Evidence map›Paper›PMID 24424564›Full record

Trial reportTargeted oncology2014

Sunitinib administered prior to radiotherapy in patients with non-resectable glioblastoma: results of a phase II study.

Carmen Balaña, Miguel J Gil, Pedro Perez, Gaspar Reynes, Oscar Gallego, Teresa Ribalta, Jaume Capellades, Sofia Gonzalez, Eugenia Verger

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Targeted oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 28 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 4 pooled it
2.5field-weighted citation impact, top 11% 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

28 citing papers in PubMed, 4 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Review
  7. Review
  8. Glioblastoma Therapy: Past, Present and Future.International journal of molecular sciences · 2024
    Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Guanabenz Sensitizes Glioblastoma Cells to Sunitinib by Inhibiting GADD34-Mediated Autophagic Signaling.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2021
    Article
  18. Article
  19. Article
  20. Delay in starting radiotherapy due to neoadjuvant therapy does not worsen survival in unresected glioblastoma patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Article
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

9 authors at 7 institutions in 1 country.

Carmen BalañaMedical Oncology Service, Catalan Institute of Oncology (ICO), Hospital Germans Trias i Pujol, Carretera Canyet sn, 08916, Badalona, Spain, cbalana@iconcologia.net.
Miguel J Gil
Pedro Perez
Gaspar Reynes
Oscar Gallego
Teresa Ribalta
Jaume Capellades
Sofia Gonzalez
Eugenia Verger
Hospital Clínic de Barcelona · ESHospital Del Mar · ESHospital Clínico San Carlos · ESHospital de Sant Pau · ESHospital Universitari Germans Trias i Pujol · ESInstitut d'Investigació Biomédica de Bellvitge · ESLeitat Technological Center · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Sunitinib is a tyrosine kinase inhibitor with direct anti-tumor and anti-angiogenesis activity targeting VEGFR 1-2, PDGFR α-β, c-kit, bFGF, (CSF-1), FLT3 and RET. The present trial examined the activity of sunitinib in 12 patients with newly diagnosed, non-resectable glioblastoma. Patients (≤75 years of age with performance status [PS] ≥2 and minimental status [MMS] ≥25) were treated post-biopsy with sunitinib 37.5 mg daily for 8 weeks pre-radiotherapy, during radiotherapy (60 Gy, 6 weeks) and post-radiotherapy until disease progression. The primary endpoints were overall response rate (ORR; RANO criteria) after 8 weeks of sunitinib and patient tolerance. Secondary endpoints were percentage of patients free of neurological deterioration pre-radiotherapy, percentage of patients completing radiotherapy, progression-free survival (PFS), overall survival (OS), and 1-year survival. A Simon 2-stage design (12 →20) based on ORR was applied to calculate the number of patients needed to detect at least 10 % response with α error of 0.05 and β error of 0.10. The trial was closed because it did not meet minimal activity criteria. ORR was 0 % with only 1/12 patients (8.3 %) achieving stable disease after sunitinib treatment. No patient showed reduction in gadolinium enhancement. The most frequent G3/4 toxicities were fatigue (24.9 %) and diarrhea (16.6 %); one patient died of a CNS hemorrhage; 10/12 patients (83.3 %) deteriorated neurologically before radiation therapy; median PFS was 7.7 weeks (95 % CI: 7.2-8.2); median OS was 12.8 weeks (95 % CI: 0.5-23.8 weeks); 1-year survival was 0 %. Sunitinib has no activity as monotherapy in glioblastoma, and further investigation of its efficacy in this setting is unwarranted.

Indexed as

AgedAntineoplastic AgentsBiopsyBrain NeoplasmsDisease-Free SurvivalDisease ProgressionFemaleGlioblastomaHumansIndolesMagnetic Resonance ImagingMaleMiddle AgedPyrrolesRadiotherapySunitinibAntineoplastic AgentsIndolesPyrrolesSunitinib

Identifiers

PMID24424564
OpenAlexW2002398236

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.