The New England Journal of MedicinePerioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer

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A phase 3 randomized trial has demonstrated significant survival benefits from adding durvalumab to standard neoadjuvant chemotherapy and surgical treatment in muscle-invasive bladder cancer patients. The study provides evidence for a potential new standard of care in the perioperative treatment setting.

Study Design:

• Phase 3, open-label, randomized trial with 1:1 allocation ratio
• Total enrollment: 1,063 patients (533 durvalumab group, 530 comparison group)
• Treatment arms:
  • Intervention: Durvalumab + gemcitabine-cisplatin (neoadjuvant) → radical cystectomy → durvalumab (adjuvant)
  • Control: Gemcitabine-cisplatin (neoadjuvant) → radical cystectomy
• Primary endpoint: Event-free survival
• Key secondary endpoint: Overall survival

Key Findings:

• Event-free survival at 24 months:
  • Durvalumab group: 67.8% (95% CI: 63.6-71.7)
  • Control group: 59.8% (95% CI: 55.4-64.0)
  • Hazard ratio: 0.68 (P<0.001)
• Overall survival at 24 months:
  • Durvalumab group: 82.2% (95% CI: 78.7-85.2)
  • Control group: 75.2% (95% CI: 71.3-78.8)
  • Hazard ratio: 0.75 (P=0.01)
• Safety Profile:
  • Grade 3-4 adverse events: Similar between groups (40.6% vs 40.9%)
  • Treatment-related deaths: 0.6% in both groups
  • Radical cystectomy completion rates: 88.0% vs 83.2%

HCN Medical Memo
The addition of durvalumab to standard perioperative care showed meaningful survival benefits without increasing severe adverse events. This evidence supports considering immunotherapy addition to the standard treatment protocol for eligible muscle-invasive bladder cancer patients. The similar safety profile and improved surgical completion rates further strengthen the case for this combined approach.

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