PlumX Metrics
Embed PlumX Metrics

How to manage intravenous vinflunine in cancer patients with renal impairment: Results of a pharmacokinetic and tolerability phase i study

British Journal of Clinical Pharmacology, ISSN: 0306-5251, Vol: 77, Issue: 3, Page: 498-508
2014
  • 8
    Citations
  • 0
    Usage
  • 27
    Captures
  • 0
    Mentions
  • 0
    Social Media
Metric Options:   Counts1 Year3 Year

Metrics Details

Article Description

Aims Vinflunine (VFL) ditartrate, a novel tubulin-targeted inhibitor, is registered for the treatment of patients with advanced or metastatic urothelial transitional cell carcinoma. This phase I study assessed the effect of renal impairment on the pharmacokinetics and tolerability of VFL. Methods VFL was infused in patients with advanced/metastatic solid tumours once every 3 weeks with anticipated dose reduction on the first cycle stratified according to the creatinine clearance (CL) values. Pharmacokinetic data were collected on the first two cycles in renally impaired patients (CL ≤ 60 ml min) and were compared with a control cohort of patients (CL > 60 ml min). Results Thirty-three patients (46-86 years) were treated, 13 in group 1 (40 ml min ≤ CL ≤ 60 ml min) and 20 in group 2 (20 ml min ≤ CL < 40 ml min). The renal dysfunction induced a mean decrease in VFL clearance of 12% in group 1 and 28% in group 2, compared with the control group. The anticipated dose reduction given in renally impaired patients (i.e. 280 mg m and 250 mg m in groups 1 and 2, respectively) yielded similar drug exposure to control patients. The tolerance profile of VFL in patients with renal dysfunction was similar to that observed in patients with CL > 60 ml min. Conclusion In conclusion, the recommended doses of intravenous VFL administered once every 3 weeks in cancer patients with renal impairment are 280 mg m when CL is between 40 and 60 ml min and 250 mg m when CL is between 20 and <40 ml min. © 2013 The British Pharmacological Society.

Bibliographic Details

Isambert, Nicolas; Delord, Jean Pierre; Tourani, Jean Marc; Fumoleau, Pierre; Ravaud, Alain; Pinel, Marie Claire; Petain, Aurelie; Nguyen, Thierry; Nguyen, Laurent

Wiley

Pharmacology, Toxicology and Pharmaceutics; Medicine

Provide Feedback

Have ideas for a new metric? Would you like to see something else here?Let us know