Summary
This phase 3 randomised controlled trial evaluated perioperative durvalumab (an anti-PD-L1 monoclonal antibody) combined with neoadjuvant gemcitabine-cisplatin chemotherapy in 1,063 cisplatin-eligible patients with muscle-invasive bladder cancer undergoing radical cystectomy. The durvalumab group demonstrated significantly improved event-free survival (67.8% vs 59.8% at 24 months) and overall survival (82.2% vs 75.2% at 24 months) compared to chemotherapy alone, with comparable safety profiles between groups.
UK applicability
The findings are directly applicable to UK clinical practice, as this trial enrolled patients from multiple countries and reflects standard radical cystectomy pathways used in the NHS. The results may inform treatment guidelines for muscle-invasive bladder cancer in UK oncology services.
Key measures
Event-free survival at 24 months (primary endpoint); overall survival at 24 months (key secondary endpoint); treatment-related adverse events (grade 3–4 severity); treatment-related mortality; radical cystectomy completion rates
Outcomes reported
The study measured event-free survival and overall survival at 24 months in patients with muscle-invasive bladder cancer receiving perioperative durvalumab plus neoadjuvant chemotherapy versus chemotherapy alone. Secondary outcomes included treatment-related adverse events and rates of radical cystectomy completion.
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