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.
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