Objective To evaluate the clinical value of iodine[131I] metuximab infusion combined with transcatheter arterial chemoembolization (TACE) for treating cases of post-intervention relapse of mid or advanced stage hepatocellular carcinoma (HCC).Methods Sixty patients who were diagnosed between March 2009 and June 2010 with relapse of mid or advanced stage HCC following previous intervention with various standard clinical methods were recruited for study.The patients were randomlyand equally divided into a control treatment group (CG; receiving TACE therapy alone) and an experimental treatment group (TG; receiving TACE combined with iodine [131I] metuximab injection).For all patients,licartin was first perfused into the tumor feeding artery and then the TACE procedure was performed 20 min later.Liver function markers and routine blood parameters,including alpha-fetoprotein (AFP) and clotting time,were examined at one week and one month after the treatment.Enhanced computed tomography or magnetic resonance imaging of the liver was performed at one month after treatment and thereafter on a bi-monthly follow-up schedule.The World Health Organization's tumor evaluation standard was used to assess the therapeutic effects in each group.Results of laboratory tests (pre-and post-treatment),reported complications,and side-effects were evaluated for their contributions to time of tumor progression (TTP)and survival time.Results Patients in the TG and CG groups had similar blood cell counts at pre-operative and 1-week postoperative time points.The TG group showed a significantly reduced level of AFP following treatment,but it was not significantly different from the level in the CG group.The TG group did however show significantly different levels of liver functional parameters (all P ＜ 0.05) and significantly higher TTP (4.84 ± 4.11 vs.CG:2.54 ± 2.08 months; t =-2.13,P ＜ 0.05) and average survival time (7.05 vs.5.15 months;x2 =4.24,P =0.039).The rates of partial response (PR),slight remission (MR),unchanged status (SD) and progressive disease (PD)were 16.7％,37.5％,25.0％ and 20.8％ in the TG group,and 8.7％,17.4％,21.7％ and 52.2％ in the CG group.The therapeutic effect rate (CR + PR + MR) and reaction rate (CR + PR + MR + SD) was significantly different between the two groups (P =0.048).No serious adverse effects were reported.Conclusion TACE combined with iodine [131I] metuximab injection is a safe and effective procedure for prolonging the survival and TTP of patients with HCC relapse following prior therapeutic intervention.%目的 探讨131I美妥昔单克隆抗体联合经肝动脉化疗栓塞术(TACE)治疗中晚期肝细胞癌介入术后复发患者的临床价值. 方法 以60例中晚期肝细胞癌介入术后复发患者为研究对象,随机分为治疗组和对照组,各30例.对照组行常规TACE治疗,治疗组先经导管向靶血管注入指定剂量的131I美妥昔单克隆抗体后再行常规TACE治疗.术后1周复查肝功能、血常规、甲胎蛋白,并与术前进行比较.术后1个月及每隔2个月复查上述检查及腹部CT或磁共振平扫、增强扫描.比较两组患者的总有效率[(完全缓解例数+部分缓解例数+轻微缓解例数)÷总例数×100％]、反应率[(完全缓解例数+部分缓解例数+轻微缓解例数+无变化例数)÷总例数×100％]、疾病进展时间、总体生存时间、并发症及不良反应等情况.用Kaplan-Meier法进行生存分析,配对t检验分析术前、术后相关检查指标的变化,x2检验评价组间疗效的差别. 结果 治疗组和对照组分别失访6例和7例.与术前相比,术后1周时治疗组和对照组内的白细胞计数、血小板计数和甲胎蛋白水平差异均无统计学意义(P值均＞ 0.05),白蛋白水平明显降低(P值均＜0.05),胆红素水平明显升高(P值均＜ 0.05).治疗组和对照组平均疾病进展时间分别为(4.84±4.11)个月和(2.54±2.08)个月,差异有统计学意义(t=-2.13,P＜0.05)；中位生存时间分别为7.05个月和5.15个月,差异有统计学意义(x2=4.24,P＜0.05).治疗组部分缓解率、微缓解率、无变化率和疾病进展率分别为16.7％ (4/24)、37.5％ (9/24)、25.0％ (6/24)和20.8％ (5/24),对照组分别为8.7％ (2/23)、17.4％ (4/23)、21.7％ (5/23)和52.2％ (12/23).治疗组和对照组的有效率分别为54.2％ (12/24)和26.1％ (6/23),反应率分别为79.2％ (19/24)和47.8％ (11/23),差异有统计学意义(x2=3.85,P＜0.05).两组均无严重不良反应发生. 结论 TACE联合131I美妥昔单克隆抗体治疗肝细胞癌介入术后复发有一定疗效,可延长生存期及肿瘤进展时间,临床应用安全可行.
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