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dc.contributor.authorBriassoulis, E. Chen
dc.contributor.authorPentheroudakis, Georgeen
dc.contributor.authorKaravasilis, V.en
dc.contributor.authorTzamakou, E.en
dc.contributor.authorRammou, D.en
dc.contributor.authorPavlidis, Nicholasen
dc.creatorBriassoulis, E. Chen
dc.creatorPentheroudakis, Georgeen
dc.creatorKaravasilis, V.en
dc.creatorTzamakou, E.en
dc.creatorRammou, D.en
dc.creatorPavlidis, Nicholasen
dc.date.accessioned2018-06-22T09:52:34Z
dc.date.available2018-06-22T09:52:34Z
dc.date.issued2004
dc.identifier.urihttps://gnosis.library.ucy.ac.cy/handle/7/41419
dc.description.abstractBackground: We aimed to define the maximum tolerated dose (MTD) and characterize the toxicity of the combination of pegylated liposomal doxorubicin (PLD; Caelyx™) and weekly paclitaxel (wPTX), and to investigate pharmacokinetics of PLD in this combination. Methods: A phase I study was performed with an initial dose of 50 mg/m2 wPTX and 30 mg/m2 PLD. The paclitaxel dose was escalated in increments of 10 mg/m2 and PLD in increments of 5 mg/m2 until the MTD was reached. The pharmacokinetics of PLD were studied at the highest achieved dose levels. Results: Forty-four cancer patients were enrolled. The MTD was 30/90 and 35/80 mg/m2 for PLD/wPTX. Dose-limiting toxicities included treatment delay for neutropenia grade 3, febrile neutropenia, palmar-plantar erythrodysesthesia and deep venous thrombosis. Toxicity below the MTD was mild: skin toxicity grade 1-2 developed at high cumulative doses and vascular thrombotic events occurred in two patients with predisposing factors. No cardiotoxicity or clinically relevant peripheral neuropathy was seen. Nausea/vomiting and alopecia were negligible. Three complete responses and nine partial responses were documented among 34 evaluable cases. PLD plasma concentrations were evaluated in seven patients treated at subMTD. Paclitaxel produced a median 53.5% increase of PLD area under the concentration curve (range 4.4%-219%). Conclusions: The combination of PLD/wPTX constitutes an active chemotherapy regimen with mild toxicity that merits investigation in phase II at 30/80 or 35/70 mg/m2. Patients should be monitored for a potentially increased risk of thromboembolic events. © 2004 European Society for Medical Oncology.en
dc.language.isoengen
dc.sourceAnnals of Oncologyen
dc.subjectArticleen
dc.subjectDoxorubicinen
dc.subjectHumanen
dc.subjectNeoplasmsen
dc.subject80 and overen
dc.subjectAgeden
dc.subjectHumansen
dc.subjectAdulten
dc.subjectAgeden
dc.subjectCancer patienten
dc.subjectControlled studyen
dc.subjectFemaleen
dc.subjectMiddle ageden
dc.subjectAdvanced canceren
dc.subjectCancer combination chemotherapyen
dc.subjectDrug responseen
dc.subjectPriority journalen
dc.subjectAlopeciaen
dc.subjectAntineoplastic combined chemotherapy protocolsen
dc.subjectClinical articleen
dc.subjectClinical trialen
dc.subjectControlled clinical trialen
dc.subjectDiarrheaen
dc.subjectDrug efficacyen
dc.subjectFatigueen
dc.subjectFebrile neutropeniaen
dc.subjectInfectionen
dc.subjectMethylprednisoloneen
dc.subjectMucosa inflammationen
dc.subjectNausea and vomitingen
dc.subjectNeurotoxicityen
dc.subjectNeutropeniaen
dc.subjectThrombocytopeniaen
dc.subjectAntineoplastic activityen
dc.subjectArea under the curveen
dc.subjectCardiotoxicityen
dc.subjectDexamethasoneen
dc.subjectDimetindeneen
dc.subjectDrug administration scheduleen
dc.subjectDrug dose regimenen
dc.subjectDose responseen
dc.subjectSolid tumoren
dc.subjectMaleen
dc.subjectRisk assessmenten
dc.subjectBlood toxicityen
dc.subjectCombination chemotherapyen
dc.subjectDrug clearanceen
dc.subjectMaximum tolerated doseen
dc.subjectPhase 1 clinical trialen
dc.subjectDisease severityen
dc.subjectPatient monitoringen
dc.subjectPeripheral neuropathyen
dc.subjectPaclitaxelen
dc.subjectRanitidineen
dc.subjectDrug blood levelen
dc.subjectDrug half lifeen
dc.subjectPhase ien
dc.subjectLiposomesen
dc.subjectBleeding disorderen
dc.subjectDeep vein thrombosisen
dc.subjectDisease predispositionen
dc.subjectDrug eruptionen
dc.subjectHand foot syndromeen
dc.subjectHemopoietic growth factoren
dc.subjectLiposomal doxorubicinen
dc.subjectMedical documentationen
dc.subjectNail diseaseen
dc.subjectSkin exfoliationen
dc.subjectSkin toxicityen
dc.subjectThromboembolismen
dc.subjectThrombosisen
dc.subjectVascular diseaseen
dc.titleWeekly paclitaxel combined with pegylated liposomal doxorubicin (Caelyx ™) given every 4 weeks: Dose-finding and pharmacokinetic study in patients with advanced solid tumorsen
dc.typeinfo:eu-repo/semantics/article
dc.identifier.doi10.1093/annonc/mdh404
dc.description.volume15
dc.description.issue10
dc.description.startingpage1566
dc.description.endingpage1573
dc.author.facultyΙατρική Σχολή / Medical School
dc.type.uhtypeArticleen


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