Issue: May 25, 2013
March 15, 2013
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Vinflunine extends survival in advanced urothelial carcinoma

Issue: May 25, 2013
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The addition of vinflunine to best supportive care extended OS in a cohort of patients with advanced urothelial carcinoma who did not respond to platinum-based chemotherapy, according to results of a phase 3 study.

Researchers randomly assigned 370 patients with transitional cell carcinoma of the urothelium to receive best supportive care with or without vinflunine (Javlor, Pierre Fabre), which was administered in doses of 320 mg/m2 or 280 mg/m2.

All patients had undergone platinum-based chemotherapy.

At median follow-up of 45.4 months, 352 of the patients had died.

Among the intention-to-treat population, researchers reported a median OS of 6.9 months for patients assigned to vinflunine and 4.6 months for patients who received best supportive care alone.

Multivariate analysis showed vinflunine was independently correlated with prolonged survival (HR=0.719; 95% CI, 0.57-0.90).

In the eligible population, median OS was 6.9 months for those who received vinflunine and 4.3 months for those who received best supportive care alone, equating to an estimated 22% reduction in risk of death, according to researchers.

“These results are consistent over time and confirm that vinflunine is a valuable option for second-line treatment in patients with advanced transitional cell carcinoma of the urothelium after failure of platinum-based regimens,” the researchers wrote.

Disclosure: The researchers report no relevant financial disclosures.