Published online Jul 21, 2020. doi: 10.3748/wjg.v26.i27.3975
Peer-review started: March 29, 2020
First decision: April 25, 2020
Revised: May 7, 2020
Accepted: July 4, 2020
Article in press: July 4, 2020
Published online: July 21, 2020
Processing time: 113 Days and 23.5 Hours
Transarterial chemoembolization (TACE) and hepatic arterial infusion chemotherapy (HAIC) have shown promising local benefits for advanced hepatocellular carcinoma (HCC). S-1, a composite preparation of a 5-fluorouracil prodrug, has proven to be a convenient oral chemotherapeutic agent with definite efficacy against advanced HCC.
To evaluate the efficacy and safety of TACE followed by HAIC with or without oral S-1 for treating advanced HCC.
In this single-center, open-label, prospective, randomized controlled trial, 117 participants with advanced HCC were randomized to receive TACE followed by oxaliplatin-based HAIC either with (TACE/HAIC + S-1, n = 56) or without (TACE/HAIC, n = 61) oral S-1 between December 2013 and September 2017. Two participants were excluded from final analysis for withdrawing consent. The primary endpoint was progression-free survival (PFS) and secondary endpoints included overall survival (OS), objective response rate, disease control rate and safety.
In total, 115 participants (100 males and 15 females; mean age, 57.7 years ± 11.9) were analyzed. The median PFS and OS were 5.0 mo (0.4–58.6 mo) (95% confidence interval (CI): 3.82 to 6.18) vs 4.4 mo (1.1–54.4 mo) (95%CI: 2.54 to 6.26; P = 0.585) and 8.4 mo (0.4–58.6 mo) (95%CI: 6.88 to 9.92) vs 8.3 mo (1.4–54.4 m) (95%CI: 5.71 to 10.96; P = 0.985) in the TACE/HAIC + S-1 and TACE/HAIC groups, respectively. The objective response rate and disease control rate were 30.9% vs 18.4% and 72.7% vs 56.7% in the TACE/HAIC + S-1 and TACE/HAIC groups, respectively. Grade 3/4 adverse events had a similar frequency in both treatment groups.
No improvements in tumor response rates, PFS or OS were observed with the addition of S-1 to TACE/HAIC in advanced HCC. Both treatment regimens had a similar safety profile.
Core tip: This randomized controlled trial showed that the addition of oral S-1 (a composite preparation of a 5-fluorouracil prodrug) to transarterial chemoembolization followed by hepatic arterial infusion chemotherapy with oxaliplatin did not lengthen the survival time of patients with advanced hepatocellular carcinoma complicating portal vein invasion or extrahepatic metastasis, although it did appear to have moderately better anti-tumor activity. Overall, transarterial chemoembolization combined with hepatic arterial infusion chemotherapy was an effective and safe treatment for patients with advanced hepatocellular carcinoma with portal vein invasion or extrahepatic metastasis.