{"_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": "\u51fa\u7248\u30bf\u30a4\u30d7", "attribute_value_mlt": [{"subitem_version_resource": "http://purl.org/coar/version/c_970fb48d4fbd8a85", "subitem_version_type": "VoR"}]}, "item_6_biblio_info_6": {"attribute_name": "\u66f8\u8a8c\u60c5\u5831", "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": "\u6284\u9332", "attribute_value_mlt": [{"subitem_description": "Purpose\u003cbr/\u003eIpilimumab (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.\u003cbr/\u003eMethods\u003cbr/\u003ePreviously 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 \u00d7 4), followed by DTIC q3w \u00d7 4 and then IPI every 12 weeks until disease progression or intolerable toxicity.\u003cbr/\u003eResults\u003cbr/\u003eAll 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.\u003cbr/\u003eConclusions\u003cbr/\u003eIPI 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": "\u8cc7\u6e90\u30bf\u30a4\u30d7\uff08\u30b3\u30f3\u30c6\u30f3\u30c4\u306e\u7a2e\u985e\uff09", "attribute_value_mlt": [{"subitem_description": "Article", "subitem_description_type": "Other"}]}, "item_6_description_5": {"attribute_name": "\u5f15\u7528", "attribute_value_mlt": [{"subitem_description": "CANCER CHEMOTHERAPY AND PHARMACOLOGY.76(5):969-975(2015)", "subitem_description_type": "Other"}]}, "item_6_link_3": {"attribute_name": "\u4fe1\u5dde\u5927\u5b66\u7814\u7a76\u8005\u7dcf\u89a7\u3078\u306e\u30ea\u30f3\u30af", "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_text": "Web of Science", "subitem_link_url": "http://gateway.isiknowledge.com/gateway/Gateway.cgi?\u0026GWVersion=2\u0026SrcAuth=ShinshuUniv\u0026SrcApp=ShinshuUniv\u0026DestLinkType=FullRecord\u0026DestApp=WOS\u0026KeyUT=:000363245800010"}]}, "item_6_publisher_4": {"attribute_name": "\u51fa\u7248\u8005", "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": "\u6a29\u5229", "attribute_value_mlt": [{"subitem_rights": "\u00a9 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_select_64": {"attribute_name": "\u8457\u8005\u7248\u30d5\u30e9\u30b0", "attribute_value_mlt": [{"subitem_select_item": "publisher"}]}, "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_39": {"attribute_name": "NII ISSN", "attribute_value_mlt": [{"subitem_source_identifier": "0344-5704", "subitem_source_identifier_type": "PISSN"}]}, "item_6_source_id_40": {"attribute_name": "\u66f8\u8a8c\u30ec\u30b3\u30fc\u30c9ID", "attribute_value_mlt": [{"subitem_source_identifier": "AA00598397", "subitem_source_identifier_type": "NCID"}]}, "item_6_text_69": {"attribute_name": "wosonly authkey", "attribute_value_mlt": [{"subitem_text_value": "Ipilimumab; Dacarbazine; Immune-checkpoint inhibitor; Melanoma; Phase 2 study; Japanese patients"}]}, "item_6_text_70": {"attribute_name": "wosonly keywords", "attribute_value_mlt": [{"subitem_text_value": "CLINICAL ACTIVITY; EFFICACY; COMBINATION; BLOCKADE; CANCER; CTLA-4; TRIAL"}]}, "item_6_textarea_68": {"attribute_name": "wosonly abstract", "attribute_value_mlt": [{"subitem_textarea_value": "Purpose 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. \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. Immunerelated 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. \u003cbr/\u003eConclusions IPI 10 mg/kg plus DTIC 850 mg/m(2) was not considered tolerable in the Japanese patient population. "}]}, "item_creator": {"attribute_name": "\u8457\u8005", "attribute_type": "creator", "attribute_value_mlt": [{"creatorNames": [{"creatorName": "Yamazaki, N.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106674", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Uhara, H.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106675", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Fukushima, S.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106676", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Uchi, H.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106677", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Shibagaki, N.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106678", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Kiyohara, Y.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106679", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Tsutsumida, A.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106680", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Namikawa, K.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106681", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Okuyama, R.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106682", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Otsuka, Y.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106683", "nameIdentifierScheme": "WEKO"}]}, {"creatorNames": [{"creatorName": "Tokudome, T.", "creatorNameLang": "en"}], "nameIdentifiers": [{"nameIdentifier": "106684", "nameIdentifierScheme": "WEKO"}]}]}, "item_files": {"attribute_name": "\u30d5\u30a1\u30a4\u30eb\u60c5\u5831", "attribute_type": "file", "attribute_value_mlt": [{"accessrole": "open_date", "date": [{"dateType": "Available", "dateValue": "2018-10-31"}], "displaytype": "detail", "download_preview_message": "", "file_order": 0, "filename": "Yamazaki2015_Article_PhaseIIStudyOfTheImmune-checkp.pdf", "filesize": [{"value": "427.3 kB"}], "format": "application/pdf", "future_date_message": "", "is_thumbnail": false, "licensefree": "\u00a9 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", "size": 427300.0, "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": "\u30ad\u30fc\u30ef\u30fc\u30c9", "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": "\u8a00\u8a9e", "attribute_value_mlt": [{"subitem_language": "eng"}]}, "item_resource_type": {"attribute_name": "\u8cc7\u6e90\u30bf\u30a4\u30d7", "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": "\u30bf\u30a4\u30c8\u30eb", "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": ["461/462"], "permalink_uri": "http://hdl.handle.net/10091/00020986", "pubdate": {"attribute_name": "PubDate", "attribute_value": "2018-10-31"}, "publish_date": "2018-10-31", "publish_status": "0", "recid": "20228", "relation": {}, "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_shared_id": -1}