From the Department of Oncology (Z.P.), Clinical Trials Unit (Z.P., J.M., B.L.), Division of Interventional Ultrasound (S.C., M.L., C.J., X.X., M.K.), Department of Liver Surgery (M.W., M.K.), and Department of Interventional Oncology (Y.W., J.L.), The First Affiliated Hospital, Sun Yat-sen University, 58 Zhongshan Road 2, Guangzhou 510080, China; Department of Hepatobiliary Surgery, Cancer Centre of Sun Yat-sen University, Guangzhou, China (M.C.); and Department of Minimal Invasion Therapy, The Affiliated Eastern Hepatobiliary Surgery Hospital, The Second Military Medical University, Shanghai, China (G.Q.).
Radiology. 2018 May;287(2):705-714. doi: 10.1148/radiol.2018171541. Epub 2018 Feb 1.
Purpose To retrospectively investigate the safety and efficacy of sorafenib combined with transarterial chemoembolization (TACE) and radiofrequency ablation (RFA) (hereafter, TACE-RFA) in the treatment of recurrent hepatocellular carcinoma (rHCC) with portal vein tumor thrombosis, extrahepatic metastases (advanced hepatocellular carcinoma), or both after initial hepatectomy. Materials and Methods The study was centrally approved by the ethics committee of three tertiary medical centers in China. From January 2010 to January 2015, 207 consecutive patients with advanced rHCC after initial hepatectomy received sorafenib combined with TACE-RFA (combination group, n = 106) or sorafenib alone (sorafenib group, n = 101) at the three medical centers. Overall survival (OS) and time to progression (TTP) were compared between the two groups. Complications were assessed. Survival curves were constructed with the Kaplan-Meier method and were compared with the log-rank test. Results Baseline characteristics were balanced between the two groups. No treatment-related death occurred in either group. The toxicity profile in the combination group was similar to that in the sorafenib group. After treatment, median OS (14.0 vs 9.0 months, respectively; P < .001) and TTP (7.0 vs 4.0 months, respectively; P < .001) were significantly longer in the combination group than in the sorafenib group. Multivariate analysis showed that treatment allocation was a significant predictor of OS and TTP, while the number of intrahepatic tumors was another prognostic factor of OS. Conclusion Sorafenib combined with TACE-RFA was well tolerated and safe and was superior to sorafenib alone in improving survival outcomes in patients with advanced rHCC after initial hepatectomy. RSNA, 2018 Online supplemental material is available for this article.
回顾性研究索拉非尼联合经动脉化疗栓塞(TACE)和射频消融(RFA)(以下简称 TACE-RFA)治疗初始肝切除术后伴门静脉癌栓、肝外转移(晚期肝癌)或两者均有的复发性肝细胞癌(rHCC)的安全性和疗效。
本研究经中国三家三级医疗中心的伦理委员会中心批准。2010 年 1 月至 2015 年 1 月,207 例初始肝切除术后伴晚期 rHCC 的患者在这三家医疗中心分别接受索拉非尼联合 TACE-RFA(联合组,n=106)或索拉非尼单药治疗(索拉非尼组,n=101)。比较两组患者的总生存期(OS)和无进展生存期(TTP)。评估并发症。采用 Kaplan-Meier 法构建生存曲线,并采用对数秩检验进行比较。
两组患者的基线特征均衡。两组均无治疗相关死亡。联合组的毒性谱与索拉非尼组相似。治疗后,联合组的中位 OS(分别为 14.0 个月和 9.0 个月;P<0.001)和 TTP(分别为 7.0 个月和 4.0 个月;P<0.001)明显长于索拉非尼组。多因素分析显示,治疗分配是 OS 和 TTP 的显著预测因素,而肝内肿瘤数目是 OS 的另一个预后因素。
与索拉非尼单药治疗相比,索拉非尼联合 TACE-RFA 治疗初始肝切除术后伴晚期 rHCC 的患者,耐受性良好且安全,可改善生存结局。RSNA,2018 在线补充材料可供本文参考。