Department of Interventional Radiology, The First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Gulou District, Nanjing, 210029, China.
Department of Interventional Radiology, The Fourth People's Hospital of Taizhou, 99 Guloubei Road, Hailing District, Taizhou, 225300, China.
Jpn J Radiol. 2022 Apr;40(4):396-403. doi: 10.1007/s11604-021-01212-7. Epub 2021 Nov 2.
This study aims to evaluate the effectiveness and safety of hepatic arterial infusion chemotherapy (HAIC) following the simultaneous placement of self-expandable metallic stent (SEMS) and iodine-125 (I) seed strands for the management of advanced cholangiocarcinoma (CCA) patients presenting with malignant obstructive jaundice (MOJ).
Data from 74 patients with MOJ caused by advanced CCA treated with stent placement with I seed strands with or without HAIC between November 2015 and October 2020 were analysed retrospectively. Eighteen patients received 5 sessions of HAIC after SEMS placement with I seed strands (HAIC group), and 56 patients only underwent SEMS placement with I seed strands and served as controls (control group). HAIC consisted of infusions of gemcitabine (600-1000 mg/m given over 30 min) followed by oxaliplatin (60-100 mg/m given over 2 h), with an interval of 4 weeks. Propensity score matching (PSM) analysis was used to adjust for differences in the baseline characteristics of the groups (including age, total bilirubin, and serum alanine aminotransferase level). Overall survival (OS), stent patency, and adverse events were compared between the two groups.
OS and stent patency were significantly better in patients in the HAIC group than in those in the control group (median survival time: before PSM, 362 vs. 185 days, p = 0.005; after PSM, 357 vs. 183 days, p = 0.012; median duration of stent patency: before PSM, 294 vs. 156 days, p = 0.001; after PSM, 287 vs. 183 days, p = 0.039). All adverse reactions were controllable by temporary symptomatic treatment. Serious complications and treatment-related deaths were not observed.
Our preliminary study showed that HAIC following SEMS placement with I seed strands is effective and safe for the management of advanced CCA patients presenting with MOJ and could improve stent patency and patient survival.
本研究旨在评估同时放置自膨式金属支架（SEMS）和碘-125（I）种子丝后进行肝动脉灌注化疗（HAIC）治疗伴有恶性梗阻性黄疸（MOJ）的晚期胆管癌（CCA）患者的疗效和安全性。
回顾性分析 2015 年 11 月至 2020 年 10 月期间，18 例接受 SEMS 联合 I 种子丝置入后行 5 次 HAIC（HAIC 组）和 56 例仅行 SEMS 联合 I 种子丝置入的晚期 CCA 伴有 MOJ 患者的临床资料。HAIC 方案为吉西他滨（600-1000mg/m，30min 输注）联合奥沙利铂（60-100mg/m，2h 输注），4 周为 1 个周期。采用倾向性评分匹配（PSM）分析调整两组间基线特征的差异（包括年龄、总胆红素和血清丙氨酸氨基转移酶水平）。比较两组患者的总生存（OS）、支架通畅率和不良事件。
HAIC 组患者的 OS 和支架通畅率均明显优于对照组（中位生存时间：未行 PSM 前，362 比 185 天，p=0.005；行 PSM 后，357 比 183 天，p=0.012；支架通畅时间：未行 PSM 前，294 比 156 天，p=0.001；行 PSM 后，287 比 183 天，p=0.039）。所有不良反应均经临时对症治疗得到控制。未观察到严重并发症和治疗相关死亡。
初步研究结果表明，SEMS 联合 I 种子丝置入后行 HAIC 治疗伴有 MOJ 的晚期 CCA 患者安全有效，可提高支架通畅率和患者生存。
