Evidence map›Paper›PMID 29722661›Full record

Trial reportInternational journal of radiation oncology, biology, physics2018

Phase 2 Study of Bortezomib Combined With Temozolomide and Regional Radiation Therapy for Upfront Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme: Safety and Efficacy Assessment.

Xiao-Tang Kong, Nhung T Nguyen, Yoon J Choi, Guicheng Zhang, HuyTram N Nguyen, Emese Filka, Stacey Green, William H Yong, Linda M Liau, Richard M Green and 6 more

Erratum issuedOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 40 papers.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed
4.2field-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

40 citing papers in PubMed, 58 citations in OpenAlex.

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  19. Transcription Factors with Targeting Potential in Gliomas.International journal of molecular sciences · 2022
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 4 institutions in 3 countries.

Xiao-Tang KongDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California; Department of Neurology, School of Medicine at University of California, Irvine, Irvine, California.
Nhung T NguyenDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Yoon J ChoiDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Guicheng ZhangSchool of Public Health, Xinxiang Medical University, Xinxiang, China, and Curtin University, Perth, Western Australia, Australia.
HuyTram N NguyenDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Emese FilkaDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Stacey GreenDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
William H YongDepartment of Pathology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Linda M LiauDepartment of Neurosurgery, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Richard M GreenKaiser Permanente Southern California, Los Angeles, California.
Tania KaprealianDepartment of Radiation Oncology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Whitney B PopeDepartment of Radiology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
P Leia NghiemphuDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Timothy CloughesyDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California.
Andrew LassmanDepartment of Neurology, Columbia University, New York, New York.
Albert LaiDepartment of Neurology, David Geffen School of Medicine at University of California, Los Angeles, Los Angeles, California. Electronic address: albertlai@mednet.ucla.edu.
University of California, Los Angeles · USColumbia University · USKaiser Permanente · USXinxiang Medical University · CN

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Samuel Wheeler French · 1985 to 2026
$134.5M
UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI David A. Nathanson · 2017 to 2026
$25.2M
NCI NIH HHS P30 CA016042NCI NIH HHS P50 CA211015
6 · The paper itself

Abstract

purposeTo assess the safety and efficacy of upfront treatment using bortezomib combined with standard radiation therapy (RT) and temozolomide (TMZ), followed by adjuvant bortezomib and TMZ for ≤24 cycles, in patients with newly diagnosed glioblastoma multiforme (GBM). METHODS AND MATERIALS: Twenty-four patients with newly diagnosed GBM were enrolled. The patients received standard external beam regional RT with concurrent TMZ beginning 3 to 6 weeks after surgery, followed by adjuvant TMZ and bortezomib for ≤24 cycles or until tumor progression. During RT, bortezomib was given at 1.3 mg/m

resultsNo unexpected adverse events occurred from the addition of bortezomib. The efficacy analysis showed a median progression-free survival (PFS) of 6.2 months (95% confidence interval [CI] 3.7-8.8), with promising PFS rates at ≥18 months compared with historical norms (25.0% at 18 and 24 months; 16.7% at 30 months). In terms of overall survival (OS), the median OS was 19.1 months (95% CI 6.7-31.4), with improved OS rates at ≥12 months (87.5% at 12, 50.0% at 24, 34.1% at 36-60 months) compared with the historical norms. The median PFS was 24.7 months (95% CI 8.5-41.0) in 10 MGMT methylated and 5.1 months (95% CI 3.9-6.2) in 13 unmethylated patients. The estimated median OS was 61 months (95% CI upper bound not reached) in the methylated and 16.4 months (95% CI 11.8-21.0) in the unmethylated patients.

conclusionsThe addition of bortezomib to current standard radiochemotherapy in newly diagnosed GBM patients was tolerable. The PFS and OS rates appeared promising, with more benefit to MGMT methylated patients. Further clinical investigation is warranted in a larger cohort of patients.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBortezomibBrain NeoplasmsChemoradiotherapyFemaleGlioblastomaHumansMaintenance ChemotherapyMaleMiddle AgedNeoplasm Recurrence, LocalProgression-Free SurvivalTemozolomideBortezomibTemozolomide

Identifiers

PMID29722661
PMCPMC6277207
OpenAlexW2781557781

What OpenQuestion holds

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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.