{"created":"2021-03-01T06:23:20.370614+00:00","id":20228,"links":{},"metadata":{"_buckets":{"deposit":"3a7c5a39-4914-48db-95f5-28f424508a4e"},"_deposit":{"id":"20228","owners":[],"pid":{"revision_id":0,"type":"depid","value":"20228"},"status":"published"},"_oai":{"id":"oai:soar-ir.repo.nii.ac.jp:00020228","sets":["461:462"]},"author_link":["106674","106675","106676","106677","106678","106679","106680","106681","106682","106683","106684"],"item_1628147817048":{"attribute_name":"出版タイプ","attribute_value_mlt":[{"subitem_version_resource":"http://purl.org/coar/version/c_970fb48d4fbd8a85","subitem_version_type":"VoR"}]},"item_6_biblio_info_6":{"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_6_description_20":{"attribute_name":"抄録","attribute_value_mlt":[{"subitem_description":"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.","subitem_description_type":"Abstract"}]},"item_6_description_30":{"attribute_name":"資源タイプ（コンテンツの種類）","attribute_value_mlt":[{"subitem_description":"Article","subitem_description_type":"Other"}]},"item_6_description_5":{"attribute_name":"引用","attribute_value_mlt":[{"subitem_description":"CANCER CHEMOTHERAPY AND PHARMACOLOGY.76(5):969-975(2015)","subitem_description_type":"Other"}]},"item_6_link_3":{"attribute_name":"信州大学研究者総覧へのリンク","attribute_value_mlt":[{"subitem_link_text":"Okuyama, Ryuhei","subitem_link_url":"http://soar-rd.shinshu-u.ac.jp/profile/ja.ZpfNHFSF.html"}]},"item_6_link_67":{"attribute_name":"WoS","attribute_value_mlt":[{"subitem_link_url":"http://gateway.isiknowledge.com/gateway/Gateway.cgi?&GWVersion=2&SrcAuth=ShinshuUniv&SrcApp=ShinshuUniv&DestLinkType=FullRecord&DestApp=WOS&KeyUT=:000363245800010"}]},"item_6_publisher_4":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"SPRINGER"}]},"item_6_relation_47":{"attribute_name":"PubMed","attribute_value_mlt":[{"subitem_relation_name":[{"subitem_relation_name_text":"26407818"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://www.ncbi.nlm.nih.gov/pubmed/26407818","subitem_relation_type_select":"PMID"}}]},"item_6_relation_48":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_name":[{"subitem_relation_name_text":"10.1007/s00280-015-2870-0"}],"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://doi.org/10.1007/s00280-015-2870-0","subitem_relation_type_select":"DOI"}}]},"item_6_rights_62":{"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."}]},"item_6_source_id_35":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"0344-5704","subitem_source_identifier_type":"PISSN"}]},"item_6_source_id_40":{"attribute_name":"書誌レコードID","attribute_value_mlt":[{"subitem_source_identifier":"AA00598397","subitem_source_identifier_type":"NCID"}]},"item_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Yamazaki, N.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Uhara, H.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Fukushima, S.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Uchi, H.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Shibagaki, N.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kiyohara, Y.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Tsutsumida, A.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Namikawa, K.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Okuyama, R.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Otsuka, Y.","creatorNameLang":"en"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Tokudome, T.","creatorNameLang":"en"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2018-10-31"}],"displaytype":"detail","filename":"Yamazaki2015_Article_PhaseIIStudyOfTheImmune-checkp.pdf","filesize":[{"value":"427.3 kB"}],"format":"application/pdf","licensefree":"© 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.","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"Yamazaki2015_Article_PhaseIIStudyOfTheImmune-checkp.pdf","url":"https://soar-ir.repo.nii.ac.jp/record/20228/files/Yamazaki2015_Article_PhaseIIStudyOfTheImmune-checkp.pdf"},"version_id":"9426f918-a2db-4fb0-8dd0-c573e4b875a1"}]},"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","subitem_title_language":"en"}]},"item_type_id":"6","owner":"1","path":["462"],"pubdate":{"attribute_name":"PubDate","attribute_value":"2018-10-31"},"publish_date":"2018-10-31","publish_status":"0","recid":"20228","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":"1","weko_shared_id":-1},"updated":"2022-12-14T04:40:38.949353+00:00"}