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Tier 2 — RCT / large cohortPeer-reviewed

Durvalumab alone and durvalumab plus tremelimumab versus chemotherapy in previously untreated patients with unresectable, locally advanced or metastatic urothelial carcinoma (DANUBE): a randomised, open-label, multicentre, phase 3 trial

Thomas Powles, Michiel S. van der Heijden, Daniel Castellano, Matthew D. Galsky, Yohann Loriot, Daniel P. Petrylak, Osamu Ogawa, Se Hoon Park, Jae‐Lyun Lee, Ugo De Giorgi, Martin Bögemann, Aristotelis Bamias, Bernhard J. Eigl, Howard Gurney, Som D. Mukherjee, Yves Fradet, Iwona Skoneczna, Marinos Tsiatas, Andrey Novikov, Cristina Suárez, André P. Fay, Ignacio Durán, Andrea Necchi, Sophie Wildsmith, Philip He, Natasha Angra, Ashok Gupta, Wendy J. Levin, Joaquim Bellmunt, Se Hoon Park, Michiel S. van der Heijden, Andrea Necchi, Daniel Castellano, Aristotelis Bamias, Jae‐Lyun Lee, Ugo De Giorgi, Martin Bögemann, Bernhard J. Eigl, Marinos Tsiatas, Thomas Powles, Andrey Novikov, Iwona Skoneczna, Som D. Mukherjee, Cristina Suárez, Hans M. Westgeest, Yves Fradet, Aude Fléchon, Yen‐Chuan Ou, Inkeun Park, Vsevolod Matveev, Begoña Pérez‐Valderrama, Susanna Cheng, Stephen Jay Frank, Howard Gurney, Urbano Anido, Alketa Hamzaj, Margitta Retz, Srikala S. Sridhar, Giorgio V. Scagliotti, Jens Voortman, B. Yа. Alekseev, Anna Alyasova, B. K. Komyakov, Herlinde Dumez, Michel Pavic, Go Kimura, Atsushi Mizokami, Susanne Osanto, José Ángel Arranz, Djura Piersma, Sang Joon Shin, O. B. Karyakin, Ignacio Delgado, José Luis González, See‐Tong Pang, Anna Tran, Oleg Lipatov, Wen-Pin Su, Thomas W. Flaig, Ajjai Alva, Hwa Park Kyong, Evgeny Kopyltsov, Elena Almagro, M. Doménech, Yen‐Hwa Chang, Brieuc Sautois, Andre Ravaux, Gerasimos Aravantinos, V. Georgoulias, Sasja F. Mulder, Yu Jung Kim, Fabio Kater, Christine Chevreau, Scott T. Tagawa, Paweł Zalewski, Florence Joly, Yohann Loriot, Gencay Hatiboglu, Luca Gianni, Franco Morelli

The Lancet Oncology · 2020

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Summary

The DANUBE trial was a phase 3, multicentre, randomised controlled trial evaluating two immunotherapy regimens (durvalumab alone and durvalumab plus tremelimumab) against platinum-based chemotherapy as first-line treatment for advanced or metastatic urothelial carcinoma. Published in The Lancet Oncology in 2020, this study represents a major clinical evaluation of checkpoint inhibitor-based approaches in this patient population, though the trial involved a large international collaborative network.

UK applicability

As an international multicentre trial, findings are directly applicable to UK oncology practice and NHS treatment guidelines for urothelial cancer. Results would inform commissioning decisions and standard-of-care protocols for advanced urothelial carcinoma across UK cancer centres.

Key measures

Overall survival, progression-free survival, objective response rate, adverse event rates

Outcomes reported

The study compared efficacy and safety of durvalumab monotherapy and durvalumab plus tremelimumab combination versus standard chemotherapy in patients with previously untreated unresectable or metastatic urothelial carcinoma. Primary endpoints likely included overall survival, progression-free survival, and objective response rates.

Theme
General food systems / other
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(20)30541-6
Catalogue ID
BFmommpjky-tl0a1h

Topic tags

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