Efficacy and safety of sunitinib in elderly patients with advanced renal cell carcinoma.

Elderly individuals represent a consistent proportion of all cancer patients. However, they are under-represented in clinical trials. The present study evaluated the actual tolerability of sunitinib in elderly Japanese patients with advanced renal cell carcinoma (RCC). A total of 56 consecutive patients with advanced RCC treated with sunitinib were enrolled. Patients were divided into two groups according to their age at the time of sunitinib initiation: i) elderly cohort (≥70 years); and ii) younger cohort (<70 years). Disease control rate, progression-free survival, overall survival and relative dose intensity (RDI) were compared between the two cohorts. The elderly cohort comprised of 14 patients (25.0%), and the younger cohort included 42 patients (75.0%). The elderly cohort had a significantly higher Charlson comorbidity index than the younger cohort (mean, 9.7 vs. 7.9; P<0.0001). Disease control rate, progression-free survival, and overall survival were not significantly different. The elderly cohort had a significantly lower RDI than the younger cohort (mean, 51.7 vs. 65.0%; P=0.0340). Thus, treatment with sunitinib is feasible and effective in elderly Japanese patients with advanced RCC. However, the RDI of elderly patients was significantly lower, and a relatively low dose of sunitinib provided optimal therapeutic efficacy.