Tolerable sorafenib therapy for a renal cell carcinoma patient with hemodialysis. A case study
Tolerable sorafenib therapy for a renal cell carcinoma patient with hemodialysis. A case study
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肾细胞癌血液透析患者的索拉非尼耐受治疗。
DOI：
10.1007/s10147-010-0070-9
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发表时间：
2010
期刊：
影响因子：
--
通讯作者：
T.
中科院分区：
文献类型：
--
作者：
Shinsako;K.;Mizuno;T.;Terada;T.;Watanabe;J.;Kamba;T.
索拉非尼（Nexavar®）已被批准用于治疗晚期肾细胞癌（RCC）和肝细胞癌。关于索拉非尼对终末期肾衰竭患者的剂量调整的信息很少。在此，我们研究了血液透析对索拉非尼及其主要活性代谢物M-2的药代动力学的影响，并评估了整个治疗过程中索拉非尼相关的毒性。患者为54岁男性，被诊断为晚期肾细胞癌。在第9天和第183天进行药代动力学分析。患者在第77天病情稳定，第181天病情进展。患者接受索拉非尼800 mg/天持续治疗约6个月，无临床相关毒性。第183天，索拉非尼的药代动力学参数cmax和auc0 - 12在肾功能正常患者的参考值范围内。我们的研究结果表明，对于接受血液透析的患者，每天两次给予400 mg剂量的索拉非尼耐受性良好，至少持续6个月。
Sorafenib (Nexavar®) has been approved for the treatment of advanced renal cell carcinoma (RCC) and hepatocellular carcinoma. There is little information on the dosage adjustment of sorafenib for patients with end-stage renal failure. Herein, we have examined the effect of hemodialysis on the pharmacokinetics of sorafenib and its major active metabolite, M-2, and assessed sorafenib-related toxicity throughout the therapy. The patient was a 54-year-old man who was diagnosed with advanced RCC. Pharmacokinetic analysis was carried out on days 9 and 183. The patient had stable disease on day 77 and showed progression on day 181. He has received about 6 months of continuous treatment with sorafenib 800 mg/day without any clinically relevant toxicity. The pharmacokinetic parameters of sorafenib such asCmaxand AUC0–12on day 183 were in the range of the reference values reported in patients with normal renal function. Our results suggest that sorafenib administered at a dose of 400 mg twice per day was well tolerated, at least for 6 months, for a patient undergoing hemodialysis.