Barcelona Clinic Liver Cancer (BCLC) group, Liver Unit, Hospital Clinic Barcelona, IDIBAPS, University of Barcelona, Spain.
J Hepatol. 2012 Apr;56(4):984-6. doi: 10.1016/j.jhep.2011.08.017. Epub 2011 Oct 17.
Hepatocellular carcinoma (HCC) results in more than 600,000 deaths per year. Transarterial embolisation(TAE) and transarterial chemoembolisation (TACE) have become standard loco-regional treatments for unresectable HCC.
To assess the beneficial and harmful effects of TACE or TAE.
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, The Cochrane Cancer Network register,The Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, and The Latin American Caribbean Health Sciences Literature(LILACS) from dates of inceptions up to September 2010.
We considered for inclusion all randomised trials that compared TACE or TAE versus placebo, sham, or no intervention.Co-interventions were allowed if comparable between intervention groups. Trials with inadequate randomisation were excluded.
For all-cause mortality, we calculated the log hazard ratio (HR) with standard error as point estimate and pooled them for meta-analysis using the inverse variance method. Sub-group analyses were performed regarding intervention regimen, trial truncation, or co-interventions. We validated the results with trial sequential analyses. We used random-effects model in all meta-analyses in anticipation of statistical heterogeneity among the trials.
We included nine trials with 645 participants. Six trials assessed TACE versus control and three trials assessed TAE versus control. Seven trials had low risk of selection bias based on adequate generation of allocation sequence and concealment – but all these trials had other risks of bias. Three trials were stopped early due to interim inspections and one due to slow accrual. For all-cause mortality,statistical heterogeneity between trials was low to moderate(I2) = 30%). Meta-analysis of trials with low risk of selection bias showed that TACE or TAE versus control does not significantly increase survival (HR 0.88; 95% CI 0.71–1.10). Two trials with low risk of selection bias, no early stopping, and no co-intervention did not establish any significant effect of TACE or TAE on overall survival(hazard ratio 1.22, 95% confidence interval 0.82–1.83; P = 0.33). Trials equential analysis confirmed the absence of evidence for a beneficial effect of TACE or TAE on survival indicating the need for future randomisation of up to 383 additional participants. Substantial differences in criteria for assessing tumor response did not allow quantitative analyses. One trial investigated quality of life but did not detect any significant differences between the intervention groups. A range of adverse events including post-embolisation syndrome and serious complications were reported. AUTHORS’
There is no firm evidence to support or refute TACE or TAE for patients with unresectable HCC. More adequately powered and bias-protected trials are needed.
肝细胞癌（HCC）导致每年超过 60 万人死亡。经动脉栓塞（TAE）和经动脉化疗栓塞（TACE）已成为不可切除 HCC 的标准局部区域治疗方法。
评估 TACE 或 TAE 的有益和有害效果。
我们检索了 Cochrane 肝胆组对照试验登记处、Cochrane 癌症网络登记处、Cochrane 中央对照试验注册中心（CENTRAL）在 Cochrane 图书馆、MEDLINE、EMBASE、科学引文索引扩展版和拉丁美洲加勒比健康科学文献（LILACS），检索时间从成立日期到 2010 年 9 月。
我们考虑纳入所有比较 TACE 或 TAE 与安慰剂、假治疗或无干预的随机试验。如果干预组之间具有可比性，则允许使用联合干预。排除随机分组不足的试验。
对于全因死亡率，我们计算了对数危害比（HR），标准误差作为点估计值，并使用逆方差法进行荟萃分析。针对干预方案、试验截断或联合干预进行了亚组分析。我们使用试验序贯分析验证了结果。我们预计试验之间存在统计学异质性，因此在所有荟萃分析中均使用了随机效应模型。
我们纳入了 9 项涉及 645 名参与者的试验。6 项试验评估了 TACE 与对照组的比较，3 项试验评估了 TAE 与对照组的比较。基于适当的分配序列生成和隐藏，有 7 项试验具有低选择偏倚风险，但所有这些试验都存在其他偏倚风险。由于中期检查和一项因入组速度缓慢而提前终止了 3 项试验。对于全因死亡率，试验之间的统计学异质性较低至中度（I2）= 30%）。对低选择偏倚风险的试验进行荟萃分析表明，TACE 或 TAE 与对照组相比并不能显著提高生存率（HR 0.88；95% CI 0.71–1.10）。2 项具有低选择偏倚风险、无早期停止和无联合干预的试验并未确定 TACE 或 TAE 对总生存率的任何显著影响（风险比 1.22，95%置信区间 0.82–1.83；P = 0.33）。试验序贯分析证实，没有证据表明 TACE 或 TAE 对生存率有有益影响，这表明需要对多达 383 名额外参与者进行进一步随机分组。评估肿瘤反应的标准存在很大差异，不允许进行定量分析。一项试验研究了生活质量，但未检测到干预组之间的任何显著差异。报告了一系列不良事件，包括栓塞后综合征和严重并发症。作者的结论：没有确凿的证据支持或反驳 TACE 或 TAE 用于不可切除的 HCC 患者。需要更多的、具有足够效力和偏倚保护的试验。
