European Journal of Cancer
Volume 46, Issue 2 , Pages 266-269, January 2010

Mild to moderate liver dysfunction does not require dose reduction of oral or intravenous vinorelbine: Results of a pharmacokinetic study

  • Jos J. Kitzen

      Affiliations

    • Dept. of Medical Oncology, Erasmus University Medical Center, Groene Hilledijk 301, 3075 EA Rotterdam, Netherlands
    • ,
  • Christian Puozzo

      Affiliations

    • Institut de recherche Pierre Fabre, 45, place Abel-Gance, 92654 Boulogne Cedex, France
    • ,
  • Maja J. de Jonge

      Affiliations

    • Dept. of Medical Oncology, Erasmus University Medical Center, Groene Hilledijk 301, 3075 EA Rotterdam, Netherlands
    • Corresponding Author InformationCorresponding author: Tel.: +31 180610450.
    • ,
  • Maud Brandely

      Affiliations

    • Institut de recherche Pierre Fabre, 45, place Abel-Gance, 92654 Boulogne Cedex, France
    • ,
  • Jaap Verweij

      Affiliations

    • Dept. of Medical Oncology, Erasmus University Medical Center, Groene Hilledijk 301, 3075 EA Rotterdam, Netherlands

Received 23 October 2009; accepted 29 October 2009. published online 30 November 2009.

Abstract 

We studied the pharmacokinetic profile of weekly oral and intravenous vinorelbine in cancer patients with various degrees of hepatic function, and assessed an intra-patient comparison of the pharmacokinetics of i.v. versus oral vinorelbine. In this open-label study, patients were randomised to receive an initial dose of vinorelbine at day 1 by either i.v. or the oral route followed by a second dose on day 8 via the alternative route.

A total of 16 patients were included, 12 patients received the planned two administrations. Toxicities were similar for all cohorts and were mainly of haematological and gastrointestinal origin. Pharmacokinetic analysis of both routes did not reveal any differences between cohort I and II.

Based on these findings in patients with mild to moderate liver dysfunction no dose modifications of vinorelbine have to be taken into consideration.

Keywords: Vinorelbine, Oral, Intravenous, Pharmacokinetic, Toxicity

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PII: S0959-8049(09)00818-1

doi:10.1016/j.ejca.2009.10.031

European Journal of Cancer
Volume 46, Issue 2 , Pages 266-269, January 2010

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