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Br J Cancer. 2013 Feb 5;108(2):311-8. doi: 10.1038/bjc.2012.543. Epub 2013 Jan 15.

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

Author information

1
Department of Medical Oncology 1, Fondazione IRCCS 'Istituto Nazionale Tumori', Milan, Italy. Giuseppe.Procopio@istitutotumori.mi.it

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.

PMID:
23322192
PMCID:
PMC3566810
DOI:
10.1038/bjc.2012.543
[Indexed for MEDLINE]
Free PMC Article
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