title: Safety and efficacy of sorafenib in elderly patients treated in the North American advanced renal cell carcinoma sorafenib expanded access program.
abstract: OBJECTIVE
  In this retrospective analysis of the Advanced Renal Cell Carcinoma Sorafenib (ARCCS) program in North America, we compared the safety and efficacy of sorafenib in patients aged ≥70 with those aged <70 years.
  
  
  METHODS
  Patients were treated with oral sorafenib twice daily until the occurrence of disease progression or treatment intolerance. The primary objective of the ARCCS program was making sorafenib available to patients with advanced renal cell carcinoma (RCC) in the USA and Canada before marketing approval was obtained; the secondary objective was the evaluation of its safety and efficacy.
  
  
  RESULTS
  Of the 2,504 patients enrolled in the ARCCS program who received at least 1 dose of sorafenib, 736 (29%) were aged ≥70 years. The most common grade ≥3 adverse events included rash/desquamation (5% in both groups), hand-foot skin reaction (8% in those aged ≥70 years vs. 10% in those <70 years of age), hypertension (5 vs. 4%) and fatigue (7 vs. 4%). Partial response was seen in 4% of the patients in both age groups. The median overall survival for the ≥70-year versus <70-year groups was also similar (46 vs. 50 weeks).
  
  
  CONCLUSIONS
  There were no substantial differences in safety and efficacy between patients aged ≥70 and <70 years with advanced RCC treated with sorafenib.
authors: Department of Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Center, Cleveland Clinic Foundation, Cleveland, OH 441214, USA. bukow464@sbcglobal.net
authors: Ronald M
authors: RM
authors: Bukowski
authors: Walter M
authors: WM
authors: Stadler
authors: David F
authors: DF
authors: McDermott
authors: Janice P
authors: JP
authors: Dutcher
authors: Jennifer J
authors: JJ
authors: Knox
authors: Wilson H
authors: WH
authors: Miller
authors: John D
authors: JD
authors: Hainsworth
authors: Charles A
authors: CA
authors: Henderson
authors: Julio
authors: J
authors: Hajdenberg
authors: Tamila L
authors: TL
authors: Kindwall-Keller
authors: Marc S
authors: MS
authors: Ernstoff
authors: Harry A
authors: HA
authors: Drabkin
authors: Brendan D
authors: BD
authors: Curti
authors: Luis
authors: L
authors: Chu
authors: Christopher W
authors: CW
authors: Ryan
authors: Sebastien J
authors: SJ
authors: Hotte
authors: Chenghua
authors: C
authors: Xia
authors: Lisa
authors: L
authors: Cupit
authors: Robert A
authors: RA
authors: Figlin
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000009:adverse effects / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005006:Ethnicity; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000009:adverse effects / Q000627:therapeutic use*; D012189:Retrospective Studies; D012449:Safety; D000077157:Sorafenib; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib