Postoperative immunotherapy lowers the risk of Bladder cance
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The findings of this study have the potential to change the standard of care for bladder cancer. Patients who received adjuvant nivolumab (Opdivo) following bladder surgery are at a lower overall risk for the recurrence of high-grade bladder cancer, according to a recent study in the New England Journal of Medicine.

In phase 3, multicenter, double-blind, randomized, controlled trial, researchers assigned patients with muscle-invasive urothelial carcinoma who had undergone radical surgery to receive, in a 1:1 ratio, either nivolumab (240 mg intravenously) or placebo every 2 weeks for up to 1 year. Neoadjuvant cisplatin-based chemotherapy before trial entry was allowed.

The primary endpoints were disease-free survival among all the patients and among patients with a tumor programmed death-ligand 1 (PD-L1) expression level of 1% or more. Survival free from recurrence outside the urothelial tract was a secondary endpoint. A total of 353 patients were assigned to receive nivolumab and 356 to receive placebo.

--The median disease-free survival in the intention-to-treat population was 20.8 months with nivolumab and 10.8 months with placebo.

--The percentage of patients who were alive and disease-free at 6 months was 74.9% with nivolumab and 60.3% with placebo.

--Among patients with a PD-L1 expression level of 1% or more, the percentage of patients was 74.5% and 55.7%, respectively.

--The median survival free from recurrence outside the urothelial tract in the intention-to-treat population was 22.9 months with nivolumab and 13.7 months with placebo.

--The percentage of patients who were alive and free from recurrence outside the urothelial tract at 6 months was 77.0% with nivolumab and 62.7% with placebo.

--Among patients with a PD-L1 expression level of 1% or more, the percentage of patients was 75.3% and 56.7%, respectively.

--Treatment-related adverse events of grade 3 or higher occurred in 17.9% of the nivolumab group and 7.2% of the placebo group. Two treatment-related deaths due to pneumonitis were noted in the nivolumab group.

Conclusively, in patients with high-risk muscle-invasive urothelial carcinoma who had undergone radical surgery, disease-free survival was longer with adjuvant nivolumab than with placebo in the intention-to-treat population and among patients with a PD-L1 expression level of 1% or more.

Source: https://www.nejm.org/doi/full/10.1056/NEJMoa2034442
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