TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial
TACE plus sorafenib for the treatment of hepatocellular carcinoma: results of the multicenter, phase II SOCRATES trial
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DOI：
10.1007/s00280-014-2568-8
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发表时间：
2014-11-01
影响因子：
3
通讯作者：
Haussinger, Dieter
中科院分区：
文献类型：
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作者：
Erhardt, Andreas;Kolligs, Frank;Haussinger, Dieter
目前的多中心II期临床试验研究了TACE和索拉非尼联合治疗HCC，合格标准包括组织学证实的、超出米兰标准的不可切除的HCC、无肝外扩散、Child-Pugh评分为千分之一货币符号8和ECOG PS 0-2。患者既往未接受过HCC治疗。索拉非尼的剂量为400 mg/bid（仅在TACE前后中断）。只要没有总体疾病进展，就重复使用阿曲库碘油、50 mg多柔比星和聚乙烯醇（PVA）颗粒的TACE，每6周1次。根据EASL标准，每6周进行一次MRI肿瘤评估。主要终点是疾病进展时间（TTP），患者（n = 43）接受平均2.6 +/- A 2.2 TACE干预（范围0-10）。中位TTP为16.4个月（95% CI 10.7-a）。中位总生存期（OS）为20.1个月（95% CI 17.6-28.2）。根据EASL标准的疾病控制率为74.4%（7%完全缓解[CR]+41.8%部分缓解[PR]+25.6%疾病稳定[SD]）。4例患者（9%）适合射频消融或肝移植; 5例（12%）患者在试验期间死亡。总的来说，有360例AE，包括56例3/4级AE和39例SAE。本试验中TACE和索拉非尼联合治疗是可耐受的，并且与有趣的反应率、TTP和OS相关。联合治疗可能会缩小目前局部晚期HCC单药治疗指南中的差距。
The present multicenter phase II trial investigated the combination of TACE and sorafenib for the treatment of HCC.Eligibility criteria included histologically confirmed, unresectable HCC beyond Milan criteria, no extrahepatic spread, Child-Pugh score a parts per thousand currency sign8 and ECOG PS 0-2. Patients had received no prior therapy for HCC. Sorafenib was given at a dose of 400 mg/bid (interrupted only around TACE). TACE with lipiodol, 50 mg doxorubicin and polyvinyl alcohol (PVA) particles was repeated q6w as long as there was no overall disease progression. Tumor assessment by MRI was performed q6w according to EASL criteria. The primary endpoint was time to progression (TTP).Patients (n = 43) received a mean of 2.6 +/- A 2.2 TACE interventions (range 0-10). Median TTP was 16.4 months (95 % CI 10.7-a). Median overall survival (OS) was 20.1 months (95 % CI 17.6-28.2). Disease control rate according to EASL criteria was 74.4 % (7 % complete responses [CRs] + 41.8 % partial responses [PRs] + 25.6 % stable diseases [SDs]). Four patients (9 %) became amenable to either radiofrequency ablation or liver transplantation; 5 (12 %) patients died during the trial. Overall, there were 360 AEs, including 56 grade 3/4 AEs and 39 SAEs.Combination treatment of TACE and sorafenib in the present trial was tolerable and associated with an interesting response rate, TTP and OS. Combination therapies will probably close gaps in the present mono therapy driven treatment guidelines for locally advanced HCC.