Ma Wenhua, Li Na, An Yonghui, Zhou Changpeng, Bo Changwen, Zhang Guangyu
Department of Oncology, The First Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
Department of Neurosurgery, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
World Neurosurg. 2016 Aug;92:197-205. doi: 10.1016/j.wneu.2016.04.011. Epub 2016 Apr 9.
To systematically evaluate safety and efficacy of temozolomide plus radiotherapy in the treatment of brain metastasis.
Literature was searched in the following databases: Cochrane Controlled Trials Register (CENTRAL), PubMed (1994-2015.10), CBM (1978-2015.10), CNKI (1994-2015.10), VIP (1994-2015.10), and WANFANG (1994-2015.10). Randomized clinical trials (RCTs) of temozolomide plus radiotherapy in comparison with radiotherapy alone were included in this review and meta-analysis. The quality of included literatures was assessed by the international Cochrane collaboration method, and meta-analysis was performed using RevMan 5.0 software.
Total 19 publications of RCTs were included, and there was no allocation concealment or blinding in any of them. Six of the 19 were multicenter RCTs. Overall response rate (ORR) was in favor of radiotherapy plus temozolomide (risk ratio [RR] = 1.35, 95% CI: 1.23-1.47). Subgroup analysis of non-small cell lung cancer (NSCLC) metastasis brain tumor also showed that ORR was in favor of radiotherapy plus temozolomide (RR = 1.38; 95% CI: 1.17-1.63). Progression-free survival (PFS) or overall survival rate, however, was not significantly different between the 2 treatment groups. In addition, incidence of side effect was significantly higher in the group of radiotherapy plus temozolomide than that of radiotherapy alone (HR = 2.03, 95% CI: 1.56-2.64).
Addition of temozolomide to radiotherapy could increase ORR in brain metastatic tumors. However, it did not significantly improve PFS or OS in the patients with brain metastases but increased risk of drug-related toxicity.
系统评价替莫唑胺联合放疗治疗脑转移瘤的安全性和疗效。
检索以下数据库：考克兰对照试验注册库（CENTRAL）、PubMed（1994 - 2015.10）、中国生物医学文献数据库（CBM，1978 - 2015.10）、中国知网（CNKI，1994 - 2015.10）、维普资讯（VIP，1994 - 2015.10）和万方数据库（1994 - 2015.10）。纳入替莫唑胺联合放疗与单纯放疗比较的随机临床试验（RCT）进行本综述和荟萃分析。采用国际考克兰协作方法评估纳入文献的质量，并用RevMan 5.0软件进行荟萃分析。
共纳入19篇RCT文献，所有文献均未提及分配隐藏或盲法。19篇文献中有6篇为多中心RCT。总缓解率（ORR）支持放疗联合替莫唑胺（风险比[RR]=1.35，95%可信区间[CI]：1.23 - 1.47）。非小细胞肺癌（NSCLC）脑转移瘤亚组分析也显示ORR支持放疗联合替莫唑胺（RR = 1.38；95%CI：1.17 - 1.63）。然而，两组的无进展生存期（PFS）或总生存率无显著差异。此外，放疗联合替莫唑胺组的副作用发生率显著高于单纯放疗组（风险比[HR]=2.03，95%CI：1.56 - 2.64）。
放疗联合替莫唑胺可提高脑转移瘤的ORR。然而，它并未显著改善脑转移患者的PFS或总生存期（OS），反而增加了药物相关毒性的风险。
