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Stratified phase II trial of cetuximab in patients with recurrent high-grade glioma
- Source :
- Vrije Universiteit Brussel, Annals of Oncology, Vol. 20, no. 9, p. 1596-603 (2009)
- Publication Year :
- 2009
- Publisher :
- Elsevier BV, 2009.
-
Abstract
- 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.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/m(2) on week 1 followed by weekly dose of 250 mg/m(2). The primary end point for this study was the response rate in both study arms separately.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) was6 months in the majority (n = 50/55) of patients, five patients (9.2%) had a PFS on cetuximab of9 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.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.
- Subjects :
- Male
Adult
Oncology
medicine.medical_specialty
EGFR
Phases of clinical research
Antineoplastic Agents
Kaplan-Meier Estimate
Antibodies, Monoclonal, Humanized
Disease-Free Survival
Internal medicine
Glioma
cetuximab
medicine
Clinical endpoint
Humans
Epidermal growth factor receptor
Aged
biology
Cetuximab
Brain Neoplasms
business.industry
glioblastoma
Antibodies, Monoclonal
Cancer
Hematology
Middle Aged
medicine.disease
Magnetic Resonance Imaging
Chemotherapy regimen
Confidence interval
Surgery
ErbB Receptors
biology.protein
Female
Receptor, Epidermal Growth Factor
business
medicine.drug
Subjects
Details
- ISSN :
- 09237534
- Volume :
- 20
- Database :
- OpenAIRE
- Journal :
- Annals of Oncology
- Accession number :
- edsair.doi.dedup.....0983223ff7c30062d4feef7ac2251e50