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首页> 外文期刊>Journal of neuro-oncology. >An open-label, two-stage, phase II study of bevacizumab and lapatinib in children with recurrent or refractory ependymoma: a collaborative ependymoma research network study (CERN)
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An open-label, two-stage, phase II study of bevacizumab and lapatinib in children with recurrent or refractory ependymoma: a collaborative ependymoma research network study (CERN)

机译：贝伐单抗和拉帕替尼治疗复发性或难治性室管膜瘤患儿的开放标签，二阶段II期研究：一项协作性室管膜瘤研究网络研究（CERN）

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Co-expression of ERBB2 and ERBB4, reported in 75 % of pediatric ependymomas, correlates with worse overall survival. Lapatinib, a selective ERBB1 and ERBB2 inhibitor has produced prolonged disease stabilization in patients with ependymoma in a phase I study. Bevacizumab exposure in ependymoma xenografts leads to ablation of tumor self-renewing cells, arresting growth. Thus, we conducted an open-label, phase II study of bevacizumab and lapatinib in children with recurrent ependymomas. Patients a parts per thousand currency sign21 years of age with recurrent ependymoma received lapatinib orally twice daily (900 mg/m(2)/dose to the first 10 patients, and then 700 mg/m(2)/dose) and bevacizumab 10 mg/kg intravenously on days 1 and 15 of a 28-day course. Lapatinib serum trough levels were analyzed prior to each course. Total and phosphorylated VEGFR2 expression was measured in peripheral blood mononuclear cells (PBMCs) before doses 1 and 2 of bevacizumab and 24-48 h following dose 2 of bevacizumab. Twenty-four patients with a median age of 10 years (range 2-21 years) were enrolled; 22 were eligible and 20 evaluable for response. Thirteen had anaplastic ependymoma. There were no objective responses; 4 patients had stable disease for a parts per thousand yen4 courses (range 4-14). Grade 3 toxicities included rash, elevated ALT, and diarrhea. Grade 4 toxicities included peri-tracheostomy hemorrhage (n = 1) and elevated creatinine phosphokinase (n = 1). The median lapatinib pre-dose trough concentration was 3.72 A mu M. Although the combination of bevacizumab and lapatinib was well tolerated in children with recurrent ependymoma, it proved ineffective.
机译：据报道，在75％的儿童室间隔膜瘤中，ERBB2和ERBB4的共表达与总体生存率下降有关。在I期研究中，选择性ERBB1和ERBB2抑制剂拉帕替尼已使室间隔膜瘤患者的疾病稳定时间延长。表皮瘤异种移植物中的贝伐单抗暴露导致肿瘤自我更新细胞的消融，从而阻止了生长。因此，我们对患有复发性室间隔膜瘤的儿童进行了贝伐单抗和拉帕替尼的II期开放性研究。年龄21岁的复发性室管膜瘤患者每天接受拉帕替尼口服治疗（前10名患者每天900 mg / m（2）/剂量，然后700 mg / m（2）/剂量）和贝伐单抗10 mg / kg，在28天疗程的第1天和第15天静脉注射。在每个疗程之前分析拉帕替尼的血清谷水平。在贝伐单抗的剂量1和2之前和贝伐单抗的剂量2之后24-48 h，测量外周血单核细胞（PBMC）的总和磷酸化VEGFR2表达。入选了24例中位年龄为10岁（2-21岁）的患者; 22位有回应，20位有回应回应。十三例患有间变性性室管膜瘤。没有客观的回应; 4位患者病情稳定，每千日元4个疗程的一部分（范围4-14）。 3级毒性包括皮疹，ALT升高和腹泻。 4级毒性包括气管切开术出血（n = 1）和肌酐磷酸激酶升高（n = 1）。拉帕替尼给药前低谷浓度的中位数为3.72 AμM。尽管贝伐单抗和拉帕替尼的组合对复发性室管膜瘤的儿童耐受良好，但事实证明无效。

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