Evidence map›Paper›PMID 28988341›Full record

Trial reportJournal of neuro-oncology2018

Randomized phase II trial comparing axitinib with the combination of axitinib and lomustine in patients with recurrent glioblastoma.

J Duerinck, S Du Four, F Bouttens, C Andre, V Verschaeve, F Van Fraeyenhove, C Chaskis, N D'Haene, M Le Mercier, A Rogiers and 3 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 45 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed, 6 pooled it
1.7field-weighted citation impact, top 15% 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

45 citing papers in PubMed, 6 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Trial
  9. Review
  10. Kinase-Targeted Therapies for Glioblastoma.International journal of molecular sciences · 2025
    Review
  11. Review
  12. Review
  13. Article
  14. Article
  15. Article
  16. Review
  17. Article
  18. Review
  19. Glioblastoma Therapy: Past, Present and Future.International journal of molecular sciences · 2024
    Review
  20. Small Molecule Tyrosine Kinase Inhibitors (TKIs) for Glioblastoma Treatment.International journal of molecular sciences · 2024
    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

13 authors at 7 institutions in 1 country.

J DuerinckDepartment of Neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Brussels, Belgium. johnny.duerinck@uzbrussel.be.ORCID http://orcid.org/0000-0001-9869-9806
S Du FourDepartment of Neurosurgery, Universitair Ziekenhuis Brussel, Laarbeeklaan 101, 1090, Brussels, Belgium.
F BouttensDepartment of Medical and Radiation Oncology, AZ Sint-Lucas Gent, Ghent, Belgium.
C AndreDepartment of Medical Oncology, CHU Liège, Liège, Belgium.
V VerschaeveDepartment of Medical Oncology, GHDC, Charleroi, Belgium.
F Van FraeyenhoveDepartment of Medical Oncology, ZNA Middelheim, Antwerp, Belgium.
C ChaskisDepartment of Neurosurgery, CHU Charleroi, Charleroi, Belgium.
N D'HaeneDepartment of Pathology, Hopital Erasme Université Libre de Bruxelles, Brussels, Belgium.
M Le MercierDepartment of Pathology, Hopital Erasme Université Libre de Bruxelles, Brussels, Belgium.
A RogiersDepartment of Psychiatry, CHU Brugmann, Brussels, Belgium.
A MichotteDepartments of Pathology and Neurology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
I SalmonDepartment of Pathology, Hopital Erasme Université Libre de Bruxelles, Brussels, Belgium.
B NeynsDepartment of Medical Oncology, Universitair Ziekenhuis Brussel, Brussels, Belgium.
Universitair Ziekenhuis Brussel · BEUniversité Libre de Bruxelles · BEGrand Charleroi Hospital · BEAZ Sint-Lucas · BECentre Hospitalier Universitaire Brugmann · BEUniversity of Liège · BEZNA Middelheim Hospital · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Axitinib is a small molecule tyrosine kinase inhibitor with high affinity and specificity for the family of vascular endothelial growth factor receptors. It has previously demonstrated anti-tumor activity in a small cohort of patients with recurrent glioblastoma (rGB). We conducted a non-comparative randomized phase II clinical trial investigating axitinib monotherapy versus axitinib plus lomustine (LOM) in patients with rGB. Primary endpoint was 6 month progression-free survival (6mPFS). Patients who progressed on axitinib-monotherapy were allowed to cross-over. Between August 2011 and July 2015, 79 patients were randomized and initiated axitinib monotherapy (n = 50; AXI) or axitinib plus lomustine (n = 29; AXILOM). Median age was 55y [range 18-80], 50M/28F. Baseline characteristics were well balanced between study arms. Nineteen patients in the AXI-arm crossed-over at the time of progression. Treatment was generally well tolerated. AXILOM patients were at higher risk for grade 3/4 neutropenia (0 vs. 21%) and thrombocytopenia (4 vs. 29%). Best Overall Response Rate (BORR) in the AXI-arm was 28 vs. 38% in the AXILOM-arm. 6mPFS was 26% (95% CI 14-38) versus 17% (95% CI 2-32) for patients treated in the AXI versus AXILOM-arms, respectively. Median overall survival was 29 weeks (95% CI 20-38) in the AXI-arm and 27.4 weeks (95% CI 18.4-36.5) in the AXILOM-arm. MGMT-promoter hypermethylation and steroid treatment at baseline correlated significantly with PFS and OS. We conclude from these results that axitinib improves response rate and progression-free survival in patients with rGB compared to historical controls. There is no indication that upfront combination of axitinib with LOM improves results (European Clinical Trials Database (EudraCT) Study Number: 2011-000900-16).

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Agents, AlkylatingAntineoplastic Combined Chemotherapy ProtocolsAxitinibBrain NeoplasmsFemaleGlioblastomaHumansLomustineMaleMiddle AgedNeoplasm Recurrence, LocalAntineoplastic AgentsAntineoplastic Agents, AlkylatingAxitinibLomustineProtein Kinase InhibitorsAxitinibGlioblastomaLomustineRecurrent

Identifiers

PMID28988341
OpenAlexW2762209305

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.