Item type |
学術雑誌論文 / Journal Article(1) |
公開日 |
2018-10-31 |
タイトル |
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タイトル |
Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma |
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言語 |
eng |
DOI |
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関連識別子 |
https://doi.org/10.1007/s00280-015-2870-0 |
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関連名称 |
10.1007/s00280-015-2870-0 |
キーワード |
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主題 |
Ipilimumab, Dacarbazine, Immune-checkpoint inhibitor, Melanoma, Phase 2 study, Japanese patients |
資源タイプ |
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資源 |
http://purl.org/coar/resource_type/c_6501 |
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タイプ |
journal article |
著者 |
Yamazaki, N.
Uhara, H.
Fukushima, S.
Uchi, H.
Shibagaki, N.
Kiyohara, Y.
Tsutsumida, A.
Namikawa, K.
Okuyama, R.
Otsuka, Y.
Tokudome, T.
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信州大学研究者総覧へのリンク |
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氏名 |
Okuyama, Ryuhei |
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URL |
http://soar-rd.shinshu-u.ac.jp/profile/ja.ZpfNHFSF.html |
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出版者 |
SPRINGER |
引用 |
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内容記述 |
CANCER CHEMOTHERAPY AND PHARMACOLOGY.76(5):969-975(2015) |
書誌情報 |
CANCER CHEMOTHERAPY AND PHARMACOLOGY
巻 76,
号 5,
p. 969-975,
発行日 2015-09-25
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抄録 |
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内容記述 |
Purpose<br/>Ipilimumab (IPI), a monoclonal antibody against immune-checkpoint receptor cytotoxic T lymphocyte antigen-4, is designed to enhance antitumor T cell function. IPI 10 mg/kg plus dacarbazine (DTIC) significantly improved overall survival in a phase 3 study involving predominantly Caucasian patients, with an adverse event (AE) profile similar to that of IPI monotherapy. We conducted a single-arm, phase 2 study to evaluate the safety and efficacy of IPI plus DTIC in Japanese patients.<br/>Methods<br/>Previously untreated patients with unresectable stage III or IV melanoma received IPI 10 mg/kg plus DTIC 850 mg/m2 every 3 weeks for four doses (q3w × 4), followed by DTIC q3w × 4 and then IPI every 12 weeks until disease progression or intolerable toxicity.<br/>Results<br/>All 15 treated patients reported drug-related AEs, the most common of which were increases in alanine aminotransferase (n = 12, 80 %) and aspartate aminotransferase (n = 11, 73 %). Treatment-related serious AEs were reported in 11 (73 %) patients. Nine patients (60 %) discontinued treatment due to drug-related toxicities. Immune-related AEs (irAEs) were reported in 14 patients (93 %). The most frequent irAEs were liver (n = 12, 80 %) and skin (n = 10, 67 %) toxicities. Five deaths were reported; all were caused by progressive disease. Efficacy evaluation showed one complete response, one partial response and four patients with stable disease. Best overall response rate was 13 % (2/15), and the disease control rate was 40 % (6/15). The study was terminated early due to frequent, high-grade liver toxicities.<br/>Conclusions<br/>IPI 10 mg/kg plus DTIC 850 mg/m2 was not considered tolerable in the Japanese patient population. |
資源タイプ(コンテンツの種類) |
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内容記述 |
Article |
ISSN |
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収録物識別子タイプ |
PISSN |
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収録物識別子 |
0344-5704 |
書誌レコードID |
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収録物識別子タイプ |
NCID |
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収録物識別子 |
AA00598397 |
PubMed |
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関連識別子 |
https://www.ncbi.nlm.nih.gov/pubmed/26407818 |
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関連名称 |
26407818 |
権利 |
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権利情報 |
© The Author(s) 2015. This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
出版タイプ |
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出版タイプ |
VoR |
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出版タイプResource |
http://purl.org/coar/version/c_970fb48d4fbd8a85 |
WoS |
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URL |
http://gateway.isiknowledge.com/gateway/Gateway.cgi?&GWVersion=2&SrcAuth=ShinshuUniv&SrcApp=ShinshuUniv&DestLinkType=FullRecord&DestApp=WOS&KeyUT=:000363245800010 |