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

Persistent ID (NDL): info:ndljp/pid/11122785

Material type: 博士論文

Author: 吉野, 孝之

Publisher: -

Publication date: 2017-07-19

Material Format: Digital

Capacity, size, etc.: -

Name of awarding university/degree: 香川大学,博士（医学）

View All

Notes on use at the National Diet Library

本資料は、掲載誌(URI)等のリンク先にある学位授与機関のWebサイトやCiNii Dissertationsから、本文を自由に閲覧できる場合があります。

Notes on use

Note (General)：: SummaryBackground In the international, phase III, randomized, double-blind CORRECT trial, regorafenib significantly prolonged overall survival (OS) v...

Search by Bookstore

Bibliographic Record

You can check the details of this material, its authority (keywords that refer to materials on the same subject, author's name, etc.), etc.

Digital

Material Type: 博士論文
Title: Randomized phase III trial of regorafenib in metastatic colorectal cancer : analysis of the CORRECT Japanese and non-Japanese subpopulations.
Author/Editor: 吉野, 孝之
Author Heading: 吉野, 孝之
Publication Date: 2017-07-19
Publication Date (W3CDTF): 2017-07-19
Degree grantor/type: 香川大学
Date Granted: 2017-07-19
Date Granted (W3CDTF): 2017-07-19
Dissertation Number: 乙第280号
Degree Type: 博士（医学）
Conferring No. (Dissertation): 乙第280号
Text Language Code: eng
Alias of Author: 吉野, 孝之
ヨシノ, タカユキ
Subject Heading: Regorafenib
Protein kinase inhibitors
Japanese
Colorectal cancer
Clinical trial
Phase III
Target Audience: 一般
Note (General): SummaryBackground 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.
DOI: info:doi/10.1007/s10637-014-0154-x
https://doi.org/info:doi/10.1007/s10637-014-0154-x
Persistent ID (NDL): info:ndljp/pid/11122785
https://dl.ndl.go.jp/pid/11122785
Collection (particular): 国立国会図書館デジタルコレクション > デジタル化資料 > 博士論文
https://dl.ndl.go.jp/collections/A00014
Acquisition Basis: 博士論文（自動収集）
Date Accepted (W3CDTF): 2018-08-03T23:36:01+09:00
Date Created (W3CDTF): 2020-10-27
Format (IMT): PDF
Access Restrictions: 国立国会図書館内限定公開
Service for the Digitized Contents Transmission Service: 図書館・個人送信対象外
Availability of remote photoduplication service: 可
Periodical Title (URI): https://kagawa-u.repo.nii.ac.jp/records/311
Data Provider (Database): 国立国会図書館 : 国立国会図書館デジタルコレクション
https://dl.ndl.go.jp