神戸大学附属図書館デジタルアーカイブ
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https://hdl.handle.net/20.500.14094/90005444
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2024-03-29
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90005444 (fulltext)
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メタデータID
90005444
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open access
出版タイプ
Version of Record
タイトル
Efficacy and safety of nivolumab in combination with ipilimumab in Japanese patients with advanced melanoma: An open-label, single-arm, multicentre phase II study
著者
Namikawa, Kenjiro ; Kiyohara, Yoshio ; Takenouchi, Tatsuya ; Uhara, Hisashi ; Uchi, Hiroshi ; Yoshikawa, Shusuke ; Takatsuka, Sumiko ; Koga, Hiroshi ; Wada, Naoko ; Minami, Hironobu ; Hatsumichi, Masahiro ; Asada, Suguru ; Namba, Yoshinobu ; Yamazaki, Naoya
著者名
Namikawa, Kenjiro
著者名
Kiyohara, Yoshio
著者名
Takenouchi, Tatsuya
著者名
Uhara, Hisashi
著者名
Uchi, Hiroshi
著者名
Yoshikawa, Shusuke
著者名
Takatsuka, Sumiko
著者名
Koga, Hiroshi
著者名
Wada, Naoko
著者ID
A1398
研究者ID
1000060450574
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/profile/ja.29f74a5e8b26a0a9520e17560c007669.html
著者名
Minami, Hironobu
南, 博信
ミナミ, ヒロノブ
所属機関名
医学研究科
著者名
Hatsumichi, Masahiro
著者名
Asada, Suguru
著者名
Namba, Yoshinobu
著者名
Yamazaki, Naoya
収録物名
European Journal of Cancer
巻(号)
105
ページ
114-126
出版者
Elsevier
刊行日
2018-12
公開日
2018-12-12
抄録
Aim: The aim of the study was to evaluate the efficacy and safety of nivolumab combined with ipilimumab in treatment-naive Japanese patients with advanced melanoma. Methods: In this multicentre, single-arm study, treatment-naive Japanese patients with unresectable stage III/IV or recurrent melanoma received nivolumab (1 mg/kg) plus ipilimumab (3 mg/kg) every 3 weeks for four doses, followed by biweekly doses of nivolumab (3 mg/kg). The primary end-point was centrally assessed objective response rate (ORR). Secondary end-points included overall survival (OS), progression-free survival (PFS), disease control rate and safety. Results: The subtypes of the thirty patients enrolled were: 12, mucosal; eight, non-acral cutaneous; seven, acral; two, uveal and one, unknown primary melanoma. The ORR was 43.3% (95% confidence interval [CI]: 25.5, 62.6) with central and local assessment. The centrally and locally assessed disease control rate (95% CI) were 73.3% (54.1, 87.7) and 86.7% (69.3, 96.2), respectively. At the median follow-up period of 14.1 months (range 5.2-27.7), median OS and centrally assessed PFS were not reached. OS (95% CI) at 6, 12, 18 and 24 months was 93.3% (75.9, 98.3), 83.3% (64.5, 92.7), 72.9% (50.0, 86.5) and 65.6% (40.4, 82.2), respectively. Treatment-related adverse events (AEs) occurred in all patients. Grade III-IV and serious AEs occurred, mostly during the combination phase, in 23 (76.7%) and 20 (66.7%) patients, respectively. No treatment-related deaths occurred. Conclusions: This study confirmed the efficacy and safety of nivolumab plus ipilimumab in treatment-naive Japanese patients with advanced melanoma including rare subtypes. Incidence rates for grade IIIeIV AEs were high but manageable with appropriate medical attention and treatment. Trial registration: JapicCTI-152869.
キーワード
Melanoma
Immunotherapy
Ipilimumab
Nivolumab
Japanese
Asian
Mucosal
Acral
Survival analysis
カテゴリ
医学研究科
学術雑誌論文
権利
© 2018 The Author(s). Published by Elsevier Ltd.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
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資源タイプ
journal article
言語
English (英語)
ISSN
0959-8049
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eISSN
1879-0852
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関連情報
DOI
https://doi.org/10.1016/j.ejca.2018.09.025
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