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中国癌症防治杂志

中国癌症防治杂志 ›› 2015, Vol. 7 ›› Issue (4): 282-287.doi: 10.3969/j.issn.1674-5671.2015.04.10

• 循证医学 • 上一篇    下一篇

贝伐单抗联合替莫唑胺同步放疗治疗新诊断的胶质母细胞瘤的有效性和安全性

  

  1. 广西医科大学附属肿瘤医院神经外科；青岛大学医学院附属烟台毓璜顶医院乳腺外科；广西医科大学研究生学院
  • 出版日期:2015-08-25 发布日期:2015-09-08
  • 通讯作者: 莫立根 ligenmo@163.com
  • 基金资助:

    广西科学研究与技术开发计划资助项目（桂科攻14124004-2-16）

Efficacy and safety of Bevacizumab combined with radiotherapy-temozolomide to treat newly diagnosed glioblastoma

  • Online:2015-08-25 Published:2015-09-08

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4

摘要：

目的 系统评价贝伐单抗联合替莫唑胺同步放疗治疗新诊断的多形性胶质母细胞瘤（glioblastoma multiforme，GBM）的有效性和安全性。 方法 以计算机检索 PubMed、Cochrane图书馆、EMBASE和万方数据库并收集所有相关临床研究资料。由两名研究者分别独立检索相关数据库，筛选相关文献并提取相关数据。采用RevMan 5.3统计学软件进行Meta分析。随机对照研究质量评价参考Cochrane系统评价手册推荐的方法。结果 纳入4个前瞻性临床研究，共计1 773例患者，其中试验组891例，对照组882例。Meta分析结果显示：与单纯替莫唑胺联合放疗相比，贝伐单抗联合替莫唑胺同步放疗治疗新诊断的GBM可以提高患者6个月（RR=0.44，95% CI：0.37～0.52， P＜0.001）和12个月（RR=0.78，95% CI：0.73～0.84， P＜0.001）的无疾病进展生存时间，同时也显著提高患者12个月（RR=0.86，95% CI：0.74～0.99，P=0.03）的总生存率，但增加了高血压病（RR=3.11，95% CI：2.39～4.06，P＜0.001）、出血（RR=1.85，95% CI：1.50～2.27，P＜0.001）不良反应的发生率，而血管栓塞性疾病、伤口愈合并发症、内脏穿孔等不良反应发生率比较的差异无统计学意义（P＞0.05）。不良反应经治疗后均得以缓解。结论 贝伐单抗联合替莫唑胺同步放疗治疗新诊断的GBM可延长患者的无疾病进展生存时间和总生存率，但增加不良反应的发生。

关键词: 脑肿瘤, 新诊断胶质母细胞瘤, 贝伐单抗, 替莫唑胺, 同步放疗, 有效性, 安全性, 系统评价

Abstract:

Objective To assess the efficacy and safety of Bevacizumab combined with  Radiotherapy-Temozolomide to treat newly diagnosed glioblastoma. Methods PubMed， The Cochrane Library，EMBASE，and the Wanfang Database were systematically searched for relevant clinical studies. Two researchers assessed trial quality according to the Cochrane Manual and extracted data independently. Data were analyzed using RevMan 5.3. Result Four prospective clinical trials，including two randomized controlled trials，were included in the review；these trials involved 891 patients who received Bevacizumab combined with radiotherapy-temozolomide and 882 control patients who received radiotherapy-temozolomide. Meta-analysis indicated that combination therapy was associated with significantly higher 6-month progression-free survival（PFS；RR 0.44，95%CI 0.37-0.52，P＜0.001），12-month PFS（RR 0.78，95%CI  0.73-0.84，P＜0.001）and 12-month overall survival（RR 0.86，95%CI  0.74-0.99，P=0.03）. At the same time， combination therapy was associated with significantly higher incidence of hypertension（RR 3.11，95%CI  2.39-4.06，P＜0.001） and bleeding （RR 1.85，95%CI  1.50-2.27，P＜0.001）. Incidence of vascular thrombus diseases，wound-healing complications and internal organ perforation was similar for the two therapies. All treatment-related adverse events were easily resolved. Conclusions Bevacizumab combined with radiotherapy-temozolomide can prolong progression-free and overall survival in patients with newly diagnosed glioblastoma， but it increases the risk of some adverse reactions.

Key words: Brain neoplasms, Newly diagnosed glioblastoma, Bevacizumab, Temozolomide, Concurrent radiotherapy, Efficacy, Safety, Systematic Review