title: Monotherapy with intravenous vinflunine in patients with advanced or metastatic urothelial cancer after failure of a platinum-containing regimen: a retrospective analysis of German routine data.
abstract: OBJECTIVE
  The objective of this retrospective study was to investigate the efficacy and safety of vinflunine monotherapy and the utility of second-line prognostic factors in patients with advanced or metastatic urothelial cancer relapsing/progressing during or after a prior platinum-containing regimen under daily routine clinical conditions in Germany.
  
  
  METHODS
  The selection was based on the marketing authorization indication and recommendations as well as on the evaluation of second-line prognostic factors issued from prior pivotal trials.
  
  
  RESULTS
  Eight centers across Germany provided a total of 21 patient records. Demographic and clinical characteristics were similar to the data previously reported in pivotal trials. Complete and partial response to vinflunine treatment was observed in 1 (4.8%) and 3 (14.3%) patients, respectively, resulting in an overall response rate of 19.1%. The disease control rate reached 47.7%. The median progression-free survival amounted to 4.4 months (95% CI 2.6-6.6), with a median overall survival of 6.2 months (95% CI 3.9-10.7). The observed toxicity profile was manageable and consistent with prior clinical trials: leukopenia (33.3%), neutropenia (9.5%), anemia (9.5%) and hyperglycemia (4.8%). The reported satisfaction rate with the treatment was 90.5 and 61.9% among patients and physicians, respectively.
  
  
  CONCLUSIONS
  This retrospective study confirms that the clinical outcomes obtained from routine medical practice in Germany with vinflunine in the treatment of advanced/metastatic urothelial cancer are in line with the data observed in prior clinical trials.
authors: Department of Urology and Pediatric Urology, University Hospital, Marburg, Germany.
authors: Axel
authors: A
authors: Hegele
authors: Peter
authors: P
authors: Goebell
authors: Ullrich
authors: U
authors: Matz
authors: Thomas
authors: T
authors: Neuhaus
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D005858:Germany; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D010984:Platinum / Q000008:administration & dosage*; D011379:Prognosis; D012008:Recurrence; D012189:Retrospective Studies; D012306:Risk; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D019459:Urothelium / Q000473:pathology*; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D000970:Antineoplastic Agents; D010984:Platinum; C111217:vinflunine; D014747:Vinblastine