Department of Oncology, the First Clinical Medical College of Three Gorges University, Yichang Central People's Hospital, Yichang 443003, People's Republic of China.
J BUON. 2021 Jul-Aug;26(4):1355-1364.
Sorafenib combined with transcatheter arterial chemoembolization (TACE) is one of the common methods in the clinical treatment of advanced hepatocellular carcinoma (HCC), but its efficacy and safety are still controversial. Therefore, we used meta-analysis to evaluate the efficacy and safety of sorafenib combined with TACE in the treatment of advanced HCC.
Up to March 14, 2021, the databases of PubMed, EMBASE, Cochrane Library, CNKI and Wanfang were searched, and the randomized controlled clinical trials (RCTs) of sorafenib combined with TACE in the treatment of primary HCC were included. Two researchers independently screened the literature, extracted data and evaluated the quality according to the inclusion and exclusion criteria. Revman5.4 software was used for meta-analysis.
A total of 3076 patients were included in 23 studies, including sorafenib combined with TACE group (n=1542) and TACE group (n=1534). The results of meta-analysis showed that sorafenib combined with TACE could increase the objective response rate (ORR) (RR=1.35, 95%CI: 1.24-1.48, p<0.00001), disease control rate (DCR) (RR=1.19, 95%CI: 1.11-1.28, p<0.00001), prolong the time of disease progression (TTP) (HR=0.80, 95%CI: 0.70-0.92, p=0.001), reduce the expression level of alpha-fetoprotein (AFP) (SMD=2.01, 95%CI: 1.27-2.75, p<0.00001) and vascular endothelial growth factor (VEGF) (SMD=2.62, 95% CI: 1.35-3.90, p<0.0001) in serum. However, the overall survival (OS) was not prolonged (HR=0.86, 95%CI: 0.73-1.02, p=0.09). The incidences of fatigue, diarrhea, elevated bilirubin, skin reaction of hands and feet, rash, hypertension and oral mucosal inflammation in sorafenib combined with TACE group were higher than those in TACE group (p<0.05).
Sorafenib combined with TACE has some clinical benefits compared with TACE alone, but it does not seem to prolong the OS of patients with HCC, and the incidence of adverse reactions is higher, so more high-quality RCTs are needed to further study the efficacy of the combination regimen.
索拉非尼联合经导管动脉化疗栓塞(TACE)是治疗晚期肝细胞癌(HCC)的常用方法之一,但疗效和安全性仍存在争议。因此,我们采用荟萃分析来评估索拉非尼联合 TACE 治疗晚期 HCC 的疗效和安全性。
截至 2021 年 3 月 14 日,检索PubMed、EMBASE、Cochrane 图书馆、中国知网和万方数据库,纳入索拉非尼联合 TACE 治疗原发性 HCC 的随机对照临床试验(RCT)。由 2 位研究者独立筛选文献、提取数据,并按照纳入和排除标准进行质量评价。采用 RevMan5.4 软件进行荟萃分析。
共纳入 23 项研究的 3076 例患者,其中索拉非尼联合 TACE 组(n=1542)和 TACE 组(n=1534)。荟萃分析结果显示,索拉非尼联合 TACE 可提高客观缓解率(ORR)(RR=1.35,95%CI:1.24-1.48,p<0.00001)、疾病控制率(DCR)(RR=1.19,95%CI:1.11-1.28,p<0.00001),延长疾病进展时间(TTP)(HR=0.80,95%CI:0.70-0.92,p=0.001),降低血清中 alpha-fetoprotein(AFP)(SMD=2.01,95%CI:1.27-2.75,p<0.00001)和血管内皮生长因子(VEGF)(SMD=2.62,95%CI:1.35-3.90,p<0.0001)的表达水平。但总生存期(OS)无延长(HR=0.86,95%CI:0.73-1.02,p=0.09)。索拉非尼联合 TACE 组的乏力、腹泻、胆红素升高、手足皮肤反应、皮疹、高血压和口腔黏膜炎发生率高于 TACE 组(p<0.05)。
与单纯 TACE 相比,索拉非尼联合 TACE 具有一定的临床获益,但似乎不能延长 HCC 患者的 OS,且不良反应发生率较高,因此需要更多高质量的 RCT 进一步研究联合方案的疗效。