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Vinflunine reduced risk of death in bladder carcinoma
Vinflunine plus best supportive care may be a feasible second-line treatment option for patients with transitional cell carcinoma of the urothelium, according to data presented by Joaquim Bellmunt, MD, department of medical oncology, University Hospital del Mar, Barcelona, during his presentation at the 2008 ASCO Annual Meeting.
Bellmunt and colleagues conducted a randomized, phase-3 trial to determine the efficacy of vinflunine plus best supportive care compared with best supportive care alone on survival duration. Patients were randomly assigned to vinflunine (performance status 0: 320 mg/m2 three times per week; performance status 0 with prior pelvic radiation and performance status 1: 280 mg/m2 that increased to 320 mg/m2) plus best supportive care (n=253) or best supportive care alone (n=117).
Though not statistically significant, the intended median two-month survival advantage favoring vinflunine plus best supportive care was achieved (6.9 months for vinflunine plus best supportive care vs. 4.6 months for best supportive care alone; HR: 0.88, 95% CI, 0.69-1.12), according to Bellmunt.
“A planned multivariate analysis adjusting for prognostic factors showed a statistically significant effect of vinflunine on overall survival (P=.036), and vinflunine plus best supportive care reduced the risk of death by 23%, compared with best supportive care alone,” Bellmunt said.
Overall response rate (P=.0002), progression-free survival (P<.0001) and disease control (P<.001) all favored vinflunine plus best supportive care. – by Stacey L. Adams
The results of this study indicate that vinflunine has a modest level of activity, as reflected by the two-month survival improvement in the eligible population; durable responses in those who responded, despite a low response rate (the duration was 7.4 months) and the improvement in progression-free survival from one and a half months to three months.
This is a particularly important trial because it addresses second-line therapy in bladder cancer in an area that is not generally addressed in a definitive manner. Vinflunine is modestly active, at best, with no clear advantage over currently available drugs. We need to invest resources wisely and efficiently in identifying novel agents and combinations to be definitively tested in phase-3 settings.
– Maha Hussain, MD
Professor of Medicine and Urology in the Departments of Internal Medicine and Urology,
University of Michigan Cancer Center
For more information:
- Molins JB, Von der Mass H, Theodore C et al. Randomized phase III trial of vinflunine (V) plus best supportive care (B) vs. B alone as 2nd line therapy after a platinum-containing regimen in advanced transitional cell carcinoma of the urothelium (TCC). Presented at: 2008 ASCO Annual Meeting; May 30-June 3, 2008; Chicago.