title: Safety and effectiveness of vinflunine in patients with metastatic transitional cell carcinoma of the urothelial tract after failure of one platinum-based systemic therapy in clinical practice.
abstract: BACKGROUND
  Patients with transitional cell carcinoma of the urothelial tract (TCCU) who fail initial platinum-based chemotherapy for advanced disease represent a challenge in daily clinical practice. Vinflunine is approved by the European Medicine Agency (EMA) but, up to now, limited experience has been reported outside clinical trials.
  
  
  METHODS
  We assessed the efficacy and safety of vinflunine in an unselected group of 102 consecutive patients with metastatic TCCU.
  
  
  RESULTS
  The median age was 67 years (range 45-83). Among the most common comorbidities that patients presented at baseline were hypertension (50.5%) and diabetes (20.7%).Distant metastases were present in retroperitoneal nodes (58%), lung (29.3%), and bone (20.2%). The ECOG 0, 1 and 2 performance status at the start of vinflunine were 31.3%, 60.6% and 8.1%, respectively. The most commonly reported adverse events of any grade were constipation 70.6% (5.9% grade 3-4), vomiting 49.1% (2% grade 3-4), neutropenia 48.1% (12.8% grade 3-4) and abdominal pain 34.3% (4.9% grade 3-4). A median of 4 cycles of vinflunine was administered per patient (range 1-18). Median progression free and overall survival for all patients (N = 102) were 3.9 months (2.3-5.5) and 10 months (7.3-12.8), respectively. Time to tumor progression was 4.3 months (2.6-5.9). Two patients (2%) achieved CR, 23 (22.5%) patients had PR, and 42 (41.2%) presented SD as best response. The clinical benefit rate with vinflunine was 65.7%.
  
  
  CONCLUSIONS
  Our results show that the behavior of vinflunine in routine clinical practice resembles that of the pivotal phase III randomized study.
authors.forename: Daniel
authors.initials: D
authors.lastname: Castellano
authors.forename: Javier
authors.initials: J
authors.lastname: Puente
authors.forename: Guillermo
authors.initials: G
authors.lastname: de Velasco
authors.forename: Isabel
authors.initials: I
authors.lastname: Chirivella
authors.forename: Pilar
authors.initials: P
authors.lastname: López-Criado
authors.forename: Nicolás
authors.initials: N
authors.lastname: Mohedano
authors.forename: Ovidio
authors.initials: O
authors.lastname: Fernández
authors.forename: Icíar
authors.initials: I
authors.lastname: García-Carbonero
authors.forename: María Belén
authors.initials: MB
authors.lastname: González
authors.affiliation: Medical Oncology Department, Ramón y Cajal University Hospital, Ctra, de Colmenar Viejo km, 9,100, 28034 Madrid, Spain. egrande@oncologiahrc.com.
authors.forename: Enrique
authors.initials: E
authors.lastname: Grande
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000494:pharmacology / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D019233:Retreatment; D016019:Survival Analysis; D017211:Treatment Failure; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; C111217:vinflunine; D014747:Vinblastine