Tolerable sorafenib therapy for a renal cell carcinoma patient with hemodialysis: a case study.

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 as C (max) and AUC(0-12) on 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.