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Annals of Oncology Advance Access originally published online on June 2, 2009
Annals of Oncology 2009 20(9):1596-1603; 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

brain tumors

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.

Key words: cetuximab, EGFR, glioblastoma

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


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