Hu Hao, Duan Zhenhua, Long Xiaoran, Hertzanu Yancu, Shi Haibin, Liu Sheng, Yang Zhengqiang
Department of Interventional Radiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Chengdu Center for Disease Control and Prevention, Chengdu, China.
PLoS One. 2014 May 9;9(5):e96620. doi: 10.1371/journal.pone.0096620. eCollection 2014.
The purpose of the present study was to compare the efficacies of transarterial chemoembolization (TACE) combined with sorafenib versus TACE monotherapy for treating patients with advanced hepatocellular carcinoma (HCC).
We enrolled 321 patients and selected 280 with advanced HCC (Barcelona Clinic Liver Cancer stage C) who underwent TACE therapy between February 2009 and February 2013. TACE alone (monotherapy group) was administered to 198 patients (70.7%), and the remaining 82 (29.3%) underwent repeat combined TACE and sorafenib therapy (combined group). To minimize selection bias, these latter 82 patients were matched using propensity-score matching at a 1∶2 ratio with 164 patients who received TACE monotherapy. The primary endpoints were overall survival (OS) and related subgroup analysis. The secondary endpoints were time to progression (TTP) and treatment-related adverse events.
Of the respective patients in the combined and monotherapy groups, 64.6% and 49.2% had vascular invasion, 87.8% and 91.1% had extrahepatic metastasis, and 54.3% and 47.1% had both. In the propensity-score-matched cohort, the OS survival of the combined group was significantly higher compared with the monotherapy group (7.0 months vs. 4.9 months, respectively, P = 0.003). The TTP was significantly longer in the combined group (2.6 months vs. 1.9 months, respectively, P = 0.001). Subgroup analysis showed that the outcomes of patients with advanced HCC without main portal vein invasion who were treated with combined therapy were significantly better compared with those who received monotherapy (P<0.05). Univariate and subsequent multivariate analyses revealed that the addition of sorafenib was an independent predictor of favorable OS and TTP (adjusted hazard ratios, 0.63 and 0.62, respectively; P<0.05 for both).
Sorafenib plus TACE was more effective than TACE monotherapy for treating patients with advanced HCC without main portal vein invasion. Future trials with larger samples are required to validate these preliminary findings.
本研究旨在比较经动脉化疗栓塞术(TACE)联合索拉非尼与单纯TACE治疗晚期肝细胞癌(HCC)患者的疗效。
我们纳入了321例患者,选取其中280例晚期HCC患者(巴塞罗那临床肝癌分期C期),这些患者在2009年2月至2013年2月期间接受了TACE治疗。198例患者(70.7%)接受单纯TACE治疗(单药治疗组),其余82例(29.3%)接受重复的TACE联合索拉非尼治疗(联合治疗组)。为尽量减少选择偏倚,后82例患者采用倾向评分匹配法按1∶2的比例与164例接受单纯TACE治疗的患者进行匹配。主要终点为总生存期(OS)及相关亚组分析。次要终点为疾病进展时间(TTP)和治疗相关不良事件。
联合治疗组和单药治疗组的患者中,分别有64.6%和49.2%有血管侵犯,87.8%和91.1%有肝外转移,54.3%和47.1%两者均有。在倾向评分匹配队列中,联合治疗组的OS显著高于单药治疗组(分别为7.0个月和4.9个月,P = 0.003)。联合治疗组的TTP显著更长(分别为2.6个月和1.9个月,P = 0.001)。亚组分析显示,联合治疗的无主要门静脉侵犯的晚期HCC患者的结局明显优于接受单药治疗的患者(P<0.05)。单因素及随后的多因素分析显示,加用索拉非尼是OS和TTP良好结局的独立预测因素(校正风险比分别为0.63和0.62;两者P均<0.05)。
索拉非尼联合TACE治疗无主要门静脉侵犯的晚期HCC患者比单纯TACE更有效。需要进行更大样本量的未来试验来验证这些初步发现。