Cohort study exploring the effect of lenvatinib on differentiated thyroid cancer
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- Tahara Makoto
- Department of Head and Neck Cancer Oncology, National Cancer Center Hospital East, Kashiwa, Chiba 277-8577, Japan
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- Takami Hiroshi
- Department of Surgery, Ito Hospital, Shibuya-ku, Tokyo 150-8308, Japan
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- Ito Yasuhiro
- Department of Clinical Trial, Department of Surgery, Kuma Hospital, Kobe, Hyogo 650-0011, Japan
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- Sugino Kiminori
- Department of Surgery, Ito Hospital, Shibuya-ku, Tokyo 150-8308, Japan
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- Takahashi Shunji
- Department of Medical Oncology, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, 3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
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- Takeyama Hiroshi
- Department of Breast and Endocrine Surgery, The Jikei University School of Medicine, Minato-ku, Tokyo 105-8461, Japan
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- Tsutsui Hidemitsu
- Department of Thoracic and Thyroid Surgery, Tokyo Medical University, Shinjuku-ku, Tokyo 160-0023, Japan
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- Hara Hisato
- Department of Breast and Endocrine Surgery, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaraki 305-8576, Japan
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- Mitsuma Ayako
- Department of Clinical Oncology and Chemotherapy, Nagoya University Hospital, Nagoya, Aichi 466-8560, Japan
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- Yamashita Hiroyuki
- Department of Surgery, Yamashita Thyroid Hospital, Fukuoka 812-0034, Japan
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- Okamoto Takahiro
- Department of Breast and Endocrine Surgery, Tokyo Women’s Medical University Hospital, Shinjuku-ku, Tokyo 162-8666, Japan
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- Sugitani Iwao
- Department of Endocrine Surgery, Nippon Medical School Graduate School of Medicine, Bunkyo-ku, Tokyo 113-8603, Japan
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- Ohashi Yasuo
- Department of Integrated Science and Engineering for Sustainable Society, Chuo University, Bunkyo-ku, Tokyo 112-8551, Japan
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- Imai Tsuneo
- National Hospital Organization, Higashinagoya National Hospital, Nagoya, Aichi 465-8620, Japan
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抄録
<p>Lenvatinib is a molecular-targeting agent that was recently approved in Japan for treatment of curatively unresectable, radioactive iodine-refractory, progressive differentiated thyroid cancer (DTC). Because only a few Japanese patients have received lenvatinib in clinical trials, there are limited domestic data on its safety and efficacy or prognostic factors. Therefore, a prospective observational study has been designed to collect safety and efficacy data in at least 300 patients with curatively unresectable DTC receiving lenvatinib therapy (24 mg/day), in order to find predictors of antitumor activity and survival. Patients with progressive curatively unresectable DTC refractory to radioiodine therapy will be enrolled and the primary endpoint will be overall survival. This study is designed to estimate the 95% confidence intervals of the 1-year and 2-year survival rates with a two-sided width of less than 10%. Secondary endpoints will be the time to treatment failure, time to strategy failure, progression-free survival time with clinical progressive disease, response rate, quality of life, safety, and patient reports. The ultimate goal is to obtain information for developing evidence-based guidelines for treatment of DTC, including recommendations on patient selection, dosages, and duration of treatment. This study has been registered with the UMIN Clinical Trials Registry (UMIN000022243).</p>
収録刊行物
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- Endocrine Journal
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Endocrine Journal 65 (11), 1071-1074, 2018
一般社団法人 日本内分泌学会