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

Onkologie. 2013;36(3):95-100. doi: 10.1159/000348522. Epub 2013 Feb 25.


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.

Patients and 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%).

Conclusion: 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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents / therapeutic use
  • Carcinoma, Renal Cell / drug therapy*
  • Carcinoma, Renal Cell / epidemiology
  • Carcinoma, Renal Cell / secondary*
  • Disease-Free Survival
  • Double-Blind Method
  • Everolimus
  • Female
  • Germany / epidemiology
  • Humans
  • Kidney Neoplasms / drug therapy*
  • Kidney Neoplasms / epidemiology*
  • Male
  • Middle Aged
  • Prevalence
  • Protein-Tyrosine Kinases / antagonists & inhibitors*
  • Receptors, Vascular Endothelial Growth Factor / antagonists & inhibitors*
  • Risk Assessment
  • Sirolimus / analogs & derivatives*
  • Sirolimus / therapeutic use
  • Treatment Failure
  • Treatment Outcome
  • Young Adult


  • Antineoplastic Agents
  • Everolimus
  • Protein-Tyrosine Kinases
  • Receptors, Vascular Endothelial Growth Factor
  • Sirolimus