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

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Title: A Phase I Study of Combination Therapy with Sorafenib and 5-Fluorouracil in Patients with Advanced Hepatocellular Carcinoma
Authors: Sho, Takuya Browse this author
Nakanishi, Mitsuru Browse this author
Morikawa, Kenichi Browse this author
Ohara, Masatsugu Browse this author
Kawagishi, Naoki Browse this author
Izumi, Takaaki Browse this author
Umemura, Machiko Browse this author
Ito, Jun Browse this author
Nakai, Masato Browse this author
Suda, Goki Browse this author →KAKEN DB
Ogawa, Koji Browse this author
Chuma, Makoto Browse this author →KAKEN DB
Meguro, Takashi Browse this author
Nakamura, Michio Browse this author
Nagasaka, Atsushi Browse this author
Horimoto, Hiromasa Browse this author
Yamamoto, Yoshiya Browse this author
Sakamoto, Naoya Browse this author →KAKEN DB
Issue Date: Sep-2017
Publisher: Springer
Journal Title: Drugs in R&D
Volume: 17
Issue: 3
Start Page: 381
End Page: 388
Publisher DOI: 10.1007/s40268-017-0187-7
Abstract: 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.
Type: article
Appears in Collections:北海道大学病院 (Hokkaido University Hospital) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)

Submitter: 森川 賢一

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