Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial. Issue 8 (4th December 2019)

• Record Type: Journal Article
• Authors: Kudo, Masatoshi; Ueshima, Kazuomi; Ikeda, Masafumi; Torimura, Takuji; Tanabe, Nobukazu; Aikata, Hiroshi; Izumi, Namiki; Yamasaki, Takahiro; Nojiri, Shunsuke; Hino, Keisuke; Tsumura, Hidetaka; Kuzuya, Teiji; Isoda, Norio; Yasui, Kohichiroh; Aino, Hajime; Ido, Akio; Kawabe, Naoto; Nakao, Kazuhiko; Wada, Yoshiyuki; Yokosuka, Osamu; Yoshimura, Kenichi; Okusaka, Takuji; Furuse, Junji; Kokudo, Norihiro; Okita, Kiwamu; Johnson, Philip James; Arai, Yasuaki
• Other Names: author non-byline.; Kudo Masatosi author non-byline.; Ueshima Kazuomi author non-byline.; Torimura Takuji author non-byline.; Ikeda Masafumi author non-byline.; Tanabe Nobukazu author non-byline.; Aikata Hiroshi author non-byline.; Izumi Namiki author non-byline.; Yamasaki Takahiro author non-byline.; Nojiri Shunsuke author non-byline.; Hino Keisuke author non-byline.; Tsumura Hidetaka author non-byline.; Kuzuya Teiji author non-byline.; Isoda Norio author non-byline.; Yasui Kohichiroh author non-byline.; Aino Hajime author non-byline.; Ido Akio author non-byline.; Kawabe Naoto author non-byline.; Nakao Kazuhiko author non-byline.; Wada Yohiyuki author non-byline.; Yokosuka Osamu author non-byline.; Yoshimura Kenichi author non-byline.; Okusaka Takashi author non-byline.; Furuse Junji author non-byline.; Kokudo Norihiro author non-byline.; Okita Kiwamu author non-byline.; Johnson Philip James author non-byline.; Arai Yasuaki author non-byline.; Fujimoto Masao author non-byline.; Koda Masahiko author non-byline.; Tomita Eiichi author non-byline.; Osaki Yukio author non-byline.; Hidaka Hisashi author non-byline.; Ogawa Hiroshi author non-byline.; Kogure Takayuki author non-byline.; Nakatsuka Atsuhiro author non-byline.; Enomoto Nobuyuki author non-byline.; Tanaka Katsuaki author non-byline.; Seike Masataka author non-byline.; Ishikawa Toru author non-byline.; Inokuma Tetsuro author non-byline.; Morimoto Manabu author non-byline.;
• Is Part Of: Gut. Volume 69:Issue 8(2020)
• Page Start: 1492
• Page End: 1501
• Publication Date: 2019-12-04
• Subjects: transarterial chemoembolization -- sorafenib -- hepatocellular carcinoma -- combination therapy with transarterial chemoembolisation and sorafenib -- progression-free survival; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2019-318934
• Languages: English
• ISSNs: 0017-5749

Abstract

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 .