Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion A Randomized Clinical Trial
Sorafenib Plus Hepatic Arterial Infusion of Oxaliplatin, Fluorouracil, and Leucovorin vs Sorafenib Alone for Hepatocellular Carcinoma With Portal Vein Invasion A Randomized Clinical Trial
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索拉非尼加奥沙利铂、氟尿嘧啶和亚叶酸的肝动脉灌注与单独索拉非尼治疗门静脉侵犯的肝细胞癌的随机临床试验
DOI：
10.1001/jamaoncol.2019.0250
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发表时间：
2019-07-01
期刊：
影响因子：
28.4
通讯作者：
Shi, Ming
中科院分区：
文献类型：
--
作者：
He, MinKe;Li, QiJiong;Shi, Ming
索拉非尼是肝细胞癌伴门静脉浸润的一线治疗药物，但其生存获益并不令人满意。索拉非尼加肝动脉灌注化疗（HAIC）奥沙利铂，氟尿嘧啶，亚叶酸钙（FOLFOX）已显示出可喜的结果，这些患者在以前的2期study. ObjectiveTo调查索拉非尼加HAIC与索拉非尼相比，肝细胞癌门静脉invasion.DESIGN，设置，和PARTICIPANTS的疗效和安全性。在818名参与者中，247名患有肝细胞癌和门静脉侵犯的患者通过计算机生成的序列被随机分配（1：1）接受索拉非尼联合HAIC或索拉非尼。本试验于2016年4月1日至2017年10月10日在中国的5家医院进行，入组患者，随访期为10个月。干预随机接受索拉非尼400 mg，每日2次（索拉非尼组）或400 mg索拉非尼每日两次加HAIC（SoraHAIC集团）（奥沙利铂85 mg/m2，亚叶酸400 mg/m2，氟尿嘧啶推注400 mg/m2，第1天，氟尿嘧啶输注2400 mg/m2，持续46小时，主要结果和测量主要终点是通过意向治疗分析的总生存率。在接受至少1剂研究治疗的患者中评估安全性。（中位年龄49岁;范围18-75岁;男性223例，女性24例），中位总生存期为13.37个月SoraHAIC组为7.13个月（95%CI，10.27-16.46），索拉非尼组为7.13个月（95%CI，6.28-7.98）（风险比[HR]，0.35; 95%CI，0.26-0.48; P
IMPORTANCE Sorafenib is the first-line treatment for hepatocellular carcinoma with portal vein invasion; however, it has shown unsatisfactory survival benefit. Sorafenib plus hepatic arterial infusion chemotherapy (HAIC) of oxaliplatin, fluorouracil, and leucovorin (FOLFOX) has shown promising results for these patients in a previous phase 2 study.OBJECTIVE To investigate the efficacy and safety of sorafenib plus HAIC compared with sorafenib for hepatocellular carcinoma with portal vein invasion.DESIGN, SETTING, AND PARTICIPANTS This randomized, open-label clinical trial enrolled 818 screened patients. Of the 818 participants, 247 with hepatocellular carcinoma and portal vein invasion were randomly assigned (1:1) via a computer-generated sequence to receive sorafenib plus HAIC or sorafenib. This trial was conducted at 5 hospitals in China and enrolled patients from April 1, 2016, to October 10, 2017, with a follow-up period of 10 months.INTERVENTIONS Randomization to receive 400 mg sorafenib twice daily (sorafenib group) or 400 mg sorafenib twice daily plus HAIC (SoraHAIC group) (oxaliplatin 85 mg/m(2), leucovorin 400 mg/m(2), fluorouracil bolus 400 mg/m(2) on day 1, and fluorouracil infusion 2400 mg/m(2) for 46 hours, every 3 weeks).MAIN OUTCOMES AND MEASURES The primary endpoint was overall survival by intention-to-treat analysis. Safety was assessed in patients who received at least 1 dose of study treatment.RESULTS For 247 patients (median age, 49 years; range, 18-75 years; 223 men and 24 women), median overall survival was 13.37 months (95% CI, 10.27-16.46) in the SoraHAIC group vs 7.13 months (95% CI, 6.28-7.98) in the sorafenib group (hazard ratio [HR], 0.35; 95% CI, 0.26-0.48; P