| タイトル |
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Randomized phase III trial of regorafenib in metastatic colorectal cancer : analysis of the CORRECT Japanese and non-Japanese subpopulations.
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| 作成者 |
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Yoshino, Takayuki
ja
吉野, 孝之
ja-Kana
ヨシノ, タカユキ
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| アクセス権 |
open access |
| 権利情報 |
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Copyright © 2014, The Author(s)
- https://creativecommons.org/licenses/by/4.0/
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This article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
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| 主題 |
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Other
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Regorafenib
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Other
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Protein kinase inhibitors
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Other
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Japanese
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Other
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Colorectal cancer
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Other
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Clinical trial
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Other
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Phase III
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| 内容注記 |
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Abstract
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Summary
Background In the international, phase III, randomized, double-blind CORRECT trial, regorafenib significantly prolonged overall survival (OS) versus placebo in patients with metastatic colorectal cancer (mCRC) that had progressed on all standard therapies. This post hoc analysis evaluated the efficacy and safety of regorafenib in Japanese and non-Japanese subpopulations in the CORRECT trial. Methods Patients were randomized 2 : 1 to regorafenib 160 mg once daily or placebo for weeks 1–3 of each 4-week cycle. The primary endpoint was OS. Outcomes were assessed using descriptive statistics. Results One hundred Japanese and 660 non-Japanese patients were randomized to regorafenib (n = 67 and n = 438) or placebo (n = 33 and n = 222). Regorafenib had a consistent OS benefit in the Japanese and non-Japanese subpopulations, with hazard ratios of 0.81 (95 % confidence interval [CI] 0.43–1.51) and 0.77 (95 % CI 0.62–0.94), respectively. Regorafenib-associated hand–foot skin reaction, hypertension, proteinuria, thrombocytopenia, and lipase elevations occurred more frequently in the Japanese subpopulation than in the non-Japanese subpopulation, but were generally manageable. Conclusion Regorafenib appears to have comparable efficacy in Japanese and non-Japanese subpopulations, with a manageable adverse-event profile, suggesting that this agent could potentially become a standard of care in patients with mCRC.
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| 言語 |
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| 資源タイプ |
doctoral thesis |
| 出版タイプ |
P |
| 資源識別子 |
URI
https://kagawa-u.repo.nii.ac.jp/records/311
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| 関連 |
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isVersionOf
DOI
https://doi.org/10.1007/s10637-014-0154-x
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isIdenticalTo
URI
https://dl.ndl.go.jp/pid/11122785
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hasVersion
URI
http://www.ncbi.nlm.nih.gov/pmc/articles/pmc4434855/
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PMID
25213161
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NAID
500001069869
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| 学位情報 |
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学位授与番号
乙第280号
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学位授与機関
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識別子名
kakenhi
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識別子
16201
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機関名称
ja
香川大学
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Kagawa University
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学位授与年月日
2017-07-19
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学位名
ja
博士（医学）
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| ファイル |
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fulltext
本文
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2.0 MB
(application/pdf)
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abstract
内容の要旨
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69.2 kB
(application/pdf)
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other
審査の結果の要旨
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500.8 kB
(application/pdf)
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| コンテンツ更新日時 |
2024-08-24 |
