title: 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 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.
authors: Dept. of Medical Oncology, Erasmus University Medical Center, 3075 EA Rotterdam, The Netherlands.
authors: Jos J
authors: JJ
authors: Kitzen
authors: Christian
authors: C
authors: Puozzo
authors: Maja J
authors: MJ
authors: de Jonge
authors: Maud
authors: M
authors: Brandely
authors: Jaap
authors: J
authors: Verweij
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D006801:Humans; D007262:Infusions, Intravenous; D008107:Liver Diseases / Q000150:complications*; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy*; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000493:pharmacokinetics; D000077235:Vinorelbine; D055815:Young Adult
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine