| アイテムタイプ |
学術雑誌論文 / Journal Article(1) |
| 公開日 |
2025-09-29 |
| タイトル |
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タイトル |
An Open-Label, Multicenter, Phase II Study of Bexarotene in Patients With Adult T-Cell Leukemia/Lymphoma |
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言語 |
en |
| 言語 |
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|
言語 |
eng |
| キーワード |
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言語 |
en |
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キーワード |
adult T‐cell leukemia |
| キーワード |
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言語 |
en |
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キーワード |
lymphoma |
| キーワード |
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言語 |
en |
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キーワード |
bexarotene |
| キーワード |
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言語 |
en |
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キーワード |
retionid |
| キーワード |
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言語 |
en |
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キーワード |
skin lesion |
| キーワード |
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言語 |
en |
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キーワード |
systemic therapy |
| 資源タイプ |
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資源タイプ |
journal article |
| アクセス権 |
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アクセス権 |
open access |
| 著者 |
Yonekura, Kentaro
Muto, Ikko
Takenaka, Motoi
Aoi, Jun
Fujimura, Taku
天野, 正宏
WEKO
9166
e-Rad_Researcher
80244200
| ja |
天野, 正宏
宮崎大学
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| ja-Kana |
アマノ, マサヒロ
|
| en |
Amano, Masahiro
University of Miyazaki
|
Search repository
Kanekura, Takuro
Miyagi, Takuya
Saito, Kanami
Kiyohara, Eiji
Shimauchi, Takatoshi
Watanabe, Ken
Miyake, Tomoko
Ito, Takamichi
Uhara, Hisashi
Fujii, Kazuyasu
Sudo, Akihito
| en |
Sudo, Akihito（Personal）
Minophagen Pharmaceutical, Tokyo, Japan.
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Search repository
Watanabe, Toshiki
Iwatsuki, Keiji
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| 抄録 |
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内容記述タイプ |
Abstract |
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内容記述 |
A multicenter, open-label, historically controlled, 2-arm Phase II study was conducted to evaluate the safety, efficacy, and pharmacokinetics of bexarotene in Japanese patients with adult T-cell lymphoma/leukemia (ATL). The study enrolled patients with indolent ATL and skin lesions and patients with aggressive ATL who had skin relapse after achieving remission following ≥ 1 regimen of systemic chemotherapy. Patients received oral bexarotene at an initial dose of 100 mg/m2 (15 patients) or 300 mg/m2 (17 patients) once daily for 24 weeks. The 100 mg/m2 group included 14 patients with indolent ATL and 1 with aggressive ATL. The 300 mg/m2 group included 14 patients with indolent ATL and 3 with aggressive ATL. Of 12 patients in the 100 mg/m2 group, 6 patients achieved complete response (CR) or partial response (PR) as the best overall response (50.0%; 95% confidence interval (CI), 25.4%-74.6%). Of 17 patients in the 300 mg/m2 group, 12 patients achieved CR or PR (70.6%; 95% CI, 46.9%-86.7%) as estimated with the modified Severity Weighted Assessment Tool (mSWAT). Drug-related adverse events (AEs) occurred in 15 patients (100%) in the 100 mg/m2 group and 16 of 17 patients (94.1%) in the 300 mg/m2 group. The most common AEs were hypothyroidism (75.1%) and hypertriglyceridemia (53.1%). This is the first report to evaluate the safety and efficacy of bexarotene in ATL focused on skin lesions. In both groups, the response rate exceeded the threshold defined for the study. Bexarotene might be effective in improving skin lesions in ATL of any type with good tolerability. Trial Registration: This study was registered with the Japan Registry of Clinical Trials (jRCT2080224172). |
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言語 |
ja |
| 書誌情報 |
en : Journal of Dermatology
発行日 2025-08-23
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| 出版者 |
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出版者 |
John Wiley and Sons Inc |
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言語 |
en |
| ISSN |
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収録物識別子タイプ |
EISSN |
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収録物識別子 |
13468138 |
| DOI |
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関連タイプ |
isVersionOf |
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識別子タイプ |
DOI |
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関連識別子 |
https://doi.org/10.1111/1346-8138.17919 |
| 著者版フラグ |
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出版タイプ |
VoR |
fulltext (1.3 MB)
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