Sorafenib tolerability in elderly patients with advanced renal cell carcinoma: results from a large pooled analysis
A partir de données issues de 8 essais cliniques menés sur un total de 4 684 patients atteints d'un carcinome à cellules rénales de stade avancé, cette méta-analyse évalue l'efficacité et la toxicité du sorafenib en fonction de l'âge des patients
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 greater than or equal to75 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; greater than or equal to75, n=559). Treatment patterns were generally similar across subgroups, although sorafenib treatment duration was ~30% shorter in the greater than or equal to75-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.