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经导管动脉化疗栓塞联合仑伐替尼治疗肝细胞癌的系统评价和随机对照试验的荟萃分析。

Transarterial Chemoembolization Combined with Lenvatinib for Hepatocellular Carcinoma: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

机构信息

Department of Oncology, Second Hospital of Lanzhou University, Lanzhou, China,

Department of General Surgery, Second Hospital of Lanzhou University, Lanzhou, China.

出版信息

Oncology. 2024;102(8):688-702. doi: 10.1159/000536006. Epub 2024 Jan 8.

Abstract

INTRODUCTION

The treatment of hepatocellular carcinoma (HCC) with transarterial chemoembolization (TACE) and lenvatinib individually has shown favorable outcomes, but there is currently no meta-analysis based on randomized controlled trials (RCTs) to investigate the efficacy and safety of this combined treatment for HCC. The aim of this study was to identify the efficacy and safety of TACE plus lenvatinib for the treatment of HCC.

METHODS

A systematic search of MEDLINE (via PubMed), the Cochrane Library, EMBASE, and the Web of Science was conducted on July 31, 2023. RCTs evaluating the efficacy and safety of TACE in combination with lenvatinib for the treatment of HCC were included. The risk of bias in the included studies was assessed using the Risk of Bias 2 tool. Outcome measures such as objective response rate (ORR), complete remission (CR), progression-free survival (PFS), overall survival (OS), and safety parameters were extracted from the included studies. Binary outcomes were analyzed using odds ratio (OR), risk ratio, or hazard ratio (HR), while continuous variables were analyzed using mean difference (MD) or standardized MD in RStudio. The quality of the evidence was graded using the GRADE approach. Heterogeneity was considered significant when the I-squared was 50% or less.

RESULTS

Five RCTs involving 638 patients were included. The meta-analysis revealed that patients in the TACE plus lenvatinib group had a significantly higher mean ORR compared to the control group (OR: 3.65, 95% confidence interval [CI]: 2.50-5.32, fixed-effects model; OR: 3.58, 95% CI: 2.45-5.24, random-effects model, I2 = 0, moderate quality). Specifically, 40.9% of patients in the TACE plus lenvatinib group achieved a PR, which was significantly higher than the control group (OR: 3.51, 95% CI: 2.41-5.13, fixed-effects model; OR: 3.46, 95% CI: 2.36-5.07, random-effects model, I2 = 0, moderate quality). The HR for OS was 0.47 (95% CI: 0.35-0.62, fixed-effects model and random-effects model, I2 = 0, moderate quality). The meta-analysis revealed that the TACE plus lenvatinib group had a significantly higher total adverse effects rate than the control group (OR: 1.86, 95% CI: 1.01-3.43, fixed-effects model; OR: 1.85, 95% CI: 1.00-3.43, random-effects model, I2 = 0, moderate quality).

CONCLUSION

Our study suggests that the combination of TACE and lenvatinib in the treatment of HCC has shown promising results, with extended OS and improved ORR.

摘要

介绍

经动脉化疗栓塞(TACE)联合仑伐替尼单独治疗肝细胞癌(HCC)已显示出良好的疗效,但目前尚无基于随机对照试验(RCT)的荟萃分析来研究这种联合治疗HCC 的疗效和安全性。本研究旨在确定 TACE 联合仑伐替尼治疗 HCC 的疗效和安全性。

方法

于 2023 年 7 月 31 日对 MEDLINE(通过 PubMed)、Cochrane 图书馆、EMBASE 和 Web of Science 进行了系统检索,纳入了评估 TACE 联合仑伐替尼治疗 HCC 的疗效和安全性的 RCT。使用风险偏倚 2 工具评估纳入研究的风险偏倚。从纳入的研究中提取客观缓解率(ORR)、完全缓解(CR)、无进展生存期(PFS)、总生存期(OS)和安全性参数等结局指标。二分类结局采用优势比(OR)、风险比或风险比(HR)进行分析,连续变量采用 RStudio 中的均数差(MD)或标准化 MD 进行分析。使用 GRADE 方法对证据质量进行分级。当 I-squared 为 50%或以下时,认为存在显著异质性。

结果

纳入了 5 项涉及 638 名患者的 RCT。荟萃分析显示,TACE 联合仑伐替尼组患者的平均 ORR 明显高于对照组(OR:3.65,95%置信区间[CI]:2.50-5.32,固定效应模型;OR:3.58,95%CI:2.45-5.24,随机效应模型,I2 = 0,中等质量)。具体来说,TACE 联合仑伐替尼组有 40.9%的患者达到了 PR,明显高于对照组(OR:3.51,95%CI:2.41-5.13,固定效应模型;OR:3.46,95%CI:2.36-5.07,随机效应模型,I2 = 0,中等质量)。OS 的 HR 为 0.47(95%CI:0.35-0.62,固定效应模型和随机效应模型,I2 = 0,中等质量)。荟萃分析显示,TACE 联合仑伐替尼组的总不良反应发生率明显高于对照组(OR:1.86,95%CI:1.01-3.43,固定效应模型;OR:1.85,95%CI:1.00-3.43,随机效应模型,I2 = 0,中等质量)。

结论

本研究表明,TACE 联合仑伐替尼治疗 HCC 具有良好的疗效,可延长 OS 并提高 ORR。

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