Stratified phase II trial of cetuximab in patients with recurrent high-grade glioma
Stratified phase II trial of cetuximab in patients with recurrent high-grade glioma
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DOI：
10.1093/annonc/mdp032
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发表时间：
2009-09-01
影响因子：
50.5
通讯作者：
De Greve, J.
中科院分区：
文献类型：
--
作者：
Neyns, B.;Sadones, J.;De Greve, J.
患者和方法：在这项两组、开放标签的II期研究中，根据表皮生长因子受体（EGFR）基因扩增状态对患者进行分层。西妥昔单抗在第1周静脉注射剂量为400mg /m(2)，随后每周剂量为250mg /m(2)。本研究的主要终点是两个研究组的反应率。结果：55例符合条件的患者（28例伴有EGFR扩增，27例未伴有EGFR扩增）对西妥昔单抗耐受良好。3例患者（5.5%）部分缓解，16例患者（29.6%）病情稳定。中位进展时间为1.9个月[95%置信区间（CI） 1.6-2.2个月]。尽管大多数患者（n = 50/55）的无进展生存期(PFS) < 6个月，但有5名患者（9.2%）的西妥昔单抗的PFS为50/ 9个月。中位总生存期为5.0个月（95% CI 4.2-5.9个月）。疗效、生存率与EGFR扩增无显著相关性。结论：西妥昔单抗耐受性良好，但在进行性HGG患者群体中活性有限。少数患者可能获得更持久的益处，但不能通过EGFR基因拷贝数进行前瞻性鉴定。
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.