Dose-ranging study of metronomic oral vinorelbine in patients with advanced refractory cancer

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dc.contributor.authorBriasoulis, E.en
dc.contributor.authorPappas, P.en
dc.contributor.authorPuozzo, C.en
dc.contributor.authorTolis, C.en
dc.contributor.authorFountzilas, G.en
dc.contributor.authorDafni, U.en
dc.contributor.authorMarselos, M.en
dc.contributor.authorPavlidis, N.en
dc.date.accessioned2015-11-24T19:23:39Z
dc.date.available2015-11-24T19:23:39Z
dc.identifier.issn1078-0432-
dc.identifier.urihttps://olympias.lib.uoi.gr/jspui/handle/123456789/22349
dc.rightsDefault Licence-
dc.subjectAdministration, Oralen
dc.subjectAdulten
dc.subjectAgeden
dc.subjectAged, 80 and overen
dc.subjectAntineoplastic Agents, Phytogenic/*administration & dosage/adverse effectsen
dc.subjectDrug Administration Scheduleen
dc.subjectDrug Evaluationen
dc.subjectFeasibility Studiesen
dc.subjectFemaleen
dc.subjectHumansen
dc.subjectMaleen
dc.subjectMiddle Ageden
dc.subjectNeoplasms/*drug therapyen
dc.subjectVinblastine/administration & dosage/adverse effects/*analogs &en
dc.subjectderivatives/pharmacokineticsen
dc.titleDose-ranging study of metronomic oral vinorelbine in patients with advanced refractory canceren
heal.abstractAIM: To determine the safe dose range and pharmacokinetics of metronomic oral vinorelbine and obtain preliminary data on biomarkers and efficacy in patients with advanced cancer. METHODS: Successive cohorts of patients received escalated doses of oral vinorelbine given thrice a week until disease progression, unacceptable toxicity (UT), or consent withdrawal. UT was any grade 4 toxicity, or grade 2 or 3 toxicity that would result to longer than 2-week break during the first 2 months of treatment. Blood samples were collected for pharmacokinetics and quantification of angiogenesis regulatory proteins. RESULTS: Sixty-two patients (median age, 60 years) enrolled at six dose levels from 20 to 70 mg and received treatment for median 12.25 weeks (range, 2-216+). Unacceptable toxicity occurred in two of six patients treated at 60 mg (leucopenia grade 4 and epistaxis grade 2) and in one at 70 mg (leucopenia grade 2). The upper metronomic dose was 50 mg. Objective antitumor response documented in eight cases and 32% of patients experienced disease stability for minimum 6 months. Three responders (renal cancer, medullary thyroid carcinoma, and Kaposi sarcoma) received nonstop treatment for over 3 years without overt toxicity. Low pretreatment levels of circulating interleukin-8, vascular endothelial growth factor, and basic fibroblast growth factor were found predictors of efficacy. Steady-state concentrations of vinorelbine and its active metabolite ranged from 0.5 to 1.5 ng/mL. CONCLUSIONS: Metronomic administration of oral vinorelbine is feasible at doses up to 50 mg thrice a week and can yield sustainable antitumor activity without overt toxicity, probably through antiangiogenic mechanism. Further clinical investigation is warranted.en
heal.accesscampus-
heal.fullTextAvailabilityTRUE-
heal.identifier.primary10.1158/1078-0432.CCR-09-0970-
heal.identifier.secondaryhttp://www.ncbi.nlm.nih.gov/pubmed/19808873-
heal.identifier.secondaryhttp://clincancerres.aacrjournals.org/content/15/20/6454.full.pdf-
heal.journalNameClin Cancer Resen
heal.journalTypepeer-reviewed-
heal.languageen-
heal.publicationDate2009-
heal.recordProviderΠανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικήςel
heal.typejournalArticle-
heal.type.elΆρθρο Περιοδικούel
heal.type.enJournal articleen

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