Raoul J L, Guyader D, Bretagne J F, Duvauferrier R, Bourguet P, Bekhechi D, Deugnier Y M, Gosselin M
Service de Radiologie, Hôpital Sud, Rennes, France.
J Nucl Med. 1994 Nov;35(11):1782-7.
Portal vein thrombosis is a poor prognostic factor in patients with hepatocellular carcinoma (HCC) and a contraindication for chemoembolization. Intra-arterial injection of 131I-iodized oil which does not modify arterial flow, is feasible in this condition. The aim of this prospective randomized controlled trial was to compare the efficacy of treatment with radiolabeled oil (treated group) versus medical support (control group) in patients with stage I or II HCC (classification of Okuda) with portal vein thrombosis.
Twenty-seven HCC patients (26 males, 1 female), aged 53-79 yr, with portal vein thrombosis were randomly assigned to Lipiocis group (n = 14) or Control group (n = 13). Additional injections of radiolabeled oil were given 2, 5, 8 and 12 mo after initial therapy. Medical support treatment consisted of: tamoxifen (n = 5), 5 FU intravenously (n = 1), NSAIDs or corticosteroids (n = 5). Efficacy was evaluated according to survival rate (Kaplan-Meier method; log rank test), AFP serum values (measured at 2, 5, 8 and 12 mo) and angiography.
The two groups were comparable (Child's classification, Okuda's classification, liver function tests, location of the thrombus). Tolerance was excellent in the Treated group. The actuarial survival curves were significantly different (p < 0.01) between the two groups, the survival rates (Cl 95%) at 3, 6 and 9 mo being 71% (48%-95%), 48% (12%-55%), 7% (1%-31%) for the Treated group; and 10% (1%-33%), 0% and 0% for the Control group.
Intra-arterial hepatic injection of 131I-labeled iodized oil is a safe and effective palliative treatment of HCC with portal vein thrombosis.
门静脉血栓形成是肝细胞癌（HCC）患者预后不良的因素，也是化疗栓塞的禁忌证。在这种情况下，动脉内注射不改变动脉血流的131I-碘化油是可行的。这项前瞻性随机对照试验的目的是比较放射性标记油治疗组与药物支持对照组对伴有门静脉血栓形成的Ⅰ期或Ⅱ期HCC（奥田分类法）患者的疗效。
27例伴有门静脉血栓形成的HCC患者（26例男性，1例女性），年龄53 - 79岁，随机分为Lipiocis组（n = 14）和对照组（n = 13）。初始治疗后2、5、8和12个月给予额外的放射性标记油注射。药物支持治疗包括：他莫昔芬（n = 5）、静脉注射5-氟尿嘧啶（n = 1）、非甾体抗炎药或皮质类固醇（n = 5）。根据生存率（Kaplan-Meier法；对数秩检验）、血清甲胎蛋白值（在2、5、8和12个月时测量）和血管造影评估疗效。
两组具有可比性（Child分级、奥田分类、肝功能检查、血栓部位）。治疗组耐受性良好。两组的精算生存曲线有显著差异（p < 0.01），治疗组3、6和9个月时的生存率（95%置信区间）分别为71%（48% - 95%）、48%（12% - 55%）、7%（1% - 31%）；对照组分别为10%（1% - 33%）、0%和0%。
肝动脉内注射131I标记的碘化油是伴有门静脉血栓形成的HCC安全有效的姑息治疗方法。
