Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.
State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People's Republic of China.
Ann Surg Oncol. 2020 Dec;27(13):5183-5190. doi: 10.1245/s10434-020-08601-8. Epub 2020 May 16.
Microvascular invasion (MVI) is a risk factor for tumor recurrence after hepatectomy in hepatocellular carcinoma (HCC) patients.
This study aimed to investigate the efficacy and safety of postoperative adjuvant transarterial infusion chemotherapy (TAI) with the FOLFOX regimen for HCC patients with MVI.
In this prospective, phase III, randomized, open-label, controlled clinical trial, HCC patients with histologically confirmed MVI were randomly assigned (1:1) after hepatectomy to receive either one to two cycles of adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group). The primary endpoint was disease-free survival (DFS), while secondary endpoints were overall survival (OS) and safety.
Between June 2016 and April 2019, 127 patients were randomly assigned to the AT group (n = 63) or FU group (n = 64). Clinicopathological characteristics of the two groups were well-balanced. The 6-, 12-, and 18-month OS rates for the AT group were 100.0%, 97.7%, and 97.7%, respectively, and 94.5%, 89.6%, and 78.5% for the FU group, respectively. The 6-, 12-, and 18-month DFS rates for the AT and FU groups were 84.7%, 61.8%, and 58.7%, and 62.9%, 48.1%, and 38.6%, respectively. OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively). No patients in the AT group experienced grade 3 or more severe adverse events.
Adjuvant TAI after hepatectomy may bring survival benefits to HCC patients with MVI.
Trial number: NCT03192618.
微血管侵犯（MVI）是肝细胞癌（HCC）患者肝切除术后肿瘤复发的危险因素。
本研究旨在探讨 MVI 肝癌患者术后辅助经肝动脉灌注化疗（TAI）联合 FOLFOX 方案的疗效和安全性。
在这项前瞻性、III 期、随机、开放标签、对照临床试验中，对经组织学证实有 MVI 的 HCC 患者，在肝切除术后按 1:1 比例随机分配接受 1-2 个周期的辅助 TAI（AT 组）或无辅助治疗（FU 组）。主要终点是无病生存期（DFS），次要终点是总生存期（OS）和安全性。
2016 年 6 月至 2019 年 4 月，127 例患者被随机分配至 AT 组（n=63）或 FU 组（n=64）。两组的临床病理特征均衡。AT 组的 6、12 和 18 个月 OS 率分别为 100.0%、97.7%和 97.7%，FU 组分别为 94.5%、89.6%和 78.5%。AT 和 FU 组的 6、12 和 18 个月 DFS 率分别为 84.7%、61.8%和 58.7%和 62.9%、48.1%和 38.6%。AT 组的 OS 和 DFS 明显优于 FU 组（p=0.037 和 0.023）。AT 组无 3 级及以上严重不良事件。
肝切除术后辅助 TAI 可能为 MVI 肝癌患者带来生存获益。
NCT03192618。
