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经导管动脉化疗栓塞术联合索拉非尼是否优于化疗栓塞术联合安慰剂治疗肝细胞癌?

Is transcatheter arterial chemoembolization plus sorafenib better than chemoembolization plus placebo in the treatment of hepatocellular carcinoma?

机构信息

Department of Interventional Radiology and Vascular Surgery, The First Affiliated Hospital of Hunan Normal University, Changsha, China.

Department of Radiology, The Second Affiliated Hospital of Hebei Medical University, Shijiazhuang, China.

出版信息

Tumori. 2021 Aug;107(4):292-303. doi: 10.1177/0300891620945029. Epub 2020 Jul 30.

Abstract

OBJECTIVE

To evaluate the efficacy and safety of transcatheter arterial chemoembolization (TACE) plus sorafenib compared with TACE plus placebo for hepatocellular carcinoma (HCC) using meta-analytical techniques.

METHODS

A search of PubMed, EMBASE, and Cochrane Library databases were done from inception to December 27, 2019. Published trials including a treatment group receiving TACE + sorafenib and a control group receiving TACE + placebo with data for at least 1-year survival or tumor response or time to progression were included.

RESULTS

Our study suggested that there was no evidence that TACE plus sorafenib was associated with a lower risk of disease progression compared with TACE plus placebo for treatment of HCC (hazard ratio 0.94 [95% confidence interval (CI), 0.84-1.05]), and no significant difference for treatment of HCC compared with TACE plus placebo in terms of 0.5-, 1-, 1.5-, and 2-year survival rates (risk ratio [RR] 1.01 [95% CI, 0.97-1.05]; RR 1.00 [95% CI, 0.92-1.08], RR 1.04 [95% CI, 0.89-1.23], RR 0.98 [95% CI, 0.72-1.34], respectively). The meta-analysis also showed that TACE + sorafenib seemed to have no significant difference for treatment of HCC compared with TACE + placebo in terms of complete response, partial response, stable disease, progressive disease, overall response rate, and disease control rate. There was an increased incidence of fatigue of grade 3/4 and elevation of aspartate aminotransferase and alanine aminotransferase of grade 3/4 in patients receiving TACE plus sorafenib compared with those receiving TACE plus placebo.

CONCLUSIONS

There is no additive benefit of TACE plus sorafenib compared to TACE plus placebo for HCC.

摘要

目的

使用荟萃分析技术评估经导管动脉化疗栓塞(TACE)联合索拉非尼与 TACE 联合安慰剂治疗肝细胞癌(HCC)的疗效和安全性。

方法

从建库至 2019 年 12 月 27 日,检索 PubMed、EMBASE 和 Cochrane Library 数据库。纳入包含 TACE+索拉非尼治疗组和 TACE+安慰剂对照组的研究,且至少随访 1 年以评估生存率、肿瘤反应或无进展生存期。

结果

我们的研究表明,与 TACE 联合安慰剂相比,TACE 联合索拉非尼并未降低 HCC 患者的疾病进展风险(风险比 0.94 [95%置信区间(CI),0.84-1.05]),也未显著提高 HCC 患者的 0.5 年、1 年、1.5 年和 2 年生存率(风险比 1.01 [95% CI,0.97-1.05];RR 1.00 [95% CI,0.92-1.08],RR 1.04 [95% CI,0.89-1.23],RR 0.98 [95% CI,0.72-1.34])。荟萃分析还表明,与 TACE 联合安慰剂相比,TACE 联合索拉非尼在完全缓解、部分缓解、疾病稳定、疾病进展、总缓解率和疾病控制率方面也没有显著差异。与 TACE 联合安慰剂相比,接受 TACE 联合索拉非尼治疗的患者发生 3/4 级乏力和 3/4 级天门冬氨酸氨基转移酶、丙氨酸氨基转移酶升高的发生率更高。

结论

与 TACE 联合安慰剂相比,TACE 联合索拉非尼对 HCC 无附加获益。

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