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

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...

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Bibliographic Details
Published in:European journal of cancer (1990) 2010-01, Vol.46 (2), p.266-269
Main Authors: Kitzen, Jos J, Puozzo, Christian, de Jonge, Maja J, Brandely, Maud, Verweij, Jaap
Format: Article
Language:English
Subjects:
Administration, Oral
Adolescent
Adult
Aged
Antineoplastic Agents, Phytogenic - administration & dosage
Antineoplastic Agents, Phytogenic - pharmacokinetics
Biological and medical sciences
Biological Availability
Hematology, Oncology and Palliative Medicine
Humans
Infusions, Intravenous
Intravenous
Liver Diseases - complications
Medical sciences
Middle Aged
Neoplasms - complications
Neoplasms - drug therapy
Oral
Pharmacokinetic
Pharmacology. Drug treatments
Toxicity
Tumors
Vinblastine - administration & dosage
Vinblastine - analogs & derivatives
Vinblastine - pharmacokinetics
Vinorelbine
Young Adult
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Summary: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.
ISSN:0959-8049
1879-0852
DOI:10.1016/j.ejca.2009.10.031