title: Everolimus in metastatic renal cell carcinoma after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy: results of an interim analysis of a non-interventional study.
abstract: BACKGROUND
  Everolimus is approved for treatment of anti-vascular endothelial growth factor (VEGF)-refractory patients with metastatic renal cell carcinoma (mRCC). Clinical trials rarely mirror treatment reality. Thus, a broader evaluation of everolimus is valuable for routine use.
  
  
  METHODS
  A German multicenter non-interventional study documented mRCC patients starting everolimus after failure of initial VEGF-targeted therapy. Primary endpoint was effectiveness, defined as time to progression (TTP) according to investigator assessment (time from first dose to progression).
  
  
  RESULTS
  Of 382 documented patients, 196 were included in this interim analysis. In the efficacy population (n = 165), median TTP was 7.0 months (95% confidence interval (CI) 5.1-9.0). Among patients with < or ≥ 6 months of previous VEGF-targeted therapy, median TTP was 6.6 months (95% CI 3.8-not estimable) and 7.4 months (95% CI 4.6-9.6), respectively. Most common adverse events were anemia (13%) and dyspnea (14%). Physicians assessed high tolerance and documented high adherence to everolimus therapy (approximately 97%).
  
  
  CONCLUSIONS
  In routine clinical practice, everolimus is effective, as measured by median TTP (longer than median progression-free survival in RECORD-1 trial), and well tolerated. Our results support everolimus use in anti-VEGF-refractory patients with mRCC.
authors.affiliation: University Hospital Frankfurt, Medical Clinic II, Frankfurt/Main, Germany. L.Bergmann@em.uni-frankfurt.de
authors.forename: Lothar
authors.initials: L
authors.lastname: Bergmann
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Goebell
authors.forename: Ulrich
authors.initials: U
authors.lastname: Kube
authors.forename: Manfred
authors.initials: M
authors.lastname: Kindler
authors.forename: Edwin
authors.initials: E
authors.lastname: Herrmann
authors.forename: Jan
authors.initials: J
authors.lastname: Janssen
authors.forename: Joerg
authors.initials: J
authors.lastname: Schmitz
authors.forename: Steffen
authors.initials: S
authors.lastname: Weikert
authors.forename: Gabriel
authors.initials: G
authors.lastname: Steiner
authors.forename: Andreas
authors.initials: A
authors.lastname: Jakob
authors.forename: Michael D
authors.initials: MD
authors.lastname: Staehler
authors.forename: Thomas
authors.initials: T
authors.lastname: Steiner
authors.forename: Friedrich
authors.initials: F
authors.lastname: Overkamp
authors.forename: Michael
authors.initials: M
authors.lastname: Albrecht
authors.forename: Gernot
authors.initials: G
authors.lastname: Guderian
authors.forename: Christian
authors.initials: C
authors.lastname: Doehn
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000453:epidemiology / Q000556:secondary*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D000068338:Everolimus; D005260:Female; D005858:Germany / Q000453:epidemiology; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000453:epidemiology*; D008297:Male; D008875:Middle Aged; D015995:Prevalence; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors*; D040262:Receptors, Vascular Endothelial Growth Factor / Q000037:antagonists & inhibitors*; D018570:Risk Assessment; D020123:Sirolimus / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017211:Treatment Failure; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D000068338:Everolimus; D011505:Protein-Tyrosine Kinases; D040262:Receptors, Vascular Endothelial Growth Factor; D020123:Sirolimus