title: The first Slovak experience with second-line vinflunine in advanced urothelial carcinomas.
abstract: BACKGROUND
  Based on the results of phase III trial, vinflunine was approved by European Medicines Agency in 2010 as second line treatment of advanced urothelial cancer in patients with good performance status (ECOG 0- 1). The objective of this prospective observational study was to assess vinflunine treatment of advanced urothelial cancer patients in terms of progression free survival and overall survival, and to evaluate vinflunine toxicity.
  
  
  METHODS
  From April 2011 to June 2014 a total of 16 patients (100%) with advanced urothelial cancer were treated with vinflunine. The median age was 62 years (range 43- 80) and the median Karnofsky index was 90% (range 80- 100%). Thirteen patients (81.25%) had urothelial bladder cancers, two patients (12.50%) suffered from urothelial cancers of ureter, and one patient (6.25%) had urothelial cancer of unknown origin (histology was obtained from liver metastasis). Histologically, all the lesions were grade 3 tumors (100%). The number of metastatic sites ranged from 1- 4 (median 3).
  
  
  RESULTS
  The effect of treatment was evaluated in accord with RECIST: two patients (12.50%) obtained partial remission, three (18.75%) stabilization, eight patients (50.00%) progressed, and treatment was suspended in one case at patients request. Vinflunine toxicity grade 3- 4 included neutropenia in six patients (37.50%), leukopenia in four patients (25.00%), anemia in one patient (6.25%), constipation in three patients (18.75%), and febrile neutropenia in one patient (6.25%). Median overall survival was 5.2 months (95% CI 3.4- 8.8) and median progression-free survival was 2.3 months (95% CI 2.1- 3.2).
  
  
  CONCLUSIONS
  This study summarizes the first Slovak experience with vinflunine therapy. Our data confirmed the efficacy of vinflunine and its acceptable toxicity in the treatment of patients with advanced urothelial cancer previously treated with a platinum-based regimen.Key words: advanced urothelial cancer -  vinflunine -  progression-free survival -  overall survival -  side effects.
authors.forename: P
authors.initials: P
authors.lastname: Palacka
authors.forename: M
authors.initials: M
authors.lastname: Mego
authors.forename: J
authors.initials: J
authors.lastname: Obertova
authors.forename: M
authors.initials: M
authors.lastname: Chovanec
authors.forename: Z
authors.initials: Z
authors.lastname: Sycova-Mila
authors.forename: J
authors.initials: J
authors.lastname: Mardiak
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002295:Carcinoma, Transitional Cell / Q000188:drug therapy* / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009382:Neoplasms, Unknown Primary / Q000188:drug therapy*; D011379:Prognosis; D018154:Slovakia; D016019:Survival Analysis; D016896:Treatment Outcome; D014516:Ureteral Neoplasms / Q000188:drug therapy; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy; D014571:Urologic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000093542:Gemcitabine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; C111217:vinflunine; D014747:Vinblastine; D002945:Cisplatin; D000093542:Gemcitabine