title: Prognostic model for survival in patients with metastatic renal cell carcinoma: results from the international kidney cancer working group.
abstract: OBJECTIVE
  To develop a single validated model for survival in metastatic renal cell carcinoma (mRCC) using a comprehensive international database.
  
  
  METHODS
  A comprehensive database of 3,748 patients including previously reported clinical prognostic factors was established by pooling patient-level data from clinical trials. Following quality control and standardization, descriptive statistics were generated. Univariate analyses were conducted using proportional hazards models. Multivariable analysis using a log-logistic model stratified by center and multivariable fractional polynomials was conducted to identify independent predictors of survival. Missing data were handled using multiple imputation methods. Three risk groups were formed using the 25th and 75th percentiles of the resulting prognostic index. The model was validated using an independent data set of 645 patients treated with tyrosine kinase inhibitor (TKI) therapy.
  
  
  RESULTS
  Median survival in the favorable, intermediate and poor risk groups was 26.9 months, 11.5 months, and 4.2 months, respectively. Factors contributing to the prognostic index included treatment, performance status, number of metastatic sites, time from diagnosis to treatment, and pretreatment hemoglobin, white blood count, lactate dehydrogenase, alkaline phosphatase, and serum calcium. The model showed good concordance when tested among patients treated with TKI therapy (C statistic = 0.741, 95% CI: 0.714-0.768).
  
  
  CONCLUSIONS
  Nine clinical factors can be used to model survival in mRCC and form distinct prognostic groups. The model shows utility among patients treated in the TKI era.
authors.affiliation: Eastern Cooperative Oncology Group Statistical Office, Dana-Farber Cancer Institute, Boston, MA 02215, USA. jmanola@jimmy.harvard.edu
authors.forename: Judith
authors.initials: J
authors.lastname: Manola
authors.forename: Patrick
authors.initials: P
authors.lastname: Royston
authors.forename: Paul
authors.initials: P
authors.lastname: Elson
authors.forename: Jennifer Bacik
authors.initials: JB
authors.lastname: McCormack
authors.forename: Madhu
authors.initials: M
authors.lastname: Mazumdar
authors.forename: Sylvie
authors.initials: S
authors.lastname: Négrier
authors.forename: Bernard
authors.initials: B
authors.lastname: Escudier
authors.forename: Tim
authors.initials: T
authors.lastname: Eisen
authors.forename: Janice
authors.initials: J
authors.lastname: Dutcher
authors.forename: Michael
authors.initials: M
authors.lastname: Atkins
authors.forename: Daniel Y C
authors.initials: DY
authors.lastname: Heng
authors.forename: Toni K
authors.initials: TK
authors.lastname: Choueiri
authors.forename: Robert
authors.initials: R
authors.lastname: Motzer
authors.forename: Ronald
authors.initials: R
authors.lastname: Bukowski
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use; D001557:Benzenesulfonates / Q000627:therapeutic use; D000068258:Bevacizumab; D002292:Carcinoma, Renal Cell / Q000175:diagnosis / Q000628:therapy*; D016208:Databases, Factual; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use; D007391:International Cooperation; D007680:Kidney Neoplasms / Q000175:diagnosis / Q000628:therapy*; D016015:Logistic Models; D008297:Male; D008954:Models, Biological; D015999:Multivariate Analysis; D009362:Neoplasm Metastasis; D009536:Niacinamide / Q000031:analogs & derivatives; D017063:Outcome Assessment, Health Care / Q000379:methods; D010671:Phenylurea Compounds; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D011725:Pyridines / Q000627:therapeutic use; D011758:Pyrroles / Q000627:therapeutic use; D015203:Reproducibility of Results; D000077157:Sorafenib; D000077210:Sunitinib; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D001557:Benzenesulfonates; D007211:Indoles; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D011725:Pyridines; D011758:Pyrroles; D009536:Niacinamide; D000068258:Bevacizumab; D000077157:Sorafenib; D000077210:Sunitinib