Evidence map›Paper›PMID 21321091›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2011

Sagopilone (ZK-EPO, ZK 219477) for recurrent glioblastoma. A phase II multicenter trial by the European Organisation for Research and Treatment of Cancer (EORTC) Brain Tumor Group.

R Stupp, A Tosoni, J E C Bromberg, P Hau, M Campone, J Gijtenbeek, M Frenay, L Breimer, H Wiesinger, A Allgeier and 7 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00424060 (Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma), which is not on this map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT00424060 phase2completednot on this map

Phase II Study of ZK 219477 in Patients With Recurrent Glioblastoma

TypeinterventionalSponsorEuropean Organisation for Research and Treatment of Cancer - EORTCRan2006Enrolled38ConditionsBrain and Central Nervous System TumorsArmssagopilone, fluorescence in situ hybridization, gene expression analysis, immunohistochemistry staining method, laboratory biomarker analysis
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Review
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  13. Microtubule targeting agents in glioma.Translational cancer research · 2016
    Article
  14. Review
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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

17 authors.

R StuppDepartment of Neurosurgery, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland. Electronic address: roger.stupp@chuv.ch.
A TosoniDepartment of Medical Oncology, Bellaria Maggiore Hospital, Bologna, Italy.
J E C BrombergDepartment of Neuro-Oncology, Daniel den Hoed Cancer Center/Erasmus University Hospital, Rotterdam, The Netherlands.
P HauDepartment of Neurology, University of Regensburg Medical School, Regensburg, Germany.
M CamponeDepartment of Medical Oncology, Institut Régional du Cancer Nantes Atlantique, CLCC René Gauducheau, Centre de Recherche en Cancérologie, St Herblain, France.
J GijtenbeekDepartment of Neurology, Radboud University Medical Centre, Nijmegen, The Netherlands.
M FrenayDepartment of Medical Oncology, Centre Antoine Lacassagne, Nice Cedex, France.
L BreimerBayer Healthcare, Montville, USA.
H WiesingerBayer Schering Pharma, Berlin, Germany.
A AllgeierEORTC Headquarters, Brussels, Belgium.
M J van den BentDepartment of Neuro-Oncology, Daniel den Hoed Cancer Center/Erasmus University Hospital, Rotterdam, The Netherlands.
U BogdahnDepartment of Neurology, University of Regensburg Medical School, Regensburg, Germany.
W van der GraafDepartment of Neurology, Radboud University Medical Centre, Nijmegen, The Netherlands.
H J YunEORTC Headquarters, Brussels, Belgium.
T GorliaEORTC Headquarters, Brussels, Belgium.
D LacombeEORTC Headquarters, Brussels, Belgium.
A A BrandesDepartment of Medical Oncology, Bellaria Maggiore Hospital, Bologna, Italy.

Funding

EORTC HEADQUARTERSU10CA011488 · NCI · EUROPEAN ORG/RES/TREATMENT/CANCER · PI LACOMBE, DENIS · 1985 to 2015
$6.6M
NCI NIH HHS 2U10 CA011488-36NCI NIH HHS 5U10 CA011488-40
6 · The paper itself

Abstract

backgroundSagopilone (ZK 219477), a lipophylic and synthetic analog of epothilone B, that crosses the blood-brain barrier has demonstrated preclinical activity in glioma models. PATIENTS AND

methodsPatients with first recurrence/progression of glioblastoma were eligible for this early phase II and pharmacokinetic study exploring single-agent sagopilone (16 mg/m(2) over 3 h every 21 days). Primary end point was a composite of either tumor response or being alive and progression free at 6 months. Overall survival, toxicity and safety and pharmacokinetics were secondary end points.

resultsThirty-eight (evaluable 37) patients were included. Treatment was well tolerated, and neuropathy occurred in 46% patients [mild (grade 1) : 32%]. No objective responses were seen. The progression-free survival (PFS) rate at 6 months was 6.7% [95% confidence interval (CI) 1.3-18.7], the median PFS was just over 6 weeks, and the median overall survival was 7.6 months (95% CI 5.3-12.3), with a 1-year survival rate of 31.6% (95% CI 17.7-46.4). Maximum plasma concentrations were reached at the end of the 3-h infusion, with rapid declines within 30 min after termination.

conclusionsNo evidence of relevant clinical antitumor activity against recurrent glioblastoma could be detected. Sagopilone was well tolerated, and moderate-to-severe peripheral neuropathy was observed in despite prolonged administration.

Indexed as

AdultAgedAntineoplastic AgentsAstrocytomaBenzothiazolesBrain NeoplasmsDisease-Free SurvivalDisease ProgressionEpothilonesFemaleGlioblastomaHumansInfusions, IntravenousMaleMiddle AgedNeoplasm Recurrence, LocalAntineoplastic AgentsBenzothiazolesEpothilonessagopilone

Identifiers

PMID21321091
PMCPMC3164435

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Registered trials

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.