Immune checkpoint blockade therapies efficacy and toxicity in patients with impaired renal function in metastatic bladder cancer

Abstract Background In this study, we reported the real-life results of data from impaired renal patients with urothelial carcinoma who were treated with ICTs. Methods The patients were categorized into 3 different groups GFR≥60mL/min (normal), 60–30mL/min (low), and less than 30 mL/min (very low) based on GFR. The primary endpoints were the overall response rate (ORR), overall survival (OS), duration of response with ICT, and safety. Median follow-up and OS were estimated by using the Kaplan-Meier method. Results One hundred-five( 60.3%) of patients were GFR normal, 26.4% were GFR low with 30–60 mL/min, and %13.2 were very low group. ORR for GFR normal, low and very low groups were 36% (n=38), 26% (n=12) and %31 (7); p=0.2, respectively. The median duration of response for GFR normal, low and very low groups were 47.2 months (95% CI, 24.5–51.4), 33.1 months (95% CI, 26.9–47), and 23.5 months (95% CI, 12.2–43.7); p=0.01, respectively. The Median OS rate for GFR normal, low and very low groups were 11.9 (7.2–16.5) months, 4.7 (1.8–7.7) and 6.8 (1.1–13.6) months, p=0.015, respectively. In addition, GFR <60 ml/min HR=1.6; 95% CI 1.12-1.80; p=0.02, maintained a significant association with OS in multivariate analysis Conclusions Long-term follow-up of real-world data confirms that the overall survival rate and durable response rate with ICT were higher in patients with GFR >60mL/min. On the other hand, we demonstrated that ICT was effective and a durable response seen in a group of patients with renal inpairement who did not have an effective systemic treatment option