Feng Jingwen, Zhao Yi, Zhai Lin, Zhou Jingxu
The First Clinical School of Guangzhou University of Chinese Medicine, Guangzhou, China.
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Medicine (Baltimore). 2024 May 3;103(18):e38037. doi: 10.1097/MD.0000000000038037.
The application of transarterial chemoembolization (TACE) in combination with targeted therapy and immunotherapy (TACE-T-I) for unresectable hepatocellular carcinoma (HCC) has gained increasing attention. However, there are variations in the efficacy and safety outcomes between TACE-T-I versus TACE combined with targeted drugs (TACE-T). This study aims to systematically evaluate the efficacy and safety of TACE-T-I versus TACE-T in unresectable HCC.
PubMed, Embase, Cochrane Library, and Web of Science databases were searched from inception to August 21, 2023, for comparative studies on TACE-T-I versus TACE-T for unresectable HCC. Outcome measures included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) and the incidence of treatment-related adverse events (TRAEs). OS was the primary outcome of this study. Weighted mean difference (WMD) or hazard ratio (HR) was used as the pooled statistic for OS and PFS. Relative risk (RR) was employed as the pooled statistic for ORR, DCR and the incidence of TRAEs. And 95% confidence intervals (CIs) were calculated for all effect measures. Data analysis was conducted using Stata 14.0 software.
The meta-analysis included 14 studies with 2144 patients. The pooled results showed that compared with patients in the TACE-T group, patients in the TACE-T-I group had higher ORR (RR = 1.61; 95%CI: 1.38-1.89) and DCR (RR = 1.17; 95%CI: 1.09-1.26). Patients in the TACE-T-I group experienced prolonged PFS (WMD = 3.08; 95%CI: 2.63-3.53) and OS (WMD = 5.76; 95%CI: 4.68-6.84). And the risk of disease progression (HR = 0.45; 95%CI: 0.37-0.55) and death (HR = 0.43; 95%CI: 0.38-0.49) was lower in the TACE-T-I group. Common TRAEs included fever, pain, abdominal pain, nausea, vomiting, elevated ALT, elevated AST, hypertension, hand-foot syndrome, proteinuria, and diarrhea. The incidence and severity of TRAEs in the TACE-T-I group were similar to those in the TACE-T group, with no significant differences (P > .05).
Current evidence suggests that, on the basis of TACE combined with targeted therapy, the addition of immunotherapy provides better clinical efficacy and survival benefits for unresectable HCC patients, with good tolerability.
经动脉化疗栓塞术(TACE)联合靶向治疗及免疫治疗(TACE-T-I)应用于不可切除肝细胞癌(HCC)已日益受到关注。然而,TACE-T-I与TACE联合靶向药物(TACE-T)在疗效和安全性结果方面存在差异。本研究旨在系统评价TACE-T-I与TACE-T治疗不可切除HCC的疗效和安全性。
检索PubMed、Embase、Cochrane图书馆和Web of Science数据库,时间范围从建库至2023年8月21日,查找关于TACE-T-I与TACE-T治疗不可切除HCC的对比研究。结局指标包括总生存期(OS)、无进展生存期(PFS)、客观缓解率(ORR)、疾病控制率(DCR)以及治疗相关不良事件(TRAEs)的发生率。OS是本研究的主要结局指标。加权均数差(WMD)或风险比(HR)用作OS和PFS的合并统计量。相对危险度(RR)用作ORR、DCR和TRAEs发生率的合并统计量。并计算所有效应量的95%置信区间(CIs)。使用Stata 14.0软件进行数据分析。
荟萃分析纳入14项研究,共2144例患者。汇总结果显示,与TACE-T组患者相比,TACE-T-I组患者的ORR更高(RR = 1.61;95%CI:1.38 - 1.89),DCR更高(RR = 1.17;95%CI:1.09 - 1.26)。TACE-T-I组患者的PFS延长(WMD = 3.08;95%CI:2.63 - 3.53),OS延长(WMD = 5.76;95%CI:4.68 - 6.84)。并且TACE-T-I组疾病进展风险(HR = 0.45;95%CI:0.37 - 0.55)和死亡风险(HR = 0.43;95%CI:0.38 - 0.49)更低。常见的TRAEs包括发热、疼痛、腹痛、恶心、呕吐、谷丙转氨酶升高、谷草转氨酶升高、高血压、手足综合征、蛋白尿和腹泻。TACE-T-I组TRAEs的发生率和严重程度与TACE-T组相似,无显著差异(P > 0.05)。
目前的证据表明,在TACE联合靶向治疗的基础上,加用免疫治疗可为不可切除HCC患者提供更好的临床疗效和生存获益,且耐受性良好。