{"created":"2023-05-15T16:13:13.080312+00:00","id":43749,"links":{},"metadata":{"_buckets":{"deposit":"78e82123-dded-41c0-afbb-b485413455b3"},"_deposit":{"created_by":25,"id":"43749","owners":[25],"pid":{"revision_id":0,"type":"depid","value":"43749"},"status":"published"},"_oai":{"id":"oai:shinshu.repo.nii.ac.jp:00043749","sets":["2668"]},"author_link":["169895","169896","169904","169899","169894","169900","169903","169901","169898","169905","169897","169902"],"item_20002_biblio_info_27":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2015-09-25","bibliographicIssueDateType":"Issued"},"bibliographicIssueNumber":"5","bibliographicPageEnd":"975","bibliographicPageStart":"969","bibliographicVolumeNumber":"76","bibliographic_titles":[{"bibliographic_title":"CANCER CHEMOTHERAPY AND PHARMACOLOGY"}]}]},"item_20002_creator_3":{"attribute_name":"作成者(その他言語)","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Yamazaki, N."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Uhara, H."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Fukushima, S."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Uchi, H."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Shibagaki, N."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kiyohara, Y."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Tsutsumida, A."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Namikawa, K."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Okuyama, R."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Otsuka, Y."}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Tokudome, T."}],"nameIdentifiers":[{}]}]},"item_20002_date_19":{"attribute_name":"日付","attribute_value_mlt":[{"subitem_date_issued_datetime":"2018-10-31","subitem_date_issued_type":"Created"}]},"item_20002_description_14":{"attribute_name":"内容記述","attribute_value_mlt":[{"subitem_description":"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.","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":[{}],"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. 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."},{"subitem_rights":"© 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."}]},"item_20002_source_id_25":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0344-5704","subitem_source_identifier_type":"ISSN"}]},"item_20002_source_id_26":{"attribute_name":"処理レコードID(総合目録DB)","attribute_value_mlt":[{"subitem_source_identifier":"AA00598397","subitem_source_identifier_type":"NCID"}]},"item_20002_version_type_51":{"attribute_name":"著者版フラグ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_access_right":{"attribute_name":"アクセス権","attribute_value_mlt":[{"subitem_access_right":"metadata only access","subitem_access_right_uri":"http://purl.org/coar/access_right/c_14cb"}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"url":{"url":"https://soar-ir.repo.nii.ac.jp/?action=repository_action_common_download&item_id=20228&item_no=1&attribute_id=65&file_no=1"}}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Ipilimumab","subitem_subject_scheme":"Other"},{"subitem_subject":"Dacarbazine","subitem_subject_scheme":"Other"},{"subitem_subject":"Immune-checkpoint inhibitor","subitem_subject_scheme":"Other"},{"subitem_subject":"Melanoma","subitem_subject_scheme":"Other"},{"subitem_subject":"Phase 2 study","subitem_subject_scheme":"Other"},{"subitem_subject":"Japanese patients","subitem_subject_scheme":"Other"}]},"item_language":{"attribute_name":"言語","attribute_value_mlt":[{"subitem_language":"eng"}]},"item_resource_type":{"attribute_name":"資源タイプ","attribute_value_mlt":[{"resourcetype":"journal article","resourceuri":"http://purl.org/coar/resource_type/c_6501"}]},"item_title":"Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma"}]},"item_type_id":"20002","owner":"25","path":["2668"],"pubdate":{"attribute_name":"公開日","attribute_value":"2020-09-04"},"publish_date":"2020-09-04","publish_status":"0","recid":"43749","relation_version_is_last":true,"title":["Phase II study of the immune-checkpoint inhibitor ipilimumab plus dacarbazine in Japanese patients with previously untreated, unresectable or metastatic melanoma"],"weko_creator_id":"25","weko_shared_id":-1},"updated":"2023-05-15T18:21:01.885585+00:00"}