{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,9]],"date-time":"2026-05-09T21:01:47Z","timestamp":1778360507507,"version":"3.51.4"},"reference-count":29,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2023,11,14]],"date-time":"2023-11-14T00:00:00Z","timestamp":1699920000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2023,11,14]],"date-time":"2023-11-14T00:00:00Z","timestamp":1699920000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002973","name":"Daiichi-Sankyo Co., Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/501100002973","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2024,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Trastuzumab deruxtecan (T-DXd) is an antibody\u2013drug conjugate that consists of an anti-human epidermal growth factor receptor 2 (HER2) antibody bound by a cleavable tetrapeptide-based linker to a cytotoxic topoisomerase I inhibitor. Prior to marketing approval in Japan in September 2020, this expanded-access study was conducted to provide T-DXd to previously treated patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinomas.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This multicenter, open-label, expanded-access study was conducted between March 25 and September 25, 2020 at 17 Japanese sites. Previously treated patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinomas received T-DXd 6.4\u00a0mg\/kg via intravenous infusions at 3-week intervals. Serious adverse events (SAEs), all potential cases of interstitial lung disease (ILD)\/pneumonitis, all liver-related events potentially meeting Hy\u2019s Law criteria, and all cases of overdose were reported on the case report forms.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>A total of 64 patients were treated with T-DXd. Among the 17 (26.6%) patients with reported SAEs, 10 (15.6%) had SAEs related to T-DXd treatment. Febrile neutropenia was the most common SAE (<jats:italic>n<\/jats:italic>\u2009=\u20096). SAEs led to death in six patients; drug-related SAEs (sepsis and febrile neutropenia) led to death in one patient. Drug-related ILD, as determined by the external Adjudication Committee, occurred in three patients (Grade 1, Grade 2, and Grade 3: all <jats:italic>n<\/jats:italic>\u2009=\u20091).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>This expanded-access study provided T-DXd to a broader population of Japanese patients prior to marketing approval in Japan, bridging the gap between clinical trials and drug approval. No new safety concerns were identified.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10147-023-02422-x","type":"journal-article","created":{"date-parts":[[2023,11,14]],"date-time":"2023-11-14T22:01:40Z","timestamp":1699999300000},"page":"27-35","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Trastuzumab deruxtecan in patients with locally advanced or metastatic HER2-positive gastric cancer: a multicenter, open-label, expanded-access study"],"prefix":"10.1007","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5196-3630","authenticated-orcid":false,"given":"Kohei","family":"Shitara","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kensei","family":"Yamaguchi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kei","family":"Muro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hisateru","family":"Yasui","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daisuke","family":"Sakai","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Oshima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Fujimura","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yuta","family":"Sato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shunsuke","family":"Yamazaki","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tatsuya","family":"Wakabayashi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masahiro","family":"Sugihara","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiro","family":"Kamio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hirokazu","family":"Shoji","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,11,14]]},"reference":[{"key":"2422_CR1","doi-asserted-by":"publisher","first-page":"1371","DOI":"10.1007\/s10620-005-9057-1","volume":"51","author":"DI Park","year":"2006","unstructured":"Park DI, Yun JW, Park JH et al (2006) HER-2\/neu amplification is an independent prognostic factor in gastric cancer. 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Kensei Yamaguchi has provided an advisory role to and has received honoraria from Daiichi Sankyo Co., Ltd. Kei Muro has received lecture fees from Eli Lilly Japan K.K., Daiichi Sankyo Co., Ltd., Ono Pharmaceutical Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Bristol-Myers Squibb K.K.; and has received research funding from Sanofi K.K., Eisai Co., Ltd., Astellas Pharma Inc., Amgen K.K., Daiichi Sankyo Co., Ltd., Novartis Pharma K.K., Taiho Pharmaceutical Co., Ltd., MSD K.K., Ono Pharmaceutical Co., Ltd., and Chugai Pharmaceutical Co., Ltd. Hisateru Yasui has received honoraria and research funding from Daiichi Sankyo Co., Ltd. Daisuke Sakai has received honoraria from Daiichi Sankyo Co., Ltd.; and has received research funding from Daiichi Sankyo Co., Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd., Eisai Co., Ltd., Taiho Pharmaceutical Co., Ltd., and Ono Pharmaceutical Co., Ltd. Takashi Oshima has no conflicts to declare. Masahiro Fujimura, Yuta Sato, Shunsuke Yamazaki, Tatsuya Wakabayashi, and Masahiro Sugihara are employees of Daiichi Sankyo Co., Ltd. Takahiro Kamio is an employee of Daiichi Sankyo, Inc. Hirokazu Shoji has received research funding from Ono Pharmaceutical Co., Ltd., MSD K.K., Amgen K.K., and Takeda Pharmaceutical Co., Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This expanded-access study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and Good Clinical Practice guidelines, the Pharmaceuticals and Medical Devices Act (November 25, 2014), and the Japan Ministry of Health and Welfare Ordinance no. 28 on Standards for Conduct of Clinical Trials (March 27, 1997). Patients were informed about the purpose of the expanded-access study, and written informed consent was obtained.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical approval"}}]}}