Vinflunine (VFL) in patients (pts) with metastatic transitional cell carcinoma of the urothelial tract (mTCCU): Clinical outcome and prognostic factors in a nationwide, real-life setting (MOVIE trial).

e16031Background: To assess the clinical impact of VFL in pts with mTCCU and verify the prognostic factors in a large, unselected population treated according to routine clinical practice (CP). Methods: This is a retrospective, observational multicenter trial. According to the Italian Regulatory Agency Registry (AIFA), all oncological centers that treated with VFL at least 4 pts from Feb 2011 to June 2014, were invited to take part to this study. Pts must have received a previous platinum therapy and were treated with VFL according to CP. Primary objective is to test whether efficacy in terms of overall survival (OS) obtained in the registration study are confirmed in the real life setting. Sample size has been determined considering the OS obtained in the registration study, with α=0.05 and 1-β=80%, 197 pts have to be enrolled. Results: 217 pts were registered in 24 centers across all Italy. Median age was 69 yrs; 84% males; ECOG was 0,1,2 in 47%, 46%, and 7%; 21% had liver metastasis. 77% received VFL a...