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

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URI http://shark.lib.kagawa-u.ac.jp/kuir/metadata/28461
Title
Randomized phase III trial of regorafenib in metastatic colorectal cancer: analysis of the CORRECT Japanese and non-Japanese subpopulations.
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Description

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)

Author
著者 吉野 孝之
著者(ヨミ) ヨシノ タカユキ
著者(別表記) Yoshino Takayuki
Publication Title
Investigational New Drugs
Publication Title Alternative
Invest New Drugs.
Volume
33
Issue
3
Start Page
740
End Page
750
Publisher
Springer
Published Date
2014-09-12
ISSN
0167-6997
NCID
AA10638782
PMID
25213161
DOI
10.1007/s10637-014-0154-x
Resource Type
Thesis or Dissertation
Language
eng
Relation
出版社版DOIリンク(URL): https://doi.org/10.1007/s10637-014-0154-x
PMCID: PMC4434855
Resource URL
https://doi.org/10.1007/s10637-014-0154-x
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4434855/
Rights
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
Text Version
ETD
Grant ID
博乙第280号
Grant Date
2018-07-19
Degree Name
博士(医学)
Grantor
香川大学
Set
香川大学
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