Prospective, noninterventional study of vinflunine treatment in advanced urothelial cell carcinoma (UCC) in routine clinical practice.

e15505 Background: Vinflunine is recommended by the European guideline for the treatment of UCC after failure of platinum-based chemotherapy. In a prospective, non-interventional study (NIS) we investigated the efficacy and tolerability of vinflunine as well as a prognostic risk model for routine clinical practice. Methods: Data were prospectively collected on 77 platinum-pretreated UCC patients undergoing vinflunine treatment in 39 German hospitals or outpatient units. Dosing of vinflunine, tumor assessments and concomitant medications were performed according to physician’s usual practice. A prognostic risk model was evaluated with the four risk factors liver metastasis, ECOG performance status ≥1, hemoglobin level < 10g/dL and time from prior chemotherapy <6 months. Results: A vinflunine starting dose of 320 mg/m² was chosen in 48 % and 280 mg/m² in 39 % of all patients. The overall response rate (ORR) was 23.4 % and median overall survival (OS) was 7.7 months. Patients receiving a starting dose of 320...