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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.
Afiliación
  • Kudo M; Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan m-kudo@med.kindai.ac.jp.
  • Ueshima K; Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.
  • Ikeda M; Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
  • Torimura T; Department of Gastroenterology and Hepatology, Kurume University School of Medicine, Kurume, Japan.
  • Tanabe N; Department of Gastroenterology, National Hospital Organisation Sendai Medical Center, Sendai, Japan.
  • Aikata H; Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.
  • Izumi N; Department of Gastroenterology, Musashino Red Cross Hospital, Tokyo, Japan.
  • Yamasaki T; Department of Gastroenterology and Hepatology, Yamaguchi University Graduate School of Medicine, Ube-Yamaguchi, Japan.
  • Nojiri S; Department of Gastroenterology and Metabolism, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
  • Hino K; Department of Hepatology and Pancreatology, Kawasaki Medical School, Kurashiki, Japan.
  • Tsumura H; Department of Gastroenterology and Hepatology, Hyogo Cancer Center, Akashi, Japan.
  • Kuzuya T; Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
  • Isoda N; Department of Medicine, Division of Gastroenterology, Jichi Medical University, Shimotsuke, Japan.
  • Yasui K; Department of Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
  • Aino H; Division of Gastroenterology, Department of Medicine, Social Insurance Tagawa Hospital, Tagawa, Japan.
  • Ido A; Department of Gastroenterology and Hepatology, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
  • Kawabe N; Department of Liver, Biliary Tract and Pancreas Diseases, Fujita Health University School of Medicine, Aichi, Japan.
  • Nakao K; Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.
  • Wada Y; Department of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
  • Yokosuka O; Department of Gastroenterology, School of Medicine, Chiba University, Chiba, Japan.
  • Yoshimura K; Center for Integrated Medical Research, Hiroshima University, Hiroshima, Japan.
  • Okusaka T; Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
  • Furuse J; Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Japan.
  • Kokudo N; Department of Surgery, National Center for Global Health and Medicine, Tokyo, Japan.
  • Okita K; Deapartment of Medicine, Shunan Memorial Hospital, Kudamatsu, Yamaguchi, Japan.
  • Johnson PJ; Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.
  • Arai Y; Department of Diagnostic Radiology, National Cancer Center Hospital, Tokyo, Japan.
Gut ; 69(8): 1492-1501, 2020 08.
Article en En | MEDLINE | ID: mdl-31801872
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Quimioembolización Terapéutica / Carcinoma Hepatocelular / Sorafenib / Neoplasias Hepáticas / Antineoplásicos Tipo de estudio: Clinical_trials / Observational_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Gut Año: 2020 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Quimioembolización Terapéutica / Carcinoma Hepatocelular / Sorafenib / Neoplasias Hepáticas / Antineoplásicos Tipo de estudio: Clinical_trials / Observational_studies Límite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Gut Año: 2020 Tipo del documento: Article País de afiliación: Japón Pais de publicación: Reino Unido