Evidence map›Paper›PMID 30131387›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2019

Phase II Study of Iniparib with Concurrent Chemoradiation in Patients with Newly Diagnosed Glioblastoma.

Jaishri O Blakeley, Stuart A Grossman, Andrew S Chi, Tom Mikkelsen, Myrna R Rosenfeld, Manmeet S Ahluwalia, L Burt Nabors, April Eichler, Ignacio Garcia Ribas, Serena Desideri and 2 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2019. 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
–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.

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.

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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

12 authors.

Jaishri O BlakeleyDepartment of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland. Jblakel3@jhmi.edu.
Stuart A GrossmanDepartment of Oncology and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Andrew S ChiLaura and Isaac Perlmutter Cancer Center, New York University School of Medicine, New York, New York.
Tom MikkelsenOntario Brain Institute, Toronto, Ontario, Canada.
Myrna R RosenfeldInstitute for Biomedical Research (IDIBAPS)/Hospital Clinic, Barcelona, Spain.ORCID 0000-0001-5095-2534
Manmeet S AhluwaliaBrain Tumor and Neuro-Oncology Center, Cleveland Clinic, Cleveland, Ohio.
L Burt NaborsDepartment of Neurology, University of Alabama at Birmingham, Birmingham, Alabama.ORCID 0000-0001-5926-2230
April EichlerDepartment of Neurology, Massachusetts General Hospital, Boston, Massachusetts.
Ignacio Garcia RibasTakeda Oncology, Cambridge, Massachusetts.
Serena DesideriDepartment of Oncology, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Xiaobu YeDepartment of Oncology and Neurosurgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.
Adult Brain Tumor Consortium

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
Adult Brain Tumor Consortium (ABTC)U01CA137443 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A, PRADOS, MICHAEL D · 2009 to 2013
$11.0M
Adult Brain Tumor Consortium (ABTC)UM1CA137443 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A · 2014 to 2020
$9.7M
NEW APPROACHES TO BRAIN TUMOR THERAPY CNS CONSORTIUMU01CA062475 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A · 1994 to 2008
$5.6M
RESEARCH TRAINING IN NEURO-ONCOLOGY FOR NEUROSURGEONST32CA009574 · NCI · JOHNS HOPKINS UNIVERSITY · PI GROSSMAN, STUART A · 1987 to 2012
$2.6M
NCI NIH HHS P30 CA006973NCI NIH HHS T32 CA009574NCI NIH HHS U01 CA062475NCI NIH HHS U01 CA137443NCI NIH HHS UM1 CA137443
6 · The paper itself

Abstract

purposeIniparib is a purported prodrug causing cell death through intracellular conversion to nitro radical ions. We assessed the efficacy and safety of iniparib with standard radiotherapy and temozolomide in patients with newly diagnosed glioblastoma (GBM). PATIENTS AND

methodsAdults meeting eligibility criteria were enrolled in this prospective, single-arm, open-label multi- institution phase II trial with median overall survival (mOS) compared with a historical control as the primary objective. A safety run-in component of radiotherapy + temozolomide + iniparib (

resultsThe median age of the 81 evaluable participants was 58 years (63% male). Baseline KPS was ≥ 80% in 87% of participants. The mOS was 22 months [95% confidence interval (CI), 17-24] and the HR was 0.44 (95% CI, 0.35-0.55) per-person-year of follow-up. The 2- and 3-year survival rates were 38% and 25%, respectively. Treatment-related grade 3 adverse events (AEs) occurred in 27% of patients; 9 patients had AEs requiring drug discontinuation including infusion-related reaction, rash, gastritis, increased liver enzymes, and thrombocytopenia.

conclusionsIniparib is well tolerated with radiotherapy and temozolomide in patients with newly diagnosed GBM at up to 17.2 mg/kg weekly. The primary objective of improved mOS compared with a historical control was met, indicating potential antitumor activity of iniparib in this setting. Dosing optimization (frequency and sequence) is needed prior to additional efficacy studies.

Indexed as

BenzamidesBrain NeoplasmsChemoradiotherapyCombined Modality TherapyFemaleGlioblastomaHumansMaleMiddle AgedTemozolomideTreatment OutcomeBenzamidesiniparibTemozolomide

Identifiers

PMID30131387
PMCPMC6367923

What OpenQuestion holds

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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.