Vinflunine/gemcitabine versus carboplatin/gemcitabine as first-line treatment in cisplatin-ineligible patients with advanced urothelial carcinoma: A randomised phase II trial (VINGEM).

•This was the first trial comparing vinflunine/gemcitabine (VG) vs carboplatin/gemcitabine (CG) in advanced urothelial cancer.•VG showed clinically meaningful efficacy with high overall and complete response rates.•VG did not improve median progression-free survival but was comparable with CG.•VG showed high incidence of neutropenia but with overall feasible side-effects.