Kudo, Masatoshi, Ueshima, Kazuomi, Ikeda, Masafumi, Torimura, Takuji, Tanabe, Nobukazu, Aikata, Hiroshi, Izumi, Namiki, Yamasaki, Takahiro, Nojiri, Shunsuke, Hino, Keisuke et al (show 18 more authors)
(2020)
Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial.
Gut, 69 (8).
pp. 1492-1501.
Text
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Abstract
OBJECTIVE:This trial compared the efficacy and safety of transarterial chemoembolisation (TACE) plus sorafenib with TACE alone using a newly established TACE-specific endpoint and pre-treatment of sorafenib before initial TACE. DESIGN:Patients with unresectable hepatocellular carcinoma (HCC) were randomised to TACE plus sorafenib (n=80) or TACE alone (n=76). Patients in the combination group received sorafenib 400 mg once daily for 2-3 weeks before TACE, followed by 800 mg once daily during on-demand conventional TACE sessions until time to untreatable (unTACEable) progression (TTUP), defined as untreatable tumour progression, transient deterioration to Child-Pugh C or appearance of vascular invasion/extrahepatic spread. Co-primary endpoints were progression-free survival (PFS), which is not a conventional one but defined as TTUP, or time to any cause of death plus overall survival (OS). Multiplicity was adjusted by gatekeeping hierarchical testing. RESULTS:Median PFS was significantly longer in the TACE plus sorafenib than in the TACE alone group (25.2 vs 13.5 months; p=0.006). OS was not analysed because only 73.6% of OS events were reached. Median TTUP (26.7 vs 20.6 months; p=0.02) was also significantly longer in the TACE plus sorafenib group. OS at 1 year and 2 years in TACE plus sorafenib group and TACE alone group were 96.2% and 82.7% and 77.2% and 64.6%, respectively. There were no unexpected toxicities. CONCLUSION:TACE plus sorafenib significantly improved PFS over TACE alone in patients with unresectable HCC. Adverse events were consistent with those of previous TACE combination trials. TRIAL REGISTRATION NUMBER:NCT01217034.
Item Type: | Article |
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Uncontrolled Keywords: | TACTICS study group |
Depositing User: | Symplectic Admin |
Date Deposited: | 22 Jan 2020 09:32 |
Last Modified: | 19 Jan 2023 00:08 |
DOI: | 10.1136/gutjnl-2019-318934 |
Related URLs: | |
URI: | https://livrepository.liverpool.ac.uk/id/eprint/3071500 |