{"created":"2023-07-25T10:25:14.567805+00:00","id":5468,"links":{},"metadata":{"_buckets":{"deposit":"186dee25-e9e8-4b8b-b62a-bb1939425fa1"},"_deposit":{"created_by":15,"id":"5468","owners":[15],"pid":{"revision_id":0,"type":"depid","value":"5468"},"status":"published"},"_oai":{"id":"oai:air.repo.nii.ac.jp:00005468","sets":["611:939:940"]},"author_link":["15343","15335","15341","15333","15350","15334","15345","15337","15342","15344","15347","15352","15349","15338","15353","15348","15351","15346","15339","15340","15336"],"item_10001_biblio_info_7":{"attribute_name":"書誌情報","attribute_value_mlt":[{"bibliographicIssueDates":{"bibliographicIssueDate":"2021","bibliographicIssueDateType":"Issued"},"bibliographicPageEnd":"402","bibliographicPageStart":"393","bibliographicVolumeNumber":"88","bibliographic_titles":[{"bibliographic_title":"Cancer Chemotherapy and Pharmacology"}]}]},"item_10001_description_5":{"attribute_name":"内容記述（抄録）","attribute_value_mlt":[{"subitem_description":"Purpose The current study aimed to determine the efficacy of trifluridine/tipiracil for elderly patients with advanced colorectal cancer. Methods This single-arm, open-label, multicenter, phase II study included elderly patients aged 65 years or more who had fluoropyrimidine-refractory advanced colorectal cancer and received trifluridine/tipiracil (70 mg/m2, days 1–5 and 8–12, every 4 weeks). The primary endpoint was progression-free survival (PFS), while secondary endpoints included overall survival (OS), overall response rate (ORR), toxicities, association between efficacy and geriatric assessment scores, and association between toxicity and plasma drug concentrations. Results A total of 30 patients with a mean age of 73 years were enrolled. Median PFS was 2.3 months (95% confidence interval, 1.9–4.3 months), while median OS was 5.7 months (95% confidence interval, 3.7–8.9 months). Patients had an ORR of 0%, with 57% having stable disease. Grade 4 neutropenia was observed in 13% of the patients. Patients with a higher G8 score (15 or more) showed longer PFS than those with a lower G8 score (median 4.6 vs. 2.0 months; p = 0.047). Moreover, patients with grade 3 or 4 neutropenia showed higher maximum trifluridine concentrations than those with grade 1 or 2 neutropenia (mean 2945 vs. 2107 ng/mL; p = 0.036). Discussion The current phase II trial demonstrated that trifluridine/tipiracil was an effective and well-tolerated option for elderly patients with advanced colorectal cancer. Moreover, geriatric assessment tools and/or plasma drug concentration monitoring might be helpful in predicting the efficacy and toxicities in elderly patients receiving this drug. Trial registration number UMIN000017589, 15/May/2015 (The University Hospital Medical Information Network)","subitem_description_type":"Other"}]},"item_10001_publisher_8":{"attribute_name":"出版者","attribute_value_mlt":[{"subitem_publisher":"Springer"}]},"item_10001_relation_14":{"attribute_name":"DOI","attribute_value_mlt":[{"subitem_relation_type":"isIdenticalTo","subitem_relation_type_id":{"subitem_relation_type_id_text":"10.1007/s00280-021-04277-3","subitem_relation_type_select":"DOI"}}]},"item_10001_relation_25":{"attribute_name":"関連リンク","attribute_value_mlt":[{"subitem_relation_type_id":{"subitem_relation_type_id_text":"https://doi.org/10.1007/s00280-021-04277-3","subitem_relation_type_select":"DOI"}}]},"item_10001_rights_15":{"attribute_name":"著作権等","attribute_value_mlt":[{"subitem_rights":"© The Author(s) 2021 Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/."}]},"item_10001_source_id_9":{"attribute_name":"ISSN","attribute_value_mlt":[{"subitem_source_identifier":"1432-0843","subitem_source_identifier_type":"ISSN"}]},"item_10001_version_type_20":{"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_creator":{"attribute_name":"著者","attribute_type":"creator","attribute_value_mlt":[{"creatorNames":[{"creatorName":"Takahashi, Masanobu"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Sakamoto, Yasuhiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Ohori, Hisatsugu"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Tsuji, Yasushi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":" Kuroki, Michio"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Kato, Satoshi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Otsuka, Kazunori"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Komine, Keigo"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Takahashi, Masahiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Takahashi, Shin"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Shirota, Hidekazu"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Ouchi, Kota"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Takahashi, Yoshikazu"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Imai, Hiroo"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Shibata, Hiroyuki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yoshioka, Takashi"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":" Tanaka, Masaki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yamaguchi, Hiroaki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Yamaguchi, Takuhiro"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Shimodaira, Hideki"}],"nameIdentifiers":[{}]},{"creatorNames":[{"creatorName":"Ishioka, Chikashi"}],"nameIdentifiers":[{}]}]},"item_files":{"attribute_name":"ファイル情報","attribute_type":"file","attribute_value_mlt":[{"accessrole":"open_date","date":[{"dateType":"Available","dateValue":"2021-11-11"}],"displaytype":"detail","filename":"iA_2021_15.pdf","filesize":[{"value":"809.5 kB"}],"format":"application/pdf","license_note":"CC BY 4.0","licensetype":"license_note","mimetype":"application/pdf","url":{"label":"iA_2021_15","url":"https://air.repo.nii.ac.jp/record/5468/files/iA_2021_15.pdf"},"version_id":"246126f3-b4ad-448c-a894-4ccc5c10fa6c"}]},"item_keyword":{"attribute_name":"キーワード","attribute_value_mlt":[{"subitem_subject":"Trifluridine","subitem_subject_scheme":"Other"},{"subitem_subject":"Tipiracil","subitem_subject_scheme":"Other"},{"subitem_subject":"Geriatric assessment","subitem_subject_scheme":"Other"},{"subitem_subject":"G8","subitem_subject_scheme":"Other"},{"subitem_subject":"Plasma concentration","subitem_subject_scheme":"Other"},{"subitem_subject":"Colorectal cancer","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 trifluridine/tipiracil (TAS‑102) therapy in elderly patients with colorectal cancer (T‑CORE1401): geriatric assessment tools and plasma drug concentrations as possible predictive biomarkers","item_titles":{"attribute_name":"タイトル","attribute_value_mlt":[{"subitem_title":"Phase II study of trifluridine/tipiracil (TAS‑102) therapy in elderly patients with colorectal cancer (T‑CORE1401): geriatric assessment tools and plasma drug concentrations as possible predictive biomarkers"}]},"item_type_id":"10001","owner":"15","path":["940"],"pubdate":{"attribute_name":"公開日","attribute_value":"2021-11-11"},"publish_date":"2021-11-11","publish_status":"0","recid":"5468","relation_version_is_last":true,"title":["Phase II study of trifluridine/tipiracil (TAS‑102) therapy in elderly patients with colorectal cancer (T‑CORE1401): geriatric assessment tools and plasma drug concentrations as possible predictive biomarkers"],"weko_creator_id":"15","weko_shared_id":-1},"updated":"2023-07-25T10:49:17.750231+00:00"}