Department of Hepatobiliary Oncology, Cancer Center, Sun Yat-sen University, Guangzhou, P.R. China.
J Natl Cancer Inst. 2013 Jan 2;105(1):59-68. doi: 10.1093/jnci/djs464. Epub 2012 Nov 12.
The aim of our study was to compare the efficacy and safety of: 1) transarterial chemolipiodolization with gelatin sponge embolization vs chemolipiodolization without embolization, and 2) chemolipiodolization with triple chemotherapeutic agents vs epirubicin alone.
A single-blind, three parallel arm, randomized trial was conducted at three clinical centers with patients with biopsy-confirmed unresectable hepatocellular carcinoma. Arm 1 received triple-drug chemolipiodolization and sponge embolization, whereas Arm 2 received triple-drug chemolipiodolization only. Patients in arm 3 were treated with single-drug chemolipiodolization and sponge embolization. We compared overall survival and time to progression. Event-time distributions were estimated by the Kaplan-Meier method. All statistical tests were two-sided.
From July 2007 to November 2009, 365 patients (Arm 1: n = 122; Arm 2: n = 121; Arm 3: n = 122) were recruited. The median tumor size was 10.9cm (range = 7-22cm), and 34.5% had macrovascular invasion. The median survivals and time to progression in Arm 1, Arm 2, and Arm 3 were 10.5 and 3.6 months, 10.1 and 3.1 months, and 5.9 and 3.1 months, respectively. Survival was statistically significantly better in Arm 1 than in Arm 3 (P < .001), whereas there was no statistically significant difference between Arm 1 and Arm 2 (P = .20). Objective response rates were 45.9%, 29.7%, and 18.9% for Arm 1, Arm 2, and Arm 3, respectively.
Chemolipiodolization played an important role in transarterial chemoembolization, and the choice of chemotherapy regimen may largely affect survival outcomes. However, the removal of embolization from chemoembolization might not statistically significantly decrease survival.
我们的研究旨在比较以下两种治疗方法的疗效和安全性：1）经动脉化学脂质碘化栓塞与化学脂质碘化治疗联合明胶海绵栓塞，2）三药化学脂质碘化与表阿霉素单药治疗。
在三家临床中心进行了一项单盲、三平行臂、随机试验，纳入经活检证实的不可切除的肝细胞癌患者。第 1 组接受三药化学脂质碘化和海绵栓塞治疗，第 2 组仅接受三药化学脂质碘化治疗。第 3 组患者接受单药化学脂质碘化和海绵栓塞治疗。我们比较了总生存期和疾病进展时间。采用 Kaplan-Meier 法估计事件时间分布。所有统计检验均为双侧检验。
2007 年 7 月至 2009 年 11 月，共纳入 365 例患者（第 1 组：n=122；第 2 组：n=121；第 3 组：n=122）。肿瘤最大直径中位数为 10.9cm（范围=7-22cm），34.5%有大血管侵犯。第 1、2、3 组的中位生存期和疾病进展时间分别为 10.5 和 3.6 个月、10.1 和 3.1 个月、5.9 和 3.1 个月。第 1 组的生存时间明显长于第 3 组（P<0.001），而第 1 组与第 2 组之间差异无统计学意义（P=0.20）。第 1、2、3 组的客观缓解率分别为 45.9%、29.7%和 18.9%。
化学脂质碘化在经动脉化疗栓塞中发挥了重要作用，化疗方案的选择可能在很大程度上影响生存结果。然而，从化疗栓塞中去除栓塞物可能不会显著降低生存时间。
