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

2009; Elsevier BV; Volume: 20; Issue: 9 Linguagem: Inglês

10.1093/annonc/mdp032

1569-8041

Bart Neyns, Jan Sadones, E. Joosens, Frank Bouttens, Luc Verbeke, Jean‐François Baurain, Lionel D’Hondt, Theo Strauven, C. Chaskis, Pieter In 'T Veld, Alex Michotte, Jacques De Grève,

Histone Deacetylase Inhibitors Research

Abstract 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/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. 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.