title: 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%).
  
  
  CONCLUSIONS
  Sorafenib was well tolerated regardless of age in a heterogeneous population of RCC patients.
authors: Department of Medical Oncology 1, Fondazione IRCCS 'Istituto Nazionale Tumori', Milan, Italy. Giuseppe.Procopio@istitutotumori.mi.it
authors: G
authors: G
authors: Procopio
authors: J
authors: J
authors: Bellmunt
authors: J
authors: J
authors: Dutcher
authors: S
authors: S
authors: Bracarda
authors: J
authors: J
authors: Knox
authors: A
authors: A
authors: Brueckner
authors: I
authors: I
authors: Molnar
authors: B
authors: B
authors: Escudier
authors: T E
authors: TE
authors: Hutson
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D047428:Protein Kinase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D009536:Niacinamide; D000077157:Sorafenib