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
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
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DOI：
10.1007/s00280-018-3638-0
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发表时间：
2018-09-01
影响因子：
3
通讯作者：
Cho, Sung Bum
中科院分区：
文献类型：
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作者：
Choi, Jong Hwan;Chung, Woo Jin;Cho, Sung Bum
晚期肝细胞癌（HCC）伴门静脉肿瘤血栓形成（PVTT）的治疗反应仍然低得令人无法接受，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。在这项随机、前瞻性、对比研究中，收集了2013年1月至2015年10月期间来自六所大学医院的58例晚期HCC伴PVTT患者的数据，Child-Turcotte-Pugh（CTP）评分为5-7分。29例患者接受索拉非尼治疗，29例患者接受HAIC治疗。HAIC组的中位总生存期（OS）和疾病进展时间（TTP）显著长于索拉非尼组（14.9 vs.7.2个月，p = 0.012和4.4 vs.2.7个月，p = 0.010）。HAIC组和索拉非尼组的客观缓解率（OR）分别为27.6%和3.4%（p = 0.001）。在单因素分析中，性别、门静脉主干侵犯和治疗方式是OS的显著预后因素（p = 0.044，0.040，0.015），而HCC的原因、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，性别和治疗方式是影响总生存率的重要因素（p = 0.008，0.005），而原发性肝癌的病因、肿瘤数目、肿瘤部位和治疗方式是影响TTP的重要因素（p = 0.038，0.038，0.015，0.011）。HAIC组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%）。
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).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.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.For managing advanced HCC with PVTT, HAIC may be a valuable treatment modality.