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Annals of Oncology Advance Access published online on June 2, 2009
Annals of Oncology, doi:10.1093/annonc/mdp032
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Stratified phase II trial of cetuximab in patients with recurrent high-grade glioma

B. Neyns1,*, J. Sadones1, E. Joosens2, F. Bouttens3, L. Verbeke4, J.-F. Baurain5, L. D'Hondt6, T. Strauven7, C. Chaskis8, P. In't Veld9, A. Michotte10,11 and J. De Greve1

1 Department of Medical Oncology, UZ Brussel, Brussels
2 Department of Medical Oncology, ZNA Middelheim, Antwerp
3 Department of Radiation therapy, AZ St Lucas, Ghent
4 Department of Radiation therapy, OLV Aalst, Aalst
5 Department of Medical Oncology, Cliniques Universitaires St Luc, Brussels
6 Department of Medical Oncology, Centre Hospitalier Notre-Dame et Reine Fabiola, Charleroi
7 Department of Neurology, Sint-Augustinus, Antwerp
8 Department of Neurosurgery
9 Department of Experimental pathology
10 Department of Neurology
11 Department of Neuropathology, UZ Brussel, Brussels, Belgium

* Correspondence to: Prof. B. Neyns, Department of Medical Oncology, UZ Brussel, Laarbeeklaan 101, 1090 Brussels, Belgium. Tel: +3224776415; Fax: +3224776012 E-mail: bart.neyns{at}uzbrussel.be

Background: To evaluate the antitumor activity and toxicity of single-agent cetuximab in patients with recurrent high-grade glioma (HGG) after failure of surgery, radiation therapy, and chemotherapy.

Patients and methods: In this two-arm, open-label, phase II study patients were stratified according to their epidermal growth factor receptor (EGFR) gene amplification status. Cetuximab was administered intravenously at a dose of 400 mg/m2 on week 1 followed by weekly dose of 250 mg/m2. The primary end point for this study was the response rate in both study arms separately.

Results: Fifty-five eligible patients (28 with and 27 without EGFR amplification) tolerated cetuximab well. Three patients (5.5%) had a partial response and 16 patients (29.6%) had stable disease. The median time to progression was 1.9 months [95% confidence interval (CI) 1.6–2.2 months]. Whereas the progression-free survival (PFS) was <6 months in the majority (n = 50/55) of patients, five patients (9.2%) had a PFS on cetuximab of >9 months. Median overall survival was 5.0 months (95% CI 4.2–5.9 months). No significant correlation was found between response, survival and EGFR amplification.

Conclusions: Cetuximab was well tolerated but had limited activity in this patient population with progressive HGG. A minority of patients may derive a more durable benefit but were not prospectively identified by EGFR gene copy number.

cetuximab, EGFR, glioblastoma

Received for publication November 11, 2008. Revision received January 25, 2009. Accepted for publication January 26, 2009.


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