Adis, a Wolters Kluwer Business, Auckland, New Zealand.
Drugs. 2010;70(2):181-9. doi: 10.2165/11203890-000000000-00000.
Bevacizumab is a recombinant humanized monoclonal IgG(1) antibody that binds to human vascular endothelial growth factor and inhibits angiogenesis and hence tumour growth. It is available in the US and other countries for the treatment of several types of cancer, including glioblastoma that has recurred after previous treatment. Two prospective phase II trials have evaluated bevacizumab 10 mg/kg every 2 weeks for the treatment of previously treated glioblastoma. In the randomized, noncomparative, multicentre AVF3708g trial in patients with glioblastoma in first or second relapse, the rate of progression-free survival at 6 months was 42.6% and the objective response rate was 28.2% in recipients of bevacizumab alone (n = 85). In the bevacizumab plus irinotecan treatment arm (n = 82), the 6-month progression-free survival rate was 50.3% and the objective response rate was 37.8%. These rates were all significantly higher than historical control data. In the supporting, single-arm, single-centre, phase II NCI 06-C-0064E trial of bevacizumab in patients with glioblastoma that had recurred after radiotherapy and temozolomide chemotherapy (n = 48), the rate of progression-free survival at 6 months was 29% and the overall response rate based on Macdonald criteria was 35%. Given the nature of the disease, bevacizumab was generally well tolerated in these two phase II trials. In the AVF3708g trial, grade 3 or higher treatment-emergent adverse events occurred in 46.4% of bevacizumab and 65.8% of bevacizumab plus irinotecan recipients.
贝伐珠单抗是一种重组人源化单克隆 IgG(1)抗体,可与人类血管内皮生长因子结合并抑制血管生成,从而抑制肿瘤生长。它在美国和其他国家被批准用于治疗多种癌症,包括在先前治疗后复发的胶质母细胞瘤。两项前瞻性 II 期试验评估了贝伐珠单抗 10 mg/kg 每 2 周用于治疗先前治疗的胶质母细胞瘤。在随机、非对照、多中心 AVF3708g 试验中,在首次或第二次复发的胶质母细胞瘤患者中,贝伐珠单抗单药治疗组(n = 85)的 6 个月无进展生存率为 42.6%,客观缓解率为 28.2%。在贝伐珠单抗联合伊立替康治疗组(n = 82)中,6 个月无进展生存率为 50.3%,客观缓解率为 37.8%。这些比率均明显高于历史对照数据。在支持性、单臂、单中心、II 期 NCI 06-C-0064E 试验中,在接受放疗和替莫唑胺化疗后复发的胶质母细胞瘤患者中,贝伐珠单抗的 6 个月无进展生存率为 29%,基于 Macdonald 标准的总缓解率为 35%。鉴于疾病的性质,在这两项 II 期试验中,贝伐珠单抗总体耐受性良好。在 AVF3708g 试验中,贝伐珠单抗和贝伐珠单抗联合伊立替康组分别有 46.4%和 65.8%的患者出现 3 级或更高级别的治疗相关不良事件。