阿帕替尼联合TACE/BAI治疗64例肝细胞癌肺转移的安全性和有效性分析

Safety and Efficacy of Apatinib Combined with TACE/BAI in the Treatment of 64 Patients with Advanced Hepatocellular Carcinoma with Pulmonary Metastases

[目的]探讨阿帕替尼联合肝动脉化疗栓塞术(transcatheter arterial chemoembolization,TACE)和支气管动脉灌注化疗(bronchial arterial infusion chemotherapy,BAI)对比TACE/BAI治疗肝细胞癌(hepatocellular carcinoma,HCC)肺转移的安全性及有效性。[方法]纳入2015年5月至2017年6月在丽水市人民医院、温州医科大学附属第一医院、浙江省人民医院和浙江省肿瘤医院四个中心收治的70例HCC肺转移患者,将患者按1∶1随机分配到阿帕替尼联合TACE/BAI(试验)组和TACE/BAI(对照)组。最终,64例患者纳入研究,其中试验组35例,对照组29例。比较两组无进展生存期(progressionfree survival,PFS)、疾病进展时间(time to progression,TTP)、总生存期(overall survival,OS)、疾病控制率(disease control rate,DCR)、客观缓解率(objective response rate,ORR)、生活质量评分(quality of life,QOL),以及治疗相关不良反应(adverse event,AE)的差异。[结果]阿帕替尼联合TACE/BAI试验组的DCR显著优于TACE/BAI组(57.14%vs 27.59%,χ^(2)=4.493,P=0.034),且总AEs发生率在两组间无明显差异。在患者生存预后方面,试验组的PFS、TTP和OS均优于对照组(P值分别为0.030、0.029、0.020)。[结论]与TACE/BAI相比,TACE/BAI联合阿帕替尼用药组对肝细胞癌肺转移患者的疗效更佳,生存获益更大,且不增加AE的发生率,对患者的QOL无明显影响。

[Objective]To investigate the safety and efficacy of apatinib combined with transcatheter arterial chemoembolization(TACE)and bronchial arterial infusion chemotherapy(BAI)versus TACE and BAI(TACE/BAI)in the treatment of advanced hepatocellular carcinoma(HCC)with pulmonary metastases.[Methods]Seventy HCC patients with lung metastasis from four different hospitals were enrolled from May2015 to June 2017.According to the ratio of 1∶1,all patients were randomly divided into the experimental group and the control group.Finally,64 patients(35 in the experimental group and 29 in the control group)were enrolled in this study.The patients in the experimental group were treated with apatinib combined with TACE and BAI,and the patients in the control group were treated with TACE and BAI.The progression-free survival(PFS),time to progress(TTP),overall survival(OS),disease control rate(DCR),objective response rate(ORR),quality of life(QOL)and percentage of adverse event(AE)between the two groups were calculated and compared.[Results]DCR was significantly better in experimental group than that in thecontrol group(57.14%vs 27.59%,χ^(2)=4.493,P=0.034)and the overall incidence of adverse events between the two groups was comparable.In terms of patient prognosis,the experimental group displayed better PFS,TTP and OS than the control group(P=0.030;P=0.029;P=0.020,respectively).[Conclusions]Compared with TACE and BAI group,patients received apatinib combined with TACE and BAI display a favorable survival benefit without adverse effect on QOL or AE incidence.