Evidence map›Paper›PMID 26040470›Full record

Trial reportBMC cancer2015

Vinflunine in routine clinical practice for the treatment of advanced or metastatic urothelial cell carcinoma - data from a prospective, multicenter experience.

Margitta Retz, Patrick de Geeter, Peter J Goebell, Ullrich Matz, Wito de Schultz, Axel Hegele

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter Study
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 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
4.7field-weighted citation impact, top 5% 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

14 citing papers in PubMed, 28 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

Margitta RetzUrologische Klinik und Poliklinik, Technische Universität München, Ismaninger Str. 22, 81675, Munich, Germany. margitta.retz@lrz.tum.de.
Patrick de GeeterDepartment of Urology, Kassel Hospital, Kassel, Germany. degeeter@klinikum-kassel.de.
Peter J GoebellDepartment of Urology, Friedrich-Alexander University, Erlangen, Germany. peter.goebell@uk-erlangen.de.
Ullrich MatzUrologic practice, Doebeln, Germany. uropraxismatz@t-online.de.
Wito de SchultzMedical Urology practice, Leipzig, Germany. wito-de-schultz@t-online.de.
Axel HegeleDepartment of Urology / Pediatric Urology, Philipps University, Marburg, Germany. hegele@med.uni-marburg.de.
Friedrich-Alexander-Universität Erlangen-Nürnberg · DEKlinikum Kassel · DEPhilipps University of Marburg · DETechnical University of Munich · DEUniversity Hospital Leipzig · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVinflunine is recommended in the European guideline for the treatment of advanced or metastatic urothelial cell carcinoma (UCC) after failure of platinum-based therapy.

methodsThis prospective, non-interventional study investigated the safety and efficacy of vinflunine in platinum-pretreated UCC patients in routine clinical practice. Data were prospectively collected on patients with advanced or metastatic UCC undergoing vinflunine treatment in 39 German hospitals and medical practices. Dosing of vinflunine, tumor assessments and concomitant medications followed physician's routine clinical practice. Primary endpoints were toxicity and assessment of vinflunine treatment modalities. Secondary aims included overall response rate (ORR), overall survival (OS) time and a prognostic risk-model.

resultsSeventy-seven platinum-pretreated patients were recruited. Vinflunine was predominantly administered as second-line (66%) therapy or in subsequent treatment lines (21%). One third of the patients received at least six cycles of vinflunine and the average number was 4.7 cycles. A vinflunine starting dose of 320 mg/m2 was chosen in 48% of patients and 280 mg/m2 in 39%. Grade 3/4 toxicities were leucopenia 16.9%, anemia 6.5%, elevated liver enzymes 6.5% and constipation 5.2%. ORR was 23.4% and OS was 7.7 (CI 4.1 to 10.4) months. Patients with zero, one, two or ≥three risk factors displayed a median OS of 18.2, 9.5, 4.1 and 2.8 months, respectively (p=0.0005; HR=1.82).

conclusionVinflunine delivers a meaningful benefit to an unselected population of advanced platinum-pretreated UCC patients managed in routine clinical practice.

Indexed as

AdultAgedCarcinomaDisease-Free SurvivalFemaleGermanyHumansMaleMiddle AgedNeoplasm MetastasisPrognosisUrinary Bladder NeoplasmsUrotheliumVinblastineVinblastinevinflunine

Identifiers

PMID26040470
PMCPMC4455983
OpenAlexW1556232272

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.