title: The Predicted Impact of Ipilimumab Usage on Survival in Previously Treated Advanced or Metastatic Melanoma in the UK.
abstract: BACKGROUND
  Evaluating long-term prognosis is important for physicians, patients and payers. This study reports the results of a model developed to predict long-term survival for UK patients receiving second-line ipilimumab.
  
  
  METHODS
  MDX010-20 trial data were used to predict survival for ipilimumab versus UK best supportive care. Two aspects of this analysis required novel approaches: 1) The overall survival Kaplan-Meier data shape is unusual: an initial steep decline is observed before a 'plateau'. 2) The need to extrapolate beyond the trial end (4.6 years). Based upon UK clinician advice, a three-part curve fit was used: from 0-1.5 years, Kaplan-Meier data from the trial; from 1.5-5 years, standard parametric curve fits; after 5 years, long-term data from the American Joint Committee on Cancer registry.
  
  
  RESULTS
  This approach provided good internal validity: low mean absolute error and good match to median and mean trial data. Lifetime predicted means were 2.77 years for ipilimumab and 1.07 for best supportive care, driven by increased long-term survival with ipilimumab.
  
  
  CONCLUSIONS
  To understand the full benefit of treatment and to meet reimbursement requirements, accurate estimation of treatment benefit is key. Models, such as the one presented, can be used to extrapolate beyond trials.
authors.affiliation: The Royal Marsden Foundation NHS Trust, Fulham Rd, London, SW3 6JJ, United Kingdom.
authors.forename: James
authors.initials: J
authors.lastname: Larkin
authors.affiliation: BresMed, 84 Queen St, Sheffield, S1 2DW, United Kingdom.
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Hatswell
authors.affiliation: Mount Vernon Cancer Centre, Rickmansworth Rd, Northwood, Middlesex, HA6 2RN, United Kingdom.
authors.forename: Paul
authors.initials: P
authors.lastname: Nathan
authors.affiliation: Bristol-Myers Squibb Pharmaceuticals Limited, Sanderson Road, Uxbridge, Middlesex, UB8 1DH, United Kingdom.
authors.forename: Maximilian
authors.initials: M
authors.lastname: Lebmeier
authors.affiliation: BresMed, 84 Queen St, Sheffield, S1 2DW, United Kingdom.
authors.forename: Dawn
authors.initials: D
authors.lastname: Lee
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D000074324:Ipilimumab; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D016879:Salvage Therapy; D012878:Skin Neoplasms / Q000188:drug therapy / Q000401:mortality* / Q000556:secondary; D015996:Survival Rate
chemical_list: D000911:Antibodies, Monoclonal; D000074324:Ipilimumab