The First Affiliated Hospital of Sun Yat-sen University, Guangdong, China.
Technol Cancer Res Treat. 2020 Jan-Dec;19:1533033820965587. doi: 10.1177/1533033820965587.
This study aimed to explore the efficacy and safety of using transarterial chemoembolization (TACE) combined with anlotinib in patients with unresectable hepatocellular carcinoma, compared with TACE alone.
This was a single-center study, retrospectively recruited 82 unresectable HCC patients who received either TACE alone (TA group; n = 46) or TACE combined with anlotinib (TC group; n = 36) between Jan 2018 and Jan 2019. The primary outcomes were progression-free survival (PFS) and overall survival (OS). While the secondary outcomes were the objective response rate (ORR), the disease control rate (DCR), and main complications. Log-rank test and Kaplan-Meier method was used to calculate the survival difference. All statistical tests were 2-sided and P value <0.05 were taken as statistically significant.
Patients in TC group had a significant higher PFS than those in TA group (7.35 months vs. 5.54 months, p = 0.035). Although 3-month survival rate in the 2 groups was not statistically different (97.2% vs. 93.5%, p = 0.627), the survival rate at 6 months and 1 year were strongly higher in TC group (83.3% vs. 56.5%, p = 0.016; 66.7% vs. 19.6%, respectively, p < 0.05). Furthermore, there was a significantly higher ORR in TC group, while no statistical difference existed in DCR. Neither treatment-related mortality nor grade 4 adverse events (AEs) occurred. However, 2 patients in TC group had grade 3 AEs (one suffered with erythra, and the other with hand-foot-skin reaction), which disappeared after prompt treatment.
TACE combined with anlotinib is safe and may improve outcomes for unresectable HCC patients comparing with TACE alone. Randomized controlled trials are warranted to further evaluate treatment effects of anlotinib in HCC.
本研究旨在探讨经动脉化疗栓塞（TACE）联合安罗替尼与单纯 TACE 治疗不可切除肝细胞癌患者的疗效和安全性。
这是一项单中心回顾性研究，纳入 2018 年 1 月至 2019 年 1 月期间接受单纯 TACE（TA 组，n=46）或 TACE 联合安罗替尼（TC 组，n=36）治疗的 82 例不可切除 HCC 患者。主要终点为无进展生存期（PFS）和总生存期（OS）。次要终点为客观缓解率（ORR）、疾病控制率（DCR）和主要并发症。采用 Log-rank 检验和 Kaplan-Meier 法计算生存差异。所有统计检验均为双侧，P 值<0.05 为统计学差异有意义。
TC 组患者的 PFS 显著长于 TA 组（7.35 个月比 5.54 个月，p=0.035）。尽管两组患者 3 个月生存率无统计学差异（97.2%比 93.5%，p=0.627），但 TC 组患者 6 个月和 1 年生存率显著更高（83.3%比 56.5%，p=0.016；66.7%比 19.6%，p<0.05）。此外，TC 组患者的 ORR 显著更高，而 DCR 无统计学差异。两组均无治疗相关死亡或 4 级不良事件（AE）发生。然而，TC 组有 2 例患者发生 3 级 AE（1 例出现红斑，1 例出现手足皮肤反应），经及时治疗后均消失。
TACE 联合安罗替尼治疗不可切除 HCC 患者安全且可能优于单纯 TACE，需要进一步开展随机对照试验来评估安罗替尼在 HCC 中的治疗效果。
