Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial.

Abstract

BACKGROUND:

Microvascular invasion (MVI) is a risk factor for tumor recurrence after hepatectomy in hepatocellular carcinoma (HCC) patients.

OBJECTIVE:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

Adjuvant TAI after hepatectomy may bring survival benefits to HCC patients with MVI.

TRIAL REGISTRATION:

Trial number: NCT03192618.

• Authors: Shaohua Li, Jie Mei, Qiaoxuan Wang, Zhixing Guo, Lianghe Lu, Yihong Ling, Li Xu, Minshan Chen, Lie Zheng, Wenping Lin, Jingwen Zou, Yuhua Wen, Wei Wei, Rongping Guo
• Journal: Annals of surgical oncology (Ann Surg Oncol) Vol. 27 Issue 13 Pg. 5183-5190 (Dec 2020) ISSN: 1534-4681 [Electronic] United States
• PMID: 32418078 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial)

Topics

• Carcinoma, Hepatocellular (drug therapy, surgery)
• Chemotherapy, Adjuvant
• Disease-Free Survival
• Hepatectomy
• Humans
• Liver Neoplasms (drug therapy, surgery)
• Neoplasm Recurrence, Local (drug therapy)
• Prospective Studies