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首页> 外文期刊>The Journal of Clinical Pharmacology: Official Journal of the American College of Clinical Pharmacology >Pharmacokinetics, safety, and efficacy of FOLFIRI plus bevacizumab in Japanese colorectal cancer patients with UGT1A1 gene polymorphisms
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Pharmacokinetics, safety, and efficacy of FOLFIRI plus bevacizumab in Japanese colorectal cancer patients with UGT1A1 gene polymorphisms

机译：FOLFIRI加贝伐单抗在日本大肠癌UGT1A1基因多态性患者中的药代动力学，安全性和有效性

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摘要

Previous reports of the influence of UGT1A1 gene polymorphisms on the pharmacokinetics of irinotecan metabolism have not assessed Asian patients treated with FOLFIRI plus bevacizumab for advanced and recurrent colorectal cancer. Twenty-one Japanese colorectal cancer patients received intravenous FOLFIRI (bolus irinotecan, folinic acid, and fluorouracil followed by 46-hour fluorouracil infusion) followed by bevacizumab (5 mg/kg) in Cycle 1. In Cycle 2, patients received bevacizumab followed by FOLFIRI. The regimen was in 2-week cycles. The area under-the-curves ratio (AUC0-last) (Cycle 2/Cycle 1) was determined from plasma concentrations of irinotecan and metabolites (SN-38, SN-38G). Safety, efficacy, and drug-drug interactions were analyzed. Median observation period was 7.8 months; median number of cycles 15. Drug-drug interactions were evaluated in eight patients without irinotecan dose reduction. Mean AUC0-last ratios (with/without bevacizumab) of irinotecan, SN-38, and SN-38G were 0.959, 0.927, and 0.931 respectively. Response rate was 65%; median progression-free survival 16.4 months. Response occurred in four patients with, and nine without, UGT1A1 polymorphism. No significant differences occurred between efficacy, safety, or polymorphism status. This cohort showed no differences in safety or efficacy compared to previous reports. Bevacizumab did not affect the pharmacokinetics of irinotecan and its metabolites, irrespective of UGT1A1 polymorphism status.
机译：先前关于UGT1A1基因多态性对伊立替康代谢药代动力学影响的报道尚未评估亚洲人接受FOLFIRI加贝伐单抗治疗的晚期和复发性结直肠癌患者。在第1周期中，有21名日本大肠癌患者接受了静脉FOLFIRI（伊立替康，亚叶酸和氟尿嘧啶推注，然后输注46小时氟尿嘧啶），然后接受贝伐单抗（5 mg / kg）。在周期2中，患者接受了贝伐单抗，随后接受FOLFIRI 。该方案为2周周期。由伊立替康和代谢产物（SN-38，SN-38G）的血浆浓度确定曲线下面积比（AUC0-last）（周期2 /周期1）。分析了安全性，功效和药物相互作用。中位观察期为7.8个月;中位周期数15.在未降低伊立替康剂量的8例患者中评估了药物相互作用。伊立替康，SN-38和SN-38G的平均AUC0-last比值（有/无贝伐单抗）分别为0.959、0.927和0.931。回应率为65％;中位无进展生存期16.4个月。有UGT1A1多态性的4名患者和9名无UGT1A1多态性的患者发生了应答。疗效，安全性或多态性状态之间无显着差异。与先前的报告相比，该队列研究显示安全性或疗效无差异。不论UGT1A1多态性状态如何，贝伐单抗均不影响伊立替康及其代谢产物的药代动力学。

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