Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045, Japan.
AJR Am J Roentgenol. 2010 Mar;194(3):830-7. doi: 10.2214/AJR.09.3308.
Although iodized oil transarterial chemoembolization (TACE) has been found to have survival benefit in the care of patients with unresectable hepatocellular carcinoma, iodized oil infusion chemotherapy without embolization has not been clearly found inferior to or equal to TACE. The purpose of this study was to determine whether one of these therapies is superior to the other or the two are equal in survival benefit and whether embolization with gelatin sponge particles is indispensable to prolonging survival.
A prospective nonrandomized observational cohort study was conducted over 8 years. Among 11,030 patients with unresectable hepatocellular carcinoma, 8,507 underwent TACE, and 2,523 underwent transarterial infusion therapy with an emulsion of iodized oil and an anticancer agent as initial treatment. Patients with extrahepatic metastasis or any previous treatment were excluded. The primary end point was all-cause mortality. To minimize selection bias, propensity score analysis was used to compare the two groups.
During the follow-up period, 5,044 patients (46%) died. In the analysis of all patients, TACE was associated with a significantly higher survival rate than infusion therapy without embolization (hazard ratio, 0.60; 95% CI, 0.56-0.64; p = 0.0001). The propensity score analysis showed that the hazard ratio for death in the TACE group (n = 1,699 patients) compared with the group who underwent infusion therapy without embolization (n = 1,699) was 0.70 (95% CI, 0.63-0.76; p = 0.0001). The median survival time of the TACE group was 2.74 years, and the 1-, 3-, and 5-year survival rates were 81%, 46%, and 25%. The corresponding values for the group who underwent transarterial infusion therapy without embolization were 1.98 years and 71%, 33%, and 16%.
Propensity score analysis showed that in the treatment of patients with unresectable hepatocellular carcinoma, TACE was associated with significantly better overall survival rates than was transarterial infusion therapy without embolization. TACE can be recommended as initial treatment of these patients.
虽然碘化油经动脉化疗栓塞术(TACE)已被发现可延长不可切除肝细胞癌患者的生存时间,但碘化油输注化疗而不栓塞并未被明确证明劣于或等同于 TACE。本研究的目的是确定这两种治疗方法中哪一种更具优势,或者在生存获益方面是否等效,以及是否栓塞明胶海绵颗粒对于延长生存时间是不可或缺的。
这是一项为期 8 年的前瞻性非随机观察性队列研究。在 11030 例不可切除的肝细胞癌患者中,8507 例行 TACE 治疗,2523 例患者接受碘化油和抗癌药物乳剂的经动脉输注治疗作为初始治疗。排除肝外转移或任何既往治疗的患者。主要终点为全因死亡率。为了最大程度地减少选择偏倚,采用倾向评分分析比较两组。
在随访期间,有 5044 例(46%)患者死亡。在所有患者的分析中,TACE 治疗的生存率明显高于无栓塞的输注治疗(风险比,0.60;95%置信区间,0.56-0.64;p=0.0001)。倾向评分分析显示,TACE 组(n=1699 例)与未行栓塞的输注治疗组(n=1699 例)的死亡风险比为 0.70(95%置信区间,0.63-0.76;p=0.0001)。TACE 组的中位生存时间为 2.74 年,1 年、3 年和 5 年生存率分别为 81%、46%和 25%。未行栓塞的输注治疗组的相应值分别为 1.98 年和 71%、33%和 16%。
倾向评分分析显示,在不可切除肝细胞癌患者的治疗中,TACE 与明显更好的总生存率相关,优于无栓塞的经动脉输注治疗。TACE 可作为这些患者的初始治疗方法。