Cilengitide combined with standard treatment for patients with newly diagnosed glioblastoma with methylated MGMT promoter (CENTRIC EORTC 26071-22072 study): a multicentre, randomised, open-label, phase 3 trial
Open accessAbstract
Background Cilengitide is a selective αvβ3 and αvβ5 integrin inhibitor. Data from phase 2 trials suggest that it has antitumour activity as a single agent in recurrent glioblastoma and in combination with standard temozolomide chemoradiotherapy in newly diagnosed glioblastoma (particularly in tumours with methylated MGMT promoter). We aimed to assess cilengitide combined with temozolomide chemoradiotherapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter.Methods In this multicentre, open-label, phase 3 study, we investigated the efficacy of cilengitide in patients from 146 study sites in 25 countries. Eligible patients (newly diagnosed, histologically proven supratentorial glioblastoma, methylated MGMT promoter, and age ≥18 years) were stratified for prognostic Radiation Therapy Oncology Group recursive partitioning analysis class and geographic region and centrally randomised in a 1:1 ratio with interactive voice response system to receive temozolomide chemoradiotherapy with cilengitide 2000 mg intravenously twice weekly (cilengitide group) or temozolomide chemoradiotherapy alone (control group). Patients and investigators were unmasked to treatment allocation. Maintenance temozolomide was given for up to six cycles, and cilengitide was given for up to 18 months or until disease progression or unacceptable toxic effects. The primary endpoint was overall survival. We analysed survival outcomes by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00689221.Findings Overall, 3471 patients were screened. Of these patients, 3060 had tumour MGMT status tested; 926 patients had a methylated MGMT promoter, and 545 were randomly assigned to the cilengitide (n=272) or control groups (n=273) between Oct 31, 2008, and May 12, 2011. Median overall survival was 26·3 months (95% CI 23·8-28·8) in the cilengitide group and 26·3 months (23·9-34·7) in the control group (hazard ratio 1·02, 95% CI 0·81-1·29, p=0·86). None of the predefined clinical subgroups showed a benefit from cilengitide. We noted no overall additional toxic effects with cilengitide treatment. The most commonly reported adverse events of grade 3 or worse in the safety population were lymphopenia (31 [12%] in the cilengitide group vs 26 [10%] in the control group), thrombocytopenia (28 [11%] vs 46 [18%]), neutropenia (19 [7%] vs 24 [9%]), leucopenia (18 [7%] vs 20 [8%]), and convulsion (14 [5%] vs 15 [6%]).Interpretation The addition of cilengitide to temozolomide chemoradiotherapy did not improve outcomes; cilengitide will not be further developed as an anticancer drug. Nevertheless, integrins remain a potential treatment target for glioblastoma.Funding Merck KGaA, Darmstadt, Germany.
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In a contemporary randomized open-label non-placebo-controlled trial, cilengitide did not translate into any benefit in outcome, with a hazard ratio for death of 1.02 (95% CI 0.81-1.29).
“In a contemporary randomized open-label non-placebo-controlled trial, patients in the experimental arm received twice weekly i.v. administration of cilengitide. Still, this did not translate into any benefit in outcome (hazard ratio for death: 1·02; 95% CI 0·81–1·29).28”
From Tumor treating fields: A novel treatment modality and its use in brain tumors (2016) · cites this paper as [28]
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- Authors
- Stupp, R., Hegi, M. E., Gorlia, T., Erridge, S. C., Perry, J., Hong, Y.-K., Aldape, K. D., Lhermitte, B., Pietsch, T., Grujicic, D., Steinbach, J. P., Wick, W., Tarnawski, R., Nam, D.-H., Hau, P., Weyerbrock, A., Taphoorn, M. J. B., Shen, C.-C., Rao, N., Thurzo, L., Herrlinger, U., Gupta, T., Kortmann, R.-D., Adamska, K., McBain, C., Brandes, A. A., Tonn, J. C., Schnell, O., Wiegel, T., Kim, C.-Y., Nabors, L. B., Reardon, D. A., van den Bent, M. J., Hicking, C., Markivskyy, A., Picard, M., & Weller, M.
