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Pharmacokinetic characteristics of vincristine sulfate liposomes in patients with advanced solid tumors
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Pharmacokinetic characteristics of vincristine sulfate liposomes in patients with advanced solid tumors
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Pharmacokinetic characteristics of vincristine sulfate liposomes in patients with advanced solid tumors
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Journal Article
Pharmacokinetic characteristics of vincristine sulfate liposomes in patients with advanced solid tumors
2012
Overview
Aim： To evaluate the singleand multiple-dose pharmacokinetics of vincristine sulfate liposomes （VSLI） in patients with advanced solid tumors. Methods： In single-dose pharmacokinetic study, 16 patients were administered VSLI （1.5, 2.0, or 2.3 mg.m-2） through intravenous infusion. Another 6 patients receiving vincristine sulfate （VCR, 2.0 mg） were taken as the control. In multiple-dose pharmacokinetic study, 12 patients were administered VSLI （1.5 or 1.8 mg.m-2） through intravenous infusion weekly for 4 consecutive weeks. The plasma concentration of VSLI was determined using the liquid chromatography-tandem mass spectrometry （LC-MS/MS） method. Results： After intravenous infusion of the single dose of VSLI, the plasma concentrations were characterized by bi-exponential decline curves. No statistically significant differences were observed between the main pharmacokinetic parameters in the 3 dose groups. Compared with the patients receiving VCR, the patients treated with VSLI displayed an increase in the area under the plasma concentration vs time curve （AUC）, and a decrease in plasma clearance rates. On the 4th cycle in the multiple-dose study, the plasma concentration of VCR in all subjects prior to the weekly administration was below the lower limit of quantification （LLOQ）. The calculated pharmacokinetic parameters from the subjects in the multipleand single-dose （1.5 mg.m 2） groups had no significant differences. Although the administration of liposomal VCR may significantly elevate the plasma concentration of VCR, VSLI-associated adverse events were similar to those associated with conventional VCR. Conclusion： VSLI exhibits a lower clearance and a higher AUC compared with conventional VCR. No accumulation was observed in patients exposed to VSLI for 4 consecutive weeks. VSLI was generally tolerated in the subjects. The phase Ⅱdose of VSLI may be recommended as 4 doses of 1.5 mg.m-2 for treatment of patients with advanced solid tumors.
Publisher
Nature Publishing Group UK,Nature Publishing Group
Subject
/ Adult
/ Aged
/ Antineoplastic Agents, Phytogenic - administration & dosage
/ Antineoplastic Agents, Phytogenic - blood
/ Antineoplastic Agents, Phytogenic - pharmacokinetics
/ Biomedical and Life Sciences
/ Drug Administration Schedule
/ Female
/ Humans
/ LC-MS/MS
/ Male
/ Original
/ Vaccine
/ Vincristine - administration & dosage
/ Vincristine - pharmacokinetics
/ 力学特点
/ 实体瘤
/ 患者
/ 晚期
/ 硫酸
/ 脂质体
/ 长春新碱
