阿帕替尼联合TACE对中晚期肝细胞癌患者优选治疗的临床研究

Clinical study of apatinib combined with transcatheter arterial chemoembolization for patients with advanced hepatocellular carcinoma

目的:研究中晚期肝细胞癌(HCC)患者分别接受肝动脉栓塞化疗术(TACE)联合阿帕替尼治疗和接受TACE联合安慰剂治疗的疗效和安全性。方法:48例中晚期HCC患者分为A、B两组,A组患者接受TACE和安慰剂治疗,B组接受TACE联合阿帕替尼治疗,分析比较两组患者3个月时甲胎蛋白(AFP)的变化和3,6,9,12个月时客观缓解率(ORR),并比较两组患者的中位病情无进展生存期(PFS)和不良反应的发生率。结果:治疗3月时两组患者AFP水平均较治疗前显著下降,差异具有统计学意义(P<0.05),但两组间比较差异无统计学意义(P>0.05)。A组患者ORR在治疗3、6、9、12个月时分别为37.5%、20.83%、12.5%、4.17%;B组患者ORR在治疗3、6、9、12个月时分别为54.55%、45.45%、40.91%、27.27%。3和6个月时两组患者ORR比较,差异无统计学意义(P>0.05),9和12个月时差异具有统计学意义(P<0.05)。A组患者中位PFS为4个月,B组则为8.5个月,两组比较,差异有统计学意义(P<0.05)。与阿帕替尼相关的不良反应如高血压、手足综合症、蛋白尿等,B组的发生率高于A组,差异具有统计学意义(P<0.05)。经过对症治疗后这些不良反应大多都能减轻。结论:对于中晚期HCC患者,长疗程的TACE联合阿帕替尼治疗比接受TACE联合安慰剂治疗能获得更高的ORR,并能延长中位PFS,且具有一定的安全性。

Objective:To evaluate the efficacy and safety of patients with advanced hepatocellular carcinoma(HCC)who underwent transcatheter arterial chemoembolization(TACE)combined with apatinib and TACE combined with placebo.Methods:A total of 48 patients with advanced HCC were enrolled,group A received TACE and placebo,group B received TACE combined with apatinib.To compare the changes in a-fetal protein(AFP)at 3 months and the objective response rate(ORR)at 3,6,9 and 12 months between these two groups.Furthermore,to compare the median progression-free survival(PFS)and the incidence of adverse events between these two groups.Results:After 3 months of treatment,the AFP levels in group A and group B were significantly lower than those before treatment,and the difference was statistically significant(P<0.05).However,there was no significant difference in AFP levels between the two groups(P>0.05).The ORR of group A was 37.5%,20.83%,12.5%,4.17%after 3,6,9 and 12 months of treatment,while the ORR of group B was 54.55%,45.45%,40.91%,27.27%after 3,6,9 and 12 months of treatment.The differences between these 2 groups were not statistically significant(P>0.05)at 3 and 6 months;while the differences between these 2 groups were statistically significant(P<0.05)at 9 and 12 months.The median PFS of group A was 4 months and 8.5 months in group B,and the differences were statistically significant(P<0.05).Adverse reactions associated with apatinib,such as hypertension,hand-foot syndrome and proteinuria,the incidence of group B was higher than group A,and the differences were statistically significant(P<0.05).Most of these adverse reactions can be alleviated after symptomatic treatment.Conclusion:For patients with advanced HCC,long-term TACE combined with apatinib treatment can obtain higher ORR and prolong the median PFS than TACE combined with placebo,and it has certain safety.