A phase II study of vinflunine in bladder cancer patients progressing after first-line platinum-containing regimen
2006

Vinflunine for Bladder Cancer Treatment

Sample size: 51 publication Evidence: moderate

Author Information

Author(s): Culine S, Theodore C, De Santis M, Bui B, Demkow T, Lorenz J, Rolland F, Delgado F-M, Longerey B, James N

Primary Institution: CRLC Val d'Aurelle, Montpellier, France

Hypothesis

Vinflunine is effective as a second-line therapy for bladder cancer patients who have progressed after first-line platinum-based chemotherapy.

Conclusion

Vinflunine shows clinically relevant activity with manageable toxicity in patients with bladder cancer who have failed prior platinum-based chemotherapy.

Supporting Evidence

  • Nine out of 51 patients responded to vinflunine, yielding an overall response rate of 18%.
  • 67% of patients achieved disease control (partial response + stable disease).
  • The median duration of response was 9.1 months.
  • The median progression-free survival was 3.0 months.
  • The median overall survival was 6.6 months.

Takeaway

Vinflunine is a medicine that helps some people with bladder cancer when other treatments don't work. It can make the cancer smaller and is usually safe to use.

Methodology

This was an open-label, multicentre, noncomparative phase II trial assessing vinflunine's efficacy in patients with advanced transitional cell carcinoma of the bladder.

Potential Biases

Potential bias due to the open-label design and lack of a control group.

Limitations

The study had a small sample size and focused only on patients who had previously received platinum-based chemotherapy.

Participant Demographics

The study included 51 patients, predominantly male (80%), with a median age of 63 years.

Statistical Information

P-Value

p<0.05

Confidence Interval

95% CI: 8.4–30.9%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6603118

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