CalliSpheres载药微球联合索拉非尼治疗TACE后进展的不可切除肝癌患者中的疗效分析

Efficacy of CalliSpheres drug-eluting beads-TACE plus sorafenib for patients with unresectable hepatocellular carcinomas progressing after conventional TACE

目的评估Calli Spheres载药微球联合索拉非尼治疗经导管动脉化疗栓塞术(TACE)后进展的不可切除肝癌患者中的有效性和安全性。方法选取2016年1月至2020年1月衢州市人民医院38例TACE后经实体瘤疗效评价标准(mRECIST)判定为进展的不可切除肝癌患者的临床资料,患者口服索拉非尼400~800 mg/d,2周后行首次使用Calli Spheres载药微球的TACE(DEB-TACE),其后继续口服索拉非尼800 mg/d,期间按需重复DEB-TACE治疗,直至出现了无法通过TACE治疗获益的进展,即肝内肿瘤直径总和增加≥25%、治疗后4周内肝功能Child-Pugh C级、出现肝内大血管转移(MVI)或肝外转移(EHS)。分析联合治疗的疗效、病变的进展模式及患者不良反应发生情况。结果 38例患者的中位无进展生存期为8.0个月,中位总生存期为12.0个月,中位疾病进展时间6.0个月。1年内出现疾病进展30例(79.0%),其表现为MVI 10例(26.3%);肝内肿瘤直径总和增加≥25%9例(23.7%);EHS 7例(18.4%);肝功能进展至Child C级4例(10.5%)。出现MVI的中位时间为8.0个月,出现EHS的中位时间为7.0个月。Ⅲ、Ⅵ级不良反应中ALT升高最常见,发生率为57.9%。结论 DEB-TACE联合索拉非尼治疗TACE后进展的不可切除肝癌临床疗效明显,安全性较好。

Objective To evaluate the efficacy and safety of CalliSpheres drug-eluting beads-transarterial chemoembolisation(DEB-TACE) plus sorafenib for patients with unresectable hepatocellular carcinomas(HCC) progressing after conventional TACE.Methods Thirty eight patients with unresectable HCC who had disease progressed after conventional TACE were included in the study.Patients received sorafenib 400 mg daily for 2 weeks before DEB-TACE,followed by 800 mg daily during on-demand DEB-TACE sessions until time to unTACEable progression which was defined as intrahepatic tumor progression(25% increase vs baseline),transient deterioration to child-Pugh C or appearance of vascular invasion/extrahepatic spread.PFS,OS and TIP were analyzed,pattern of unTACEable progression and AEs were also observed.Results The median PFS was 8.0 months,median OS was 12.0 months and median TTP was 6.0 months.The unTACEable progression occurred within 1 year in 30 patients(79.0%),including intrahepatic tumor progression in 9 cases(23.7%),MVI in 10 cases(26.3%),EHS in 7 cases(18.4%),and transient deterioration to child-Pugh C in 4 cases(10.5%).The times to MVI and EHS were 8.0 months and 7.0 months,respectively.The most frequent grade 3 and 4 adverse effect was elevated ALT(57.9%).Conclusion CalliSpheres DEB-TACE combined with sorafenib may improve PFS and OS in patients with unresectable HCC patients who have disease progress a fter conventional TACE.