Urology Medical News about Urothelial tract, Vinflunine, Microtubule inhibitor

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Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract
Journal of Clinical Oncology, 08/24/09

Bellmunt J et al. - A phase III study reports that vinflunine (VFL; a new microtubule inhibitor) demonstrates a survival advantage in second-line treatment for advanced transitional cell carcinoma of urothelial tract (TCCU). Safety profile was acceptable, and therefore, VFL seems to be a reasonable option.

Methods

Study of VFL and best supportive care (BSC) vs BSC alone in the treatment of pts with advanced TCCU who had experienced progression after a first-line platinum-containing regimen
Overall survival (OS) was compared between patients receiving VFL + BSC or BSC

Results

370 pts were randomly assigned to VFL + BSC, n=253; or BSC, n=117
Both arms were well balanced except there were more pts with PS more than 1 (10% difference) in the BSC arm
Main grade 3 or 4 toxicities for VFL + BSC were neutropenia (50%), febrile neutropenia (6%), anemia (19%), fatigue (19%), and constipation (16%)
In the intent-to-treat population, the objective of a median 2-mo survival advantage was achieved, but was not statistically significant
Multivariate Cox analysis adjusting for prognostic factors showed significant effect of VFL on OS, reducing the death risk by 23%
Median OS was longer for VFL+ BSC than BSC
Overall response rate, disease control, and progression-free survival were all significant favoring VFL + BSC

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