作者
Thomas Powles, Tibor Csőszi, Mustafa Özgüroğlu, Nobuaki Matsubara, Lajos Géczi, Susanna YS Cheng, Yves Fradet, Stephane Oudard, Christof Vulsteke, Rafael Morales Barrera, Aude Fléchon, Seyda Gunduz, Yohann Loriot, Alejo Rodriguez-Vida, Ronac Mamtani, Y Yu Evan, Kijoeng Nam, Kentaro Imai, Blanca Homet Moreno, Ajjai Alva, Diana Vera Cascallar, Mirta Varela, Mauricio Fernandez Lazzaro, Diego Lucas Kaen, Gabriela Gatica, David Hugo Flores, Agustin Falco, Matias Molina, Filip Van Aelst, Brieuc Sautois, Jean-Pascal Machiels, Denis Schallier, Leandro Brust, Liane Rapatoni, Sergio J Azevedo, Gisele Marinho, Joao Paulo Holanda Soares, Carlos Dzik, Jamile Almeida Silva, Andre Poisl Fay, Joel Gingerich, Cristiano Ferrario, Kylea Potvin, Marie Vanhuyse, Mahmoud Abdelsalam, Susanna Cheng, Christian Caglevic, Felipe Reyes, Jose Luis Leal, Francisco Francisco, Carolina Ibanez, Florence Joly, Brigitte Laguerre, Sylvain Ladoire, Aude Flechon, Delphine Topart, Olivier Huillard, Stéphane Oudard, Marine Gross-Goupil, Stephane Culine, Gwenaelle Gravis, Peter Reichardt, Margitta Retz, Jan Herden, David Pfister, Carsten Ohlman, Michael Stoeckle, Manfred Wirth, Anja Lorch, Guenter Niegisch, Peter J Goebell, Martin Boegemann, Axel Merseburger, Georgios Gakis, Jens Bedke, Andreas Neisius, Christian Thomas, Thomas Hoefner, Andras Telekes, Judit Erzsebet Kosa, Janos Revesz, Gyorgy Bodoky, Tibor Csoszi, Andras Csejtei, Lajos Geczi, Agnes Ruzsa, Zsuzsanna Kolonics, Jozsef Erfan, Ray McDermott, Richard Bambury, Avishay Sella, Stephen Jay Frank, Daniel Kejzman, Olesya Goldman, Eli Rosenbaum, Avivit Peer, Raanan Berger, Keren Rouvinov, David Sarid, Satoshi Fukasawa, Gaku Arai, Akito Yamaguchi, Akira Yokomizo, Tatsuya Takayama, Hidefumi Kinoshita, Eiji Kikuchi, Ryuichi Mizuno, Yasuhisa Fujii, Naoto Sassa, Yoshihisa Matsukawa, Kiyohide Fujimoto, Toshiki Tanikawa, Yoshihiko Tomita, Kazuo Nishimura, Masao Tsujihata, Masafumi Oyama, Naoya Masumori, Hiroomi Kanayama, Toshimi Takano, Yuji Miura, Jun Miyazaki, Akira Joraku, Tomokazu Kimura, Yoshiaki Yamamoto, Kazuki Kobayashi, Ronald De Wit, Maureen Aarts, Winald Gerritsen, Maartje Los, Laurens Beerepoot, Adel Izmailov, Sergey Igorevich Gorelov, Boris Yakovlevich Alekseev, Andrey Semenov, Vladimir Anatolyevich Kostorov, Sergey M Alekseev, Alexander Zyryanov, Vasiliy Nikolaevich Oschepkov, Vladimir Aleksandrovich Shidin, Vladimir Ivanovich Vladimirov, Rustem Airatovich Gafanov, Petr Alexandrovich Karlov, David Brian Anderson, Lucinda Shepherd, Graham Lawrence Cohen, Bernardo Louis Rapoport, Paul Ruff, Nari Lee, Woo Kyun Bae, Hyo Jin Lee
发表日期
2021/7/1
期刊
The Lancet Oncology
卷号
22
期号
7
页码范围
931-945
出版商
Elsevier
简介
Background
PD-1 and PD-L1 inhibitors are active in metastatic urothelial carcinoma, but positive randomised data supporting their use as a first-line treatment are lacking. In this study we assessed outcomes with first-line pembrolizumab alone or combined with chemotherapy versus chemotherapy for patients with previously untreated advanced urothelial carcinoma.
Methods
KEYNOTE-361 is a randomised, open-label, phase 3 trial of patients aged at least 18 years, with untreated, locally advanced, unresectable, or metastatic urothelial carcinoma, with an Eastern Cooperative Oncology Group performance status of up to 2. Eligible patients were enrolled from 201 medical centres in 21 countries and randomly allocated (1:1:1) via an interactive voice-web response system to intravenous pembrolizumab 200 mg every 3 weeks for a maximum of 35 cycles plus intravenous chemotherapy (gemcitabine [1000 mg/m2] on …
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T Powles, T Csőszi, M Özgüroğlu, N Matsubara… - The Lancet Oncology, 2021