经导管动脉化疗栓塞术联合低剂量阿帕替尼治疗老年不可切除肝细胞癌患者的临床效果和安全性

Clinical efficacy and safety of transcatheter arterial chemoembolization combined with low-dose apatinib for treatment of elderly patients with unresectable hepatocellular carcinoma

目的探讨经导管动脉化疗栓塞术(TACE)联合低剂量阿帕替尼治疗老年不可切除肝细胞癌患者的临床效果和安全性。方法将120例老年不可切除肝细胞癌患者随机分为A、B、C组各40例。A组接受TACE联合低剂量阿帕替尼(250 mg/d)治疗,B组接受TACE联合常规剂量阿帕替尼(500 mg/d)治疗,C组仅接受常规TACE治疗。比较3组患者完成TACE次数,治疗前、治疗后1个月和3个月的甲胎蛋白水平、近期疗效和中位生存期,以及治疗期间不良反应发生情况。结果A组、B组TACE治疗次数少于C组(均P<0.05)。3组患者甲胎蛋白水平均有随时间而降低的趋势(P<0.05),治疗后1个月、3个月A组、B组的甲胎蛋白水平均低于C组(均P<0.05)。治疗后1个月、3个月,A组、B组的客观缓解率(ORR)、疾病控制率(DCR)均高于C组(均P<0.05),但A组、B组间差异无统计学意义(均P>0.05),治疗后3个月,A组DCR高于B组(P<0.05)。A组、B组中位生存期均长于C组(均P<0.05),但A组、B组中位生存期差异无统计学意义(P>0.05)。A组患者乏力、高血压、厌食、手足综合征的程度均轻于B组(均P<0.05)。结论与单纯TACE治疗相比,TACE联合阿帕替尼治疗老年不可切除肝细胞癌患者的疗效更好,患者生存期更长,且低剂量与常规剂量的阿帕替尼疗效相当,但安全性更好。

Objective To explore the clinical efficacy and safety of transcatheter arterial chemoembolization(TACE)combined with low-dose apatinib for the treatment of elderly patients with unresectable hepatocellular carcinoma.Methods A total of 120 elderly patients with unresectable hepatocellular carcinoma were randomly divided into group A(n=40),group B(n=40)and group C(n=40).Group A received TACE combined with low-dose apatinib(250 mg/d)therapy,group B received TACE combined with conventional-dose apatinib(500 mg/d)therapy,and group C received conventional TACE therapy alone.The number of TACE treatments completed successfully,the levels of alpha-fetoprotein before treatment and one and three months after treatment,short-term efficacy,median survival time,and incidence of adverse reactions during treatment were compared among the three groups.Results Groups A and B exhibited decreased number of TACE treatments than group C(all P<0.05).The level of alpha-fetoprotein decreased over time in the three groups(P<0.05).One and three months after treatment,groups A and B yielded a lower level of alpha-fetoprotein than group C(all P<0.05).One and three months after treatment,the objective response rate(ORR)and disease control rate(DCR)in group A or B were higher than those in group C(all P<0.05),but no statistically significant difference was found between group A and group B(all P>0.05),whereas three months after treatment,group A exhibited a higher DCR than group B(P<0.05).The median survival time in group A or B was longer than that in group C(all P<0.05),but there was no statistically significantly difference in median survival time between group A and group B(P>0.05).Patients in group A suffered from milder fatigue,hypertension,anorexia,and hand-foot syndrome as compared with group B(all P<0.05).Conclusion Compared with TACE therapy alone,TACE combined with apatinib therapy has better efficacy for elderly patients with unresectable hepatocellular carcinoma,and can prolong the survival time of the patients.Low dose of apatinib has a similar efficacy as conventional dose and demonstrates preferable safety.