Malagari Κ, Kiakidis Th, Moschouris Hip, Deutsch M, Tanteles S, Pantou Eir, Panagiotou I, Koskinas J, Glantzounis G K, Alexopoulou A, Filippiadis D, Brountzos E, Kelekis N
2nd Department of Radiology, School of Medicine, Attikon University Hospitals, National and Kapodistrian University of Athens, Katerina Malagari, 19 Monis Kyccou, 15 669, Papagou, Athens, Greece.
Department of Tzanion, General Hospital Pireus, Pireus, Greece.
Cardiovasc Intervent Radiol. 2023 Mar;46(3):337-349. doi: 10.1007/s00270-022-03346-1. Epub 2023 Jan 18.
The primary objectives of this study were to evaluate safety, and efficacy of Transarterial Chemoembolization (TACE) using doxorubicin-loaded radiopaque microspheres (DC Bead LUMI™) for the treatment of early and intermediate stage Hepatocellular Carcinoma (HCC) not amenable for curative treatments. Distribution of the microspheres was correlated with results post embolization.
This was a prospective, single arm, open label study. The primary outcome measures were distribution of the radiopaque microspheres as showed by computerized tomography (CT) and local response measured by modified Response Evaluation Criteria (mRECIST) after Magnetic Resonance Imaging (MRI). Secondary measures were Time to Progression (TTP) and Overall Survival (OS).
Fifty patients were enrolled over 36 months. Median age was 69.0 years; mean sum of target lesions diameters was 78.6 ± 36.8 mm. There were no Grade 4 or 5 adverse events (AEs). At 6 months Complete Response (CR) (18%), Partial Response (PR) (62%), Objective Response OR (80%) and Stable Disease (SD) (20%) were recorded. Before embolization, Diffusion Weighted Imaging (DWI) showed high signal (restricted diffusion). Post procedure, patients with dense deposition (< 5 mm distance of microsphere aggregations) showed 100% absence of enhancement and no restriction in 30.6%. Median TTP was 8.3 months. TTP for patients with CR was 13.3 months and 7.2 and 5.6 for PR and SD, respectively. At 6 and 36 months, survival was 94% and 34%, respectively.
DC Bead LUMI™ is well tolerated and effective in early and intermediate stage HCC with maximal necrosis obtained in dense deposition in the target.
本研究的主要目的是评估使用载有多柔比星的不透射线微球（DC Bead LUMI™）经动脉化疗栓塞术（TACE）治疗不宜进行根治性治疗的早期和中期肝细胞癌（HCC）的安全性和有效性。微球的分布与栓塞后的结果相关。
这是一项前瞻性、单臂、开放标签研究。主要结局指标是计算机断层扫描（CT）显示的不透射线微球的分布，以及磁共振成像（MRI）后根据改良的实体瘤疗效评价标准（mRECIST）测量的局部反应。次要指标是疾病进展时间（TTP）和总生存期（OS）。
在36个月内招募了50名患者。中位年龄为69.0岁；目标病灶直径总和的平均值为78.6±36.8毫米。没有4级或5级不良事件（AE）。在6个月时，记录到完全缓解（CR）（18%）、部分缓解（PR）（62%）、客观缓解率（OR）（80%）和疾病稳定（SD）（20%）。栓塞前，扩散加权成像（DWI）显示高信号（扩散受限）。术后，微球聚集距离<5毫米的致密沉积患者显示100%无强化，30.6%无扩散受限。中位TTP为8.3个月。CR患者的TTP为13.3个月，PR和SD患者的TTP分别为7.2个月和5.6个月。在6个月和36个月时，生存率分别为94%和34%。
DC Bead LUMI™耐受性良好，对早期和中期HCC有效，在靶区致密沉积时可实现最大程度的坏死。
