Abstract Background Avelumab maintenance therapy has demonstrated a survival benefit in patients with advanced urothelial carcinoma who respond to first-line platinum-based chemotherapy. However, real-world data on its effectiveness and the prognostic value of baseline clinical factors remain limited. Methods This was a multicenter prospective observational study including a retrospective cohort of patients treated before study initiation included 251 patients with advanced or metastatic urothelial carcinoma treated with Avelumab as maintenance therapy between 2021 and 2023 across several Italian centers. Primary endpoints were overall survival (OS) and progression-free survival (PFS); secondary endpoints included overall response rate (ORR) and disease control rate (DCR). Results Median OS was 22.4 months and median PFS was 7 months. The ORR and DCR were 26.75% and 69.30%, respectively. Multivariate analysis identified ECOG ≥1 (HR 1.57), bone metastases (HR 1.88), brain metastases (HR 7.02), and baseline steroid use (HR 2.42) as independent predictors of worse OS. ECOG performance status ≥1, presence of bone metastases, and corticosteroid use at baseline were identified as independent prognostic factors and were used to construct an exploratory stratification into three prognostic groups. Patients with none, one, or two or more negative factors had significantly different OS (median: 39.9 vs. 14.1 vs. 8.4 months) and ORR (33.6% vs. 28.0% vs. 6.9%). Conclusions In this real-world cohort, Avelumab maintenance confirmed its effectiveness and safety in advanced urothelial carcinoma. A simple exploratory prognostic stratification score based on ECOG status, bone metastases, and steroid use at baseline effectively stratified patients by prognosis and may support personalized treatment strategies.
Roviello et al. (2025) studied this question.