Posted: Wednesday, June 28, 2023
According to research presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract 4023), some patients with resectable hepatocellular carcinoma who received neoadjuvant FOLFOX (leucovorin, fluorouracil, and oxaliplatin) plus hepatic arterial infusion chemotherapy (HAIC) prior to resection may experience improved survival outcomes. Wei Wei, MD, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China, and colleagues evaluated the efficacy and safety of this combination treatment approach in patients whose cancer was rated stage A/B on the Barcelona Clinic Liver Cancer staging system and was beyond Milan criteria, impacting their consideration for transplantation.
The multicenter, phase III trial included 392 patients from across seven hospitals in China. Patients were randomly assigned to receive either neoadjuvant FOLFOX-HAIC prior to hepatectomy (n = 195) or hepatectomy without neoadjuvant treatment (n = 197), making up the intent-to-treat population. The per-protocol population included 181 patients in the FOLFOX-HAIC group and 184 patients in the control group.
In both populations, overall survival and progression-free survival were better with FOLFOX-HAIC. Among the intent-to-treat population, 1-, 2-, and 3-year overall survival rates were 97.7%, 86.3%, and 77.1% in the neoadjuvant treatment group versus 90.0%, 80.9%, and 70.6%, respectively, in the control cohort. Median progression-free survival was 17.4 months for the treatment group and 9.8 months for the control group. Among patients in the intent-to-treat population receiving FOLFOX-HAIC, the complete regression, objective response, and disease control rates were 11.3%, 61.5%, and 97.4%, respectively. Nearly all patients (97.9%) in the treatment cohort experienced grade 0 to 2 adverse events related to HAIC treatment, whereas adverse events related to hepatectomy were comparable between the treatment and control groups.
The study reported survival outcomes for its per-protocol population as well. The FOLFOX-HAIC cohort’s overall survival rates at 1, 2, and 3 years were 98.7%, 91.1%, and 79.7%, respectively, versus 89.2%, 79.3%, and 67.7%, respectively, for the control group. Median progression-free survival was 22.7 months for the treatment group versus 10.2 months for the control group.
Disclosure: The study authors reported no conflicts of interest.