Hepatic artery infusion chemotherapy using mFOLFOX versus transarterial chemoembolization for massive unresectable hepatocellular carcinoma: a prospective non.randomized study

• Published in: 癌症：英文版 2017, Vol.36 (12), p.704-711
• Main Authors: Min-Ke He, Yong Le, Qi-Jiong Li, Zi-Shan Yu, Shao-Hua Li, Wei Wei, Rong-Ping Guo, Ming Shi
• Format: Article
• Language: English
• Subjects: artery; carcinoma; chemoembolization; chemotherapy; Hepatic; Hepatocellular; infusion; mFOLFOX; Transarterial
• ISSN: 1000-467X; 1944-446X

Background: Transarterial chemoembolization (TACE) is recommended as the standard care for unresectable hepatocellular carcinoma (HCC) at Barcelona Clinic Liver Cancer (BCLC) stage A–B. However, the efficacy of TACE on large (≥ 10 cm) stage A–B HCC is far from satisfactory, and it is proposed that hepatic artery infusion chemotherapy (HAIC)might be a better first-line treatment of this disease. Hence, we compared the safety and efficacy of HAIC with the modified FOLFOX (mFOLFOX) regimen and those of TACE in patients with massive unresectable HCC.Methods: A prospective, non-randomized, phase II study was conducted on patients with massive unresectable HCC. The protocol involved HAIC with the mFOLFOX regimen (oxaliplatin, 85 mg/m2 intra-arterial infusion; leucovorin,400 mg/m2 intra-arterial infusion; and fluorouracil, 400 mg/m2 bolus infusion and 2400 mg/m2 continuous infusion) every 3 weeks and TACE with 50 mg of epirubicin, 50 mg of lobaplatin, 6 mg of mitomycin, and lipiodol and polyvinyl alcohol particles. The tumor responses, time-to-progression (TTP), and safety were assessed.Results: A total of 79 patients were recruited for this study: 38 in the HAIC group and 41 in the TACE group. The HAIC group exhibited higher partial response and disease control rates than did the TACE group (52.6% vs. 9.8%, P < 0.001;83.8% vs. 52.5%, P = 0.004). The median TTPs for the HAIC and TACE groups were 5.87 and 3.6 months (hazard radio [HR] = 2.35, 95% confidence interval [CI] = 1.16–4.76, P = 0.015). More patients in the HAIC group than in the TACE group underwent resection (10 vs. 3, P = 0.033). The proportions of grade 3–4 adverse events (AE) and serious adverse events (SAE) were lower in the HAIC group than in the TACE group (grade 3–4 AEs: 13 vs. 27, P = 0.007; SAEs: 6 vs. 15,P = 0.044). More patients in the TACE group than in the HAIC group had the study treatment terminated early due to intolerable treatment-related adverse events or the withdrawal of consent (10 vs. 2, P = 0.026).Conclusions: HAIC with mFOLFOX yielded significantly better treatment responses and less serious toxicity than did TACE. HAIC might represent a feasible and promising first-line treatment for patients with massive unresectable HCC.