A dose escalation and pharmacokinetic study of biweekly pegylated liposomal doxorubicin, paclitaxel and gemcitabine in patients with advanced solid tumours (Journal article)

Bozionelou, V./ Vamvakas, L./ Pappas, P./ Agelaki, S./ Androulakis, N./ Kalykaki, A./ Nikolaidou, M./ Kentepozidis, N./ Giassas, S./ Marselos, M./ Georgoulias, V./ Mavroudis, D.

To determine the maximum tolerated doses (MTDs) and dose-limiting toxicities (DLTs) of pegylated liposomal doxorubicin (PLD), paclitaxel (PCX) and gemcitabine (GEM) combination administered biweekly in patients with advanced solid tumours. Twenty-two patients with advanced-stage solid tumours were treated with escalated doses of PLD on day 1 and PCX plus GEM on day 2 (starting doses: 10, 100 and 800 mg m(-2), respectively) every 2 weeks. DLTs and pharmacokinetic (PK) parameters of all drugs were determined during the first cycle of treatment. All but six (73%) patients had previously received at least one chemotherapy regimen. The DLT dose level was reached at PLD 12 mg m(-2), PCX 110 mg m(-2) and GEM 1000 mg m(-2) with neutropaenia being the dose-limiting event. Of the 86 chemotherapy cycles delivered, grade 3 and 4 neutropaenia occurred in 20% with no cases of febrile neutropaenia. Non-haematological toxicities were mild. The recommended MTDs are PLD 12 mg m(-2), PCX 100 mg m(-2) and GEM 1000 mg m(-2) administered every 2 weeks. The PK data revealed no obvious drug interactions. Biweekly administration of PLD, PCX and GEM is a well-tolerated chemotherapy regimen, which merits further evaluation in various types of solid tumours.
Institution and School/Department of submitter: Πανεπιστήμιο Ιωαννίνων. Σχολή Επιστημών Υγείας. Τμήμα Ιατρικής
Keywords: Adult,Aged,Antineoplastic Combined Chemotherapy Protocols/*administration & dosage/adverse,effects/pharmacokinetics,Deoxycytidine/administration & dosage/*analogs & derivatives/pharmacokinetics,Doxorubicin/administration & dosage/*analogs & derivatives/pharmacology,Female,Humans,Male,Maximum Tolerated Dose,Middle Aged,Neoplasms/*drug therapy,Neutropenia/chemically induced,Paclitaxel/*administration & dosage/pharmacokinetics,Polyethylene Glycols/*administration & dosage/pharmacology,Survival Rate
URI: https://olympias.lib.uoi.gr/jspui/handle/123456789/24357
ISSN: 0007-0920
Link: http://www.ncbi.nlm.nih.gov/pubmed/17551496
Appears in Collections:Άρθρα σε επιστημονικά περιοδικά ( Ανοικτά)

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