Stratified phase II trial of cetuximab in patients with recurrent high-grade glioma |
| |
Affiliation: | 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 |
| |
Abstract: | BackgroundTo 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 methodsIn 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.ResultsFifty-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.ConclusionsCetuximab 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. |
| |
Keywords: | |
本文献已被 ScienceDirect 等数据库收录! |
|