Evidence map›Paper›PMID 25762461›Full record

Trial reportNeuro-oncology2015

Two cilengitide regimens in combination with standard treatment for patients with newly diagnosed glioblastoma and unmethylated MGMT gene promoter: results of the open-label, controlled, randomized phase II CORE study.

L Burt Nabors, Karen L Fink, Tom Mikkelsen, Danica Grujicic, Rafal Tarnawski, Do Hyun Nam, Maria Mazurkiewicz, Michael Salacz, Lynn Ashby, Vittorina Zagonel and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neuro-oncology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 144 papers, 11 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
144citing papers in PubMed, 11 pooled it
15.9field-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

144 citing papers in PubMed, 11 syntheses or guidelines pooled it, 231 citations in OpenAlex.

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  6. Anti-epidermal growth factor receptor therapy for glioblastoma in adults.The Cochrane database of systematic reviews · 2020
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  9. Anti-vascular endothelial growth factor in glioblastoma: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2018
    Pooled it
  10. Anti-angiogenic therapy for high-grade glioma.The Cochrane database of systematic reviews · 2018
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84 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 8 countries.

L Burt NaborsUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Karen L FinkUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Tom MikkelsenUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Danica GrujicicUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Rafal TarnawskiUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Do Hyun NamUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Maria MazurkiewiczUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Michael SalaczUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Lynn AshbyUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Vittorina ZagonelUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Roberta DepenniUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
James R PerryUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Christine HickingUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Martin PicardUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Monika E HegiUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
Benoit LhermitteUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
David A ReardonUniversity of Alabama at Birmingham, Birmingham, Alabama (L.B.N.); Baylor University Medical Center, Dallas, Texas (K.L.F.); Henry Ford Hospital, Detroit, Michigan (T.M.); Clinic for Neurosurgery, Clinical Center of Serbia, Medical Faculty University of Belgrade, Belgrade, Serbia (D.G.); Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology Gliwice Branch, Radiotherapy and Chemotherapy Clinic, Gliwice, Poland (R.T.); Samsung Medical Center, Seoul, South Korea (D.H.N.); Centrum Onkologii Ziemi Lubelskiej, Lublin, Poland (M.M.); St. Luke's Brain Tumor Center, St. Luke's Hospital, Kansas City, Missouri (M.S.); Barrow Neurological Institute, Phoenix, Arizona (L.A.); Medical Oncology Unit 1, IOV, IRCCS, Padova, Italy (V.Z.); Policlinico di Modena, Modena, Italy (R.D.); Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada (J.R.P.); Merck KGaA, Darmstadt, Germany (C.H., M.P.); Department of Clinical Neurosciences, University Hospital Lausanne, Lausanne, Switzerland (M.E.H.); Institute of Pathology, University Hospital Lausanne, Lausanne, Switzerland (B.L.); Dana-Farber Cancer Institute, Boston, Massachusetts (D.A.R.).
The Maria Sklodowska-Curie National Research Institute of Oncology · PLBaylor University · USHenry Ford Health System · USIstituto Oncologico Veneto · ITLublin Oncology Center · PLMerck (Germany) · DESt. Joseph's Hospital and Medical Center · USUniversity of Lausanne · CHUniversity of Toronto · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSurvival outcomes for patients with glioblastoma remain poor, particularly for patients with unmethylated O(6)-methylguanine-DNA methyltransferase (MGMT) gene promoter. This phase II, randomized, open-label, multicenter trial investigated the efficacy and safety of 2 dose regimens of the selective integrin inhibitor cilengitide combined with standard chemoradiotherapy in patients with newly diagnosed glioblastoma and an unmethylated MGMT promoter.

methodsOverall, 265 patients were randomized (1:1:1) to standard cilengitide (2000 mg 2×/wk; n = 88), intensive cilengitide (2000 mg 5×/wk during wk 1-6, thereafter 2×/wk; n = 88), or a control arm (chemoradiotherapy alone; n = 89). Cilengitide was administered intravenously in combination with daily temozolomide (TMZ) and concomitant radiotherapy (RT; wk 1-6), followed by TMZ maintenance therapy (TMZ/RT→TMZ). The primary endpoint was overall survival; secondary endpoints included progression-free survival, pharmacokinetics, and safety and tolerability.

resultsMedian overall survival was 16.3 months in the standard cilengitide arm (hazard ratio [HR], 0.686; 95% CI: 0.484, 0.972; P = .032) and 14.5 months in the intensive cilengitide arm (HR, 0.858; 95% CI: 0.612, 1.204; P = .3771) versus 13.4 months in the control arm. Median progression-free survival assessed per independent review committee was 5.6 months (HR, 0.822; 95% CI: 0.595, 1.134) and 5.9 months (HR, 0.794; 95% CI: 0.575, 1.096) in the standard and intensive cilengitide arms, respectively, versus 4.1 months in the control arm. Cilengitide was well tolerated.

conclusionsStandard and intensive cilengitide dose regimens were well tolerated in combination with TMZ/RT→TMZ. Inconsistent overall survival and progression-free survival outcomes and a limited sample size did not allow firm conclusions regarding clinical efficacy in this exploratory phase II study.

Indexed as

AdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBrain NeoplasmsDacarbazineDNA MethylationDNA Modification MethylasesDNA Repair EnzymesFemaleGlioblastomaHumansKaplan-Meier EstimateMaleMiddle AgedPromoter Regions, GeneticAntineoplastic AgentsCilengitideDacarbazineDNA Modification MethylasesDNA Repair EnzymesMGMT protein, humanSnake VenomsTemozolomideTumor Suppressor Proteinscilengitidenewly diagnosed glioblastomarandomized phase II studyunmethylated MGMT promoter

Identifiers

PMID25762461
PMCPMC4482861
OpenAlexW2105932257

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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.