A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer: Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial)

Takeshi Suzuki; Yasutaka Sukawa; Chiyo K. Imamura; Toshiki Masuishi; Hironaga Satake; Yosuke Kumekawa; Shinsuke Funakoshi; Masahito Kotaka; Yoshiki Horie; Sadayuki Kawai; Hiroyuki Okuda; Tetsuji Terazawa; Chihiro Kondoh; Ken Kato; Kenichi Yoshimura; Hideki Ishikawa; Yasuo Hamamoto; Narikazu Boku; Hiromasa Takaishi; Takanori Kanai

doi:10.1016/j.clcc.2019.10.004

A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer: Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial)

Takeshi Suzuki, Yasutaka Sukawa, Chiyo K. Imamura, Toshiki Masuishi, Hironaga Satake, Yosuke Kumekawa, Shinsuke Funakoshi, Masahito Kotaka, Yoshiki Horie, Sadayuki Kawai, Hiroyuki Okuda, Tetsuji Terazawa, Chihiro Kondoh, Ken Kato, Kenichi Yoshimura, Hideki Ishikawa, Yasuo Hamamoto, Narikazu Boku, Hiromasa Takaishi, Takanori Kanai

研究成果: Article › 査読

14 被引用数 (Scopus)

抄録

To improve the tolerability and maintain sufficient efficacy of regorafenib, we conducted a phase II study of regorafenib with a lower starting dose of 120 mg/day for patients with refractory metastatic colorectal cancer. Using this dose-escalation strategy, the disease control rate for the 68 evaluable patients was lower than that in our statistical hypothesis, and a relationship of unbound exposure with toxicity was observed.

本文言語	English
ページ（範囲）	13-21.e3
ジャーナル	Clinical Colorectal Cancer
巻	19
号	1
DOI	https://doi.org/10.1016/j.clcc.2019.10.004
出版ステータス	Published - 2020 3月

ASJC Scopus subject areas

腫瘍学
消化器病学

UN SDG

この成果は、次の持続可能な開発目標に貢献しています

文献へのアクセス

10.1016/j.clcc.2019.10.004

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「A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer: Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial)」の研究トピックを掘り下げます。これらがまとまってユニークなフィンガープリントを構成します。

引用スタイル

Suzuki, T., Sukawa, Y., Imamura, C. K., Masuishi, T., Satake, H., Kumekawa, Y., Funakoshi, S., Kotaka, M., Horie, Y., Kawai, S., Okuda, H., Terazawa, T., Kondoh, C., Kato, K., Yoshimura, K., Ishikawa, H., Hamamoto, Y., Boku, N., Takaishi, H., & Kanai, T. (2020). A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer: Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial). Clinical Colorectal Cancer, 19(1), 13-21.e3. https://doi.org/10.1016/j.clcc.2019.10.004

Suzuki, T, Sukawa, Y, Imamura, CK, Masuishi, T, Satake, H, Kumekawa, Y, Funakoshi, S, Kotaka, M, Horie, Y, Kawai, S, Okuda, H, Terazawa, T, Kondoh, C, Kato, K, Yoshimura, K, Ishikawa, H, Hamamoto, Y, Boku, N, Takaishi, H & Kanai, T 2020, 'A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer: Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial)', Clinical Colorectal Cancer, vol. 19, no. 1, pp. 13-21.e3. https://doi.org/10.1016/j.clcc.2019.10.004

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title = "A Phase II Study of Regorafenib With a Lower Starting Dose in Patients With Metastatic Colorectal Cancer: Exposure–Toxicity Analysis of Unbound Regorafenib and Its Active Metabolites (RESET Trial)",

abstract = "To improve the tolerability and maintain sufficient efficacy of regorafenib, we conducted a phase II study of regorafenib with a lower starting dose of 120 mg/day for patients with refractory metastatic colorectal cancer. Using this dose-escalation strategy, the disease control rate for the 68 evaluable patients was lower than that in our statistical hypothesis, and a relationship of unbound exposure with toxicity was observed.",

keywords = "Advanced colorectal cancer, Dose escalation, Multikinase inhibitor, Pharmacokinetics, Protein binding",

author = "Takeshi Suzuki and Yasutaka Sukawa and Imamura, {Chiyo K.} and Toshiki Masuishi and Hironaga Satake and Yosuke Kumekawa and Shinsuke Funakoshi and Masahito Kotaka and Yoshiki Horie and Sadayuki Kawai and Hiroyuki Okuda and Tetsuji Terazawa and Chihiro Kondoh and Ken Kato and Kenichi Yoshimura and Hideki Ishikawa and Yasuo Hamamoto and Narikazu Boku and Hiromasa Takaishi and Takanori Kanai",

note = "Funding Information: The present study was supported by Keio Gijuku Academic Development Funds and the Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (grant JP17K08961). We thank all the patients who participated in the present study and their families. We also thank Ms Minae Nishiguchi for data management. Funding Information: The present study was supported by Keio Gijuku Academic Development Funds and the Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (grant JP17K08961 ). We thank all the patients who participated in the present study and their families. We also thank Ms Minae Nishiguchi for data management. Publisher Copyright: {\textcopyright} 2019 Elsevier Inc.",

year = "2020",

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doi = "10.1016/j.clcc.2019.10.004",

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AU - Suzuki, Takeshi

AU - Sukawa, Yasutaka

AU - Imamura, Chiyo K.

AU - Masuishi, Toshiki

AU - Satake, Hironaga

AU - Kumekawa, Yosuke

AU - Funakoshi, Shinsuke

AU - Kotaka, Masahito

AU - Horie, Yoshiki

AU - Kawai, Sadayuki

AU - Okuda, Hiroyuki

AU - Terazawa, Tetsuji

AU - Kondoh, Chihiro

AU - Kato, Ken

AU - Yoshimura, Kenichi

AU - Ishikawa, Hideki

AU - Hamamoto, Yasuo

AU - Boku, Narikazu

AU - Takaishi, Hiromasa

AU - Kanai, Takanori

N1 - Funding Information: The present study was supported by Keio Gijuku Academic Development Funds and the Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (grant JP17K08961). We thank all the patients who participated in the present study and their families. We also thank Ms Minae Nishiguchi for data management. Funding Information: The present study was supported by Keio Gijuku Academic Development Funds and the Japan Society for the Promotion of Science Grants-in-Aid for Scientific Research (grant JP17K08961 ). We thank all the patients who participated in the present study and their families. We also thank Ms Minae Nishiguchi for data management. Publisher Copyright: © 2019 Elsevier Inc.

PY - 2020/3

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