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Adjuvant PD-1/-L1 Inhibition Significantly Improves Disease-Free Survival for Muscle-Invasive Urothelial Carcinoma Regardless of PD-L1 Status

Updated results from a meta-analysis demonstrated that adjuvant immunotherapy with PD-1 and PD-L1 inhibitors significantly improved disease-free survival (DFS) for patients with muscle-invasive urothelial carcinoma (MIUC), regardless of PD-L1 status. 

“Neoadjuvant cisplatin-based chemotherapy followed by radical surgery is the standard treatment [however]... post-surgery, many patients still suffer from muscle-invasive urothelial cancer,” stated Isadora Mamede, MD, Federal University of São João del-Rei, Minas Gerais, Brazil, and coauthors. “Consequently, this meta-analysis aimed to assess the effectiveness of strategies involving checkpoint inhibitors in managing high-risk MIUC.” 

In this study, researchers collected data from 2220 patients with high-risk, upper and lower tract MIUC enrolled in 3 randomized controlled trials comparing PD-1 and PD-L1 inhibitors against placebo or observation. Adjuvant immunotherapy was administered to 1113 patients. Primary end points included DFS, overall survival (OS), and safety. 

At analysis, treatment with PD-1/-L1 inhibitors significantly improved DFS compared to placebo or observation (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.65 to 0.90; P < .01). This improvement was observed mainly among patients with lower tract tumors (HR, 0.71; 95% CI, 0.56 to 0.91; P < .01) and there was no substantial improvement observed among patients with upper tract tumors (P = .28). PD-L1 status and prior administration of neoadjuvant chemotherapy did not significantly affect treatment outcomes. Immunotherapy was correlated with higher incidences of grade ≥3 adverse events (P < .01) with no notable difference in OS (P = .07). 

“These findings support immunotherapy, especially anti-PD1, as a valuable adjuvant treatment strategy for high-risk MIUC patients,” concluded Dr Mamede et al.


Source: 

Mamede I, Silva C, Alves AC, et al. Adjuvant immunotherapy in high-risk muscle-invasive urothelial cancer: an updated meta-analysis of randomized controlled trials. Clin Genitourin Cancer. Published online: December 4, 2024. doi: 10.1016/j.clgc.2024.102288