Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations.

( 最大 2000 件 )
URI http://shark.lib.kagawa-u.ac.jp/kuir/metadata/28461
タイトル
Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations.
ファイル
内容記述

Abstract
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.

Keywords:

Regorafenib Protein kinase inhibitors Japanese Colorectal cancer Clinical trial Phase III

(医博乙280)

著者
著者 吉野 孝之
著者(ヨミ) ヨシノ タカユキ
著者(別表記) Yoshino Takayuki
掲載誌
Investigational New Drugs
掲載誌(別表記)
Invest New Drugs.
33
3
開始ページ
740
終了ページ
750
出版者
Springer
出版年月日
2014-09-12
ISSN
0167-6997
NCID
AA10638782
PMID
25213161
DOI
10.1007/s10637-014-0154-x
資料タイプ
学位論文
言語
英語
関連情報
出版社版DOIリンク(URL): https://doi.org/10.1007/s10637-014-0154-x
PMCID: PMC4434855
関連情報URL
https://doi.org/10.1007/s10637-014-0154-x
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4434855/
権利関係
Copyright © The Author(s) 2014
Open Access 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.
DOI: https://doi.org/10.1007/s10637-014-0154-x
博士論文(全文を含む)
学位授与番号
博乙第280号
学位授与年月日
2018-07-19
学位名
博士(医学)
学位授与機関
香川大学
区分
香川大学
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