title: Phase II study of vinflunine in patients with metastatic renal cell carcinoma.
abstract: OBJECTIVE
  An open-label, multicentre, non-comparative phase II trial to determine the response rate of intravenous vinflunine as first line chemotherapy in patients with metastatic renal cell carcinoma (RCC).
  
  
  METHODS
  Patients with metastatic RCC were treated with vinflunine 350 mg/m2 (n = 11) or 320 mg/m2 (n = 22) administered intravenously every 21 days.
  
  
  RESULTS
  Out of 33 patients included in this study, one partial response was observed in the group treated at 350 mg/m2 and none in the group receiving 320 mg/m2 resulting in a response rate in this population of 9.1% (95% CI: 0.2-41.3). Median progression free survival was 5.6 months (95% CI: 2.8-14.4) for patients treated at 350 mg/m2, and 3.3 months (95% CI: 1.6-6.4) for those treated at 320 mg/m2.The median survival time was 10.4 months (95% CI: 6.8-12.4) for the whole study population. The principal toxicities were grade 3/4 neutropaenia -90.9% at 350 mg/m2 and 68.1% at 320 mg/m2, febrile neutropaenia was recorded in 3 patients (27.3%) at 350 mg/m2 and in 5 patients (22.7%) at 320 mg/m2. One episode of thromboembolic event was reported in 1 patient at each dose level.
  
  
  CONCLUSIONS
  Vinflunine given intravenously once every 3 weeks has not shown any clinically relevant activity in the management of patients with metastatic renal cell carcinoma; tolerance of the treatment was better at a dose of 320 mg/m2 than at 350 mg/m2.
authors.affiliation: Prince of Wales Hospital, Randwick, Australia. d.goldstein@unsw.edu.au
authors.forename: D
authors.initials: D
authors.lastname: Goldstein
authors.forename: S P
authors.initials: SP
authors.lastname: Ackland
authors.forename: D R
authors.initials: DR
authors.lastname: Bell
authors.forename: I N
authors.initials: IN
authors.lastname: Olver
authors.forename: I D
authors.initials: ID
authors.lastname: Davis
authors.forename: M A
authors.initials: MA
authors.lastname: Rosenthal
authors.forename: G C
authors.initials: GC
authors.lastname: Toner
authors.forename: M C
authors.initials: MC
authors.lastname: Pinel
authors.forename: M
authors.initials: M
authors.lastname: Byrne
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; C111217:vinflunine; D014747:Vinblastine