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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. \u003cbr/\u003eMethods Previously untreated patients with unresectable stage III or IV melanoma received IPI 10 mg/kg plus DTIC 850 mg/m(2) every 3 weeks for four doses (q3w x 4), followed by DTIC q3w x 4 and then IPI every 12 weeks until disease progression or intolerable toxicity. \u003cbr/\u003eResults 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. 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  1. 050 医学部, 大学院医学系研究科
  2. 0501 学術論文

Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma

http://hdl.handle.net/10091/00020986
638f6827-44bd-494e-886b-27f4ec6ec4a5
名前 / ファイル ライセンス アクション
Yamazaki2015_Article_PhaseIIStudyOfTheImmune-checkp.pdf Yamazaki2015_Article_PhaseIIStudyOfTheImmune-checkp.pdf (427.3 kB)
Item type 学術雑誌論文 / Journal Article(1)
公開日 2018-10-31
タイトル
言語 en
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
言語
言語 eng
キーワード
主題Scheme Other
主題 Ipilimumab
キーワード
主題Scheme Other
主題 Dacarbazine
キーワード
主題Scheme Other
主題 Immune-checkpoint inhibitor
キーワード
主題Scheme Other
主題 Melanoma
キーワード
主題Scheme Other
主題 Phase 2 study
キーワード
主題Scheme Other
主題 Japanese patients
資源タイプ
資源 http://purl.org/coar/resource_type/c_6501
タイプ journal article
著者 Yamazaki, N.

× Yamazaki, N.

WEKO 106674

en Yamazaki, N.

Search repository
Uhara, H.

× Uhara, H.

WEKO 106675

en Uhara, H.

Search repository
Fukushima, S.

× Fukushima, S.

WEKO 106676

en Fukushima, S.

Search repository
Uchi, H.

× Uchi, H.

WEKO 106677

en Uchi, H.

Search repository
Shibagaki, N.

× Shibagaki, N.

WEKO 106678

en Shibagaki, N.

Search repository
Kiyohara, Y.

× Kiyohara, Y.

WEKO 106679

en Kiyohara, Y.

Search repository
Tsutsumida, A.

× Tsutsumida, A.

WEKO 106680

en Tsutsumida, A.

Search repository
Namikawa, K.

× Namikawa, K.

WEKO 106681

en Namikawa, K.

Search repository
Okuyama, R.

× Okuyama, R.

WEKO 106682

en Okuyama, R.

Search repository
Otsuka, Y.

× Otsuka, Y.

WEKO 106683

en Otsuka, Y.

Search repository
Tokudome, T.

× Tokudome, T.

WEKO 106684

en Tokudome, T.

Search repository
信州大学研究者総覧へのリンク
氏名 Okuyama, Ryuhei
URL http://soar-rd.shinshu-u.ac.jp/profile/ja.ZpfNHFSF.html
出版者
出版者 SPRINGER
引用
内容記述タイプ Other
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
抄録
内容記述タイプ Abstract
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)
内容記述タイプ Other
内容記述 Article
ISSN
収録物識別子タイプ PISSN
収録物識別子 0344-5704
書誌レコードID
収録物識別子タイプ NCID
収録物識別子 AA00598397
PubMed
関連識別子
識別子タイプ PMID
関連識別子 https://www.ncbi.nlm.nih.gov/pubmed/26407818
関連名称
関連名称 26407818
DOI
関連識別子
識別子タイプ DOI
関連識別子 https://doi.org/10.1007/s00280-015-2870-0
関連名称
関連名称 10.1007/s00280-015-2870-0
権利
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
出版タイプ VoR
出版タイプResource http://purl.org/coar/version/c_970fb48d4fbd8a85
WoS
表示名 Web of Science
URL http://gateway.isiknowledge.com/gateway/Gateway.cgi?&GWVersion=2&SrcAuth=ShinshuUniv&SrcApp=ShinshuUniv&DestLinkType=FullRecord&DestApp=WOS&KeyUT=:000363245800010
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