Real-World Effectiveness of Avelumab Maintenance in Advanced Urothelial Carcinoma: Results from the Italian Multicenter MALVA Study (Meet-URO 25)
Menée en Italie dans un contexte de vie réelle à partir de données portant sur 251 patients atteints d'un carcinome urothélial de stade avancé, cette étude de cohorte multicentrique évalue l'efficacité, du point de vue de la survie sans progression et de la survie globale, de l'avélumab en traitement d'entretien après une chimiothérapie de première ligne à base de sels de platine
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.
The Oncologist , article en libre accès, 2025