• Lothar Bergmann, Peter J Goebell, Ulrich Kube, Manfred Kindler, Edwin Herrmann, Jan Janssen, Joerg Schmitz, Steffen Weikert, Gabriel Steiner, Andreas Jakob, Michael D Staehler, Thomas Steiner, Friedrich Overkamp, Michael Albrecht, Gernot Guderian, and Christian Doehn.
• University Hospital Frankfurt, Medical Clinic II, Frankfurt/Main, Germany. L.Bergmann@em.uni-frankfurt.de
• Onkologie. 2013 Jan 1;36(3):95-100.

BackgroundEverolimus 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 MethodsA 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).ResultsOf 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%).ConclusionIn 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.Copyright © 2013 S. Karger AG, Basel.

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