RT Journal Article
SR Electronic
T1 Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial
JF Gut
JO Gut
FD BMJ Publishing Group Ltd and British Society of Gastroenterology
SP 1492
OP 1501
DO 10.1136/gutjnl-2019-318934
VO 69
IS 8
A1 Kudo, Masatoshi
A1 Ueshima, Kazuomi
A1 Ikeda, Masafumi
A1 Torimura, Takuji
A1 Tanabe, Nobukazu
A1 Aikata, Hiroshi
A1 Izumi, Namiki
A1 Yamasaki, Takahiro
A1 Nojiri, Shunsuke
A1 Hino, Keisuke
A1 Tsumura, Hidetaka
A1 Kuzuya, Teiji
A1 Isoda, Norio
A1 Yasui, Kohichiroh
A1 Aino, Hajime
A1 Ido, Akio
A1 Kawabe, Naoto
A1 Nakao, Kazuhiko
A1 Wada, Yoshiyuki
A1 Yokosuka, Osamu
A1 Yoshimura, Kenichi
A1 Okusaka, Takuji
A1 Furuse, Junji
A1 Kokudo, Norihiro
A1 Okita, Kiwamu
A1 Johnson, Philip James
A1 Arai, Yasuaki
A1 ,
YR 2020
UL http://gut.bmj.com/content/69/8/1492.abstract
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.