Nivolumab Demonstrates Longer DFS Vs Placebo in Urothelial Carcinoma
Experts conducted a double-blind controlled trial to assess the unclear role of adjuvant treatment in high-risk muscle-invasive urothelial carcinoma patients after radical surgery in a 1:1 ratio for every 2 weeks up to 1 year.
All patients were randomized with a total of 353 who were eligible to receive nivolumab and 356 for placebo. The median disease free survival in the intention-treat-population was 20.8 months, in addition to median survival free from reoccurance was 22.9 months. Additionally, survival with nivolumab was reported 10.8 months with placebo.
“The primary end points were disease-free survival among all the patients (intention-to-treat population) and among patients with a tumor programmed death ligand 1 (PD-L1) expression level of 1% or more,” wrote Dean Bajorin, MD, Memorial Sloan Kettering Cancer Center, and co-researchers.
Further in the study, Dr Bajorin et al concluded that the percentage of patients who survived and were disease-free at 6 months was 74.9% with nivolumab and 60.3% with placebo (hazard ratio for disease recurrence or death, 0.70; 98.22% CI, 0.55 to 0.90; P<0.001).
Treatment-related adverse events of grade 3 or higher occurred in 17.9% of patients of the nivolumab group and 7.2% of the placebo group.
“In this trial involving 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,” concluded Dr Bajorin, et al. – Alexa Stoia