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

被引：180

作者：

Neyns, B. ^{[1
]}

Sadones, J. ^{[1
]}

Joosens, E. ^{[2
]}

Bouttens, F. ^{[3
]}

Verbeke, L. ^{[4
]}

Baurain, J. -F. ^{[5
]}

D'Hondt, L. ^{[6
]}

Strauven, T. ^{[7
]}

Chaskis, C. ^{[8
]}

Veld, P. In't ^{[9
]}

Michotte, A. ^{[10
,11
]}

De Greve, J. ^{[1
]}

机构：

[1] UZ Brussel, Dept Med Oncol, B-1090 Brussels, Belgium

[2] ZNA Middelheim, Dept Med Oncol, Antwerp, Belgium

[3] AZ St Lucas, Dept Radiat Therapy, Ghent, Belgium

[4] OLV Aalst, Dept Radiat Therapy, Aalst, Belgium

[5] Clin Univ St Luc, Dept Med Oncol, B-1200 Brussels, Belgium

[6] Ctr Hosp Notre Dame & Reine Fabiola, Dept Med Oncol, Charleroi, Belgium

[7] Dept Neurol, Antwerp, Belgium

[8] UZ Brussel, Dept Neurosurg, B-1090 Brussels, Belgium

[9] UZ Brussel, Dept Expt Pathol, B-1090 Brussels, Belgium

[10] UZ Brussel, Dept Neurol, B-1090 Brussels, Belgium

[11] UZ Brussel, Dept Neuropathol, B-1090 Brussels, Belgium

来源：

ANNALS OF ONCOLOGY | 2009年 / 20卷 / 09期

关键词：

cetuximab; EGFR; glioblastoma; GROWTH-FACTOR-RECEPTOR; REFRACTORY COLORECTAL-CANCER; CELL LUNG-CANCER; MONOCLONAL-ANTIBODY; GLIOBLASTOMA-MULTIFORME; EGFR; MUTATIONS; GEFITINIB; GENE; AMPLIFICATION;

D O I：

10.1093/annonc/mdp032

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1596 / 1603

页数：8

共 58 条

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