Real-world benchmarks for metastatic urothelial carcinoma: a single-center analysis of two standard immunotherapy pathways in Romania.

Abstract

Aim: To establish a real-world benchmark for treatment with the immune checkpoint inhibitors (ICI) and clinical outcomes for patients with metastatic urothelial carcinoma (mUC) by analyzing two distinct, standard-of-care therapeutic sequences at a single Romanian tertiary care center.

Methods: We conducted a retrospective analysis of 30 patients with mUC treated between January 1, 2020, and April 30, 2025. Patients were analyzed in two clinically distinct cohorts: the Avelumab Maintenance Cohort (N=12), which included platinum-eligible patients who responded to first-line platinum-based chemotherapy (PBC) followed by avelumab maintenance, and the Pembrolizumab Cohort (N=18), consisting of patients who received pembrolizumab therapy following disease progression after PBC. The primary endpoint was time to treatment failure (TTF). Secondary endpoints included overall survival (OS) and the incidence of grade ≥3 treatment-related adverse events (TRAEs).

Results: The two cohorts displayed different baseline characteristics and clinical trajectories. The Avelumab Maintenance cohort, selected for chemotherapy-sensitive disease, demonstrated a higher disease control rate (DCR) of 91.7%. The Pembrolizumab cohort, representing a more clinically diverse and challenging population, had a DCR of 55.6%. In the Avelumab cohort, median TTF and median OS were not reached. In the Pembrolizumab cohort, the median TTF was 10.2 months and median OS was 21.8 months. Grade ≥3 TRAEs were infrequent, occurring in 1 of 12 patients (8.3%) in the Avelumab cohort and 2 of 18 patients (11.1%) in the Pembrolizumab cohort, with no new safety signals identified.

Conclusion: This single-center study provides a context-specific presentation of mUC treated with ICIs effectiveness and safety in the Romanian healthcare context and highlights the impact of systemic factors, such as national healthcare reimbursement policies, on clinical practice.