Hepatic arterial infusion therapy for advanced hepatocellular carcinoma after systemic treatment failure: Multicenter, real‐world study

Abstract Aim The study was conducted to evaluate the feasibility and safety profile of hepatic arterial infusion chemotherapy with oxaliplatin, 5‐fluorouracil, and leucovorin (HAIC‐FOLFOX) as an alternative therapeutic choice for patients with advanced hepatocellular carcinoma (HCC) that is refractory to systemic treatment including immune checkpoint blockades or molecular targeting agents. Methods Two hundred and forty five consecutive patients with advanced HCC who received HAIC‐FOLFOX treatment after systemic treatment failure were retrospectively reviewed in six institutions and their survival, tumor response, and tolerance were assessed. Results The median overall survival (OS) and progression‐free survival of the 209 included participants were 10.5 months (95% confidence interval [CI], 8.1–12.9) and 6.0 months (95% CI, 5.1–6.9), respectively. According to Response Evaluation Criteria in Solid Tumors 1.1 criteria, the objective response rate was 21.1%, and the disease control rate was 64.6%. Multivariate analysis of risk factors of OS were albumin–bilirubin grade (2 and 3 vs. 1, hazard ratio [HR] 1.57; 95% CI, 1.05–2.34; p = 0.028), tumor number (>3 vs. 1–3, HR 2.18; 95% CI, 1.10–4.34; p = 0.026), extrahepatic spread (present vs. absent, HR 1.61, 95% CI, 1.06–2.45; p = 0.027), synchronous systemic treatment (present vs. absent, HR 0.55, 95% CI, 0.37–0.83; p = 0.004) and treatment response (responder vs. nonresponder, HR 0.30, 95% CI, 0.17–0.53; p < 0.001). Grade 3–4 adverse events (AEs) occurred in 59 (28.2%) HCC patients. All AEs were manageable, and deaths related to hepatic artery infusion chemotherapy treatment were not observed. Conclusions Our findings support the effectiveness and safety of HAIC‐FOLFOX treatment for patients with advanced HCC who have failed systemic treatment.