Gu Huiying, Li Jing, You Nan, Wu Ke, Wang Zheng, Wang Liang, Zhu Yinan, Liu Qinqin, Peng Xuehui, Zheng Lu
Department of Hepatobiliary Surgery, Xinqiao Hospital, Army Medical University, Chongqing, China.
Ann Transl Med. 2020 Dec;8(24):1677. doi: 10.21037/atm-20-7244.
Apatinib, a vascular endothelial growth factor receptor 2 (VEGFR-2) inhibitor, has shown promising therapeutic effect for hepatocellular carcinoma (HCC). This prospective clinical study was implemented to evaluate the efficacy and safety of apatinib combined with transarterial chemoembolization (TACE) versus TACE alone in treating patients with recurrent HCC after hepatectomy.
Eligible patients with postoperative recurrent HCC from January 2018 to January 2020 were enrolled at the Xinqiao Hospital of Army Medical University. Patients were randomized 1:1 into TACE plus apatinib group or TACE-alone group. The clinical information of patients was collected, and the patients were followed up until untreatable progression or the end of the study. Adverse events (AEs), overall survival (OS) and progression-free survival (PFS) between the two groups were evaluated. In addition, the objective response rate (ORR) and the disease control rate (DCR) were determined according to the modified Response Evaluation Criteria In Solid Tumors (mRECIST). Among those indexes, PFS was the primary endpoint.
This study enrolled 80 patients with recurrent HCC, and the demographics and primary tumor characteristics were balanced between the two groups. However, TACE plus apatinib treatment could significantly improve the median PFS of patients when compared with the TACE-alone group (17.2 12.5 months, P=0.041). The 1- and 2-year overall survival (OS) rates showed a tendency of improving in the TACE plus apatinib group, but not significantly (95.0% 85.0%, and 90.0% 75.0%; both P>0.05). Furthermore, the TACE plus apatinib treatment did significantly increase the short-term ORR and DCR when compared with the TACE-alone group (all P<0.05). And no unexpected toxicity or procedure-related mortality was occurred during this study.
The combination treatment of apatinib and TACE might be safe and of potential benefit on patients with intrahepatic recurrent HCC.
阿帕替尼是一种血管内皮生长因子受体2（VEGFR - 2）抑制剂，已显示出对肝细胞癌（HCC）有良好的治疗效果。本前瞻性临床研究旨在评估阿帕替尼联合经动脉化疗栓塞术（TACE）与单纯TACE治疗肝切除术后复发性HCC患者的疗效和安全性。
选取2018年1月至2020年1月在陆军军医大学新桥医院的术后复发性HCC合格患者。患者按1:1随机分为TACE加阿帕替尼组或单纯TACE组。收集患者的临床信息，并对患者进行随访直至不可治疗的进展或研究结束。评估两组之间的不良事件（AE）、总生存期（OS）和无进展生存期（PFS）。此外，根据改良的实体瘤疗效评价标准（mRECIST）确定客观缓解率（ORR）和疾病控制率（DCR）。在这些指标中，PFS是主要终点。
本研究纳入80例复发性HCC患者，两组患者的人口统计学和原发肿瘤特征均衡。然而，与单纯TACE组相比，TACE加阿帕替尼治疗可显著改善患者的中位PFS（17.2对12.5个月，P = 0.041）。TACE加阿帕替尼组1年和2年总生存率（OS）有改善趋势，但不显著（95.0%对85.0%，90.0%对75.0%；P均>0.05）。此外，与单纯TACE组相比，TACE加阿帕替尼治疗确实显著提高了短期ORR和DCR（P均<0.05）。并且在本研究期间未发生意外毒性或与手术相关的死亡。
阿帕替尼与TACE联合治疗对肝内复发性HCC患者可能是安全且有潜在益处的。
