Qiu Zhiyu, Shen Lujun, Jiang Yiquan, Qiu Jiliang, Xu Zining, Shi Mengting, Yu Zhentao, Ma Yanping, He Wei, Zheng Yun, Li Binkui, Wang Guoying, Yuan Yunfei
State Key Laboratory of Oncology in South China and Collaborative Innovation Center of Cancer Medicine, Sun Yat-sen University, Guangzhou, China.
Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.
Ann Transl Med. 2021 Feb;9(4):283. doi: 10.21037/atm-20-5360.
The combination of transarterial chemoembolization (TACE) with sorafenib has demonstrated superior efficacy over sorafenib and TACE monotherapy in hepatocellular carcinoma (HCC). Apatinib, a new targeted agent, has been recently reported to prolong the survival of HCC patients, either alone or in combination with TACE. However, the superior regimen between TACE-apatinib and TACE-sorafenib in HCC patients has not been determined. In this study, we compared the efficacy and safety of TACE-apatinib versus TACE-sorafenib in advanced stage HCC patients.
The data of 201 HCC patients who had received TACE-sorafenib or TACE-apatinib between January 2016 and June 2018 in three hospitals were retrospectively reviewed. Overall survival (OS), progression-free survival (PFS), and adverse effects (AEs) between the two treatment groups were compared. A subgroup analysis based on the doses of targeted agents was also performed.
No significant differences in baseline clinicopathological features were found between the two groups except for dose reduction. The TACE-apatinib group had higher incidences of hypertension, oral or anal ulcer and proteinuria, while the TACE-sorafenib group had higher incidences of diarrhea and alopecia. Grade 3/4 AEs occurred more frequently in the TACE-apatinib group than in the TACE-sorafenib group (52.3% 22.6%, P<0.001). The TACE-sorafenib group had better PFS than the TACE-apatinib group (median PFS: 5.0 6.0 months, P=0.002) while the two groups showed no difference in OS (median OS: 13.0 13.0 months, P=0.448). The TACE-apatinib group had a higher rate of targeted agent dose reduction than the TACE-sorafenib group (53.5% 17.4%, P<0.001). When the patients were stratified into normal and reduced-dose subgroups, those who received TACE-sorafenib exhibited improved PFS but similar OS compared with the patients who received TACE-apatinib in the reduced-dose subgroup (median OS: 12.0 13.3 months, P=0.614; median PFS: 3.0 7.0 months, P<0.001). Multivariable analysis validated that treatments and dose reduction were independent prognostic factors for PFS among all patients.
Compared with TACE-sorafenib, the strategy of TACE-apatinib yielded shorter PFS in advanced HCC patients while no difference in OS was observed. A high rate of AE-related dose reduction of apatinib could account for the observed differences.
经动脉化疗栓塞术（TACE）联合索拉非尼在肝细胞癌（HCC）治疗中已显示出优于索拉非尼单药治疗及TACE单药治疗的疗效。阿帕替尼是一种新型靶向药物，近期有报道称其单独使用或与TACE联合使用均可延长HCC患者的生存期。然而，HCC患者中TACE-阿帕替尼与TACE-索拉非尼哪种方案更优尚未确定。在本研究中，我们比较了TACE-阿帕替尼与TACE-索拉非尼在晚期HCC患者中的疗效和安全性。
回顾性分析了2016年1月至2018年6月期间在三家医院接受TACE-索拉非尼或TACE-阿帕替尼治疗的201例HCC患者的数据。比较了两个治疗组的总生存期（OS）、无进展生存期（PFS）和不良反应（AE）。还基于靶向药物剂量进行了亚组分析。
除剂量减少外，两组患者的基线临床病理特征无显著差异。TACE-阿帕替尼组高血压、口腔或肛门溃疡及蛋白尿的发生率较高，而TACE-索拉非尼组腹泻和脱发的发生率较高。3/4级AE在TACE-阿帕替尼组的发生频率高于TACE-索拉非尼组（52.3%对22.6%，P<0.001）。TACE-索拉非尼组的PFS优于TACE-阿帕替尼组（中位PFS：5.0对6.0个月，P=0.002），而两组的OS无差异（中位OS：13.0对13.0个月，P=0.448）。TACE-阿帕替尼组靶向药物剂量减少的发生率高于TACE-索拉非尼组（53.5%对17.4%，P<0.001）。当将患者分为正常剂量和减量亚组时，与减量亚组中接受TACE-阿帕替尼治疗的患者相比，接受TACE-索拉非尼治疗的患者PFS有所改善，但OS相似（中位OS：12.0对13.3个月，P=0.614；中位PFS：3.0对7.0个月，P<0.001）。多变量分析证实，治疗和剂量减少是所有患者PFS的独立预后因素。
与TACE-索拉非尼相比，TACE-阿帕替尼方案在晚期HCC患者中的PFS较短，而OS无差异。阿帕替尼与AE相关的高剂量减少率可能是观察到的差异的原因。
