Evidence map›Paper›PMID 20511192›Full record

Trial reportNeuro-oncology2010

Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel wafers for recurrent glioblastoma.

Sandeep Kunwar, Susan Chang, Manfred Westphal, Michael Vogelbaum, John Sampson, Gene Barnett, Mark Shaffrey, Zvi Ram, Joseph Piepmeier, Michael Prados and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuro-oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 244 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
244citing papers in PubMed, 8 pooled it
14.6field-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.

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

244 citing papers in PubMed, 8 syntheses or guidelines pooled it, 474 citations in OpenAlex.

  1. Pooled it
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184 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

17 authors at 9 institutions in 3 countries.

Sandeep KunwarDivision of Neuro-Oncology, Department of Neurological Surgery, University of California, 400 Parnassus Avenue, A-808, San Francisco, CA 94143-0350, USA. changs@neurosurg.ucsf.edu
Susan Chang
Manfred Westphal
Michael Vogelbaum
John Sampson
Gene Barnett
Mark Shaffrey
Zvi Ram
Joseph Piepmeier
Michael Prados
David Croteau
Christoph Pedain
Pamela Leland
Syed R Husain
Bharat H Joshi
Raj K Puri
PRECISE Study Group
NeoPhotonics (United States) · USUniversität Hamburg · DEUniversity of Virginia · USCleveland Clinic · USBrainlab (Germany) · DECenter for Biologics Evaluation and Research · USDuke University · USNeurological Surgery · USTel Aviv Sourasky Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Convection-enhanced delivery (CED) of cintredekin besudotox (CB) was compared with Gliadel wafers (GW) in adult patients with glioblastoma multiforme (GBM) at first recurrence. Patients were randomized 2:1 to receive CB or GW. CB (0.5 microg/mL; total flow rate 0.75 mL/h) was administered over 96 hours via 2-4 intraparenchymal catheters placed after tumor resection. GW (3.85%/7.7 mg carmustine per wafer; maximum 8 wafers) were placed immediately after tumor resection. The primary endpoint was overall survival from the time of randomization. Prestated interim analyses were built into the study design. Secondary and tertiary endpoints were safety and health-related quality-of-life assessments. From March 2004 to December 2005, 296 patients were enrolled at 52 centers. Demographic and baseline characteristics were balanced between the 2 treatment arms. Median survival was 36.4 weeks (9.1 months) for CB and 35.3 weeks (8.8 months) for GW (P = .476). For the efficacy evaluable population, the median survival was 45.3 weeks (11.3 months) for CB and 39.8 weeks (10 months) for GW (P = .310). The adverse-events profile was similar in both arms, except that pulmonary embolism was higher in the CB arm (8% vs 1%, P = .014). This is the first randomized phase III evaluation of an agent administered via CED and the first with an active comparator in GBM patients. There was no survival difference between CB administered via CED and GW. Drug distribution was not assessed and may be crucial for evaluating future CED-based therapeutics.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsBrain NeoplasmsCarmustineCatheters, IndwellingConvectionDecanoic AcidsDrug Administration RoutesExotoxinsFemaleGlioblastomaHumansInterleukin-13Kaplan-Meier EstimateAntineoplastic AgentsCarmustinedecanedioic acid-4,4'-(1,3-propanediylbis(oxy))bis(benzoic acid) copolymerDecanoic AcidsExotoxinsIL13-PE38Interleukin-13PolyestersRecombinant Fusion Proteins

Identifiers

PMID20511192
PMCPMC2940677
OpenAlexW2151264866

What OpenQuestion holds

Textmetadata
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.