Treatment of hemodialyzed patients with sunitinib in renal cell carcinoma.

Background: Understanding the effect of adverse events from commonly used agents such as sunitinib in hemodialyzed renal cell carcinoma (RCC) patients is important in clinical practice. Despite its clinical relevance, little information has been provided on the safety and toxicity profile of sunitinib when administered in hemodialyzed patients with RCC.

Methods: Six patients undergoing hemodialysis were treated with sunitinib for metastatic RCC between February 2007 and May 2009. We retrospectively reviewed the medical records of these patients and examined the administered dose of sunitinib, treatment-related toxicity, and the clinical response to therapy.

Results: The initial dose of sunitinib was 25 mg (cases 1 and 5), 37.5 mg (cases 2 and 3), and 50 mg (cases 4 and 6), respectively. Toxicities greater than grade 3 were observed in cases 3 and 6, and subsequently the dose was reduced in case 6. No patient had to stop sunitinib due to toxicities. Among the 6 patients, 3 (cases 2, 3, and 5) had disease progression after 1, 2, and 2 cycles of sunitinib, respectively. Three patients (cases 1, 4, and 6) had stable disease after 12, 5, and 4 cycles of treatment, respectively, and 2 of them (cases 4 and 6) were still on sunitinib 8 and 7 months, respectively, after the start of treatment.

Conclusions: The toxicity of and response to sunitinib in dialyzed patients seem to be comparable to those in patients with normal renal function. However, due to the limitations of this study, i.e. a small number of participants and lack of pharmacokinetic data, prospective clinical trials with pharmacokinetic studies in a larger cohort of patients are required.