;  Hyun Cheol Chung  ;  Min-Hee Ryu  ;  Maria Alsina Maqueda  ;  Federico Longo Munoz  ;  Andres Cervantes Aguilar  ;  Enrique Aranda Aguilar  ;  Pilar Garcia Alfonso  ;  Fernando Rivera  ;  Jaime Feliu Batle  ;  Roberto Pazo Cid  ;  Kun-Huei Yeh  ;  Jen-Shi Chen  ;  Yee Chao  ;  Chia-Jui Yen  ;  Mustafa Özgüroğlu  ;  Oguz Kara  ;  Suayib Yalcin  ;  Daniel Hochhauser  ;  Ian Chau  ;  Al Benson  ;  Veena Shankaran  ;  Walid Shaib  ;  Philip Philip  ;  Vivek Sharma  ;  Robert Siegel  ;  Weijing Sun  ;  Zev Wainberg  ;  Ben George  ;  Andrea Bullock  ;  Samuel Myrick  ;  Josephine Faruol  ;  Richard Siegel  ;  Timothy Larson  ;  Carlos Becerra  ;  Suresh Ratnam  ;  Donald A. Richards  ;  Stephen L. Riche 
Citation
 Lancet, Vol.392(10142) : 123-133, 2018 
Journal Title
 Lancet 
ISSN
 0140-6736 
Issue Date
2018
MeSH
Adenocarcinoma/drug therapy* ; Adenocarcinoma/mortality ; Adenocarcinoma/pathology ; Aged ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/therapeutic use* ; Esophageal Neoplasms/drug therapy* ; Esophageal Neoplasms/mortality ; Esophageal Neoplasms/pathology ; Esophagogastric Junction*/pathology ; Female ; Humans ; Infusions, Intravenous ; Male ; Middle Aged ; Neoplasm Staging ; Paclitaxel/adverse effects ; Paclitaxel/therapeutic use* ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/pathology ; Survival Rate ; Treatment Outcome
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.
Full Text
https://www.sciencedirect.com/science/article/pii/S0140673618312571
DOI
10.1016/S0140-6736(18)31257-1
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
정현철(Chung, Hyun Cheol) ORCID logo https://orcid.org/0000-0002-0920-9471
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URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/167098
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