Evidence map›Paper›PMID 26285768›Full record

Trial reportJournal of neuro-oncology2015

A phase II trial of tamoxifen and bortezomib in patients with recurrent malignant gliomas.

Yazmín Odia, Teri N Kreisl, Dawit Aregawi, Ellen K Innis, Howard A Fine

Abstract readClinical Trial, Phase II
PubMed Publisher
In one paragraph

Trial report in Journal of neuro-oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.4field-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

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 46 citations in OpenAlex.

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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

5 authors at 5 institutions in 3 countries.

Yazmín OdiaDivision of Neuro-Oncology, Neurological Institute of New York, Columbia University College of Physicians and Surgeons, 710 West 168th Street, NI 9-017, New York, NY, 10032, USA. yo2240@cumc.columbia.edu.
Teri N KreislDivision of Neuro-Oncology, Neurological Institute of New York, Columbia University College of Physicians and Surgeons, 710 West 168th Street, NI 9-017, New York, NY, 10032, USA.
Dawit AregawiDivision of Neuro-oncology, Penn State Milton S. Hershey Medical Center, Hershey, PA, USA.
Ellen K InnisUniversity of Maryland School of Medicine, Baltimore, MD, USA.
Howard A FineDivision of Neuro-Oncology, Director of the Brain Tumor Center, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.
Columbia University · USNewYork–Presbyterian Hospital · USPenn State Milton S. Hershey Medical Center · USRoyal College of Physicians · GBUniversity of Maryland, Baltimore · US

Funding

Intramural NIH HHS
6 · The paper itself

Abstract

NF-kB inhibition by bortezomib enhances tamoxifen-induced apoptosis in preclinical glioma models. We conducted a single institution, phase II trial to evaluate efficacy and safety of high dose tamoxifen with bortezomib in adults with recurrent malignant gliomas. The primary endpoint was radiographic response. Concurrent enzyme inducing anticonvulsants and grade ≥2 peripheral neuropathy were exclusion criteria. Patients received tamoxifen (120 mg PO twice daily) and bortezomib (1.3 mg/m2 IV on days 3, 6, 10, 13, 24, 27, 31, and 34) per 6-week cycles. We enrolled 42 patients with anaplastic gliomas (AGs, n = 12) and glioblastomas (GBMs, n = 30), 32 males and 10 females. Median age was 38 years (range 22-65) and 48 years (range 19-68) for AGs and GBMs, respectively. median karnofsky performance status was 90% (range 70-100) for AGs and 80% (range 60-100) for GBMs. Median prior therapies was 3, ranging 1-7. Grade ≥3 toxicities included lymphopenia (4/42), hypophosphatemia (3/42), thromobocytopenia (2/42), and 1/42 with hyponatremia, headache, dyspnea, or DVT. One patient withdrew consent, two were removed for toxicity, and all others discontinued for progression. Among 40 patients evaluable for response, only one achieved stable disease for 3 months; all others progressed rapidly. For AGs and GBMs respectively, median progression-free survival was 5.9 and 5.7 weeks and median overall survival was 25.6 and 14.7 weeks. The study was closed due to poor accrual and therapeutic futility. Combination tamoxifen and bortezomib has no activity in recurrent malignant gliomas. Poor penetration across blood brain barrier of bortezomib likely limited efficacy.

Indexed as

AdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBortezomibBrain NeoplasmsDisease-Free SurvivalDisease ProgressionDose-Response Relationship, DrugFemaleFollow-Up StudiesGliomaHumansMaleMiddle AgedNeoplasm Recurrence, LocalAntineoplastic AgentsBortezomibTamoxifenBortezomibGlioblastomaGliomaTamoxifen

Identifiers

PMID26285768
OpenAlexW2146308079

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.