Evidence map›Paper›PMID 25925846›Full record

Trial reportBMC cancer2015

Everolimus in metastatic renal cell carcinoma after failure of initial anti-VEGF therapy: final results of a noninterventional study.

Lothar Bergmann, Ulrich Kube, Christian Doehn, Thomas Steiner, Peter J Goebell, Manfred Kindler, Edwin Herrmann, Jan Janssen, Steffen Weikert, Michael T Scheffler and 3 more

Open access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
3.6field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 23 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Lothar BergmannMedical Clinic II, J. W., Goethe University Frankfurt, Theodor-Stern-Kai 7, Frankfurt/Main, 60590, Germany. L.Bergmann@em.uni-frankfurt.de.
Ulrich KubePrivate Practice for Urology, Goethestrasse 5, 09119, Chemnitz, Germany. ulrichkube@arcor.de.
Christian DoehnUrologikum Luebeck, Am Kaufhof 2, 23566, Luebeck, Germany. doehn@urologikum-luebeck.de.
Thomas SteinerDepartment of Urology, Hospital Erfurt, Nordhaeusertrasse 74, 99089, Erfurt, Germany. thomas.steiner@helios-kliniken.de.
Peter J GoebellDepartment of Urology, University Hospital Erlangen, Rathsberger Strasse 57, 91054, Erlangen, Germany. Peter.Goebell@uk-erlangen.de.
Manfred KindlerPrivate Practice for Oncology, Landsberger Allee 277a, 13055, Berlin, Germany. praxis@drkindler.de.
Edwin HerrmannDepartment of Urology, University Hospital Muenster, Albert Schweitzer Campus 1, Gebaeude A1, 48149, Muenster, Germany. herrmae@ukmuenster.de.
Jan JanssenPrivate Practice for Oncology, Kuhlenstrasse 53d, 26655, Westerstede, Germany. gensch-janssen@t-online.de.
Steffen WeikertDepartment of Urology, Vivantes Humboldt-Hospital and Charité-University Medicine, Am Nordgraben 2, 13509, Berlin, Germany. steffen.weikert@vivantes.de.
Michael T SchefflerPrivate Practice for Urology, Friedrich Staude Strasse 2, 08060, Zwickau, Germany. info@urologie-drscheffler.de.
Joerg SchmitzSt. Johannes-Hospital, Springufer 7, 59755, Arnsberg, Germany. DrJoergSchmitz@googlemail.com.
Michael AlbrechtNovartis Pharma GmbH, Roonstrasse 25, 90429, Nuremberg, Germany. michael.albrecht@novartis.com.
Michael StaehlerDepartment of Urology, University Hospital Munich-Grosshadern, Marchioninistrasse, 15, 81377, Germany. michael.staehler@med.uni-muenchen.de.
Charité - Universitätsmedizin Berlin · DEGoethe University Frankfurt · DEKlinikum Chemnitz · DENovartis (Germany) · DEUniversitätsklinikum Erlangen · DEUniversity Hospital Münster · DEWestsächsische Hochschule Zwickau · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundData 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.

methodsEverolimus 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.

resultsIn 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.

conclusionsThis 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/).

Indexed as

AdultAgedAged, 80 and overCarcinoma, Renal CellDisease-Free SurvivalEverolimusFemaleGermanyHumansKaplan-Meier EstimateMaleMiddle AgedMolecular Targeted TherapyNeoplasm MetastasisProspective StudiesProtein Kinase InhibitorsEverolimusProtein Kinase InhibitorsVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID25925846
PMCPMC4413536
OpenAlexW2082218024

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.