Sorafenib tolerability in elderly patients with advanced renal cell carcinoma: results from a large pooled analysis.

Abstract

Background:Elderly patients tend to be underrepresented in renal cell carcinoma (RCC) clinical trials. The Sorafenib RCC Integrated Database includes data from six clinical trials and two expanded-access studies evaluating sorafenib monotherapy in >4600 patients with RCC. Using this database, sorafenib tolerability and treatment patterns were analysed according to age group (<55, 55–<65, 65–<75, or ⩾75 years).Methods:Dosing patterns, and incidence, prevalence and cumulative incidence of drug-related adverse events (DRAEs) and fatal DRAEs were assessed.Results:Overall, 4684 patients were evaluable (<55 years, n=1126; 55–<65, n=1579; 65–<75, n=1382; ⩾75, n=559). Treatment patterns were generally similar across subgroups, although sorafenib treatment duration was ∼30% shorter in the ⩾75-years subgroup. There were no substantial differences in any-grade DRAEs with sorafenib between subgroups. Drug-related adverse events and dose modifications due to DRAEs tended to occur in months 0–3 and declined thereafter; there was no evidence of cumulative toxicity. Fatal DRAEs were rare (0.7% overall; 95% confidence interval, 0.5–1.0%).Conclusion:Sorafenib was well tolerated regardless of age in a heterogeneous population of RCC patients.