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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.MethodsPreviously 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.ResultsAll 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 %). 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The study was terminated early due to frequent, high-grade liver toxicities.ConclusionsIPI 10 mg/kg plus DTIC 850 mg/m2 was not considered tolerable in the Japanese patient population.", "subitem_description_type": "Other"}]}, "item_20002_description_20": {"attribute_name": "資源タイプ", "attribute_value_mlt": [{"subitem_description": "Article", "subitem_description_type": "Other"}]}, "item_20002_description_22": {"attribute_name": "その他の資源識別子", "attribute_value_mlt": [{"subitem_description": "CANCER CHEMOTHERAPY AND PHARMACOLOGY.76(5):969-975(2015)", "subitem_description_type": "Other"}]}, "item_20002_full_name_16": {"attribute_name": "公開者(その他言語)", "attribute_value_mlt": [{"nameIdentifiers": [{"nameIdentifier": "169905", "nameIdentifierScheme": "WEKO"}], "names": [{"name": "SPRINGER"}]}]}, "item_20002_identifier_23": {"attribute_name": "資源識別子URI", "attribute_value_mlt": [{"subitem_identifier_type": "HDL", "subitem_identifier_uri": "http://hdl.handle.net/10091/00020986"}]}, "item_20002_relation_31": {"attribute_name": "PubMed番号", "attribute_value_mlt": [{"subitem_relation_type": "isIdenticalTo", "subitem_relation_type_id": {"subitem_relation_type_id_text": "https://www.ncbi.nlm.nih.gov/pubmed/26407818", "subitem_relation_type_select": "PMID"}}]}, "item_20002_relation_32": {"attribute_name": "DOI", "attribute_value_mlt": [{"subitem_relation_type": "isIdenticalTo", "subitem_relation_type_id": {"subitem_relation_type_id_text": "https://doi.org/10.1007/s00280-015-2870-0", "subitem_relation_type_select": "DOI"}}]}, "item_20002_rights_50": {"attribute_name": "権利", "attribute_value_mlt": [{"subitem_rights": "© The Author(s) 2015. 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Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma
https://shinshu.repo.nii.ac.jp/records/43749
https://shinshu.repo.nii.ac.jp/records/43749457d9292-4b3a-4f3b-b948-a1a5be70b1a2
名前 / ファイル | ライセンス | アクション |
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https://soar-ir.repo.nii.ac.jp/?action=repository_action_common_download&item_id=20228&item_no=1&attribute_id=65&file_no=1
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Item type | Journal Article(1) | |||||
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公開日 | 2020-09-04 | |||||
タイトル | ||||||
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 | |||||
作成者(その他言語) |
Yamazaki, N.
× 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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公開者(その他言語) | ||||||
姓名 | SPRINGER | |||||
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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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 | ||||||
資源タイプ識別子 | http://purl.org/coar/resource_type/c_6501 | |||||
資源タイプ | journal article | |||||
アクセス権 | ||||||
アクセス権 | metadata only access | |||||
アクセス権URI | http://purl.org/coar/access_right/c_14cb | |||||
内容記述 | ||||||
内容記述タイプ | Other | |||||
内容記述 | PurposeIpilimumab (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.MethodsPreviously 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.ResultsAll 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.ConclusionsIPI 10 mg/kg plus DTIC 850 mg/m2 was not considered tolerable in the Japanese patient population. | |||||
日付 | ||||||
日付 | 2018-10-31 | |||||
日付タイプ | Created | |||||
資源タイプ | ||||||
内容記述タイプ | Other | |||||
内容記述 | Article | |||||
その他の資源識別子 | ||||||
内容記述タイプ | Other | |||||
内容記述 | CANCER CHEMOTHERAPY AND PHARMACOLOGY.76(5):969-975(2015) | |||||
資源識別子URI | ||||||
識別子 | http://hdl.handle.net/10091/00020986 | |||||
識別子タイプ | HDL | |||||
ISSN | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 0344-5704 | |||||
処理レコードID(総合目録DB) | ||||||
収録物識別子タイプ | NCID | |||||
収録物識別子 | AA00598397 | |||||
PubMed番号 | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | PMID | |||||
関連識別子 | https://www.ncbi.nlm.nih.gov/pubmed/26407818 | |||||
DOI | ||||||
関連タイプ | isIdenticalTo | |||||
識別子タイプ | DOI | |||||
関連識別子 | https://doi.org/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. | |||||
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. | |||||
著者版フラグ | ||||||
出版タイプ | VoR | |||||
出版タイプResource | http://purl.org/coar/version/c_970fb48d4fbd8a85 |