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論文種別	原著
言語種別	英語
査読の有無	査読なし
表題	Sorafenib plus low-dose cisplatin and fluorouracil hepatic arterial infusion chemotherapy versus sorafenib alone in patients with advanced hepatocellular carcinoma (SILIUS): a randomised, open label, phase 3 trial
掲載誌名	正式名：The lancet. Gastroenterology&hepatology 略　 称：Lancet Gastroenterol Hepatol ISSNコード：2468-1253(Electronic)
掲載区分	国外
巻・号・頁	3(6),pp.424-32
著者・共著者	Kudo Masatoshi, Ueshima Kazuomi, Yokosuka Osamu, Ogasawara Sadahisa, Obi Shuntaro, Izumi Namiki, Aikata Hiroshi, Nagano Hiroaki, Hatano Etsuro, Sasaki Yutaka, Hino Keisuke, Kumada Takashi, Yamamoto Kazuhide, Imai Yasuharu, Iwadou Shouta, Ogawa Chikara, Okusaka Takuji, Kanai Fumihiko, Akazawa Kohei, Yoshimura Ken-Ichi, Johnson Philip, Arai Yasuaki, SILIUS study group
発行年月	2018/06
概要	BACKGROUND:Hepatic arterial infusion chemotherapy plus sorafenib in phase 2 trials has shown favourable tumour control and a manageable safety profile in patients with advanced, unresectable hepatocellular carcinoma. However, no randomised phase 3 trial has tested the combination of sorafenib with continuous arterial infusion chemotherapy. We aimed to compare continuous hepatic arterial infusion chemotherapy plus sorafenib with sorafenib alone in patients with advanced, unresectable hepatocellular carcinoma.METHODS:We did an open-label, randomised, phase 3 trial (SILIUS) at 31 sites in Japan. Eligible patients were aged 20 years or older, with advanced hepatocellular carcinoma not suitable for resection, local ablation, or transarterial chemoembolisation; Eastern Cooperative Oncology Group (ECOG) performance status 0-1; Child-Pugh score 7 or lower; and adequate bone marrow, liver, and renal function. Patients were randomly assigned (1:1) via an interactive web response system with a computer-generated sequence to receive 400 mg sorafenib orally twice daily or 400 mg sorafenib orally twice daily plus hepatic arterial infusion chemotherapy (cisplatin 20 mg/m2FINDINGS:Between Nov 4, 2010, and June 10, 2014, 206 patients were randomly assigned (103 to the sorafenib group, 103 to the sorafenib plus hepatic arterial infusion chemotherapy group). One patient in the sorafenib plus hepatic arterial infusion chemotherapy group withdrew after randomisation. Median overall survival was similar in the sorafenib plus hepatic arterial infusion chemotherapy (n=102) and sorafenib monotherapy (n=103) groups (11·8 months [95% CI 9·1-14·5]vs 11·5 months [8·2-14·8]; hazard ratio 1·009 [95% CI 0·743-1·371]; p=0·955). Grade 3-4 adverse events that were more frequent in the sorafenib plus hepatic arterial infusion chemotherapy group than in the sorafenib monotherapy group included anaemia (15 [17%]of 88 vs six [6%]of 102), neutropenia (15 [17%]vs one [1%]), thrombocytopenia (30 [34%]vs 12
DOI	10.1016/S2468-1253(18)30078-5
PMID	29631810