Adjuvant HAIC with FOLFOX for HCC
Trial question
What is the role of postoperative adjuvant hepatic arterial infusion chemotherapy with 5-FU and oxaliplatin in HCC patients with microvascular invasion?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
13.0% female
87.0% male
N = 315
315 patients (40 female, 275 male).
Inclusion criteria: patients with HCC with microvascular invasion.
Key exclusion criteria: histologically proven positive resection margin; severe functional impairment of organs; allergy to related drugs or intolerance to hepatic arterial infusion chemotherapy; previous or concomitant antitumor therapy; history of organ transplantation, neurologic, or psychiatric diseases.
Interventions
N=157 adjuvant FOLFOX-HAIC (1-2 cycles of adjuvant hepatic arterial infusion chemotherapy with 5-FU and oxaliplatin).
N=158 routine follow-up (routine follow-up without any adjuvant treatment).
Primary outcome
Median disease-free survival
20.3 months
10 months
20.3 months
15.2 months
10.2 months
5.1 months
0.0 months
Adjuvant
FOLFOX-HAIC
Routine
follow-up
Significant
increase ▲
Significant increase in median disease-free survival (20.3 months vs. 10 months; HR 1.69, 95% CI 1.23 to 2.33).
Secondary outcomes
No significant difference in overall survival at 3 years (80.4% vs. 74.9%; HR 1.56, 95% CI 0.88 to 2.78).
Safety outcomes
No significant difference in operation-related adverse events.
Conclusion
In patients with HCC with microvascular invasion, adjuvant FOLFOX-HAIC was superior to routine follow-up with respect to median disease-free survival.
Reference
Shao-Hua Li, Jie Mei, Yuan Cheng et al. Postoperative Adjuvant Hepatic Arterial Infusion Chemotherapy With FOLFOX in Hepatocellular Carcinoma With Microvascular Invasion: A Multicenter, Phase III, Randomized Study. J Clin Oncol. 2023 Apr 1;41(10):1898-1908.
Open reference URL