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- Title
Sorafenib tolerability in elderly patients with advanced renal cell carcinoma: results from a large pooled analysis.
- Authors
Procopio G; Bellmunt J; Dutcher J; Bracarda S; Knox J; Brueckner A; Molnar I; Escudier B; Hutson TE; Procopio, G; Bellmunt, J; Dutcher, J; Bracarda, S; Knox, J; Brueckner, A; Molnar, I; Escudier, B; Hutson, T E
- Abstract
<bold>Background: </bold>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).<bold>Methods: </bold>Dosing patterns, and incidence, prevalence and cumulative incidence of drug-related adverse events (DRAEs) and fatal DRAEs were assessed.<bold>Results: </bold>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%).<bold>Conclusion: </bold>Sorafenib was well tolerated regardless of age in a heterogeneous population of RCC patients.
- Publication
British Journal of Cancer, 2013, Vol 108, Issue 2, p311
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/bjc.2012.543