Vinflunine plus gemcitabine may be safe and effective as first-line chemotherapy in patients with advanced urothelial carcinoma who are unfit for treatment with cisplatin, a new study published online ahead of print in the journal Annals of Oncology has shown.1

Because there is no standard first-line chemotherapy for advanced urothelial carcinoma in patients ineligible to receive cisplatin, researchers sought to evaluate the efficacy and tolerability profile of 2 vinflunine-based regimens, 1 with gemcitabine and 1 with carboplatin, in this treatment setting.

For the phase 2 trial, researchers enrolled 69 patients with advanced urothelial carcinoma who had received no prior chemotherapy for advanced disease. Participants were randomly assigned to receive vinflunine 250 or 280 mg/m2 on day 1, plus either gemcitabine 750 – 1000 mg/m2 on days 1 and 8 or carboplatin AUC 4.5 on day 1 every 3 weeks.

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Results showed that the overall response rate was 44.1% with vinflunine plus gemcitabine compared with 28.6% with vinflunine plus carboplatin. Median progression-free survival was 5.9 months vs 6.1 months, respectively, and median overall survival was 14.0 months vs 12.8 months, respectively.

In regard to safety, there were no major differences between the 2 groups in terms of non-hematological adverse events. Furthermore, influnine plus gemcitabine was associated with fewer grade 3 or 4 hematological adverse events.

RELATED: VTE Incidence Higher With Gemcitabine, Carboplatin in Urothelial Carcinoma

Both vinflunine-based doublets offer a similar DCR [disease control rate], ORR [overall response rate], and OS [overall survival],” the investigators concluded. “The better hematological tolerance favors the vinflunine-gemcitabine combination, which warrants further study.”


  1. De Santis M, Wiechno PJ, Bellmunt J, et al. Vinflunine-gemcitabine versus vinflunine-carboplatin as first-line chemotherapy in cisplatin-unfit patients with advanced urothelial carcinoma: results of an international randomized phase II trial (JASINT1) [published online ahead of print December 16, 2015]. Ann Oncol. doi: 10.1093/annonc/mdv609.