Yang Hong-Jie, Ye Bin, Liao Jia-Xu, Lei Lei, Chen Kai
Department of Radiology, The Sixth People's Hospital of Chengdu, Chengdu 610000, Sichuan Province, China.
Department of Oncology, The Sixth People's Hospital of Chengdu, Chengdu 610000, Sichuan Province, China.
World J Hepatol. 2024 Jan 27;16(1):91-102. doi: 10.4254/wjh.v16.i1.91.
Although the past decade has seen remarkable advances in treatment options for hepatocellular carcinoma (HCC), the dismal overall prognosis still envelops HCC patients. Several comparative trials have been conducted to study whether transarterial chemoembolization (TACE) could improve clinical outcomes in patients receiving sorafenib for advanced HCC; however, the findings have been inconsistent.
To study the potential synergies and safety of sorafenib plus TACE sorafenib alone for treating advanced HCC, by performing a systematic review and meta-analysis.
This study was conducted following the PRISMA statement. A systematic literature search was conducted using the Cochrane Library, Embase, PubMed, and Web of Science databases. Data included in the present work were collected from patients diagnosed with advanced HCC receiving sorafenib plus TACE or sorafenib alone. Data synthesis and meta-analysis were conducted using Review Manager software.
The present study included 2780 patients from five comparative clinical trials (1 was randomized control trial and 4 were retrospective studies). It was found that patients receiving sorafenib plus TACE had better prognoses in terms of overall survival (OS), with a combined hazard ratio (HR) of 0.65 [95% confidence interval (95%CI): 0.46-0.93, = 0.02, = 2780]. Consistently, progression free survival (PFS) and time to progression (TTP) differed significantly between the sorafenib plus TACE arm and sorafenib arm (PFS: HR = 0.62, 95%CI: 0.40-0.96, = 0.03, = 443; TTP: HR = 0.73, 95%CI: 0.64-0.83, < 0.00001, = 2451). Disease control rate (DCR) was also significantly increased by combination therapy (risk ratio = 1.36, 95%CI: 1.02-1.81, = 0.04, = 641). Regarding safety, the incidence of any adverse event (AE) was increased due to the addition of TACE; however, no significant difference was found in grade ≥ 3 AEs.
The combination of sorafenib with TACE has superior efficacy to sorafenib monotherapy, as evidenced by prolonged OS, PFS, and TTP, as well as increased DCR. Additional high-quality trials are essential to further validate the clinical benefit of this combination in the treatment of advanced HCC.
尽管在过去十年中，肝细胞癌（HCC）的治疗选择取得了显著进展，但HCC患者的总体预后仍然不佳。已经进行了几项比较试验，以研究经动脉化疗栓塞术（TACE）是否能改善晚期HCC患者接受索拉非尼治疗的临床结局；然而，研究结果并不一致。
通过进行系统评价和荟萃分析，研究索拉非尼联合TACE与单用索拉非尼治疗晚期HCC的潜在协同作用和安全性。
本研究按照PRISMA声明进行。使用Cochrane图书馆、Embase、PubMed和Web of Science数据库进行系统文献检索。本研究纳入的数据来自被诊断为晚期HCC并接受索拉非尼联合TACE或单用索拉非尼治疗的患者。使用Review Manager软件进行数据合成和荟萃分析。
本研究纳入了来自五项比较性临床试验的2780例患者（1项为随机对照试验，4项为回顾性研究）。结果发现，接受索拉非尼联合TACE治疗的患者在总生存期（OS）方面预后更好，合并风险比（HR）为0.65[95%置信区间（95%CI）：0.46 - 0.93，P = 0.02，n = 2780]。同样，索拉非尼联合TACE组与索拉非尼组在无进展生存期（PFS）和疾病进展时间（TTP）方面存在显著差异（PFS：HR = 0.62，95%CI：0.40 - 0.96，P = 0.03，n = 443；TTP：HR = 0.73，95%CI：0.64 - 0.83，P < 0.00001，n = 2451）。联合治疗还显著提高了疾病控制率（DCR）（风险比 = 1.36，95%CI：1.02 - 1.81，P = 0.04，n = 641）。在安全性方面，由于添加了TACE，任何不良事件（AE）的发生率有所增加；然而，≥3级AE未发现显著差异。
索拉非尼与TACE联合使用比索拉非尼单药治疗具有更高的疗效，这通过延长OS、PFS和TTP以及提高DCR得到证明。额外的高质量试验对于进一步验证这种联合治疗在晚期HCC治疗中的临床益处至关重要。
