The effect of thalidomide on the pharmacokinetics of irinotecan and metabolites in advanced solid tumor patients.
The effect of thalidomide on the pharmacokinetics of irinotecan and metabolites in advanced solid tumor patients.
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DOI：
10.1007/s00280-011-1727-4
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发表时间：
2011-12
影响因子：
3
通讯作者：
Ratain, Mark J.
中科院分区：
文献类型：
--
作者：
Ramirez, Jacqueline;Wu, Kehua;Janisch, Linda;Karrison, Theodore;House, Larry K.;Innocenti, Federico;Cohen, Ezra E. W.;Ratain, Mark J.
伊立替康和沙利度胺是常用的抗肿瘤药物。联合治疗可增强其抗肿瘤作用，防止伊立替康的肠道毒性。我们研究了沙利度胺是否可以调节伊立替康及其代谢物的药代动力学。该研究采用交叉设计，晚期实体瘤患者随机分为两组，每3周静脉注射伊立替康350mg /m2和口服沙利度胺。每天400毫克。使用配对t检验将伊立替康在每组中单独给药时的药代动力学数据与两种研究药物联合给药时的数据进行比较。还计算了真实差异的80%和90%置信区间。沙利度胺给药后药代动力学参数和代谢指标的差异很小，不太可能具有临床意义。除APC T1/2外，没有一个置信度上限的增幅超过50%。本研究未发现沙利度胺对伊立替康及其代谢物的药代动力学有任何临床意义的影响。
Irinotecan and thalidomide are commonly administered antineoplastic drugs. Combination treatment may potentiate their antitumor effect and protect against irinotecan's intestinal toxicity. We investigated whether thalidomide can modulate the pharmacokinetics of irinotecan and metabolites. The study employed a crossover design in which advanced solid tumor patients were randomized to two arms and treated with irinotecan 350 mg/m2 intravenously (IV) every 3 weeks and thalidomide orally (p.o.) 400 mg daily. Pharmacokinetic data when irinotecan was administered as a single agent in each arm were compared to data when the two study agents were co-administered using paired t tests. Eighty percent and 90% confidence intervals for the true difference were also calculated. The differences in pharmacokinetic parameters and metabolic markers after thalidomide administration were small and unlikely to be clinically significant. With the exception of APC T1/2, none of the upper confidence limits exceeds a 50% increase. This study did not find any clinically meaningful effects of thalidomide on the pharmacokinetics of irinotecan or its metabolites.
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影响因子：
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作者：
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通讯作者：
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