In a Chinese phase III trial reported in the Journal of Clinical Oncology, Li et al found that adjuvant hepatic arterial infusion chemotherapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin) significantly improved disease-free survival vs routine follow-up in patients with hepatocellular carcinoma with microvascular invasion.
In the multicenter, open-label trial, 315 patients were randomly assigned between June 2016 and August 2021 to receive one or two cycles of hepatic arterial infusion chemotherapy (n = 157) or routine follow-up (control group; n = 158) at 4 to 6 weeks after surgery. Hepatic arterial infusion chemotherapy consisted of oxaliplatin at 85 mg/m2 from 0 to 3 hours, leucovorin at 400 mg/m2 from 3 to 4.5 hours, and fluorouracil at 400 mg/m2 from 4.5 to 6.5 hours all once on day 1, plus fluorouracil at 2,400 mg/m2 once over 46 hours from days 1 to 3. A second cycle of hepatic arterial infusion chemotherapy could be given at 4 to 5 weeks after the first cycle. The primary endpoint was disease-free survival in the intention-to-treat population.
Median follow-up was 23.7 months (95% confidence interval [CI] = 21.0–26.5 months) in the hepatic arterial infusion chemotherapy group and 21.5 months (95% CI = 17.6–25.4 months) in the control group.
Median disease-free survival was 20.3 months (95% CI = 10.4–30.3 months) in the hepatic arterial infusion chemotherapy group vs 10.0 months (95% CI = 6.8–13.2 months) in the control group (hazard ratio [HR] = 0.59, 95% CI = 0.43–0.81, P = .001). Estimated rates at 1, 2, and 3 years were 62.2% vs 47.2%, 46.8% vs 30.1%, and 41.1% vs 22.6%, respectively.
Estimated overall survival rates at 1, 2, and 3 years were 93.8% vs 92.0%, 86.4% vs 86.0%, and 80.4% vs 74.9% (HR = 0.64, 95% CI = 0.36–1.14, P = .130).
Overall, 83.8% of adverse events not associated with surgery in the hepatic arterial infusion chemotherapy group were grade 1. No treatment-related adverse events resulted in death in either group.
The investigators concluded, “Postoperative adjuvant hepatic arterial infusion chemotherapy with FOLFOX significantly improved the disease-free survival benefits with acceptable toxicities in [patients with] hepatocellular carcinoma with microvascular invasion.”
Rong-Ping Guo, MD, of the Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by the National Natural Science Foundation of China, Natural Science Foundation of Guangdong Province, and others. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.