PT  - JOURNAL ARTICLE
AU  - Kudo, Masatoshi
AU  - Ueshima, Kazuomi
AU  - Ikeda, Masafumi
AU  - Torimura, Takuji
AU  - Tanabe, Nobukazu
AU  - Aikata, Hiroshi
AU  - Izumi, Namiki
AU  - Yamasaki, Takahiro
AU  - Nojiri, Shunsuke
AU  - Hino, Keisuke
AU  - Tsumura, Hidetaka
AU  - Kuzuya, Teiji
AU  - Isoda, Norio
AU  - Yasui, Kohichiroh
AU  - Aino, Hajime
AU  - Ido, Akio
AU  - Kawabe, Naoto
AU  - Nakao, Kazuhiko
AU  - Wada, Yoshiyuki
AU  - Yokosuka, Osamu
AU  - Yoshimura, Kenichi
AU  - Okusaka, Takuji
AU  - Furuse, Junji
AU  - Kokudo, Norihiro
AU  - Okita, Kiwamu
AU  - Johnson, Philip James
AU  - Arai, Yasuaki
ED  - ,
TI  - Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial
AID  - 10.1136/gutjnl-2019-318934
DP  - 2020 Aug 01
TA  - Gut
PG  - 1492--1501
VI  - 69
IP  - 8
4099  - http://gut.bmj.com/content/69/8/1492.short
4100  - http://gut.bmj.com/content/69/8/1492.full
SO  - Gut2020 Aug 01; 69
AB  - 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.