Background Data are limited regarding routine use of everolimus after initial
vascular endothelial growth factor (VEGF)–targeted therapy. The aim of this
prospective, noninterventional, observational study was to assess efficacy and
safety of everolimus after initial VEGF-targeted treatment in patients with
metastatic renal cell carcinoma (mRCC) in routine clinical settings. Methods
Everolimus was administered per routine clinical practice. Patients with mRCC
of any histology from 116 active sites in Germany were included. The main
objective was to determine everolimus efficacy in time to progression (TTP).
Progression-free survival (PFS), treatment duration, tumor response, adherence
to everolimus regimen, treatment after everolimus, and safety were also
assessed. Results In the total population (N = 334), median follow-up was 5.2
months (range, 0–32 months). Median treatment duration (safety population, n =
318) was 6.5 months (95% confidence interval [CI], 5–8 months). Median TTP and
median PFS were similar in populations investigated. In patients who received
everolimus as second-line treatment (n = 211), median (95% CI) TTP was 7.1
months (5–9 months) and median PFS was 6.9 months (5–9 months). Commonly
reported adverse events (safety population, n = 318) were dyspnea (17%),
anemia (15%), and fatigue (12%). Limitations of the noninterventional design
should be considered. Conclusions This study reflects routine clinical use of
everolimus in a large sample of patients with mRCC. Favorable efficacy and
safety were seen for everolimus after previous therapy with one VEGF-targeted
agent. Results of this study confirm everolimus as one of the standard options
in second-line therapy for patients with mRCC. Novartis study code,
CRAD001LD27: VFA registry for noninterventional studies
(http://www.vfa.de/de/forschung/nisdb/ webcite)