- Affiliations
- Centre Hospitalier Universitaire Vaudois (CH)
- European Organisation for Research and Treatment of Cancer (BE)
- Edinburgh Cancer Research (GB)
- Sunnybrook Health Science Centre (CA)
- The Catholic University of Korea Seoul St. Mary's Hospital (KR)
- The University of Texas MD Anderson Cancer Center (US)
- University of Bonn (DE)
- Goethe University Frankfurt (DE)
- German Cancer Research Center (DE)
- Samsung Medical Center (KR)
- University Hospital Regensburg (DE)
- University Medical Center Freiburg (DE)
- Medisch Centrum Haaglanden (NL)
- Taichung Veterans General Hospital (TW)
- Tata Memorial Hospital (IN)
- University Hospital Leipzig (DE)
- Greater Poland Cancer Center (PL)
- The Christie Hospital (GB)
- Istituto delle Scienze Neurologiche di Bologna (IT)
- LMU Klinikum (DE)
- University Hospital Ulm (DE)
- Seoul National University Bundang Hospital (KR)
- Dana-Farber Cancer Institute (US)
- Merck KGaA, Darmstadt (Germany) (DE)
- University Hospital Zurich (CH)
- Corresponding author
- Stupp, Roger
- ORCID
- Stupp, Roger
- Hegi, Monika E
- Gorlia, Thierry
- Erridge, Sara C
- Perry, James
- Aldape, Kenneth D
- Pietsch, Torsten
- Steinbach, Joachim Peter
- Wick, Wolfgang
- Nam, Do-Hyun
- Hau, Peter
- Weyerbrock, Astrid
- Taphoorn, Martin J B
- Shen, Chiung-Chyi
- Herrlinger, Ulrich
- Gupta, Tejpal
- Kortmann, Rolf-Dieter
- McBain, Catherine
- Brandes, Alba A
- Tonn, Joerg Christian
- Schnell, Oliver
- Wiegel, Thomas
- Kim, Chae-Yong
- Reardon, David A
- Hicking, Christine
- Picard, Martin
- Weller, Michael
- Venue
- The Lancet Oncology
- Publisher
- Elsevier BV
- Published
- 2014-09
- Volume
- 15
- Issue
- 10
- Pages
- 1100-1108
- ISSN
- 1470-2045 (ISSN-L)
- OpenAlex
- W2101922439
- Cited by
- 1,052
- References
- 33
- Citations by year
- 2026: 51 · 2025: 86 · 2024: 80 · 2023: 79 · 2022: 87 · 2021: 98 · 2020: 80 · 2019: 87 · 2018: 92 · 2017: 116 · 2016: 102 · 2015: 77 · 2014: 13
- FWCI
- 51.52
- Type
- journal article
- Language
- en
- Open access
- green
- www.zora.uzh.ch
- Licence
- Locations
- The Lancet Oncology (publishedVersion)
- PubMed (publishedVersion)
- Amsterdam UMC (VU Amsterdam) - Institutional Repository (publishedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (publishedVersion)
- Zurich Open Repository and Archive (University of Zurich) (acceptedVersion, other-oa)
- University of Regensburg Publication Server (University of Regensburg) (acceptedVersion)
- EUR Research Repository (Erasmus University Rotterdam) (submittedVersion)
- IRIS (submittedVersion)
- Pure Amsterdam UMC (submittedVersion)
- SERVAL (Université de Lausanne) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich) (submittedVersion, other-oa)
- Data Archiving and Networked Services (DANS) (submittedVersion)
- Zurich Open Repository and Archive (University of Zurich)
- Funders
- Merck KGaA
- Topics
- Health Sciences › Medicine › Genetics › Glioma Diagnosis and Treatment
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Health Sciences › Medicine › Reproductive Medicine › Ovarian cancer diagnosis and treatment
- Keywords
- cilengitide, glioblastoma, newly diagnosed glioblastoma, MGMT promoter methylation, temozolomide, chemoradiotherapy, integrin inhibitors, overall survival, maintenance chemotherapy, treatment toxicity, disease-free survival, progression-free survival
- MeSH terms
- Temozolomide, Aged, Antineoplastic Combined Chemotherapy Protocols, Brain Neoplasms, Dacarbazine, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Follow-Up Studies, Glioblastoma, Humans, Male, Middle Aged, Neoplasm Invasiveness, Neoplasm Staging, Promoter Regions, Genetic, Reference Values, Snake Venoms, DNA Modification Methylases, Confidence Intervals, Proportional Hazards Models, Survival Analysis, Treatment Outcome, Disease-Free Survival, Patient Selection, Maximum Tolerated Dose, Tumor Suppressor Proteins, DNA Repair Enzymes, Kaplan-Meier Estimate, Early Detection of Cancer
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