Treatment of unresectable hepatocellular carcinoma with lipiodol chemoembolization:: a multicenter randomized trial
Treatment of unresectable hepatocellular carcinoma with lipiodol chemoembolization:: a multicenter randomized trial
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DOI：
10.1016/s0168-8278(98)80187-6
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发表时间：
1998-07-01
影响因子：
25.7
通讯作者：
Roche, A
中科院分区：
文献类型：
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作者：
Pelletier, G;Ducreux, M;Roche, A
背景/目标：碘油化疗栓塞是一种广泛应用于不可切除肝细胞癌患者的治疗方法，但其疗效仍存在争议。本研究的目的是评估阿曲库碘油化疗栓塞在不能切除的肝细胞癌患者中的疗效。73例不能切除的肝细胞癌患者，但没有严重的肝脏疾病或门静脉阻塞，被随机分配接受重复阿比碘油化疗栓塞，（向肝动脉中注射碘油、顺铂（2 mg/kg）、卵磷脂和明胶海绵）加他莫昔芬（40 mg）或单独他莫昔芬。结果：碘油化疗栓塞组37例患者共接受104个疗程（平均3个疗程）。到1996年9月1日，58名患者死亡：30名在阿托碘油化疗栓塞组，28名在他莫昔芬组。两组之间的生存率无差异（p=0.77）。与他莫昔芬组相比，碘油化疗栓塞加他莫昔芬组的相对死亡风险为0.92（95%置信区间为0.55至1.56）。1年生存率分别为51%和55%。阿托碘油化疗栓塞组中观察到的客观肿瘤反应比他莫昔芬组更频繁（分别为24%和5.5%，p=0.046）。碘油化疗栓塞造成两人死亡，并在51%的患者分配到这个treatment.Conclusion：在我们的随机研究中，碘油化疗栓塞并没有提高与他莫昔芬治疗不可切除的肝细胞癌患者的生存率诱导肝功能衰竭的迹象。
Background/Aims: Lipiodol chemoembolization is a widely used method of treatment in patients with unresectable hepatocellular carcinoma, but its efficacy is still debated. The aim of our study was to assess the efficacy of lipiodol chemoembolization in patients with unresectable hepatocellular carcinoma.Methods: Seventy-three patients with unresectable hepatocellular carcinoma, but without severe liver disease or portal vein occlusion, were randomly assigned to receive either repeated lipiodol chemoembolization (lipiodol, cisplatin (2 mg/kg), lecithin, and gelatin sponge injected into the hepatic artery) plus tamoxifen (40 mg) or tamoxifen alone. The main end-point was survival.Results: The 37 patients in the lipiodol chemoembolization group received 104 courses (median 3 per patient). By 1 September 1996, 58 patients had died: 30 in the lipiodol chemoembolization group and 28 in the tamoxifen group. There was no difference in survival between the two groups (p=0.77). The relative risk of death in the lipiodol chemoembolization plus tamoxifen group as compared to the tamoxifen group was 0.92 (95% confidence interval 0.55 to 1,56). At 1 year, survival was 51% and 55%, respectively. An objective tumoral response was more frequently observed in the lipiodol chemoembolization group than in the tamoxifen group (24 versus 5.5%, respectively, p=0.046). Lipiodol chemoembolization caused two deaths and induced signs of liver failure in 51% of the patients assigned to this treatment.Conclusion: In our randomized study, lipiodol chemoembolization did not improve the survival of patients with unresectable hepatocellular carcinoma treated with tamoxifen.