Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma
Randomized controlled trial of transarterial lipiodol chemoembolization for unresectable hepatocellular carcinoma
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DOI：
10.1053/jhep.2002.33156
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发表时间：
2002-05-01
期刊：
影响因子：
13.5
通讯作者：
Wong, J
中科院分区：
文献类型：
--
作者：
Lo, CM;Ngan, H;Wong, J
本随机对照试验评估了经动脉碘油（超液化碘油，加栢公司，Anlnay-Sous-Bois，法国）化疗栓塞在不可切除肝细胞癌患者中的疗效。从1996年3月至1997年10月，279例新诊断为不可切除肝细胞癌的亚洲患者中有80例符合入选标准，并被随机分配接受化疗栓塞治疗，通过肝动脉注射不同剂量的顺铂碘油乳剂和明胶海绵颗粒化疗栓塞组40例，对照组40例。一名患者被分配到对照组第二次被排除，因为未识别的全身转移。化疗栓塞每2 - 3个月重复一次，除非有禁忌症或疾病进展的证据。生存率是主要终点。化疗栓塞组共接受了192个疗程的化疗栓塞，中位数为4.5（范围，1-15）个疗程/例患者。化疗栓塞导致了显著的肿瘤反应，化疗栓塞组的精确生存率（1年，57%; 2年，31%; 3年，26%）明显优于对照组（1年，32%; 2年，31%; 3年，3%; P = 0.002）。当用多变量考克斯模型对单变量分析中具有预后意义的基线变量进行调整时，化疗栓塞的生存获益仍然显著（死亡相对风险，0.49; 95%CI，0.29-0-81; P = 0.006）。虽然接受化疗栓塞的患者死于肝功能衰竭的频率更高，但幸存者的肝功能没有显著差异。总之，在亚洲不可切除的肝细胞癌患者中，经动脉碘油化疗栓塞可显著提高生存率，是一种有效的治疗形式。
This randomized, controlled trial assessed the efficacy of transarterial Lipiodol (Lipiodol Ultrafluide, Laboratoire Guerbet, Anlnay-Sous-Bois, France) chemoembolization in patients with unresectable hepatocellular carcinoma. From March 1996 to October 1997, 80 out of 279 Asian patients with newly diagnosed unresectable hepatocellular carcinoma fulfilled the entry criteria and randomly were assigned to treatment with chemoembolization using a variable dose of an emulsion of cisplatin in Lipiodol and gelatin-sponge particles injected through the hepatic artery (chemoembolization group, 40 patients) or symptomatic treatment (control group, 40 patients). One patient assigned to the control group secondarily was excluded because of unrecognized systemic metastasis. Chemoembolization was repeated every 2 to 3 months unless there was evidence of contraindications or progressive disease. Survival was the main end point. The chemoembolization group received a total of 192 courses of chemoembolization with a median of 4.5 (range, 1-15) courses per patient. Chemoembolization resulted in a marked tumor response, and the actuarial survival was significantly better in the chemoembolization group (I year, 57%; 2 years, 31%; 3 years, 26%) than in the control group (1 year, 32%; 2 years, 31%; 3 years, 3%; P = .002). When adjustments for baseline variables that were prognostic on univariate analysis were made with a multivariate Cox model, the survival benefit of chemoembolization remained significant (relative risk of death, 0.49; 95% CI, 0.29-0-81; P = .006). Although death from liver failure was more frequent in patients who received chemoembolization, the liver functions of the survivors were not significantly different. In conclusion, in Asian patients with unresectable hepatocellular carcinoma, transarterial Lipiodol chemoembolization significantly improves survival and is an effective form of treatment.