Sorafenib tolerability in elderly patients with advanced renal cell carcinoma: results from a large pooled analysis.
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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.
SUBMITTER: Procopio G
PROVIDER: S-EPMC3566810 | biostudies-other | 2013 Feb
REPOSITORIES: biostudies-other
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