Evidence map›Paper›PMID 24670608›Full record

Trial reportNeuro-oncology2014

Phase II trial of 7 days on/7 days off temozolmide for recurrent high-grade glioma.

Seunggu J Han, John D Rolston, Annette M Molinaro, Jennifer L Clarke, Michael D Prados, Susan M Chang, Mitchel S Berger, Ashley DeSilva, Nicholas A Butowski

Registry-linked trialAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuro-oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00619112 (Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma), which is not on this map. Cited by 32 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 4 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.

NCT00619112 phase2completednot on this map

Phase II Study of 7 Days On/7 Days Off Temozolomide in Patients With High-Grade Glioma

TypeinterventionalSponsorUniversity of California, San FranciscoRan2007 to 2012Enrolled60ConditionsRecurrent Central Nervous System NeoplasmArmstemozolomide
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Molecular Biomarkers in Glioblastoma: A Systematic Review and Meta-Analysis.International journal of molecular sciences · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors.

Seunggu J HanDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).
John D RolstonDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).
Annette M MolinaroDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).
Jennifer L ClarkeDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).
Michael D PradosDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).
Susan M ChangDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).
Mitchel S BergerDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).
Ashley DeSilvaDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).
Nicholas A ButowskiDepartment of Neurological Surgery, University of California, San Francisco, California (S.J.H., J.D.R., A.M.M., J.L.C., M.D.P., S.M.C., M.S.B., A.D., N.A.B.); Department of Epidemiology and Biostatistics, University of California, San Francisco, California (A.M.M.).

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundA phase II trial was performed to evaluate the efficacy of a dose-dense, 7 days on/7 days off schedule of temozolomide for patients with recurrent high-grade gliomas (HGG).

methodsSixty patients with recurrent HGG received temozolomide at 150 mg/m(2)/day on days 1-7 and days 15-21 during each 4-week cycle. The primary endpoint was 6-month progression-free survival (PFS-6), with a secondary endpoint of overall survival (OS). A further exploratory objective included the investigation of whether methylation status of the O(6)-methylguanine-DNA methyltransferase (MGMT) promoter within tumor tissue predicted outcomes.

resultsAmong patients with glioblastoma (n = 40), PFS-6 was 10% (95% CI, 3%-24%) with median OS of 21.6 weeks (95% CI, 16.9-30.6 weeks). PFS-6 for grade III glioma patients (n = 20) was 50% (95% CI, 27%-73%), and median OS was 100.6 weeks (95% CI, 67 weeks to not reached). There were trends towards longer PFS and OS with MGMT promoter methylation (log-rank test; P = .06 for PFS; P = .07 for OS). Additionally, bevacizumab-naïve glioblastoma patients had significantly longer PFS and OS (median PFS was 8.07 weeks [95% CI, 8 weeks to not reached] vs 7.57 weeks [95% CI, 7.29-8.29 weeks], log-rank test, P < .001; median OS was 62 weeks [26.1 weeks to not reached] vs 18.2 weeks [13.9-27.3 weeks], log-rank test, P < .001).

conclusionsThe dose-dense temozolomide regimen was well tolerated, although it has no significant activity in this population. Clinical trials.gov identified. NCT00619112 (available at http://clinicaltrials.gov/ct2/show/NCT00619112).

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Agents, AlkylatingBevacizumabBrain NeoplasmsDacarbazineDisease-Free SurvivalDNA MethylationDNA Modification MethylasesDNA Repair EnzymesFemaleGliomaHumansKaplan-Meier EstimateMaleAntibodies, Monoclonal, HumanizedAntineoplastic Agents, AlkylatingBevacizumabDacarbazineDNA Modification MethylasesDNA Repair EnzymesMGMT protein, humanTemozolomideTumor Suppressor Proteinsbevacizumabchemotherapyglioblastomagliomatemozolomide

Identifiers

PMID24670608
PMCPMC4136897

What OpenQuestion holds

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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.