Everolimus in metastatic renal cell carcinoma after failure of initial anti-VEGF therapy: final results of a noninterventional study.
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/).
Medical Clinic II, J. W., Goethe University Frankfurt, Theodor-Stern-Kai 7, Frankfurt/Main, 60590, Germany. L.Bergmann@em.uni-frankfurt.de.
Lothar
L
Bergmann
Private Practice for Urology, Goethestrasse 5, 09119, Chemnitz, Germany. ulrichkube@arcor.de.
Ulrich
U
Kube
Urologikum Luebeck, Am Kaufhof 2, 23566, Luebeck, Germany. doehn@urologikum-luebeck.de.
Christian
C
Doehn
Department of Urology, Hospital Erfurt, Nordhaeusertrasse 74, 99089, Erfurt, Germany. thomas.steiner@helios-kliniken.de.
Thomas
T
Steiner
Department of Urology, University Hospital Erlangen, Rathsberger Strasse 57, 91054, Erlangen, Germany. Peter.Goebell@uk-erlangen.de.
Peter J
PJ
Goebell
Private Practice for Oncology, Landsberger Allee 277a, 13055, Berlin, Germany. praxis@drkindler.de.
Manfred
M
Kindler
Department of Urology, University Hospital Muenster, Albert Schweitzer Campus 1, Gebaeude A1, 48149, Muenster, Germany. herrmae@ukmuenster.de.
Edwin
E
Herrmann
Private Practice for Oncology, Kuhlenstrasse 53d, 26655, Westerstede, Germany. gensch-janssen@t-online.de.
Jan
J
Janssen
Department of Urology, Vivantes Humboldt-Hospital and Charité-University Medicine, Am Nordgraben 2, 13509, Berlin, Germany. steffen.weikert@vivantes.de.
Steffen
S
Weikert
Private Practice for Urology, Friedrich Staude Strasse 2, 08060, Zwickau, Germany. info@urologie-drscheffler.de.
Michael T
MT
Scheffler
St. Johannes-Hospital, Springufer 7, 59755, Arnsberg, Germany. DrJoergSchmitz@googlemail.com.
Joerg
J
Schmitz
Novartis Pharma GmbH, Roonstrasse 25, 90429, Nuremberg, Germany. michael.albrecht@novartis.com.
Michael
M
Albrecht
Department of Urology, University Hospital Munich-Grosshadern, Marchioninistrasse, 15, 81377, Germany. michael.staehler@med.uni-muenchen.de.
Michael
M
Staehler
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D018572:Disease-Free Survival; D000068338:Everolimus / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D005858:Germany; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D058990:Molecular Targeted Therapy; D009362:Neoplasm Metastasis; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors* / Q000235:genetics
D047428:Protein Kinase Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D000068338:Everolimus