Postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with FOLFOX to improve outcomes of patients with hepatocellular carcinoma with microvascular invasion: A prospective multicenter, phase 3, randomized, controlled clinical trial.

• DOI: 10.1200/jco.2022.40.16_suppl.4013
• Publication Date: 2022-06-06T16:16:56Z
• Authors: 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; Lie Zheng; Wei Wei; Huanwei Chen; Chong Zhong; Rongping Guo
• Keywords: FOLFOX; Clinical endpoint; Intention-to-treat analysis

4013 Background: To report the efficacy and safety of postoperative adjuvant hepatic arterial infusion chemotherapy (HAIC) with FOLFOX (5- fluorouracil, leucovorin, oxaliplatin) in hepatocellular carcinoma (HCC) patients microvascular invasion (MVI). Methods: In this randomized, open label, multicenter, phase 3 trial, histologically confirmed HCC MVI were randomized (1:1) to receive either 1 2 cycles HAIC-FOLFOX (treatment group) or routine follow-up without any treatment (control group). The primary endpoint was disease free survival (DFS), Secondary endpoints included overall (OS), recurrence rate safety. Survival rates calculated by Kaplan-Meier plots. Adverse events (AE) graded according NCI-CTCAE version 5.0. Results: Between June, 2016 August, 2021, a total 315 5 centers enrolled study eligible randomly assigned group (n = 157) control 158) intention-to-treat (ITT) population. Among these 14 from 15 excluded per-protocol (PP) 148 underwent at least cycle HAIC analyses. median DFS 27.0 months (95% CI, 17.0-37.0) 11.3 7.9-14.7), respectively ITT population, while which 20.4 9.5-31.3) 9.7 6.9-12.4), PP significantly better than both population (p 0.001 < 0.001, respectively). 1, 2, 3-years 64.3%, 50.4%, 44.3% 47.3%, 33.3%, 24.2% group, 64.0%, 48.2%, 42.2% 43.3%, 27.1%, 18.4% OS 3-year for 94.7%, 87.6%, 80.5%, 91.9%, 85.9%, 77.0% 94.9%, 86.7%, 80.9% 91.8%, 84.9%, 75.3% Furthermore, there 63 (40.1%) 88 (55.7%) had recurrence. Majority AEs observed grade 0-1 124 (83.8%)) no related death during period. Conclusions: Postoperative improved benefits acceptable toxicities MVI. Clinical trial information: NCT03192618.