title: Final results of the European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) expanded-access study: a large open-label study in diverse community settings.
abstract: BACKGROUND
  The European Advanced Renal Cell Carcinoma Sorafenib (EU-ARCCS) expanded-access study provided sorafenib to advanced renal cell carcinoma (RCC) patients in whom previous systemic therapy had failed. The study assessed the safety and use of sorafenib for the treatment of advanced RCC in a large community-based patient population across 11 countries in Europe.
  
  
  METHODS
  EU-ARCCS was a single-arm, open-label trial of sorafenib in advanced RCC patients. End points included safety, time to progression, progression-free survival (PFS), and disease control rate (DCR). Subgroup analyses included age, Eastern Cooperative Oncology Group performance status, histology, prior therapy, and number and sites of metastases.
  
  
  RESULTS
  About 1159 advanced RCC patients were enrolled. Most patients (94%) experienced drug-related adverse events (AEs) of any grade, with the most common grade ≥3 AEs including hand-foot skin reaction (13%), diarrhea (7%), fatigue (7%), hypertension (6%), and rash/desquamation (5%). The incidence of AEs in the subgroups was similar to that in the overall population. Median PFS was 6.6 months; DCR at ≥8 and ≥12 weeks was 85% and 78%, respectively.
  
  
  CONCLUSIONS
  The sorafenib safety profile in European community-based practice settings was similar to that reported in clinical trials. The heterogeneous advanced RCC patient population in EU-ARCCS permitted assessment of sorafenib in important subpopulations of advanced RCC patients.
authors.affiliation: Johannes Gutenberg University Medical Center, Mainz, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Beck
authors.forename: G
authors.initials: G
authors.lastname: Procopio
authors.forename: E
authors.initials: E
authors.lastname: Bajetta
authors.forename: U
authors.initials: U
authors.lastname: Keilholz
authors.forename: S
authors.initials: S
authors.lastname: Negrier
authors.forename: C
authors.initials: C
authors.lastname: Szczylik
authors.forename: C
authors.initials: C
authors.lastname: Bokemeyer
authors.forename: S
authors.initials: S
authors.lastname: Bracarda
authors.forename: D J
authors.initials: DJ
authors.lastname: Richel
authors.forename: M
authors.initials: M
authors.lastname: Staehler
authors.forename: U P
authors.initials: UP
authors.lastname: Strauss
authors.forename: S
authors.initials: S
authors.lastname: Mersmann
authors.forename: K
authors.initials: K
authors.lastname: Burock
authors.forename: B
authors.initials: B
authors.lastname: Escudier
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001557:Benzenesulfonates / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D057176:Compassionate Use Trials; D018572:Disease-Free Survival; D005060:Europe; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib