title: Prognostic factors for survival following initiation of second-line treatment with everolimus for metastatic renal cell carcinoma: evidence from a nationwide sample of clinical practice in the United States.
abstract: OBJECTIVE
  Comparing prognostic factors for overall survival (OS) in community-practice metastatic renal cell carcinoma (mRCC) patients receiving second-line everolimus with those previously reported in clinical trials.
  
  
  METHODS
  Two separate chart sets (2009 - 2012) were used to develop and validate a prognostic model for patients initiating second-line everolimus after first-line tyrosine kinase inhibitor (TKI).
  
  
  METHODS
  Prognostic factors for OS have been identified and validated in separate samples.
  
  
  RESULTS
  One-year OS probabilities in the study (n = 220) and validation (n = 97) samples were 68 and 67%; median OS was 19 and 23 months - higher than the 1-year OS of 60% and median OS of 14.8 months of RECORD-1. Karnofsky performance score < 80%, duration of mRCC < 1 year, progression on first-line TKI, liver metastasis and clear cell histology were significant prognostic factors for shorter survival. One-year OS estimates were 84% for validation sample patients with 0 - 2 risk factors, 63% for 3 risk factors and 22% for 4 - 5 risk factors (log-rank p < 0.001).
  
  
  CONCLUSIONS
  Real-world prognostic factors for OS following second-line everolimus for mRCC were largely consistent with those previously identified in trial data; however, OS was longer in the practice setting than in clinical trials and was not associated with type of first-line TKI.
authors.affiliation: University of Southern California Norris Comprehensive Cancer Center , Los Angeles, CA , USA.
authors.forename: Michael K
authors.initials: MK
authors.lastname: Wong
authors.forename: Eric
authors.initials: E
authors.lastname: Jonasch
authors.forename: Sumanta K
authors.initials: SK
authors.lastname: Pal
authors.forename: James E
authors.initials: JE
authors.lastname: Signorovitch
authors.forename: Peggy L
authors.initials: PL
authors.lastname: Lin
authors.forename: Xufang
authors.initials: X
authors.lastname: Wang
authors.forename: Zhimei
authors.initials: Z
authors.lastname: Liu
authors.forename: Ken
authors.initials: K
authors.lastname: Culver
authors.forename: Jeffrey A
authors.initials: JA
authors.lastname: Scott
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: George
authors.forename: Nicholas J
authors.initials: NJ
authors.lastname: Vogelzang
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D018450:Disease Progression; D000068338:Everolimus; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D000068338:Everolimus; D020123:Sirolimus
keywords: everolimus; metastatic renal cell carcinoma; overall survival; prognostic; second-line; targeted therapy; tyrosine kinase inhibitor