Evidence map›Paper›PMID 23553268›Full record

Trial reportNeuro-oncology2013

Phase 2 study of dose-intense temozolomide in recurrent glioblastoma.

Andrew D Norden, Glenn J Lesser, Jan Drappatz, Keith L Ligon, Samantha N Hammond, Eudocia Q Lee, David R Reardon, Camilo E Fadul, Scott R Plotkin, Tracy T Batchelor and 11 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter 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 54 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 4 pooled it
7.2field-weighted citation impact, top 2% 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

54 citing papers in PubMed, 4 syntheses or guidelines pooled it, 92 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Incorporation of biomarkers in phase II studies of recurrent glioblastoma.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015
    Pooled it
  5. Trial
  6. Trial
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  8. Article
  9. Review
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  11. Review
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  16. 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

21 authors at 10 institutions in 1 country.

Andrew D NordenCenter for Neuro-Oncology, Dana-Farber/Brigham and Women's Cancer Center, 450 Brookline Ave., Boston, MA 02215, USA.
Glenn J Lesser
Jan Drappatz
Keith L Ligon
Samantha N Hammond
Eudocia Q Lee
David R Reardon
Camilo E Fadul
Scott R Plotkin
Tracy T Batchelor
Jay-Jiguang Zhu
Rameen Beroukhim
Alona Muzikansky
Lisa Doherty
Debra Lafrankie
Katrina Smith
Vida Tafoya
Rosina Lis
Edward C Stack
Myrna R Rosenfeld
Patrick Y Wen
Dana-Farber Brigham Cancer Center · USDartmouth–Hitchcock Medical Center · USAtrium Health Wake Forest Baptist · USBrigham and Women's Hospital · USCenter for Neuro-Oncology · USMassachusetts General Hospital · USThe University of Texas Health Science Center at Houston · USUniversity of Pennsylvania · USUniversity of Pittsburgh Medical Center · USDana-Farber Cancer Institute · US

Funding

Tumor Tissue CoreP30CA012197 · NCI · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI Ruben A. Mesa · 1985 to 2026
$55.4M
NCI NIH HHS P30 CA012197
6 · The paper itself

Abstract

backgroundAmong patients with glioblastoma (GBM) who progress on standard temozolomide, the optimal therapy is unknown. Resistance to temozolomide is partially mediated by O(6)-methylguanine-DNA methyltransferase (MGMT). Because MGMT may be depleted by prolonged temozolomide administration, dose-intense schedules may overcome resistance.

methodsThis was a multicenter, phase 2, single-arm study of temozolomide (75-100 mg/m(2)/day) for 21 days of each 28-day cycle. Patients had GBM in first recurrence after standard therapy. The primary end point was 6-month progression-free survival (PFS6).

resultsFifty-eight participants were accrued, 3 of whom were ineligible for analysis; one withdrew before response assessment. There were 33 men (61%), with a median age of 57 years (range, 25-79 years) and a median Karnofsky performance score of 90 (range, 60-100). Of 47 patients with MGMT methylation results, 36 (65%) had methylated tumors. There were 7 (13%) partial responses, and PFS6 was only 11%. Response and PFS did not depend on MGMT status; MSH2, MLH1, or ERCC1 expression; the number of prior temozolomide cycles; or the time off temozolomide. Treatment was well tolerated, with limited grade 3 neutropenia (n = 2) or thrombocytopenia (n = 2).

conclusionsDose-intense temozolomide on this schedule is safe in recurrent GBM. However, efficacy is marginal and predictive biomarkers are needed.

Indexed as

Adaptor Proteins, Signal TransducingAdultAgedAntineoplastic Agents, AlkylatingBiomarkers, TumorBrain NeoplasmsDacarbazineDNA MethylationDNA Modification MethylasesDNA Repair EnzymesDose-Response Relationship, DrugFemaleFollow-Up StudiesGlioblastomaHumansImmunoenzyme TechniquesAdaptor Proteins, Signal TransducingAntineoplastic Agents, AlkylatingBiomarkers, TumorDacarbazineDNA Modification MethylasesDNA Repair EnzymesMGMT protein, humanMLH1 protein, humanMSH2 protein, humanMutL Protein Homolog 1MutS Homolog 2 ProteinNuclear ProteinsTemozolomideTumor Suppressor Proteinsdose-intense temozolomideMGMT promoter methylationrecurrent glioblastoma

Identifiers

PMID23553268
PMCPMC3688016
OpenAlexW2147806499

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.