title: From Clinical Trials to the Front Line: Vinflunine for Treatment of Urothelial Cell Carcinoma at the National Cancer Institute of Naples.
abstract: BACKGROUND
  The efficacy of Vinflunine, after failure of platinum-based chemotherapy in patients with metastatic or recurrent Transitional Cell Cancer of the Urothelial Tract, TCCU, has been demonstrated in an international, randomized, phase III trial comparing Vinflunine plus Best Supportive Care, BSC, with BSC alone. On the basis of that study vinflunine has been approved by the European Medicine Association, EMA, for treatment of TCCU patients after failure of a platinum treatment. However, since data in clinical trials often differ from routine clinical practice due to unselected population and less strict monitoring, "real life" experiences are very helpful to verify the efficacy of a new therapy.
  
  
  METHODS
  This was a spontaneous, observational, retrospective study involving 43 patients with metastatic TCCU treated with vinflunine at our cancer center, data about demographics, disease characteristics, and previous treatments were collected and outcome and toxicities of vinflunine were analyzed.
  
  
  RESULTS
  41 of 43 patients were eligible for RR analysis, the Overall RR was 12%, the Disease Control Rate was 29%; when including only patients treated in II line the DCR rose to 33%; the median PFS and the median OS were 2.2 and 6.9 months, respectively.
  
  
  CONCLUSIONS
  Our findings were consistent with the outcome data emerged in the phase III randomized trial and in the other observational studies conducted all around Europe in the last 2-3 years. This experience supports the use of vinflunine in patients with advanced TTCU as effective and manageable antineoplastic drug.
authors.affiliation: Division of MedicalOncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Gaetano
authors.initials: G
authors.lastname: Facchini
authors.affiliation: Division of MedicalOncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Chiara
authors.initials: C
authors.lastname: Della Pepa
authors.affiliation: Division of MedicalOncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Carla
authors.initials: C
authors.lastname: Cavaliere
authors.affiliation: Division of MedicalOncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Sabrina C
authors.initials: SC
authors.lastname: Cecere
authors.affiliation: Division of MedicalOncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Marilena
authors.initials: M
authors.lastname: Di Napoli
authors.affiliation: Department of Onco-Ematology Medical Oncology, S.G. Moscati Hospital of Taranto Taranto, Italy.
authors.forename: Carmine
authors.initials: C
authors.lastname: D'Aniello
authors.affiliation: Unit of Epidemiology, Struttura Complessa di Statistica Medica, Biometria e Bioinformatica, Fondazione Istituto Nazionale Tumori Naples, Italy.
authors.forename: Anna
authors.initials: A
authors.lastname: Crispo
authors.affiliation: Division of MedicalOncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Gelsomina
authors.initials: G
authors.lastname: Iovane
authors.affiliation: Pharmacy Unit, Istituto Nazionale Tumori, Istituto Nazionale Tumori-Fondazione G. Pascale Naples, Italy.
authors.forename: Piera
authors.initials: P
authors.lastname: Maiolino
authors.affiliation: Pharmacy Unit, Istituto Nazionale Tumori, Istituto Nazionale Tumori-Fondazione G. Pascale Naples, Italy.
authors.forename: Teresa
authors.initials: T
authors.lastname: Tramontano
authors.affiliation: Pharmacy Unit, Istituto Nazionale Tumori, Istituto Nazionale Tumori-Fondazione G. Pascale Naples, Italy.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Piscitelli
authors.affiliation: Department of Onco-Ematology Medical Oncology, S.G. Moscati Hospital of Taranto Taranto, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Pisconti
authors.affiliation: Unit of Epidemiology, Struttura Complessa di Statistica Medica, Biometria e Bioinformatica, Fondazione Istituto Nazionale Tumori Naples, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Montella
authors.affiliation: Division of Medical Oncology-CRO Aviano, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Berretta
authors.affiliation: Division of Urology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Sorrentino
authors.affiliation: Division of Urology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Sisto
authors.initials: S
authors.lastname: Perdonà
authors.affiliation: Division of MedicalOncology, Department of Uro-Gynaecological Oncology, Istituto Nazionale Tumori Fondazione G. Pascale Naples, Italy.
authors.forename: Sandro
authors.initials: S
authors.lastname: Pignata
keywords: overall survival; progression free survival; response rate; transitional cell cancer of the urothelial tract; vinflunine