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Although level 1 evidence supports the use of neoadjuvant cisplatin-based chemotherapy before radical cystectomy in patients with muscle-invasive bladder cancer, uptake in clinical practice has been uneven and impact on overall survival remains very modest. Several immune checkpoint inhibitors are approved for use in advanced urothelial cancer based on phase 2 and 3 trials.
Investigators conducted an industry-supported international phase 3 trial of adjuvant nivolumab in high-risk urothelial cancer. Patients who underwent radical surgery (cystectomy or nephroureterectomy) with pathologic evidence of high-risk disease, with or without neoadjuvant cisplatin-based chemotherapy, were randomized to nivolumab or placebo every 2 weeks for up to 1 y…