Bai Gui-Rong, An Jin-Bing, Chu Yang, Wang Xiang-Yang, Li Shu-Ming, Yan Kai-Jing, Lü Fu-Rong, Gu Ning, Griffin Amanda N, Sun Bin-Yuan, Li Wei, Wang Guo-Cheng, Zhou Shui-Ping, Sun He, Liu Chang-Xiao
aTasly Academy bTasly Holding Group Co. Ltd cTianjin State Key Laboratory of Pharmacokinetics and Pharmacodynamics, Tianjin Institute of Pharmaceutical Research, Tianjin dDepartment of Natural Science for Medicine, Peking University Health Science Center, Beijing, People's Republic of China eTasly Pharmaceuticals Inc., Rockville, Maryland fCellMosaic Inc., Worcester, Massachusetts, USA.
Anticancer Drugs. 2016 Jan;27(1):1-8. doi: 10.1097/CAD.0000000000000295.
Temozolomide (TMZ) combination with whole-brain radiotherapy (WBRT) has been tested by many randomized controlled trials in the treatment of brain metastases (BMs) in China and other countries. We performed an up-to-date meta-analysis to determine (i) the log odds ratios (LORs) of objective response (ORR) and adverse effects (AEs) for all-grade, and (ii) the T value of mean overall survival in patients with BMs treated with WBRT combined with TMZ versus WBRT alone. PubMed, Chinese National Knowledge Infrastructure, and WanFang Data were searched for articles published up to 28 January 2015. Eligible studies were selected according to the PRISMA statement. ORR, AEs, and 95% confidence intervals were calculated using random-effects models. Eighteen studies were included in our analysis. A total of 1028 participants were enrolled. Summary LORs of ORR were 1.0239 (P<0.0001) on comparing WBRT plus TMZ with WBRT ORR (n=17). The overall mean difference of mean overall survival (n=17) between TMZ plus WBRT and WBRT was 2.2505 weeks (P=0.02185). There was a significant difference between WBRT plus TMZ and WBRT alone with a LOR of AEs for all-grade of (i) 0.923 for gastrointestinal toxicity and (ii) 0.7978 for myelosuppression. Sensitivity analysis and subgroup analysis were also performed. The 18 eligible randomized controlled trials demonstrated that the combination of WBRT and TMZ significantly improves the ORR and is statistically insignificant in prolonging the survival of patients with BMs. In addition, an increase in the incidence of gastrointestinal toxicity and myelosuppression was significant for all-grade.
在中国和其他国家,替莫唑胺(TMZ)联合全脑放疗(WBRT)已在多项随机对照试验中用于脑转移瘤(BMs)的治疗测试。我们进行了一项最新的荟萃分析,以确定:(i)所有级别客观缓解率(ORR)和不良反应(AE)的对数优势比(LOR);(ii)接受WBRT联合TMZ治疗的BMs患者与仅接受WBRT治疗的患者的平均总生存期的T值。检索了截至2015年1月28日在PubMed、中国知网和万方数据上发表的文章。根据PRISMA声明选择符合条件的研究。使用随机效应模型计算ORR、AE和95%置信区间。我们的分析纳入了18项研究。共纳入1028名参与者。比较WBRT加TMZ与WBRT的ORR时,ORR的汇总LOR为1.0239(P<0.0001)(n=17)。TMZ加WBRT与WBRT之间的平均总生存期总体平均差异(n=17)为2.2505周(P=0.02185)。WBRT加TMZ与单纯WBRT之间存在显著差异,所有级别的AE的LOR为:(i)胃肠道毒性为0.923,(ii)骨髓抑制为0.7978。还进行了敏感性分析和亚组分析。这18项符合条件的随机对照试验表明,WBRT与TMZ联合使用可显著提高ORR,但在延长BMs患者生存期方面无统计学意义。此外,所有级别的胃肠道毒性和骨髓抑制发生率均显著增加。