METHODS: This study retrospectively enrolled 90 patients with advanced HCC treated with apatinib plus TACE (A-TACE group, n = 52) or apatinib plus ICIs and TACE (IA-TACE group, n = 38).
RESULTS: The objective response rate was numerically higher in IA-TACE group compared with A-TACE group without statistical significance (57.9% vs. 36.5%, P = 0.055). Disease control rate was not different between groups (86.8% vs. 76.9%, P = 0.248). Progression-free survival (PFS) was improved in IA-TACE group compared with A-TACE group (P = 0.018). The median PFS (95% confidence interval) was 12.5 (8.7-16.3) months in IA-TACE group and 8.5 (5.6-11.4) months in A-TACE group. Overall survival (OS) was also prolonged in IA-TACE group compared with A-TACE group (P = 0.007). The median OS (95% confidence interval) was 21.1 (15.8-26.4) months in IA-TACE group and 14.3 (11.5-17.1) months in A-TACE group. By multivariate Cox regression model, IA-TACE was independently associated with prolonged PFS (hazard ratio = 0.539, P = 0.038) and OS (hazard ratio = 0.447, P = 0.025). Most adverse events were not different between groups. Only the incidence of reactive cutaneous capillary endothelial proliferation was higher in IA-TACE group compared with A-TACE group (10.5% vs. 0.0%, P = 0.029).
CONCLUSIONS: Apatinib plus ICIs and TACE may be an effective and safe treatment for patients with advanced HCC, but further large-scale studies are needed for verification.
方法:本研究回顾性纳入了90例接受阿帕替尼联合TACE治疗的晚期HCC患者(A-TACE组,n=52)或阿帕替尼+ICIs和TACE(IA-TACE组,n=38)。
结果:与A-TACE组相比,IA-TACE组的客观缓解率在数值上较高,无统计学意义(57.9%vs.36.5%,P=0.055)。组间疾病控制率无差异(86.8%vs.76.9%,P=0.248)。与A-TACE组相比,IA-TACE组的无进展生存期(PFS)提高(P=0.018)。IA-TACE组的中位PFS(95%置信区间)为12.5(8.7-16.3)个月,A-TACE组为8.5(5.6-11.4)个月。与A-TACE组相比,IA-TACE组的总生存期(OS)也延长(P=0.007)。IA-TACE组的中位OS(95%置信区间)为21.1(15.8-26.4)个月,A-TACE组为14.3(11.5-17.1)个月。通过多元Cox回归模型,IA-TACE与延长的PFS(风险比=0.539,P=0.038)和OS(风险比=0.447,P=0.025)独立相关。大多数不良事件在组间没有差异。与A-TACE组相比,IA-TACE组只有反应性皮肤毛细血管内皮增生的发生率更高(10.5%vs.0.0%,P=0.029)。
结论:阿帕替尼联合ICIs和TACE治疗晚期肝癌可能是一种安全有效的治疗方法。但需要进一步的大规模研究进行验证。