Evidence map›Paper›PMID 26847813›Full record

Trial reportJournal of neuro-oncology2016

Bevacizumab and temozolomide versus temozolomide alone as neoadjuvant treatment in unresected glioblastoma: the GENOM 009 randomized phase II trial.

Carmen Balana, Ramon De Las Penas, Juan Manuel Sepúlveda, Miguel J Gil-Gil, Raquel Luque, Oscar Gallego, Cristina Carrato, Carolina Sanz, Gaspar Reynes, Ana Herrero and 14 more

Abstract readClinical Trial, Phase IIComparative StudyMulticenter Study
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 10 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.

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

40 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
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  9. Anti-vascular endothelial growth factor in glioblastoma: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018
    Pooled it
  10. Anti-angiogenic therapy for high-grade glioma.The Cochrane database of systematic reviews · 2018
    Pooled it
  11. Trial
  12. Review
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  14. Article
  15. Article
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  18. Intrinsic and Microenvironmental Drivers of Glioblastoma Invasion.International journal of molecular sciences · 2024
    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

24 authors.

Carmen BalanaMedical Oncology Service, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Carretera Canyet, s/n, 08916, Badalona, Spain. cbalana@iconcologia.net.
Ramon De Las PenasMedical Oncology Service, Hospital Provincial de Castellón, Castellón, Spain.
Juan Manuel SepúlvedaMedical Oncology Service, Hospital Universitario, 12 de Octubre, Madrid, Spain.
Miguel J Gil-GilMedical Oncology Service, Institut Català d'Oncologia-IDIBELL, Hospitalet de Llobregat, Barcelona, Spain.
Raquel LuqueMedical Oncology Service, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Oscar GallegoMedical Oncology Service, Hospital de Sant Pau, Barcelona, Spain.
Cristina CarratoPathology Service, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Carolina SanzPathology Service, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Gaspar ReynesMedical Oncology Service, Hospital Universitario La Fe, Valencia, Spain.
Ana HerreroMedical Oncology Service, Hospital Miguel Servet, Zaragoza, Spain.
Jose Luis RamirezCancer Molecular Biology Laboratory, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Pedro Pérez-SeguraMedical Oncology Service, Hospital Universitario Clínico San Carlos, Madrid, Spain.
Alfonso BerrocalMedical Oncology Service, Hospital General Universitario de Valencia, Valencia, Spain.
Jose Maria VieitezMedical Oncology Service, Hospital Universitario Central de Asturias, Oviedo, Spain.
Almudena GarciaMedical Oncology Service, Hospital Marqués de Valdecilla, Santander, Spain.
Sergio Vazquez-EstevezMedical Oncology Service, Hospital Universitario Lucus Augusti, Lugo, Spain.
Sergi PeraltaMedical Oncology Service, Hospital Sant Joan de Reus, Reus, Spain.
Isaura FernandezMedical Oncology Service, Hospital Xeral-Cies, Vigo, Spain.
Ivan HenriquezRadiation Oncology Service, Hospital Sant Joan de Reus, Reus, Spain.
Maria Martinez-GarciaMedical Oncology Service, Hospital del Mar, Barcelona, Spain.
Juan Jose De la CruzDepartment of Preventive Medicine and Public Health, School of Medicine, Autonomous University of Madrid, Madrid, Spain.
Jaume CapelladesRadiology Service, Hospital del Mar, Barcelona, Spain.
Pilar GinerPharmacy Department, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.
Salvador VillàRadiation Oncology Service, Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We sought to determine the impact of bevacizumab on reduction of tumor size prior to chemoradiotherapy in unresected glioblastoma patients. Patients were randomized 1:1 to receive temozolomide (TMZ arm) or temozolomide plus bevacizumab (TMZ + BEV arm). In both arms, neoadjuvant treatment was temozolomide (85 mg/m(2), days 1-21, two 28-day cycles), concurrent radiation plus temozolomide, and six cycles of adjuvant temozolomide. In the TMZ + BEV arm, bevacizumab (10 mg/kg) was added on days 1 and 15 of each neoadjuvant cycle and on days 1, 15 and 30 of concurrent treatment. The primary endpoint was investigator-assessed response to neoadjuvant treatment. Secondary endpoints included progression-free survival (PFS), overall survival (OS), and the impact on outcome of MGMT methylation in tumor and serum. One hundred and two patients were included; 43 in the TMZ arm and 44 in the TMZ + BEV arm were evaluable for response. Results favored the TMZ + BEV arm in terms of objective response (3 [6.7 %] vs. 11 [22.9 %]; odds ratio 4.2; P = 0.04). PFS and OS were longer in the TMZ + BEV arm, though the difference did not reach statistical significance. MGMT methylation in tumor, but not in serum, was associated with outcome. More patients experienced toxicities in the TMZ + BEV than in the TMZ arm (P = 0.06). The combination of bevacizumab plus temozolomide is more active than temozolomide alone and may well confer benefit in terms of tumor shrinkage in unresected patients albeit at the expense of greater toxicity.

Indexed as

Neoadjuvant TherapyAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabBrain NeoplasmsDacarbazineFemaleFollow-Up StudiesGlioblastomaHumansMaleMiddle AgedNeoplasm StagingPrognosisSurvival RateBevacizumabDacarbazineTemozolomideBevacizumabGlioblastomaMGMTNeoadjuvantSerum MGMTTemozolomide

Identifiers

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.