Long-term clinical outcomes of hepatic arterial infusion chemotherapy with cisplatin with or without 5-fluorouracil in locally advanced hepatocellular carcinoma

Purpose: Hepatic arterial infusion chemotherapy (HAIC) has often been used as a therapeutic option for patients with advanced hepatocellular carcinoma (HCC). This study aimed to evaluate the efficacy and safety of HAIC using cisplatin with or without 5-fluorouracil in patients with advanced HCC. Methods: Between January 2002 and December 2007, we enrolled patients with advanced HCC who underwent HAIC via implantable port systems with cisplatin (60 mg/m ² on Day 1) with or without 5-fluorouracil (500 mg/m ² on Days 1-3) every 4 weeks. Tumor response was assessed every two cycles. Results: During follow-up (median 9.5 months), we recorded patient (n = 138) and disease characteristics including median age (53 years), Child-Pugh class A/B (n = 103/35, respectively), portal vein thrombosis (n = 115), and death (n = 121). In total, 561 cycles of HAIC were administered (median four cycles, range 1-14). Ninety-one patients received cisplatin plus 5-fluorouracil, while 47 received only cisplatin. The median progression-free survival (PFS) and overall survival (OS) were 6.0 and 9.5 months, respectively, while the overall disease control rate was 62.3% (3 complete responses, 29 partial responses and 54 stable diseases). Patients treated with cisplatin plus 5-fluorouracil had longer median PFS (7.0 vs. 4.6 months in those given cisplatin only; p = 0.004) and OS (12.0 vs. 7.5 months in those given cisplatin only; p = 0.001). Adverse reactions were tolerable and successfully managed with conservative treatment. Conclusions: Repetitive HAIC seems well-tolerated and effective in treating advanced HCC, with more therapeutic benefit when treated with cisplatin plus 5-fluorouracil. Future randomized comparative studies are warranted for its efficacy.