Evidence map›Paper›PMID 18955445›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2008

Phase I/II trial of erlotinib and temozolomide with radiation therapy in the treatment of newly diagnosed glioblastoma multiforme: North Central Cancer Treatment Group Study N0177.

Paul D Brown, Sunil Krishnan, Jann N Sarkaria, Wenting Wu, Kurt A Jaeckle, Joon H Uhm, Francois J Geoffroy, Robert Arusell, Gaspar Kitange, Robert B Jenkins and 10 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 138 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
138citing papers in PubMed, 4 pooled it
12.0field-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

138 citing papers in PubMed, 4 syntheses or guidelines pooled it, 274 citations in OpenAlex.

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78 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

20 authors at 3 institutions in 1 country.

Paul D BrownMayo Clinic and Mayo Foundation, Rochester, MN 55905, USA. brown.paul@mayo.edu
Sunil Krishnan
Jann N Sarkaria
Wenting Wu
Kurt A Jaeckle
Joon H Uhm
Francois J Geoffroy
Robert Arusell
Gaspar Kitange
Robert B Jenkins
John W Kugler
Roscoe F Morton
Kendrith M Rowland
Paul Mischel
William H Yong
Bernd W Scheithauer
David Schiff
Caterina Giannini
Jan C Buckner
North Central Cancer Treatment Group Study N0177
Iowa Oncology Research Association · USMayo Clinic · USMayo Clinic in Florida · US

Funding

TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
SUPPLEMENTU10CA037404 · NCI · MAYO CLINIC ROCHESTER · PI LOPRINZI, CHARLES L · 1985 to 2014
$34.8M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
W METRO-MINNEAPOLIS COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035267 · NCI · PARK NICOLLET INSTITUTE · PI LEACH, JOSEPH · 1985 to 2014
$23.2M
Targeted MV-CEA as a Potent Antitumor Agent against GBMP50CA108961 · NCI · MAYO CLINIC ROCHESTER · PI O'NEILL, BRIAN PATRICK · 2004 to 2015
$22.5M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
MISSOURI VALLEY CANCER CONSORTIUM CCOPU10CA063849 · NCI · MISSOURI VALLEY CANCER CONSORTIUM, INC. · PI SOORI, GAMINI · 1994 to 2014
$11.3M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035195 · NCI · CARLE FOUNDATION HOSPITAL (URBANA, IL) · PI ROWLAND, KENDRITH MARTIN · 1985 to 2014
$11.3M
Illinois Oncology Research Association Community Clinical Oncology ProgramU10CA035113 · NCI · ONCOLOGY-HEMATOLOGY ASSOC-CENTRAL ILL · PI LE-LINDQWISTER, NGUYET A. · 1985 to 2014
$10.8M
DULUTH COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035269 · NCI · ESSENTIA INSTITUTE OF RURAL HEALTH · PI NIKCEVICH, DANIEL A · 1985 to 2014
$10.7M
IOWA ONCOLOGY RESEARCH ASSOCIATION CCOPU10CA035101 · NCI · IOWA ONCOLOGY RESEARCH ASSOCIATION · PI BEHRENS, ROBERT J. · 1985 to 2014
$10.1M
North Central Cancer Treatment Group (NCCTG) Biospecimen ResourceU24CA114740 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 2005 to 2014
$8.6M
NCI NIH HHS CA-108961NCI NIH HHS CA-114740NCI NIH HHS CA-25224NCI NIH HHS CA-35101NCI NIH HHS CA-35103NCI NIH HHS CA-35113NCI NIH HHS CA-35195NCI NIH HHS CA-35267NCI NIH HHS CA-35269NCI NIH HHS CA-35431NCI NIH HHS CA-37404NCI NIH HHS CA-37417NCI NIH HHS CA-60276NCI NIH HHS CA-63848NCI NIH HHS CA-63849NCI NIH HHS R01 CA127716
6 · The paper itself

Abstract

purposeEpidermal growth factor receptor (EGFR) amplification in glioblastoma multiforme (GBM) is a common occurrence and is associated with treatment resistance. Erlotinib, a selective EGFR inhibitor, was combined with temozolomide (TMZ) and radiotherapy (RT) in a phase I/II trial. PATIENTS AND

methodsAdults not taking enzyme-inducing anticonvulsants after resection or biopsy of GBM were treated with erlotinib (150 mg daily) until progression. Erlotinib was delivered alone for 1 week, then concurrently with TMZ (75 mg mg/m(2) daily) and RT (60 Gy), and finally, concurrently with up to six cycles of adjuvant TMZ (200 mg/m(2) daily for 5 days every 28 days). The primary end point was survival at 1 year.

resultsNinety-seven eligible patients were accrued with a median follow-up time of 22.2 months. By definition, the primary end point was successfully met with a median survival time of 15.3 months. However, there was no sign of benefit in overall survival when comparing N0177 with the RT/TMZ arm of the European Organisation for Research and Treatment of Cancer/National Cancer Institute of Canada trial 26981/22981 (recursive partitioning analysis [RPA] class III, 19 v 21 months; RPA class IV, 16 v 16 months; RPA class V, 8 v 10 months, respectively). Presence of diarrhea, rash, and EGFRvIII, p53, phosphatase and tensin homolog (PTEN), combination EGFR and PTEN, and EGFR amplification status were not predictive (P > .05) of survival.

conclusionAlthough the primary end point was successfully met using nitrosourea-based (pre-TMZ) chemotherapy era historic controls, there was no sign of benefit compared with TMZ era controls. Analyses of molecular subsets did not reveal cohorts of patients sensitive to erlotinib. TMZ chemotherapy combined with RT resulted in improved outcomes compared with historical controls who received nitrosourea-based chemotherapies.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCohort StudiesCombined Modality TherapyDacarbazineDisease ProgressionErlotinib HydrochlorideFemaleGlioblastomaHumansMaleMiddle AgedQuinazolinesRadiotherapyDacarbazineErlotinib HydrochlorideQuinazolinesTemozolomide

Identifiers

PMID18955445
PMCPMC2651097
OpenAlexW2165254737

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.