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EFFICACY AND TOXICITY OF SUNITINIB IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA WITH SEVERE RENAL IMPAIRMENT OR ON HAEMODIALYSIS

Despite the fact that over 4 years have passed since sunitinib was first USA Food and Drug Administration (FDA)-approved for use in patients with renal cancer, there has remained a lingering question, and perhaps a reluctance on the part of clinicians, about its use in patients with renal impairment, probably because of the fact that until recently relatively little was known about sunitinib use in such patients. The concern on the part of clinicians is perhaps natural, given the fact that all of the studies which led to the approval of sunitinib excluded patients with significant renal impairment [1], making such patients arguably quite unlike the patients with renal cancer that clinicians are actually seeing in practice. For example, one study (reported in abstract form) suggests that renal impairment (defined as a glomerular filtration rate of <60 mL/min/1.73m) is found in 37% of systemically treated patients with renal cancer [2]. Furthermore, the large phase III trial of sunitinib [3] showed that ≈90% of patients receiving sunitinib in the metastatic setting had prior nephrectomies, and such a population is inherently at greater risk of having or developing renal insufficiency: a retrospective study of >10 000 patients undergoing partial or complete nephrectomy for renal cancer showed that ≈20% of those patients eventually develop adverse renal complications (hospitalization for renal insufficiency, need for nephrology consultation, dialysis, or renal transplantation) [4].