Evidence map›Paper›PMID 22090453›Full record

Trial reportNeuro-oncology2012

Phase II trial of vorinostat in combination with bortezomib in recurrent glioblastoma: a north central cancer treatment group study.

Bret B Friday, S Keith Anderson, Jan Buckner, Chunrong Yu, Caterina Giannini, Francois Geoffroy, John Schwerkoske, Miroslaw Mazurczak, Howard Gross, Eduardo Pajon and 2 more

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Neuro-oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 126 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
126citing papers in PubMed, 2 pooled it
8.7field-weighted citation impact, top 1% 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

126 citing papers in PubMed, 2 syntheses or guidelines pooled it, 211 citations in OpenAlex.

  1. 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
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66 more citing papers are in PubMed but not listed here.

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

12 authors at 7 institutions in 1 country.

Bret B FridayEssentia Health-Duluth Clinic Cancer Center, Duluth, Minnesota, USA.
S Keith Anderson
Jan Buckner
Chunrong Yu
Caterina Giannini
Francois Geoffroy
John Schwerkoske
Miroslaw Mazurczak
Howard Gross
Eduardo Pajon
Kurt Jaeckle
Evanthia Galanis
Mayo Clinic · USDayton Clinical Oncology Program · USMetro-Minnesota Community Oncology Research Consortium · USMorristown Medical Center · USRoswell Park Comprehensive Cancer Center · USSioux Valley Hospital · USUniversity of Colorado Denver · US

Funding

TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
Measles Virotherapy and radiovirotherapy in the Treatment of recurrent gliomasR01CA154348 · NCI · MAYO CLINIC ROCHESTER · PI GALANIS, EVANTHIA · 2011 to 2014
$1.3M
NCI NIH HHS R01 CA 154348NCI NIH HHS U10 CA 25224
6 · The paper itself

Abstract

Vorinostat, a histone deacetylase (HDAC) inhibitor, has shown evidence of single-agent activity in glioblastoma (GBM), and in preclinical studies, we have demonstrated significant synergistic cytotoxicity between HDAC inhibitors and proteasome inhibitors in GBM cell lines. We therefore conducted a phase II trial to evaluate the efficacy of vorinostat in combination with the proteasome inhibitor bortezomib in patients with recurrent GBM. Vorinostat was administered at a dose of 400 mg daily for 14 days of a 21-day cycle, and bortezomib was administered at a dose of 1.3 mg/m(2) intravenously on days 1, 4, 8, and 11 of the cycle. A total of 37 patients were treated, and treatment was well tolerated: grade 3, 4 nonhematologic toxicity occurred in 30% of patients and consisted mainly of fatigue (14%) and neuropathy (5%); grade 3, 4 hematologic toxicity occurred in 37% of patients and consisted of thrombocytopenia (30%), lymphopenia (4%), and neutropenia (4%). The trial was closed at the predetermined interim analysis, with 0 of 34 patients being progression-free at 6 months. One patient achieved a partial response according to the Macdonald criteria. The median time to progression for all patients was 1.5 months (range, 0.5-5.6 months), and median overall survival (OS) was 3.2 months. Patients who had received prior bevacizumab therapy had a shorter time to progression and OS, compared with those who had not. On the basis of the results of this phase II study, further evaluation of the vorinostat-bortezomib combination in GBM patients in this dose and schedule is not recommended.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBoronic AcidsBortezomibBrain NeoplasmsDisease ProgressionFemaleGlioblastomaHumansHydroxamic AcidsMaleMiddle AgedPyrazinesSurvival AnalysisBoronic AcidsBortezomibHydroxamic AcidsPyrazinesVorinostat

Identifiers

PMID22090453
PMCPMC3266383
OpenAlexW2111013340

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.