Evidence map›Paper›PMID 26853339›Full record

ArticleInternational journal of radiation oncology, biology, physics2016

Gemcitabine Plus Radiation Therapy for High-Grade Glioma: Long-Term Results of a Phase 1 Dose-Escalation Study.

Michelle M Kim, Sandra Camelo-Piragua, Matthew Schipper, Yebin Tao, Daniel Normolle, Larry Junck, Aaron Mammoser, Bryan L Betz, Yue Cao, Christopher J Kim and 4 more

Abstract readClinical Trial, Phase I
In one paragraph

Article in International journal of radiation oncology, biology, physics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

13 citing papers in PubMed, 21 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

14 authors at 3 institutions in 1 country.

Michelle M KimDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan. Electronic address: michekim@med.umich.edu.
Sandra Camelo-PiraguaDepartment of Pathology, University of Michigan, Ann Arbor, Michigan.
Matthew SchipperDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan; Department of Biostatistics, University of Michigan, Ann Arbor, Michigan.
Yebin TaoDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan; Department of Biostatistics, University of Michigan, Ann Arbor, Michigan.
Daniel NormolleDepartment of Biostatistics, University of Pittsburgh, Pittsburgh, Pennsylvania.
Larry JunckDepartment of Neurology, University of Michigan, Ann Arbor, Michigan.
Aaron MammoserDepartment of Neurology, University of Michigan, Ann Arbor, Michigan.
Bryan L BetzDepartment of Pathology, University of Michigan, Ann Arbor, Michigan.
Yue CaoDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan; Department of Radiology, University of Michigan, Ann Arbor, Michigan; Department of Biomedical Engineering, University of Michigan, Ann Arbor, Michigan.
Christopher J KimDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Jason HethDepartment of Neurosurgery, University of Michigan, Ann Arbor, Michigan.
Oren SagherDepartment of Neurosurgery, University of Michigan, Ann Arbor, Michigan.
Theodore S LawrenceDepartment of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.
Christina I TsienDepartment of Radiation Oncology, Washington University, St. Louis, Missouri.
University of Michigan–Ann Arbor · USUniversity of Pittsburgh · USWashington University in St. Louis · US

Funding

XenograftP30CA046592 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI THEODORE S LAWRENCE · 1988 to 2026
$178.2M
VECTOR CORE FACILITYP30CA047904 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI Jessie Nedrow · 1988 to 2026
$158.0M
NCI NIH HHS P30 CA046592NCI NIH HHS P30 CA047904
6 · The paper itself

Abstract

purposeTo evaluate the tolerability and efficacy of gemcitabine plus radiation therapy (RT) in this phase 1 study of patients with newly diagnosed malignant glioma (HGG). PATIENTS AND

methodsBetween 2004 and 2012, 29 adults with HGG were enrolled. After any extent of resection, RT (60 Gy over 6 weeks) was given concurrent with escalating doses of weekly gemcitabine. Using a time-to-event continual reassessment method, 5 dose levels were evaluated starting at 500 mg/m(2) during the last 2 weeks of RT and advanced stepwise into earlier weeks. The primary objective was to determine the recommended phase 2 dose of gemcitabine plus RT. Secondary objectives included progression-free survival, overall survival (OS), and long-term toxicity.

resultsMedian follow-up was 38.1 months (range, 8.9-117.5 months); 24 patients were evaluable for toxicity. After 2005 when standard practice changed, patients with World Health Organization grade 4 tumors were no longer enrolled. Median progression-free survival for 22 patients with grade 3 tumors was 26.0 months (95% confidence interval [CI] 15.6-inestimable), and OS was 48.5 months (95% CI 26.8-inestimable). In 4 IDH mutated, 1p/19q codeleted patients, no failures occurred, with all but 1 alive at time of last follow-up. Seven with IDH mutated, non-codeleted tumors with ATRX loss had intermediate OS of 73.5 months (95% CI 32.8-inestimable). Six nonmutated, non-codeleted patients had a median OS of 26.5 months (95% CI 25.4-inestimable). The recommended phase 2 dose of gemcitabine plus RT was 750 mg/m(2)/wk given the last 4 weeks of RT. Dose reductions were most commonly due to grade 3 neutropenia; no grade 4 or 5 toxicities were seen.

conclusionsGemcitabine concurrent with RT is well-tolerated and yields promising outcomes, including in patients with adverse molecular features. It is a candidate for further study, particularly for poor-prognosis patient subgroups with HGG.

Indexed as

AdultAgedBrain NeoplasmsDeoxycytidineDisease-Free SurvivalDrug Administration ScheduleFemaleGemcitabineGliomaHumansMaleMaximum Tolerated DoseMiddle AgedNeutropeniaRadiation-Sensitizing AgentsRadiotherapy DosageDeoxycytidineGemcitabineRadiation-Sensitizing Agents

Identifiers

PMID26853339
PMCPMC4746478
OpenAlexW2105207519

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.