Enfortumab Vedotin Following Platinum Chemotherapy and Avelumab Maintenance in Patients with Metastatic Urothelial Carcinoma: A Retrospective Data from the ARON-2EV Study.
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Fiala Ondřej, Massari Francesco, Basso Umberto, Giannatempo Patrizia, Grande Enrique, Buti Sebastiano, Myint Zin W, De Giorgi Ugo, Pichler Renate, Grillone Francesco, Ürün Yüksel, Calabrò Fabio, Bourlon Maria T, Galli Luca, Kanesvaran Ravindran, Roviello Giandomenico, Kucharz Jakub, Rizzo Mimma, Park Se Hoon, Cerbone Linda, Seront Emmanuel, Messina Carlo, Molina-Cerrillo Javier, Santini Daniele, Yano Akihiro, Incorvaia Lorena, Catalano Martina, Pinto Alvaro, Formisano Luigi, Soares Andrey, Facchini Gaetano, Fornarini Giuseppe, Poprach Alexandr, Rebuzzi Sara Elena, Nasso Cecilia, Spinelli Gian Paolo, Angel Martin, Stellato Marco, Tural Deniz, Aurilio Gaetano, Epstein Ilana, Carrozza Francesco, Monteiro Fernando Sabino Marques, Benedetti Giovanni, Büchler Tomáš, Ortega Cinzia, Zakopoulou Roubini, Battelli Nicola, Porta Camillo, Bellmunt Joaquin, Gupta Shilpa, Santoni Matteo
Аннотация
OBJECTIVE: The aim of the present retrospective analysis was to assess the effectiveness of EV following avelumab in patients with mUC enrolled in the ARON-2EV study.
PATIENTS AND METHODS: The study included 182 patients with mUC treated with EV following avelumab maintenance. The primary objective was to assess clinical outcomes, including progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and duration of response (DoR). Statistical analysis involved Fisher exact test, Kaplan-Meier method, log-rank test, and univariate/multivariate Cox proportional hazard regression models.
RESULTS: Median OS and PFS were 12.7 (95% CI 10.2-14.1) and 7.9 (95% CI 6.4-9.9) months, respectively. Complete response (CR) was achieved in 5% and partial response (PR) in 34% of patients, with an ORR of 39%. The DoR in patients who achieved CR/PR was 10.9 months (95% CI 8.1-11.4). The incidence of grade ≥ 3 peripheral neuropathy and skin rash was 9%, followed by 8% of grade ≥ 3 diarrhea and 4% of grade ≥ 3 hyperglycemia.
CONCLUSIONS: The results of our large international retrospective study confirm the effectiveness of EV and endorse its use in the population of patients with mUC treated with EV following the frontline platinum-based chemotherapy and subsequent maintenance treatment with avelumab.