Evidence map›Paper›PMID 21345842›Full record

Trial reportNeuro-oncology2011

Temozolomide in the treatment of children with newly diagnosed diffuse intrinsic pontine gliomas: a report from the Children's Oncology Group.

Kenneth J Cohen, Richard L Heideman, Tianni Zhou, Emiko J Holmes, Robert S Lavey, Eric Bouffet, Ian F Pollack

2 registry-linked trialsOpen access · bronzeAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuro-oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 179 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
179citing papers in PubMed, 3 pooled it
10.7field-weighted citation impact, top 1% 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.

NCT00028795 phase2completednot on this map

A Phase II Study of Temozolomide in the Treatment of Children With High Grade Glioma

TypeinterventionalSponsorChildren's Oncology GroupRan2002 to 2012Enrolled170ConditionsBrain and Central Nervous System TumorsArmstemozolomide, adjuvant therapy, radiation therapy
NCT02758366 phase2terminatednot on this mapstarted 2016, after this paper: background citation

An Open-label, Single-arm, Phase II Study to Evaluate Safety and Efficacy of Doxorubicin in Combination With Radiotherapy, Temozolomide and Valproic Acid in Patients With Glioblastoma Multiforme (GBM) and Diffuse Intrinsic Pontine Glioma (DIPG)

TypeinterventionalSponsorMeyer Children's Hospital IRCCSRan2016 to 2020Enrolled21ConditionsGlioblastoma (GBM), DIPG, Brainstem Glioma, Pediatric, Diffuse Spinal GliomaArmsDoxorubicin
3 · Its place in the literature

Who cites it

179 citing papers in PubMed, 3 syntheses or guidelines pooled it, 338 citations in OpenAlex.

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119 more citing papers are in PubMed but not listed here.

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

7 authors at 5 institutions in 2 countries.

Kenneth J CohenThe Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD 21287, USA. kcohen@jhmi.edu
Richard L Heideman
Tianni Zhou
Emiko J Holmes
Robert S Lavey
Eric Bouffet
Ian F Pollack
Children's Oncology Group · USMoffitt Cancer Center · USArcadia · USHospital for Sick Children · CAUniversity of Southern California · US

Funding

COG FOREIGN ACCRUALU10CA098543 · NCI · NATIONAL CHILDHOOD CANCER FOUNDATION · PI ADAMSON, PETER C. · 2003 to 2013
$335.5M
Children's Oncology Group Statistics &Data Center GrantU10CA098413 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI ANDERSON, JAMES R · 2003 to 2013
$67.5M
NCI NIH HHS U10 CA98413-08NCI NIH HHS U10 CA98543-08
6 · The paper itself

Abstract

An open-label phase II study (ACNS0126) testing the efficacy of chemoradiotherapy with temozolomide (TMZ) followed by adjuvant TMZ was conducted by the Children's Oncology Group. During the period from July 6, 2004 through September 6, 2005, 63 children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) were enrolled in the study. All patients received TMZ at a dosage of 90 mg/m(2)/day for 42 days to a dose of 59.4 Gy. Four weeks following irradiation, TMZ was given at a dosage of 200 mg/m(2)/day for 5 days every 28 days, for a total of 10 cycles. The primary objective of the statistical analysis was to determine whether the current treatment produced a 1-year event-free survival (EFS) rate higher than the historical baseline of 21.9% observed in CCG-9941. The mean 1-year EFS (± standard deviation) was 14% ± 4.5%, compared with 21.9% ± 5% for CCG-9941. The P value of the test of comparison of 1-year EFS, based on a 1-sided, 1-sample test of proportions, was .96. There was no evidence that temozolomide produced a 1-year EFS rate higher than 21.9%. The mean 1-year OS (± standard deviation) was 40% ± 6.5%, compared with 32% ± 6% for CCG-9941. The median time to death was 9.6 months. Chemoradiotherapy with TMZ followed by adjuvant TMZ is not more effective than previously reported regimens for the treatment of children with DIPG.

Indexed as

PonsAdolescentAntineoplastic Agents, AlkylatingBrain Stem NeoplasmsChemotherapy, AdjuvantChildChild, PreschoolCombined Modality TherapyDacarbazineFemaleHumansMaleRadiotherapy DosageSurvival RateTemozolomideTreatment OutcomeAntineoplastic Agents, AlkylatingDacarbazineTemozolomide

Identifiers

PMID21345842
PMCPMC3064697
OpenAlexW2106343920

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.