Disitamab vedotin (RC48) combined with PD-1 inhibitors in locally advanced or metastatic urothelial carcinoma: clinical outcomes and prognostic factors from a multicenter real-world study

Background and objectivesThe combination of disitamab vedotin (RC48) with PD-1 inhibitors has shown synergistic potential in preclinical studies for treating advanced urothelial carcinoma (UC). Nevertheless, real-world evidence regarding its clinical efficacy and safety profile remains limited.

This multicenter real-world study aims to comprehensively evaluate the therapeutic outcomes and safety of RC48 combined with PD-1 inhibitors in patients with locally advanced or metastatic urothelial carcinoma (La/mUC), with a particular focus on analyzing the impact of comorbidities on treatment efficacy and prognosis.Patients and methodsA retrospective analysis was conducted on 132 patients with La/mUC who received RC48 combined with a PD-1 inhibitor at six treatment centers between June 2022 and March 2024. Clinical–pathological characteristics, treatment regimens, and follow-up data were collected from electronic medical record systems.

Efficacy outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and disease control rate (DCR). Safety was assessed by recording treatment-related adverse events (TRAEs), with efficacy evaluated across different disease subpopulations.