Academic Journal
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
| العنوان: | 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 |
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| المؤلفون: | Bergmann, Lothar, Goebell, Peter J., Kube, Ulrich, Kindler, Manfred, Herrmann, Edwin, Janssen, Jan, Schmitz, Joerg, Weikert, Steffen, Steiner, Gabriel, Jakob, Andreas, Staehler, Michael D., Steiner, Thomas, Overkamp, Friedrich, Albrecht, Michael, Guderian, Gernot, Doehn, Christian |
| سنة النشر: | 2014 |
| المجموعة: | OPUS FAU - Online publication system of Friedrich-Alexander-Universität Erlangen-Nürnberg |
| مصطلحات موضوعية: | ddc:610 |
| الوصف: | Background: Everolimus is approved for treatment of antivascular 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. ; Hintergrund: Everolimus ist für die Behandlung des metastasierten Nierenzellkarzinoms (mRCC) nach Versagen einer gegen VEGF (vascular endothelial growth factor) gerichteten Therapie zugelassen. Daten aus Zulassungsstudien reflektieren nicht alle Aspekte einer späteren Anwendung in der Routine. Daher stellt eine systematische Untersuchung von Everolimus in der Praxis eine wichtige Quelle klinisch relevanter Daten dar. Patienten und Methoden: Patienten wurden in einer deutschen, multizentrischen, nicht-interventionellen Studie unter Everolimus-Therapie eines mRCC nach Versagen der ersten gegen VEGF gerichteten Therapie dokumentiert. Primärer Zielparameter ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| Relation: | https://opus4.kobv.de/opus4-fau/frontdoor/index/index/docId/4554; urn:nbn:de:bvb:29-opus4-45544; https://nbn-resolving.org/urn:nbn:de:bvb:29-opus4-45544; https://doi.org/10.1159/000348522; https://opus4.kobv.de/opus4-fau/files/4554/bergmann_everolimus.pdf |
| DOI: | 10.1159/000348522 |
| الاتاحة: | https://opus4.kobv.de/opus4-fau/frontdoor/index/index/docId/4554 https://nbn-resolving.org/urn:nbn:de:bvb:29-opus4-45544 https://doi.org/10.1159/000348522 https://opus4.kobv.de/opus4-fau/files/4554/bergmann_everolimus.pdf |
| Rights: | http://www.gesetze-im-internet.de/urhg/index.html ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.87BE4658 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1159/000348522 |
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