A phase I study of sorafenib in combination with S-1 plus cisplatin in patients with advanced gastric cancer |
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Authors: | Yasuhide Yamada Naomi Kiyota Nozomu Fuse Ken Kato Hironobu Minami Kensei Hashizume Yoshihiro Kuroki Yuichiro Ito Atsushi Ohtsu |
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Institution: | 1. Gastrointestinal Medical Oncology Division, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan 2. Kobe University Hospital, Hyogo, Japan 3. National Cancer Hospital East, Chiba, Japan 4. National Cancer Center Hospital, Tokyo, Japan 5. Bayer Yakuhin Ltd, Osaka, Japan 6. National Cancer Hospital, Chiba, Japan
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Abstract: | Background Sorafenib inhibits several receptor tyrosine kinases involved in tumor progression and angiogenesis. S-1, an oral fluorouracil antitumor drug, plus cisplatin (CDDP) is the standard regimen for advanced gastric adenocarcinoma (AGC) in Japan. The purpose of this phase I study was to evaluate the safety, pharmacokinetics, and preliminary efficacy of sorafenib in combination with S-1 plus CDDP. Methods Patients with histologically confirmed previously untreated AGC were evaluated for eligibility and treated with sorafenib (400 mg bid, days 1–35), S-1 (40 mg/m2 bid, days 1–21), and CDDP (60 mg/m2, day 8). Treatment was continued until disease progression or unacceptable toxicity. Pharmacokinetics for sorafenib, 5-FU, and CDDP were investigated in cycle 1. Results Thirteen patients were enrolled and received at least one dose of the study treatment. No specific or serious adverse event was newly reported in this study. Five patients had partial response and 8 had stable disease as the best response. Pharmacokinetic analysis showed no significant differences in the exposures of sorafenib when administered alone or in combination with S-1 and CDDP. Conclusions The present phase I study demonstrates the acceptable toxicity and preliminary efficacy of combined treatment with S-1, CDDP, and sorafenib. |
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