Department of Radiology and Nuclear Medicine, Otto-von-Guericke University, Magdeburg, Germany.
Liver Int. 2015 Feb;35(2):620-6. doi: 10.1111/liv.12622. Epub 2014 Jul 8.
BACKGROUND & AIMS: The benefits of combined systemic and liver-directed treatments in inoperable intermediate- or advanced-stage hepatocellular carcinoma (HCC) have yet to be defined. This article presents the planned safety analyses for the first 40 patients randomized to radioembolization with yttrium-90 ((90) Y) resin microspheres followed by sorafenib (n = 20) or sorafenib only (n = 20) in the SORAMIC study.
Patients identified for palliative treatment who were poor candidates for transarterial (chemo)embolization (including those failing TACE) with preserved liver function (Child-Pugh ≤B7) and ECOG performance status <2 were screened. Radioembolization was administered using a sequential lobar approach. On day 3 after the last radioembolization procedure, sorafenib 200 mg twice daily was initiated escalating to 400 mg twice daily 1 week later; a matching sorafenib dose schedule was initiated in the control arm.
Patients were followed up for a median of 8.3 months. Median total implanted activity of (90) Y was 1.87 (range: 0.54-2.35) GBq. Patients received a similar intensity and duration of sorafenib in the combination-treatment arm (median daily dose 614 mg over 8.5 months) and control arm (557 mg over 9.6 months). The incidence of total (196 vs. 222) and grade ≥3 (43 vs. 47) adverse events was similar in combination-treatment arm and control arm respectively (P > 0.05). No significant differences in the number of total or grade 3/4 toxicities were recorded for: total bilirubin, albumin, liver enzymes, ascites, Child-Pugh, fatigue, hand-foot skin reaction, blood pressure or diarrhoea.
Radioembolization followed by sorafenib appears to be as well tolerated as sorafenib alone.
联合系统和肝脏靶向治疗在不可切除的中晚期肝细胞癌（HCC）中的益处尚未明确。本文介绍了 SORAMIC 研究中前 40 例随机接受钇-90（90Y）树脂微球放射性栓塞联合索拉非尼（n=20）或仅索拉非尼（n=20）治疗的患者的计划安全性分析。
筛选出姑息性治疗的患者，这些患者因肝功能（Child-Pugh ≤B7）和 ECOG 表现状态 <2 而不适合经动脉（化疗）栓塞（包括 TACE 失败的患者）。放射性栓塞采用序贯叶段法进行。最后一次放射性栓塞治疗后第 3 天，开始每日两次口服索拉非尼 200mg，1 周后增至每日两次 400mg；在对照组中开始使用相同的索拉非尼剂量方案。
患者中位随访时间为 8.3 个月。（90）Y 的中位总植入活度为 1.87（范围：0.54-2.35）GBq。联合治疗组（中位日剂量 614mg，持续 8.5 个月）和对照组（557mg，持续 9.6 个月）接受了相似强度和持续时间的索拉非尼治疗。联合治疗组和对照组的总（196 例与 222 例）和≥3 级（43 例与 47 例）不良事件发生率相似（P>0.05）。总胆红素、白蛋白、肝酶、腹水、Child-Pugh、疲劳、手足皮肤反应、血压或腹泻的总或 3/4 级毒性的数量没有显著差异。
放射性栓塞后联合索拉非尼治疗与单独使用索拉非尼治疗一样耐受良好。
