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Tier 2 — RCT / large cohortPeer-reviewed

Pembrolizumab alone or combined with chemotherapy versus chemotherapy as first-line therapy for advanced urothelial carcinoma (KEYNOTE-361): a randomised, open-label, phase 3 trial

Thomas Powles, Tibor Csőszi, Mustafa Özgüroğlu, Nobuaki Matsubara, Lajos Géczi, Susanna Cheng, Yves Fradet, Stéphane Oudard, Christof Vulsteke, Rafael Morales‐Barrera, Aude Fléchon, Şeyda Gündüz, Yohann Loriot, Alejo Rodríguez‐Vida, Ronac Mamtani, Evan Y. Yu, Kijoeng Nam, Kentaro Imai, Blanca Homet Moreno, Ajjai Alva, D. Cascallar, Mirta Varela, Mauricio Fernández Lazzaro, Diego Kaen, Gabriela Gatica, David Hugo Flores, Agustín Falco, Matias Molina, F. Van Aelst, Christof Vulsteke, Brieuc Sautois, Jean‐Pascal Machiels, Denis Schallier, Leandro Brust, Liane Rapatoni, Sérgio Jobim Azevedo, GISELE LOPES MARINHO, João Paulo Holanda Soares, Carlos Dzik, Jamile Almeida Silva, André P. Fay, Joel Gingerich, Yves Fradet, Cristiano Ferrario, Kylea Potvin, Marie Vanhuyse, Mahmoud Abdelsalam, Susanna Cheng, Christian Caglevic, Felipe Reyes, José Luis Leal, Francisco Francisco, Carolina Ibáñez, Florence Joly, Brigitte Laguerre, Sylvain Ladoire, Aude Fléchon, Delphine Topart, Olivier Huillard, Stéphane Oudard, Marine Gross‐Goupil, Stéphane Culine, Yohann Loriot, Gwénaëlle Gravis, Peter Reichardt, Margitta Retz, Jan Herden, David G. Pfister, Carsten Ohlman, Michael Stöeckle, Manfred P. Wirth, Anja Lorch, Guenter Niegisch, Peter J. Goebell, Martin Boegemann, Axel S. Merseburger, Georgios Gakis, Jens Bedke, Andreas Neisius, Christian A. Thomas, Thomas Hoefner, András Telekes, Judit Kósa, János Révész, Gyorgy Bodoky, Tibor Csőszi, András Csejtei, Lajos Géczi, Ágnes Ruzsa, Zsuzsanna Kolonics, József Erfán, Ray McDermott, Richard Bambury, Avishay Sella, Stephen Jay Frank, Daniel Kejzman, Olesya Goldman, Eli Rosenbaum, Avivit Peer, Raanan Berger

The Lancet Oncology · 2021

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Summary

KEYNOTE-361 was a phase 3 randomised controlled trial evaluating pembrolizumab monotherapy and pembrolizumab plus chemotherapy as first-line treatments for advanced urothelial carcinoma compared to chemotherapy alone. The trial enrolled patients internationally and measured survival outcomes, response rates, and treatment toxicity. As this is a cancer immunotherapy study, findings are relevant to oncological practice rather than agricultural or nutritional systems.

UK applicability

This trial's findings would inform National Health Service oncology guidelines and clinical practice for urothelial carcinoma treatment. The results are directly applicable to UK cancer care pathways and treatment decision-making in urology and medical oncology.

Key measures

Overall survival, progression-free survival, objective response rate, adverse events, quality of life metrics

Outcomes reported

The study compared efficacy and safety of pembrolizumab monotherapy or combined with chemotherapy versus chemotherapy alone as first-line treatment for advanced urothelial carcinoma. Primary outcomes likely included overall survival, progression-free survival, and objective response rates.

Theme
Nutrition & health
Subject
Other / interdisciplinary
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s1470-2045(21)00152-2
Catalogue ID
SNmoh0dtvu-nlq2bx

Topic tags

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