Enfortumab vedotin (EV), an antibody–drug conjugate, has demonstrated survival benefits in patients with locally advanced or metastatic urothelial carcinoma (UC). However, most participants in clinical trials had relatively preserved renal function, whereas in real-world practice, many UC patients present with advanced chronic kidney disease (CKD). This study aimed to evaluate the outcomes of EV in UC patients with impaired renal function

We conducted a retrospective review of patients with locally advanced or metastatic UC treated with EV between July 2021 and June 2024 at two medical centers. Patients were stratified based on creatinine clearance (CrCl) into two groups: CrCl < 45 mL/min and CrCl ≥ 45 mL/min. Treatment response, progression-free survival (PFS), and overall survival (OS) were analyzed and compared between the groups.

A total of 57 patients were included in the study. Among them, 36 patients (63.2%) had a CrCl < 45 mL/min, and 30 patients (42.3%) had upper tract UC. The objective response rate was comparable between the two groups (CrCl < 45 vs. CrCl ≥ 45: 30.6% vs. 42.9%, p = 0.13). Median PFS was also similar (8 months in both groups, p = 0.4). However, patients with CrCl ≥ 45 mL/min demonstrated significantly better OS (median OS, CrCl < 45 vs. CrCl ≥ 45: 10 months vs. not reached, p = 0.04).

Enfortumab vedotin demonstrated comparable efficacy regardless of renal function, with similar response rates and PFS observed between patients with and without advanced CKD. However, patients with impaired renal function experienced significantly worse overall survival, highlighting the potential impact of CKD on long-term outcomes