Pharmacokinetics of liposomal cisplatin (lipoplatin) in combination with 5-FU in patients with advanced head and neck cancer: first results of a phase III study.
作者： A Kourvetaris , C F Jehn , K Possinger , D Lüftner , T Boulikas
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摘要: Background: Lipoplatin, a novel liposomal formulation of cisplatin, is composed cisplatin and liposomes based on dipalmityl phosphatidyl glycerol (DPPG), soy choline (SPC-3), cholesterol methoxypoly- ethylene glycol-distearoyl phosphatidylethanolamine (mPEG2000- DSPE). Liposomal encapsulation designed to increase safety tolerability by decreasing, e.g., nephrotoxicity through decreased exposure organs while effectively delivering the drug tumor. In an ongoing phase III trial comparing lipoplatin (both in combination with infusional high-dose 5-Fluoruracil) advanced head neck cancer (HNC), sub-study determine pharmacokinetic profile comparison conventional was undertaken. Materials Methods: total, twelve patients HNC received chemotherapy either lipoplatin/5-FU or cisplatin/5-FU. Plasma samples were analyzed for concentration total platinum from both arms. Results: All male Caucasians at mean age 60 years. There no difference kidney function between two treatment groups. The body clearance 1.25 L/(hxm 2 ) formulation, compared 0.62 cisplatin. terminal half life as long (10.98 h) (24.5h). Even though maximum observed plasma (Cmax) greater than area under time-curve (AUC) less (6.5 Ig/ml vs. 4.07 66.85 Ig/h/ml 130.33 Ig/h/ml, respectively). Conclusion: (in 5-FU) suggests that results shorter
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