Real-world (RW) evidence of vinflunine in metastatic urothelial cancer (mUC): A systematic review of seven European studies.

Abstract

463 Background: Vinflunine is the only chemotherapy agent for which there is a marketing authorisation in Europe for platinum-pretreated patients (pts) with mUC, based on a randomized phase III clinical trial. However, RW data regarding long-term efficacy and safety of vinflunine in unselected populations is needed. We conducted a systematic review gathering RW data from published observational European studies. Methods: Controlled studies and case series were excluded. We systematically explored the following endpoints: Overall Response Rate (ORR), Progression-Free Survival (PFS), Overall Survival (OS) and toxicity. Results: From 2014 to 2017, seven post-marketing studies including 750 pts were published: one was prospective and six were retrospective. Median ORR and median OS ranged from 13% to 29% and 6.3 to 11.9 months (mo) respectively (see Table below). In long-term survivors, OS reached 20.5 mo. Initial doses ranged from 250 to 320 mg/m2 adapted to patient’s conditions. In multivariate analysis, OS was found to be associated with the following risk-factors at baseline: ECOG PS >0, hemoglobin <10 g/dl, and presence of liver metastasis. The favorable safety profile demonstrated in randomized trials was confirmed. Main toxicity was hematological: neutropenia (G 3/4 in 1% to 23%) and anemia (G 3/4 in 4% to 33%). Constipation seemed to be less frequent than previously reported (G 3/4 in 5% to 22%). Conclusions: This is the largest experience of vinflunine use in platinum-pretreated pts with mUC. In our RW evidence, vinflunine shows both efficacy and a safe profile in an unselected patient population with similar criteria as in the pivotal trial. These findings reinforce the role of vinflunine in mUC, particularly if compared to evidence with taxanes or the increasing costs of immunotherapy.[Table: see text]