载药微球动脉化疗栓塞联合阿帕替尼与载药微球动脉化疗栓塞治疗不可切除肝细胞癌的疗效比较：一项随机、前瞻性、多中心 III 期临床试验。

Comparison of drug-eluting bead transarterial chemoembolization combined with apatinib versus drug-eluting bead transarterial chemoembolization for the treatment of unresectable hepatocellular carcinoma: a randomized, prospective, multicenter phase III trial.

机构信息

Department of Interventional Radiology, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan, China.

Department of Interventional and Oncology, Dengzhou People's Hospital, Nanyang, Henan, China.

出版信息

Signal Transduct Target Ther. 2024 Nov 13;9(1):304. doi: 10.1038/s41392-024-02012-x.

DOI:10.1038/s41392-024-02012-x

PMID:39532849

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11557926/

Abstract

This randomized, prospective, multicenter (12 centers in China) phase III trial (Chinese Clinical Trial Registry #ChiCTR2000041170) compared drug-eluting bead transarterial chemoembolization (DEB-TACE) combined with apatinib and DEB-TACE monotherapy for patients with unresectable hepatocellular carcinoma (uHCC). Progression-free survival (PFS) was the primary endpoint. Overall survival (OS), mRECIST-based objective response rates (ORR) and disease control rates (DCR), and treatment-related adverse events (TRAEs) were secondary endpoints. Totally 243 cases were randomized, with 122 and 121 in the DEB-TACE + apatinib and DEB-TACE groups, respectively. Cases administered DEB-TACE + apatinib displayed markedly improved median PFS (7.1 months [95%CI 6.6-8.3] vs. 5.2 months [95%CI 5.0-5.9]) and OS (23.3 months [95%CI 20.7-29.6] vs. 18.9 months [95%CI 17.9-20.1] compared with those treated with DEB-TACE (both p < 0.001). Additionally, patients administered DEB-TACE + apatinib had elevated ORR (56.6% vs. 38.8%) and DCR (89.3% vs. 80.2%) versus the DEB-TACE group (both p < 0.001). Majority of TRAEs were mild and manageable. Regarding DEB-TACE-related TRAEs, the rates of hepatic artery thinning and spasms were elevated during the second DEB-TACE in cases administered DEB-TACE + apatinib vs. DEB-TACE. The commonest apatinib-related TRAEs in the DEB-TACE + apatinib group included hypertension, hand-foot syndrome, fatigue, and diarrhea. In conclusion, DEB-TACE plus apatinib demonstrates superior PFS versus DEB-TACE monotherapy in uHCC cases, maintaining a favorable safety profile with similar occurrences of AEs.

摘要

这项随机、前瞻性、多中心（中国 12 个中心）的 III 期临床试验（中国临床试验注册中心 #ChiCTR2000041170）比较了载药微球动脉化疗栓塞（DEB-TACE）联合阿帕替尼与 DEB-TACE 单药治疗不可切除肝细胞癌（uHCC）患者的疗效。无进展生存期（PFS）是主要终点。总生存期（OS）、基于 mRECIST 的客观缓解率（ORR）和疾病控制率（DCR）以及治疗相关不良反应（TRAEs）为次要终点。共 243 例患者随机分组，DEB-TACE+阿帕替尼组和 DEB-TACE 组各 122 例和 121 例。与 DEB-TACE 组相比，DEB-TACE+阿帕替尼组中位 PFS（7.1 个月[95%CI 6.6-8.3] vs. 5.2 个月[95%CI 5.0-5.9]）和 OS（23.3 个月[95%CI 20.7-29.6] vs. 18.9 个月[95%CI 17.9-20.1]）明显改善（均 p<0.001）。此外，DEB-TACE+阿帕替尼组的 ORR（56.6% vs. 38.8%）和 DCR（89.3% vs. 80.2%）均高于 DEB-TACE 组（均 p<0.001）。大多数 TRAEs 为轻度且可管理。在 DEB-TACE 相关 TRAEs 中，DEB-TACE+阿帕替尼组第二次 DEB-TACE 时肝动脉变薄和痉挛的发生率高于 DEB-TACE 组。DEB-TACE+阿帕替尼组最常见的阿帕替尼相关 TRAEs 包括高血压、手足综合征、疲劳和腹泻。总之，DEB-TACE 联合阿帕替尼在 uHCC 患者中较 DEB-TACE 单药治疗具有更好的 PFS，同时保持了相似的 AE 发生率，具有良好的安全性。