title: Long-term survival results of a randomized phase III trial of vinflunine plus best supportive care versus best supportive care alone in advanced urothelial carcinoma patients after failure of platinum-based chemotherapy.
abstract: BACKGROUND
  To compare long-term, updated overall survival (OS) of patients with advanced transitional cell carcinoma of the urothelium (TCCU) treated with vinflunine plus best supportive care (BSC) or BSC alone, after failure of platinum-based chemotherapy.
  
  
  METHODS
  Three hundred and seventy patients were randomly assigned in a phase III trial and allocated (2:1) to vinflunine (320 or 280 mg/m(2)) plus BSC or BSC alone. The first report (Bellmunt J, Theodore C, Demkov T et al. Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinumcontaining regimen in patients with advanced transitional cell carcinoma of the urothelial tract. J Clin Oncol 2009; 27(27): 4454-4461) had a median follow-up of 22.1 m and the current report has a follow-up of 45.4 m.
  
  
  RESULTS
  Three hundred and fifty-two patients had died (censoring rate 5%). In the intention-to-treat (ITT) population, the median OS was 6.9 m and 4.6 m for vinflunine plus BSC versus BSC alone, respectively (n.s.). In multivariate Cox analysis, the addition of vinflunine was independently correlated with improved survival (HR: 0.719; 95% CI:0.570-0.906, P = 0.0052). In the eligible population, the median OS in both the arms was 6.9 and 4.3 m, respectively (HR: 0.78; 95% CI:0.61-0.96; P = 0.0227), indicating an estimated 22% reduction in the risk of death.
  
  
  CONCLUSIONS
  The updated OS data confirm the positive treatment effect of vinflunine on survival that was previously reported. These results are consistent over time and confirm that vinflunine is a valuable option for second-line treatment in patients with advanced TCCU after failure of platinum-based regimens.
authors: Department of Oncology, University Hospital del Mar-L'Institut Municipal d'Investigació Mèdica IMIM, Barcelona, Spain. jbjbellmunt@parcdesalutmar.cat
authors: J
authors: J
authors: Bellmunt
authors: R
authors: R
authors: Fougeray
authors: J E
authors: JE
authors: Rosenberg
authors: H
authors: H
authors: von der Maase
authors: F A
authors: FA
authors: Schutz
authors: Y
authors: Y
authors: Salhi
authors: S
authors: S
authors: Culine
authors: T K
authors: TK
authors: Choueiri
mesh_terms: D000368:Aged; D002295:Carcinoma, Transitional Cell / Q000175:diagnosis* / Q000188:drug therapy* / Q000628:therapy; D002945:Cisplatin / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017671:Platinum Compounds / Q000627:therapeutic use; D011446:Prospective Studies; D015996:Survival Rate / Q000639:trends; D013997:Time Factors; D017211:Treatment Failure; D001749:Urinary Bladder Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000628:therapy; D019459:Urothelium / Q000473:pathology; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D017671:Platinum Compounds; C111217:vinflunine; D014747:Vinblastine; D002945:Cisplatin
keywords: antineoplastic; bladder neoplasms; survival analysis; transitional cell carcinoma; urologic tumor