基于CalliSpheres®新型载药微球的化疗栓塞治疗肝细胞癌患者疗效及安全性分析

摘要/Abstract

摘要： 目的评估基于CalliSpheres^®(CSM)载药微球的经动脉化疗栓塞(DEB-TACE)治疗中国肝细胞癌(HCC)患者的治疗应答、生存获益、肝功能变化以及不良反应。方法回顾性纳入南昌大学第二附属医院接受基于CSM的DEB-TACE治疗的HCC患者66例。收集患者基线期信息,记录患者术后1个月的治疗应答、术后的不良反应和肝功能指标,评估患者的无病生存期(DFS)和总体生存期(OS)。结果DEB-TACE术后1个月,患者完全缓解率、总体应答率(ORR)和疾病控制率分别为18.2%,75.8%和93.9%。亚组分析显示, Child-Pugh分级较高(B级50.0% vs. A级80.4%,P=0.039)和BCLC分期较高(C期40.0% vs. B期82.4% vs. A期94.1%,P=0.001)的患者ORR更低。中位DFS和OS分别为6.0个月和20.0个月,亚组分析显示Child-Pugh B级以及BCLC 分期较高的患者DFS较差(P=0.015和P=0.009),OS也较差(P=0.018和P=0.002);此外,多病灶的患者DFS较差(P=0.007)。术后1个月患者的Alb(中位值34.7 g/L比37.7 g/L,P<0.001)和Scr水平(中位值66.7 μmol/L比70.7 μmol/L,P=0.016)与基线期相比降低,TBil水平与基线期相比升高(中位值20.4 μmol/L比16.8 μmol/L,P=0.025),而其他生化指标无差异。术后最常见的不良反应为疼痛(47.0%发生率)。结论综上所述,基于CSM的DEB-TACE治疗中国HCC患者实现了较好的治疗应答、较长的生存获益以及较好的安全性,且病灶数、Child-Pugh 分级以及BCLC分期可作为DEB-TACE治疗HCC患者的预后因素。

关键词: 肝细胞癌, 经动脉化疗栓塞术, 载药微球, 疗效, 安全性

Abstract: Objective To evaluate the treatment response, survival benefit, change of liver function and adverse events (AEs) of CalliSpheres^® (CSM) based drug-eluting beads transarterial chemoembolization (DEB-TACE) in treating hepatocellular carcinoma (HCC). Methods Sixty-six HCC patients who underwent CSM-based DEB-TACE in the Second Affiliated Hospital of Nanchang University were consecutively enrolled in this retrospective cohort study. The baseline characteristics of HCC patients were recorded. Treatment responses at 1 month after treatment, liver function related laboratory indexes pre and post-treatment, and the post-treatment AEs were recorded. Disease-free survival (DFS) and overall survival (OS) were documented and evaluated. Results Complete response (CR), Overall Response Rate (ORR) and Disease Control Rate (DCR) within 1 month post treatment were 18.2%, 75.8%, and 93.9%, respectively. Subgroup analysis revealed that patient with higher Child-Pugh stage (B stage 50.0% vs A stage 80.4%, P=0.039) and higher BCLC stage (C stage 40.0% vs B stage 82.4% vs A stage 94.1%, P=0.001) had worse ORR. The median PFS and OS were 6.0 months and 20.0 months, respectively. Subgroup analysis disclosed that patients with Child-Pugh B and higher BCLC C had both shorter DFS (P=0.015 and P=0.009), as well as worse OS (P=0.018 and P=0.002); additionally, the patients with multifocal disease had worse DFS (P=0.007). The Alb (median 34.7 g/L vs 37.7 g/L, P<0.001) and Scr (median 66.7 μmol/L vs 70.7 μmol/L, P=0.016) level decreased, while TBil (median 20.4 μmol/L vs. 16.8 μmol/L, P=0.025) increased after treatment. Other liver function-related indexes did not change after treatment. The most common AEs post treatment was pain (incidence rate of 47.0%). Conclusion CSM based DEB-TACE achieves favorable treatment response and survival benefit in Chinese HCC patients, also with good tolerance. Several clinical features might have the potentials to serve as prognostic markers.

Key words: Hepatocellular, Transarterial chemoembolization, Drug-eluting beads, Efficacy, Safety

郑亚璐, 熊恺, 石青, 杨慧, 郑雄. 基于CalliSpheres^®新型载药微球的化疗栓塞治疗肝细胞癌患者疗效及安全性分析[J]. 肝脏, 2024, 29(10): 1194-1199.

ZHENG Ya-lu, XIONG Kai, SHI Qing, YANG Hui, ZHENG Xiong. Efficacy and safety of CalliSpheres^® microspheres-based drug-eluting beads transaterial chemoembolization in the treatment of hepatocellular carcinoma[J]. Chinese Hepatolgy, 2024, 29(10): 1194-1199.

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