Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial
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...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7398460/ https://www.ncbi.nlm.nih.gov/pubmed/31801872 http://dx.doi.org/10.1136/gutjnl-2019-318934 |
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author | 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 |
author_facet | 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 |
author_sort | Kudo, Masatoshi |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-7398460 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-73984602020-08-17 Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial 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 Gut Hepatology 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. BMJ Publishing Group 2020-08 2019-12-04 /pmc/articles/PMC7398460/ /pubmed/31801872 http://dx.doi.org/10.1136/gutjnl-2019-318934 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Hepatology 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 Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial |
title | Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial |
title_full | Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial |
title_fullStr | Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial |
title_full_unstemmed | Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial |
title_short | Randomised, multicentre prospective trial of transarterial chemoembolisation (TACE) plus sorafenib as compared with TACE alone in patients with hepatocellular carcinoma: TACTICS trial |
title_sort | randomised, multicentre prospective trial of transarterial chemoembolisation (tace) plus sorafenib as compared with tace alone in patients with hepatocellular carcinoma: tactics trial |
topic | Hepatology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7398460/ https://www.ncbi.nlm.nih.gov/pubmed/31801872 http://dx.doi.org/10.1136/gutjnl-2019-318934 |
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