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

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Μικρογραφία εικόνας

Ημερομηνία

Συγγραφείς

Briasoulis, E.
Pappas, P.
Puozzo, C.
Tolis, C.
Fountzilas, G.
Dafni, U.
Marselos, M.
Pavlidis, N.

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Εκδότης

Περίληψη

Τύπος

Είδος δημοσίευσης σε συνέδριο

Είδος περιοδικού

peer-reviewed

Είδος εκπαιδευτικού υλικού

Όνομα συνεδρίου

Όνομα περιοδικού

Clin Cancer Res

Όνομα βιβλίου

Σειρά βιβλίου

Έκδοση βιβλίου

Συμπληρωματικός/δευτερεύων τίτλος

Περιγραφή

AIM: 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.

Περιγραφή

Λέξεις-κλειδιά

Administration, Oral, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Phytogenic/*administration & dosage/adverse effects, Drug Administration Schedule, Drug Evaluation, Feasibility Studies, Female, Humans, Male, Middle Aged, Neoplasms/*drug therapy, Vinblastine/administration & dosage/adverse effects/*analogs &, derivatives/pharmacokinetics

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Σύνδεσμος

http://www.ncbi.nlm.nih.gov/pubmed/19808873
http://clincancerres.aacrjournals.org/content/15/20/6454.full.pdf

Γλώσσα

en

Εκδίδον τμήμα/τομέας

Όνομα επιβλέποντος

Εξεταστική επιτροπή

Γενική Περιγραφή / Σχόλια

Ίδρυμα και Σχολή/Τμήμα του υποβάλλοντος

Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής

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Χορηγός

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