Efficacy and safety of Vinflunine for advanced or metastatic urothelial carcinoma in routine practice based on the French multi-centre CURVE study

BACKGROUND: To retrospectively assess the efficacy and safety of Vinflunine (VFL) under routine conditions and identify overall survival (OS) prognostic factors. METHODS: Twenty centres participated in the retrospective study (minimum 4 patients undergoing VFL treatment for advanced/metastatic UC after platinum-based regimen progression. Primary endpoint was OS. Secondary endpoints: progression-free survival (PFS), radiological response rate (RR) RECIST criteria and toxicity (CTC NCI v3). RESULTS: These centres enrolled 134 patients. Prior chemotherapy (CT) lines (≥1 palliative): 1 and ≥2 in 69 % and 26 % of patients, respectively. Performance status (PS): 0, 1, 2 in 25 %, 46 % and 23 % of patients. Median OS = 8.2 months [6.5–9.4], PFS = 4.2 months and RR 22 %, median number of 5 cycles. In risk groups based on 0–3 presence of adverse prognostic factors (PS ≥1, haemoglobin ≤10 g/dl and liver metastasis), median OS: 13.2, 9.9, 3.6, and 2.4 months (P < .0001), respectively; 3.3 months (1.9–5.6) in PS ≥ 2 subgroup. CONCLUSION: This study reflects routine UC management and confirmed VFL patient efficacy. The drug is safe with gastro-intestinal and haematological prophylaxis. Analysis of prognostic factors for OS is consistent with pivotal trials.