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A phase II trial of single-agent bevacizumab in patients with recurrent anaplastic glioma

机译:贝伐单抗单药治疗复发性间变性神经胶质瘤的II期临床试验

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摘要

The purpose of this study was to evaluate the activity of single-agent bevacizumab in patients with recurrent anaplastic glioma and assess correlative advanced imaging parameters. Patients with recurrent anaplastic glioma were treated with bevacizumab 10 mg/kg every 2 weeks. Complete patient evaluations were repeated every 4 weeks. Correlative dynamic contrast-enhanced MR and 18fluorodeoxyglucose PET imaging studies were obtained to evaluate physiologic changes in tumor and tumor vasculature at time points including baseline, 96 h after the first dose, and after the first 4 weeks of therapy. Median overall survival was 12 months (95% confidence interval [CI]: 6.08–22.8). Median progression-free survival was 2.93 months (95% CI: 2.01–4.93), and 6-month progression-free survival was 20.9% (95% CI: 10.3%–42.5%). Thirteen (43%) patients achieved a partial response. The most common grade ≥3 treatment-related toxicities were hypertension, hypophosphatemia, and thromboembolism. Single-agent bevacizumab produces significant radiographic response in patients with recurrent anaplastic glioma but did not meet the 6-month progression-free survival endpoint. Early change in enhancing tumor volume at 4 days after start of therapy was the most significant prognostic factor for overall and progression-free survival.
机译:这项研究的目的是评估复发性间变性胶质瘤患者中单药贝伐单抗的活性并评估相关的先进影像学参数。复发性间变性神经胶质瘤患者每2周接受10 mg / kg贝伐单抗治疗。每4周重复一次完整的患者评估。获得了动态动态对比增强MR和 18 氟脱氧葡萄糖PET成像研究,以评估在基线时,首次给药后96小时和首次给药后4周后肿瘤和肿瘤脉管系统的生理变化。治疗。中位总生存期为12个月(95%置信区间[CI]:6.08-22.8)。中位无进展生存期为2.93个月(95%CI:2.01–4.93),而6个月无进展生存率为20.9%(95%CI:10.3%–42.5%)。十三名(43%)患者获得了部分缓解。最常见的≥3级与治疗相关的毒性为高血压,低磷血症和血栓栓塞。单药贝伐单抗在复发性间变性神经胶质瘤患者中产生显着的放射学反应,但未达到6个月无进展生存期终点。开始治疗后第4天,肿瘤体积增强的早期变化是总体生存和无进展生存的最重要预后因素。

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