Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With FOLFOX in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study

作者：Shaohua Li, Jie Mei, Yuan Cheng, Qiang Li, Qiaoxuan Wang, Chongkai Fang, Qiucheng Lei, Huakun Huang, Mingrong Cao, Rui Luo, Jingduo Deng, Yuchuan Jiang, Rongce Zhao, Lianghe Lu, Jingwen Zou, Min Deng, Wenping Lin, Renguo Guan, Yuhua Wen, Jibin Li, Lie Zheng, Zhixing Guo, Yihong Ling, Huanwei Chen, Chong Zhong, Wei Wei, Rong Guo · 发表于：Journal of Clinical Oncology · 年份：2022 · DOI：10.1200/jco.22.01142 · 被引用次数：175 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Organ Transplantation Techniques and Outcomes、Cholangiocarcinoma and Gallbladder Cancer Studies

PURPOSE To report the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with 5-fluorouracil and oxaliplatin (FOLFOX) in hepatocellular carcinoma (HCC) patients with microvascular invasion (MVI). PATIENTS AND METHODS In this randomized, open-label, multicenter trial, histologically confirmed HCC patients with MVI were randomly assigned (1:1) to receive adjuvant FOLFOX-HAIC (treatment group) or routine follow-up (control group). The primary end point was disease-free survival (DFS) by intention-to-treat (ITT) analysis while secondary end points were overall survival, recurrence rate, and safety. RESULTS Between June 2016 and August 2021, a total of 315 patients (ITT population) at five centers were randomly assigned to the treatment group (n = 157) or the control group (n = 158). In the ITT population, the median DFS was 20.3 months (95% CI, 10.4 to 30.3) in the treatment group versus 10.0 months (95% CI, 6.8 to 13.2) in the control group (hazard ratio, 0.59; 95% CI, 0.43 to 0.81; P = .001). The overall survival rates at 1 year, 2 years, and 3 years were 93.8% (95% CI, 89.8 to 98.1), 86.4% (95% CI, 80.0 to 93.2), and 80.4% (95% CI, 71.9 to 89.9) for the treatment group and 92.0% (95% CI, 87.6 to 96.7), 86.0% (95% CI, 79.9 to 92.6), and 74.9% (95% CI, 65.5 to 85.7) for the control group (hazard ratio, 0.64; 95% CI, 0.36 to 1.14; P = .130), respectively. The recurrence rates were 40.1% (63/157) in the treatment group and 55.7% (88/158) in...