dc.contributor.author
Bergmann, Lothar
dc.contributor.author
Kube, Ulrich
dc.contributor.author
Doehn, Christian
dc.contributor.author
Steiner, Thomas
dc.contributor.author
Goebell, Peter J.
dc.contributor.author
Kindler, Manfred
dc.contributor.author
Herrmann, Edwin
dc.contributor.author
Janssen, Jan
dc.contributor.author
Weikert, Steffen
dc.contributor.author
Scheffler, Michael T.
dc.contributor.author
Schmitz, Joerg
dc.contributor.author
Albrecht, Michael
dc.contributor.author
Staehler, Michael
dc.date.accessioned
2018-06-08T03:30:43Z
dc.date.available
2015-05-27T11:02:24.103Z
dc.identifier.uri
https://refubium.fu-berlin.de/handle/fub188/15337
dc.identifier.uri
http://dx.doi.org/10.17169/refubium-19525
dc.description.abstract
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).
de
dc.rights.uri
http://creativecommons.org/licenses/by/4.0/
dc.subject.ddc
600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit
dc.title
Everolimus in metastatic renal cell carcinoma after failure of initial
anti–VEGF therapy
dc.type
Wissenschaftlicher Artikel
dcterms.bibliographicCitation
BMC Cancer. - 15 (2015), Artikel Nr. 303
dc.title.subtitle
final results of a noninterventional study
dcterms.bibliographicCitation.doi
10.1186/s12885-015-1309-7
dcterms.bibliographicCitation.url
http://www.biomedcentral.com/1471-2407/15/303
refubium.affiliation
Charité - Universitätsmedizin Berlin
de
refubium.mycore.fudocsId
FUDOCS_document_000000022476
refubium.note.author
Der Artikel wurde in einer Open-Access-Zeitschrift publiziert.
refubium.resourceType.isindependentpub
no
refubium.mycore.derivateId
FUDOCS_derivate_000000004944
dcterms.accessRights.openaire
open access