Evidence map›Paper›PMID 24293233›Full record

Trial reportJournal of neuro-oncology2014

Bevacizumab and fotemustine for recurrent glioblastoma: a phase II study of AINO (Italian Association of Neuro-Oncology).

Riccardo Soffietti, Elisa Trevisan, Luca Bertero, Paola Cassoni, Isabella Morra, Maria Grazia Fabrini, Francesco Pasqualetti, Ivan Lolli, Anna Castiglione, Giovannino Ciccone and 1 more

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Journal of neuro-oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 2 pooled it
4.6field-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

36 citing papers in PubMed, 2 syntheses or guidelines pooled it, 72 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Observational
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Receptor-Targeted Glial Brain Tumor Therapies.International journal of molecular sciences · 2018
    Review
  18. The Clinical Significance of OFrontiers in neurology · 2018
    Article
  19. Clinical outcomes in recurrent glioblastoma with bevacizumab therapy: An analysis of the literature.Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia · 2017
    Review
  20. Review
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

11 authors at 3 institutions in 1 country.

Riccardo SoffiettiDept. Neuro-Oncology, University and City of Health and Science Hospital of Turin, Via Cherasco 15, 10126, Turin, Italy, riccardo.soffietti@unito.it.
Elisa Trevisan
Luca Bertero
Paola Cassoni
Isabella Morra
Maria Grazia Fabrini
Francesco Pasqualetti
Ivan Lolli
Anna Castiglione
Giovannino Ciccone
Roberta Rudà
Piedmont Reference Center for Epidemiology and Cancer Prevention · ITAzienda Ospedaliera Universitaria Pisana · ITGastroenterology Hospital "Saverio de Bellis" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The optimal combination of bevacizumab with cytotoxic or cytostatic drugs in recurrent glioblastoma is unknown. We performed a phase 2 trial of combined bevacizumab and fotemustine for patients with glioblastoma at first relapse after radiotherapy and temozolomide. The primary endpoint was 6-month progression-free survival (PFS), while secondary endpoints were overall survival (OS), response rate based on RANO criteria and toxicity. Fifty-four patients with recurrent GBM were enrolled. The authors observed a 6-month PFS rate of 42.6% (95% CI 29.3-55.2) and a median PFS of 5.2 months (95% CI 3.8-6.6). The median OS was 9.1 months (95% CI 7.3-10.3). Twenty-eight patients (52%) had a radiographic response, and a significant neurological improvement with steroid reduction was observed in 25/42 symptomatic patients (60%). MGMT promoter methylation was significantly associated with improved PFS in univariate analysis. Most unifocal tumors at baseline had a focal enhancing progression (76%), while the diffuse non-enhancing progression accounted for 9.5%. Response or survival were not associated with any pattern of progression. Survival after failure of treatment was short. Twelve out of 54 patients (22%) discontinued fotemustine for grade 3/4 myelotoxicity, while 4/54 (7.4%) discontinued bevacizumab. This study failed to demonstrate a superiority of the combination of bevacizumab and fotemustine over either bevacizumab or fotemustine alone as historical controls. Future studies should explore alternative regimens of combination of the two drugs.

Indexed as

AgedAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabBrain NeoplasmsDNA MethylationDNA Modification MethylasesDNA Repair EnzymesFemaleGlioblastomaHumansItalyMagnetic Resonance ImagingMaleMiddle AgedNeoplasm Recurrence, LocalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabDNA Modification MethylasesDNA Repair EnzymesfotemustineMGMT protein, humanNitrosourea CompoundsOrganophosphorus CompoundsTumor Suppressor Proteins

Identifiers

PMID24293233
PMCPMC3905193
OpenAlexW2171714209

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.