Department for Gastroenterology and Hepatology, University Hospital Essen, Essen, Germany.
Hepatology. 2010 Nov;52(5):1741-9. doi: 10.1002/hep.23944.
Radioembolization has been demonstrated to allow locoregional therapy of patients with hepatocellular carcinoma not eligible for transarterial chemoembolization or other local therapies. The aim of this study was to validate evidence of the safety and efficacy of this treatment in a European sample of patients with advanced hepatocellular carcinoma (HCC). Therefore, 108 consecutive patients with advanced HCC and liver cirrhosis were included. Yttrium-90 (Y-90) microspheres were administered in a lobar fashion over the right or left branch of the hepatic artery. The response to treatment was evaluated by computed tomography (CT) imaging applying Response Evaluation Criteria in Solid Tumors (RECIST) and World Health Organization (WHO) criteria with recent European Association for the Study of the Liver / National Cancer Institute (EASL/NCI) amendments. Time to progression (TTP) and overall survival were estimated by the Kaplan-Meier method. In all, 159 treatment sessions were performed ranging between one to three treatments per patient. The mean radiation dose per treatment was 120 (± 18) Gy. According to EASL criteria, complete responses were determined in 3% of patients, partial responses in 37%, stable disease 53%, and primary progression in 6% of patients. TTP was 10.0 months, whereas the median overall survival was 16.4 months. No lung or visceral toxicity was observed. The most frequently observed adverse events was a transient fatigue-syndrome.
Radioembolization with Y-90 glass microspheres for patients with advanced HCC is a safe and effective treatment which can be utilized even in patients with compromised liver function. Because TTP and survival appear to be comparable to systemic therapy in selected patients with advanced HCC, randomized controlled trials in combination with systemic therapy are warranted.
本研究旨在验证钇-90（Y-90）玻璃微球放射性栓塞术治疗不可进行经动脉化疗栓塞术或其他局部治疗的晚期肝细胞癌（HCC）患者的安全性和有效性的证据。
共纳入 108 例晚期 HCC 合并肝硬化患者。采用放射性栓塞术将 Y-90 微球按叶状分布于肝右或左支动脉。采用实体瘤反应评估标准（RECIST）和世界卫生组织（WHO）标准，并结合最近的欧洲肝脏研究协会/国家癌症研究所（EASL/NCI）修正案，通过计算机断层扫描（CT）评估治疗反应。采用 Kaplan-Meier 法估计无进展时间（TTP）和总生存期。所有患者均进行了 159 次治疗，每位患者的治疗次数为 1 至 3 次。每次治疗的平均辐射剂量为 120（±18）Gy。根据 EASL 标准，3%的患者完全缓解，37%的患者部分缓解，53%的患者病情稳定，6%的患者出现原发性进展。TTP 为 10.0 个月，中位总生存期为 16.4 个月。未观察到肺或内脏毒性。最常见的不良反应是短暂的疲劳综合征。
Y-90 玻璃微球放射性栓塞术治疗晚期 HCC 是一种安全有效的治疗方法，即使在肝功能受损的患者中也可使用。由于 TTP 和生存似乎与选定的晚期 HCC 患者的系统治疗相当，因此需要进行随机对照试验联合系统治疗。
