Sunitinib has been approved for the treatment of advanced and/or metastatic
renal cell carcinoma (RCC). Information on the dosage adjustment of
sunitinib for patients undergoing
hemodialysis is limited. Especially, efficacy and tolerance of
sunitinib at a low dose in such patients are not fully understood. Thus, we examined the effect of
hemodialysis on the pharmacokinetics, safety and efficacy of 25 mg of
sunitinib. The patient was a 66-year-old man diagnosed with RCC and undergoing
hemodialysis. He was treated with
sunitinib at 25 mg daily for 4 weeks of a 6-week cycle. There were little differences in the AUC(0-24 h) of
sunitinib and its major active metabolite
SU12662 on day 17 (on
hemodialysis) and day 18 (off
hemodialysis) of the first cycle. The total
sunitinib concentration (
sunitinib and
SU12662) was approximately 50 ng/ml at a steady state in every cycle. The patient's genotype was wild type for ABCG2 421C>A, which is associated with increased
sunitinib exposure. In the following two cycles of
sunitinib, computed tomography scan showed a partial response of the lung
metastasis. During the first cycle, the patient developed grade 2
thrombocytopenia and
leukocytopenia. After four cycles of treatment, the patient developed grade 3
fatigue and the
sunitinib treatment was discontinued. Our patient on
hemodialysis could be safely and effectively treated with 25 mg of
sunitinib, and a total
sunitinib concentration of about 50 ng/ml was maintained. The pharmacokinetics of
sunitinib and
SU12662 were rarely affected by
hemodialysis. Therapeutic drug monitoring could be helpful during
sunitinib therapy, especially in a specific population.