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A Phase I Study of Combination Therapy with Sorafenib and 5-Fluorouracil in Patients with Advanced Hepatocellular Carcinoma


10.1007_s40268-017-0187-7.pdf510.38 kBPDF見る/開く

タイトル: A Phase I Study of Combination Therapy with Sorafenib and 5-Fluorouracil in Patients with Advanced Hepatocellular Carcinoma
著者: Sho, Takuya 著作を一覧する
Nakanishi, Mitsuru 著作を一覧する
Morikawa, Kenichi 著作を一覧する
Ohara, Masatsugu 著作を一覧する
Kawagishi, Naoki 著作を一覧する
Izumi, Takaaki 著作を一覧する
Umemura, Machiko 著作を一覧する
Ito, Jun 著作を一覧する
Nakai, Masato 著作を一覧する
Suda, Goki 著作を一覧する
Ogawa, Koji 著作を一覧する
Chuma, Makoto 著作を一覧する
Meguro, Takashi 著作を一覧する
Nakamura, Michio 著作を一覧する
Nagasaka, Atsushi 著作を一覧する
Horimoto, Hiromasa 著作を一覧する
Yamamoto, Yoshiya 著作を一覧する
Sakamoto, Naoya 著作を一覧する
発行日: 2017年 9月
出版者: Springer
誌名: Drugs in R&D
巻: 17
号: 3
開始ページ: 381
終了ページ: 388
出版社 DOI: 10.1007/s40268-017-0187-7
抄録: Background and aims: Sorafenib is the first molecular targeted drug approved for the treatment of advanced hepatocellular carcinoma (HCC) and is a potent small molecule inhibitor of multiple kinases. Combination therapy with sorafenib and other cytotoxic agents for HCC may result in additive anticancer activity. The purpose of this phase I study was to investigate the safety and tolerability of combination therapy with sorafenib and 5-fluorouracil (5-FU) and to determine the optimum dose of 5-FU for a phase II trial. Methods: This phase I study used a conventional 3 + 3 dose-escalation design. The primary endpoint was to determine the maximum tolerated dose (MTD) of 5-FU in combination with sorafenib and to determine the recommended dosage (RD) for phase II. The secondary endpoints evaluated were toxicity and the tumor response rate. All patients received 800 mg of sorafenib daily and three different dosages of 5-FU (250, 350, and 450 mg/m2/day) for 20 days by intravenous infusion in 1 month as one cycle. Results: Twelve patients with advanced HCC were evaluated. The MTD of 5-FU in combination with sorafenib was 450 mg/m2/day, and 350 mg/m2/day was selected as the RD for a phase II study. Thrombocytopenia, stomatitis, and hand-foot skin reaction were observed as grade 3 adverse events. Nine patients achieved stable disease (75%), and three patients (25%) were judged to have progressive disease. The disease control rate was 75%. Conclusions: Combination therapy with sorafenib and 5-FU appears to be well tolerated and may have the potential to be an option for advanced HCC.
資料タイプ: article
出現コレクション:雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

提供者: 森川 賢一


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