Evidence map›Paper›PMID 20124186›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Phase III study of enzastaurin compared with lomustine in the treatment of recurrent intracranial glioblastoma.

Wolfgang Wick, Vinay K Puduvalli, Marc C Chamberlain, Martin J van den Bent, Antoine F Carpentier, Lawrence M Cher, Warren Mason, Michael Weller, Shengyan Hong, Luna Musib and 3 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00295815 (Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma), which is not on this map. Cited by 256 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
256citing papers in PubMed, 10 pooled it
18.6field-weighted citation impact, top 1% 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.

NCT00295815 phase3completednot on this map

Randomized Phase 3 Open Label Study - Enzastaurin vs. Lomustine in Glioblastoma

TypeinterventionalSponsorEli Lilly and CompanyRan2006 to 2014Enrolled397ConditionsGlioblastomaArmsenzastaurin, lomustine
3 · Its place in the literature

Who cites it

256 citing papers in PubMed, 10 syntheses or guidelines pooled it, 510 citations in OpenAlex.

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  15. Circulating Immune Cell and Outcome Analysis from the Phase II Study of PD-L1 Blockade with Durvalumab for Newly Diagnosed and Recurrent Glioblastoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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  16. Infigratinib in Patients with Recurrent Gliomas and FGFR Alterations: A Multicenter Phase II Study.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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196 more citing papers are in PubMed but not listed here.

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 1 institution in 2 countries.

Wolfgang WickDepartment of Neurooncology, University of Heidelberg, Im Neuenheimer Feld, 400 D-69120 Heidelberg. wolfgang.wick@med.uni-heidelberg.de
Vinay K Puduvalli
Marc C Chamberlain
Martin J van den Bent
Antoine F Carpentier
Lawrence M Cher
Warren Mason
Michael Weller
Shengyan Hong
Luna Musib
Astra M Liepa
Donald E Thornton
Howard A Fine
Heidelberg University · DE

Funding

Brain Tumor Clinical and Clinical Research ProgramZIDBC011098 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI GRESS, RONALD · 2009 to 2014
$19.3M
6 · The paper itself

Abstract

purposeThis phase III open-label study compared the efficacy and safety of enzastaurin versus lomustine in patients with recurrent glioblastoma (WHO grade 4). PATIENTS AND

methodsPatients were randomly assigned 2:1 to receive 6-week cycles of enzastaurin 500 mg/d (1,125-mg loading dose, day 1) or lomustine (100 to 130 mg/m(2), day 1). Assuming a 45% improvement in progression-free survival (PFS), 397 patients were required to provide 80% power to achieve statistical significance at a one-sided level of .025.

resultsEnrollment was terminated at 266 patients (enzastaurin, n = 174; lomustine, n = 92) after a planned interim analysis for futility. Patient characteristics were balanced between arms. Median PFS (1.5 v 1.6 months; hazard ratio [HR] = 1.28; 95% CI, 0.97 to 1.70), overall survival (6.6 v 7.1 months; HR = 1.20; 95% CI, 0.88 to 1.65), and 6-month PFS rate (P = .13) did not differ significantly between enzastaurin and lomustine, respectively. Stable disease occurred in 38.5% and 35.9% of patients and objective response occurred in 2.9% and 4.3% of patients, respectively. Time to deterioration of physical and functional well-being and symptoms did not differ between arms (HR = 1.12; P = .54). Four patients discontinued enzastaurin because of drug-related serious adverse events (AEs). Eleven patients treated with enzastaurin died on study (four because of AEs; one was drug-related). All four deaths that occurred in patients receiving lomustine were disease-related. Grade 3 to 4 hematologic toxicities were significantly higher with lomustine (46 events) than with enzastaurin (one event; P < or = .001).

conclusionEnzastaurin was well tolerated and had a better hematologic toxicity profile but did not have superior efficacy compared with lomustine in patients with recurrent glioblastoma.

Indexed as

AdultAgedBrain NeoplasmsFemaleGlioblastomaHumansIndolesLomustineMaleMiddle AgedNeoplasm Recurrence, LocalenzastaurinIndolesLomustine

Identifiers

PMID20124186
PMCPMC2834468
OpenAlexW2123808042

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.