Evidence map›Paper›PMID 23911595›Full record

Trial reportNeuro-oncology2013

Enzastaurin before and concomitant with radiation therapy, followed by enzastaurin maintenance therapy, in patients with newly diagnosed glioblastoma without MGMT promoter hypermethylation.

Wolfgang Wick, Joachim P Steinbach, Michael Platten, Christian Hartmann, Frederik Wenz, Andreas von Deimling, Peipei Shei, Valerie Moreau-Donnet, Clemens Stoffregen, Stephanie E Combs

Open access · bronzeAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in Neuro-oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
4.4field-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

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 59 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

10 authors at 8 institutions in 3 countries.

Wolfgang WickCorresponding Author: Wolfgang Wick, MD, Department of Neurooncology, National Center for Tumor Diseases and Neurology Clinic, University Clinic Heidelberg and German Cancer Research Centre, Im Neuenheimer Feld 400, 69120-Heidelberg, Germany. wolfgang.wick@med.uni-heidelberg.de.
Joachim P Steinbach
Michael Platten
Christian Hartmann
Frederik Wenz
Andreas von Deimling
Peipei Shei
Valerie Moreau-Donnet
Clemens Stoffregen
Stephanie E Combs
Goethe University Frankfurt · DEUniversity Medical Centre Mannheim · DEEli Lilly (Germany) · DEEli Lilly (United States) · USGerman Cancer Research Center · DEHeidelberg University · DEUniversity Hospital Frankfurt · DEUniversity Hospital Heidelberg · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study's primary objective was evaluation of the progression-free survival rate at 6 months (PFS-6) in patients with newly diagnosed glioblastoma without O(6)-methylguanine-DNA-methyltransferase (MGMT) promoter hypermethylation postsurgically treated with enzastaurin before and concomitantly with radiation therapy, followed by enzastaurin maintenance therapy. PFS-6 of at least 55% was set to be relevant compared with the data of the EORTC 26981/22981 NCIC CE.3 trial.

methodsAdult patients with a life expectancy of at least 12 weeks who were newly diagnosed with a histologically proven supratentorial glioblastoma without MGMT promoter hypermethylation were eligible. Patients were treated with enzastaurin prior to, concomitantly with, and after standard partial brain radiotherapy. Here we report on a multicenter, open-label, uncontrolled phase II study of patients with newly diagnosed glioblastoma without MGMT promoter hypermethylation treated with enzastaurin and radiation therapy within 4 study periods.

resultsPFS-6 was 53.6% (95% confidence interval [CI]: 39.8-65.6). The median overall survival was 15.0 months (95% CI: 11.9-17.9) for all patients, 3.9 months (95% CI: 0.8-9.0) for patients with biopsy, 15.4 months (95% CI: 10.1-17.9) for patients with partial resection, and 18.9 months (95% CI: 13.9-28.5) for patients with complete resection. The safety profile in this study was as expected from previous trials, and the therapy was well tolerated.

conclusionsPFS-6 missed the primary planned outcome of 55%. The secondary exploratory analysis according to resection status of the different subgroups of patients with biopsies, partial resection, and complete resection demonstrates the strong prognostic influence of resection on overall survival.

Indexed as

ChemoradiotherapyDNA MethylationAdultAgedBrain NeoplasmsDNA Modification MethylasesDNA Repair EnzymesFemaleFollow-Up StudiesGlioblastomaHumansIndolesMaleMiddle AgedNeoplasm StagingPrognosisDNA Modification MethylasesDNA Repair EnzymesenzastaurinIndolesMGMT protein, humanTumor Suppressor Proteinsbrain tumorsenzastauringlioblastomaMGMTradiotherapy

Identifiers

PMID23911595
PMCPMC3779043
OpenAlexW2150442444

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.