随机、前瞻性、比较研究索拉非尼与肝动脉灌注化疗治疗伴有门静脉癌栓的晚期肝细胞癌的疗效和安全性。
Randomized, prospective, comparative study on the effects and safety of sorafenib vs. hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma with portal vein tumor thrombosis.
机构信息
Department of Internal Medicine, Keimyung University School of Medicine, Daegu, Republic of Korea.
Department of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
出版信息
Cancer Chemother Pharmacol. 2018 Sep;82(3):469-478. doi: 10.1007/s00280-018-3638-0. Epub 2018 Jul 7.
BACKGROUND/AIMS: Treatment responses of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) remain unacceptably low and treatment modalities are limited. We compared the efficacy and safety of sorafenib and hepatic arterial infusion chemotherapy (HAIC).
METHODS
In this randomized, prospective, comparative study, data on 58 patients with advanced HCC with PVTT, with Child-Turcotte-Pugh (CTP) scores of 5-7, were collected from six university hospitals between January 2013 and October 2015. Twenty-nine patients were treated with sorafenib and twenty-nine with HAIC.
RESULTS
The median overall survival (OS) and time to progression (TTP) were significantly longer in the HAIC group than in the sorafenib group (14.9 vs.7.2 months, p = 0.012 and 4.4 vs. 2.7 months, p = 0.010). The objective response (OR) rates were 27.6 and 3.4% in the HAIC and sorafenib groups, respectively (p = 0.001). In univariate analysis, sex, main portal vein invasion and treatment modality were significant prognostic factors of OS (p = 0.044, 0.040, 0.015), whereas cause of HCC, tumor number, tumor location and treatment modality were significant prognostic factors of TTP (p = 0.040, 0.002, 0.034, 0.014). In multivariate analysis, sex and treatment modality were significant prognostic factors of OS (p = 0.008, 0.005), whereas cause of HCC, tumor number, tumor location and treatment modality were significant prognostic factors of TTP (p = 0.038, 0.038, 0.015, 0.011). Major complications included hyperbilirubinemia (44.8%), AST elevation (34.5%), ascites (13.8%) and catheter-related complications (3.4%) in the HAIC group and hyperbilirubinemia (34.5%), hand-foot syndrome (31.0%) and AST elevation (27.6%) in the sorafenib group.
CONCLUSIONS
For managing advanced HCC with PVTT, HAIC may be a valuable treatment modality.
背景/目的：晚期伴有门静脉癌栓（PVTT）的肝细胞癌（HCC）的治疗反应仍然不能令人接受，治疗方式有限。我们比较了索拉非尼和肝动脉灌注化疗（HAIC）的疗效和安全性。
方法
在这项随机、前瞻性、对照研究中，收集了 2013 年 1 月至 2015 年 10 月期间六所大学医院的 58 例伴有晚期 HCC 合并 PVTT、Child-Turcotte-Pugh（CTP）评分 5-7 分的患者数据。29 例患者接受索拉非尼治疗，29 例患者接受 HAIC 治疗。
结果
HAIC 组的中位总生存期（OS）和无进展生存期（TTP）明显长于索拉非尼组（14.9 个月比 7.2 个月，p=0.012 和 4.4 个月比 2.7 个月，p=0.010）。HAIC 组和索拉非尼组的客观缓解（OR）率分别为 27.6%和 3.4%（p=0.001）。单因素分析显示，性别、主门静脉侵犯和治疗方式是 OS 的显著预后因素（p=0.044、0.040、0.015），而 HCC 病因、肿瘤数量、肿瘤位置和治疗方式是 TTP 的显著预后因素（p=0.040、0.002、0.034、0.014）。多因素分析显示，性别和治疗方式是 OS 的显著预后因素（p=0.008、0.005），而 HCC 病因、肿瘤数量、肿瘤位置和治疗方式是 TTP 的显著预后因素（p=0.038、0.038、0.015、0.011）。HAIC 组的主要并发症包括高胆红素血症（44.8%）、AST 升高（34.5%）、腹水（13.8%）和导管相关并发症（3.4%），索拉非尼组的主要并发症包括高胆红素血症（34.5%）、手足综合征（31.0%）和 AST 升高（27.6%）。
结论
对于伴有门静脉癌栓的晚期 HCC，HAIC 可能是一种有价值的治疗方法。
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