title: Sunitinib in Metastatic Renal Cell Carcinoma: A Systematic Review of UK Real World Data.
abstract: BACKGROUND
  Real world data (RWD) are increasingly used to inform drug reimbursement decisions, but it is unclear how well outcomes from real world studies compare to those of clinical trials. This systematic review seeks to compare outcomes for sunitinib in routine UK clinical practice with the sunitinib registrational and expanded-access program clinical trials.
  
  
  METHODS
  Systematic review of the real world published literature was undertaken. UK observational studies recording first- or second-line sunitinib efficacy were included. A qualitative summary of the results and comparison to the controlled clinical trials was conducted. Fifteen real world studies were included, 14 of which were only available as posters/presentations.
  
  
  RESULTS
  Real world study reporting quality was generally low, making comparisons with the clinical trials difficult. Practice relating to starting dose, dose modification, timing of therapy initiation, and other factors varied between centers. Median progression-free survival and adverse events were generally comparable to the clinical trial outcomes, but overall survival was not.
  
  
  CONCLUSIONS
  There are few published data on sunitinib use in UK clinical practice. Studies are characterized by lack of peer reviewed publication and heterogeneity in design, reporting, and analysis. For use of RWD in the reimbursement setting, data collection and reporting will need to improve.
  
  
  CONCLUSIONS
  There are few published data on sunitinib use in UK clinical practice. Studies are characterized by lack of peer reviewed publication and heterogeneity in design, reporting, and analysis. Practice varies considerably between different UK centers. Median progression-free survival and adverse events are generally comparable to the clinical trial outcomes, but overall survival is not. For use of real world data in the reimbursement setting, data collection and reporting will need to improve.
authors.affiliation: Pfizer Limited , Tadworth , UK.
authors.forename: Miriam
authors.initials: M
authors.lastname: Argyropulo-Palmer
authors.affiliation: Pfizer Limited , Tadworth , UK.
authors.forename: Aaron
authors.initials: A
authors.lastname: Jenkins
authors.affiliation: Pfizer Limited , Tadworth , UK.
authors.forename: Davinder Singh
authors.initials: DS
authors.lastname: Theti
authors.affiliation: Department of Medical Oncology, The Royal Marsden Hospital , London , UK.
authors.forename: James
authors.initials: J
authors.lastname: Larkin
authors.affiliation: Pfizer Limited , Tadworth , UK.
authors.forename: David
authors.initials: D
authors.lastname: Montgomery
keywords: United Kingdom; carcinoma; clinical practice variations; drug reimbursement; real world data; renal cell; sunitinib