Department of Oncology, UCL Medical School, Royal Free Campus, London NW3 2QG, UK.
Br J Cancer. 2013 Apr 2;108(6):1252-9. doi: 10.1038/bjc.2013.85. Epub 2013 Feb 28.
Transarterial chemoembolisation (TACE) has not been shown to be superior to bland embolisation (TAE) for treatment of hepatocellular carcinoma (HCC).
We conducted a randomised phase II/III trial in patients with untreated HCC. Patients were randomised to TAE with polyvinyl alcohol (PVA) particles alone or sequential TACE (sTACE) in which cisplatin 50 mg was administered intrarterially 4-6 h before PVA embolisation. Treatment was repeated 3-weekly for up to three treatments. The primary endpoint was overall survival and secondary endpoints were progression-free survival, toxicity and response. Target sample sizes for phase II and III were 80 and 322.
The trial was terminated at phase II after 86 patients had been randomised. Patients were well matched for prognostic criteria. All three planned treatments were given to 57.1% (TAE) and 56.8% (TACE) patients. Grade 3/4 toxicity occurred in 63.5% and 83.7%, respectively (P=0.019). End-of-treatment RECIST response (CR+PR) was 13.2 and 32.6% (P=0.04) (mRECIST 47.3% and 67.4) and median overall survival and progression-free survival was 17.3 vs 16.3 (P=0.74) months and 7.2 vs 7.5 (P=0.59), respectively.
Transarterial chemoembolisation according this novel schedule is feasible and associated with a higher response rate than TAE alone. The survival benefit of TACE over TAE remains unproven.
经动脉化疗栓塞术（TACE）并未显示优于单纯动脉栓塞术（TAE）治疗肝细胞癌（HCC）。
我们在未经治疗的 HCC 患者中进行了一项随机 II/III 期试验。患者被随机分配接受单独使用聚乙烯醇（PVA）颗粒的 TAE 或序贯 TACE（sTACE），其中顺铂 50mg 在 PVA 栓塞前 4-6 小时经动脉内给药。每 3 周重复治疗，最多进行三次。主要终点是总生存期，次要终点是无进展生存期、毒性和反应。II 期和 III 期的目标样本量分别为 80 和 322。
在 86 名患者随机分组后，该试验在 II 期阶段终止。患者在预后标准方面匹配良好。所有三种计划的治疗均给予 57.1%（TAE）和 56.8%（TACE）的患者。分别有 63.5%和 83.7%的患者出现 3/4 级毒性（P=0.019）。治疗结束时 RECIST 反应（CR+PR）分别为 13.2%和 32.6%（P=0.04）（mRECIST 分别为 47.3%和 67.4%），中位总生存期和无进展生存期分别为 17.3 与 16.3 个月（P=0.74）和 7.2 与 7.5 个月（P=0.59）。
根据该新方案进行的经动脉化疗栓塞术是可行的，与单独 TAE 相比，其反应率更高。TACE 相对于 TAE 的生存获益仍未得到证实。
