Evidence map›Paper›PMID 22687197›Full record

ArticleInternational journal of radiation oncology, biology, physics2013

A phase I study of the combination of sorafenib with temozolomide and radiation therapy for the treatment of primary and recurrent high-grade gliomas.

Robert B Den, Mitchell Kamrava, Zhi Sheng, Maria Werner-Wasik, Erin Dougherty, Michelle Marinucchi, Yaacov R Lawrence, Sarah Hegarty, Terry Hyslop, David W Andrews and 5 more

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

Article in International journal of radiation oncology, biology, physics, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 2 pooled it
2.1field-weighted citation impact, top 13% 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

26 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
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  13. From imaging to biology of glioblastoma: new clinical oncology perspectives to the problem of local recurrence.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2018
    Review
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  20. Radiation recall dermatitis induced by sorafenib : A case study and review of the literature.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2016
    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

15 authors at 4 institutions in 2 countries.

Robert B DenDepartment of Radiation Oncology, Jefferson Medical College of Thomas Jefferson University, Philadelphia, Pennsylvania 19107, USA. robert.den@jeffersonhospital.org
Mitchell Kamrava
Zhi Sheng
Maria Werner-Wasik
Erin Dougherty
Michelle Marinucchi
Yaacov R Lawrence
Sarah Hegarty
Terry Hyslop
David W Andrews
Jon Glass
David P Friedman
Michael R Green
Kevin Camphausen
Adam P Dicker
Thomas Jefferson University · USNational Cancer Institute · USUniversity of Massachusetts Chan Medical School · USJefferson Hospital · US

Funding

X-Ray Crystallography and Macromolecular CharacterizationP30CA056036 · NCI · THOMAS JEFFERSON UNIVERSITY · PI DANIEL P SILVER · 1995 to 2026
$94.8M
Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI STEPHEN W BYERS · 1990 to 2026
$71.5M
NCI NIH HHS P30 CA051008NCI NIH HHS P30 CA056036NCI NIH HHS P30 CA56036
6 · The paper itself

Abstract

purposeDespite recent advances in the management of high-grade and recurrent gliomas, survival remains poor. Antiangiogenic therapy has been shown to be efficacious in the treatment of high-grade gliomas both in preclinical models and in clinical trials. We sought to determine the safety and maximum tolerated dose of sorafenib when combined with both radiation and temozolomide in the primary setting or radiation alone in the recurrent setting. METHODS AND MATERIALS: This was a preclinical study and an open-label phase I dose escalation trial. Multiple glioma cell lines were analyzed for viability after treatment with radiation, temozolomide, or sorafenib or combinations of them. For patients with primary disease, sorafenib was given concurrently with temozolomide (75 mg/m(2)) and 60 Gy radiation, for 30 days after completion of radiation. For patients with recurrent disease, sorafenib was combined with a hypofractionated course of radiation (35 Gy in 10 fractions).

resultsCell viability was significantly reduced with the combination of radiation, temozolomide, and sorafenib or radiation and sorafenib. Eighteen patients (11 in the primary cohort, 7 in the recurrent cohort) were enrolled onto this trial approved by the institutional review board. All patients completed the planned course of radiation therapy. The most common toxicities were hematologic, fatigue, and rash. There were 18 grade 3 or higher toxicities. The median overall survival was 18 months for the entire population.

conclusionsSorafenib can be safely combined with radiation and temozolomide in patients with high-grade glioma and with radiation alone in patients with recurrent glioma. The recommended phase II dose of sorafenib is 200 mg twice daily when combined with temozolomide and radiation and 400 mg with radiation alone. To our knowledge, this is the first publication of concurrent sorafenib with radiation monotherapy or combined with radiation and temozolomide.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsCell Line, TumorCell SurvivalChemoradiotherapyDacarbazineFemaleGliomaHumansMaleMaximum Tolerated DoseMiddle AgedNeoplasm ProteinsNeoplasm Recurrence, LocalDacarbazineNeoplasm ProteinsNiacinamidePhenylurea CompoundsSorafenibTemozolomideVascular Endothelial Growth Factor A

Identifiers

PMID22687197
PMCPMC3635494
OpenAlexW2038567855

What OpenQuestion holds

Textmetadata
LicenceTDM
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.