Evidence map›Paper›PMID 34751786›Full record

ArticleNeuro-oncology2022

Volumetric measurements are preferred in the evaluation of mutant IDH inhibition in non-enhancing diffuse gliomas: Evidence from a phase I trial of ivosidenib.

Benjamin M Ellingson, Grace Hyun J Kim, Matt Brown, Jihey Lee, Noriko Salamon, Lori Steelman, Islam Hassan, Shuchi S Pandya, Saewon Chun, Michael Linetsky and 5 more

Registry-linked trialAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Neuro-oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02073994 (A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation), which is not on this map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
–field-weighted citation impact
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.

NCT02073994 phase1completednot on this map

A Phase 1, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation

TypeinterventionalSponsorInstitut de Recherches Internationales ServierRan2014 to 2024Enrolled174ConditionsCholangiocarcinoma, Chondrosarcoma, Glioma, Other Advanced Solid TumorsArmsAG-120
3 · Its place in the literature

Who cites it

44 citing papers in PubMed.

  1. Trial
  2. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma.The New England journal of medicine · 2023
    Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Review
  13. Review
  14. Article
  15. Review
  16. Review
  17. Review
  18. Article
  19. Updated Response Assessment in Neuro-Oncology (RANO) for Gliomas.Current neurology and neuroscience reports · 2024
    Review
  20. Tumor Volume Growth Rates and Doubling Times during Active Surveillance of IDH-mutant Low-Grade Glioma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2024
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Benjamin M EllingsonUCLA Brain Tumor Imaging Laboratory, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.ORCID 0000-0002-2764-6640
Grace Hyun J KimUCLA Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Matt BrownUCLA Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Jihey LeeUCLA Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Noriko SalamonDepartment of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Lori SteelmanServier Pharmaceuticals, LLC, Boston, Massachusetts, USA.
Islam HassanServier Pharmaceuticals, LLC, Boston, Massachusetts, USA.
Shuchi S PandyaServier Pharmaceuticals, LLC, Boston, Massachusetts, USA.
Saewon ChunUCLA Brain Tumor Imaging Laboratory, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Michael LinetskyDepartment of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Bryan YooDepartment of Radiological Sciences, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Patrick Y WenCenter for Neuro-Oncology, Dana-Farber Cancer Institute & Harvard Medical School, Boston, Massachusetts, USA.
Ingo K MellinghoffDepartment of Neurology, Memorial Sloan Kettering Cancer Center, New York, New York, USA.
Jonathan GoldinUCLA Center for Computer Vision and Imaging Biomarkers, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.
Timothy F CloughesyDepartment of Neurology, David Geffen School of Medicine, University of California Los Angeles, Los Angeles, California, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
UCLA SPORE in Brain CancerP50CA211015 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Yvonne Yu-Hsuan Chen · 2017 to 2026
$25.2M
EPA EP-C-15-003NCI NIH HHS P30 CA008748NCI NIH HHS P50 CA211015
6 · The paper itself

Abstract

backgroundSince IDH-mutant (mIDH) low-grade gliomas (LGGs) progress slowly and have a relatively long survival, there is a significant need for earlier measurements of clinical benefit. Guidance using the LGG RANO criteria recommends serial bidirectional (2D) measurements on a single slice; however, questions remain as to whether volumetric (3D) measurements are better, since they would allow for more accurate measurements in irregular shaped lesions and allow readers to better assess areas of subtle change.

methodsTwenty-one (out of 24) non-enhancing, recurrent mIDH1 LGGs were enrolled in a phase I, multicenter, open-label study of oral ivosidenib (NCT02073994), and with imaging pre- and post-treatment as part of this exploratory ad hoc analysis. 2D and 3D measurements on T2-weighted FLAIR images were centrally evaluated at an imaging contract research organization using a paired read and forced adjudication paradigm. The effects of 2D vs 3D measurements on progression-free survival (PFS), growth rate measurement variability, and reader concordance and adjudication rates were quantified.

results3D volumetric measurements showed significantly longer estimated PFS (P = .0181), more stable (P = .0063) and considerably slower measures of tumor growth rate (P = .0037), the highest inter-reader agreement (weighted kappa = 0.7057), and significantly lower reader discordance rates (P = .0002) with 2D LGG RANO.

conclusion3D volumetric measurements are better for determining response assessment in LGGs due to more stable measures of tumor growth rates (ie, less "yo-yo-ing" of measurements over time), highest inter-reader agreement, and lowest reader discordance rates. Continued evaluation in future studies is warranted to determine whether these measurements reflect clinical benefit.

Indexed as

Brain NeoplasmsGliomaGlycineHumansIsocitrate DehydrogenaseMagnetic Resonance ImagingPyridinesGlycineIsocitrate DehydrogenaseivosidenibPyridinesIDH-mutant gliomasivosidenibLGG RANOlow-grade gliomas

Identifiers

PMID34751786
PMCPMC9071341

What OpenQuestion holds

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Registered trials

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.