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.
Study Details
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.
Key Findings
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.
