{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,12]],"date-time":"2026-09-12T01:20:03Z","timestamp":1789176003064,"version":"build-2803163510"},"reference-count":18,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2022,7,21]],"date-time":"2022-07-21T00:00:00Z","timestamp":1658361600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>In this open\u2010label, Phase 1 study, we explore the safety and efficacy of E7389\u2010LF (liposomal formulation of eribulin) in Japanese patients with advanced solid tumors.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This open\u2010label, Phase 1 study enrolled Japanese adult patients to receive E7389\u2010LF for the treatment of advanced solid tumors. Treatment with E7389\u2010LF 2.0\u00a0mg\/m<jats:sup>2<\/jats:sup> every 3\u00a0weeks (previously determined maximum tolerated dose) was tested for the treatment of adenoid cystic carcinoma, gastric cancer, esophageal cancer, or small lung cell cancer in the expansion part of this study. Secondary endpoints included safety, objective response rate, best overall response, and progression\u2010free survival.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>As of October 16, 2020, 43 patients were enrolled (adenoid cystic carcinoma, <jats:italic>n<\/jats:italic>\u00a0=\u00a012; gastric cancer, <jats:italic>n<\/jats:italic>\u00a0=\u00a010; esophageal cancer, <jats:italic>n<\/jats:italic>\u00a0=\u00a011; small cell lung cancer, <jats:italic>n<\/jats:italic>\u00a0=\u00a010). Thirty\u2010three patients experienced a Grade\u00a0\u22653 treatment\u2010related treatment\u2010emergent adverse event, most commonly neutropenia (53.5%). Additionally, the incidence of hypersensitivity did not appear to change with a reduced number of infusion steps (2 vs. 4) and patients who were administered prophylactic pegylated granulocyte\u2010colony stimulating factor had a noticeably lower incidence of Grade 3\u20134 neutropenia (although this did not have a proper control). The overall objective response rate was 11.6% (95% confidence interval: 3.9\u201325.1), corresponding to two partial responses in patients with adenoid cystic carcinoma, two partial responses in gastric cancer, and one partial response in esophageal cancer. Median progression\u2010free survival was longer in the adenoid cystic carcinoma population (16.6\u00a0months) than in others.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>E7389\u2010LF 2.0\u00a0mg\/m<jats:sup>2<\/jats:sup> every 3\u00a0weeks was well tolerated for the treatment of several different tumor types, and larger studies in these populations are warranted.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cam4.4996","type":"journal-article","created":{"date-parts":[[2022,7,22]],"date-time":"2022-07-22T04:15:58Z","timestamp":1658463358000},"page":"1269-1278","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":11,"title":["Liposomal eribulin for advanced adenoid cystic carcinoma, gastric cancer, esophageal cancer, and small cell lung cancer"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8822-2684","authenticated-orcid":false,"given":"Hibiki","family":"Udagawa","sequence":"first","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital East  Kashiwa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shunji","family":"Takahashi","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Motohiro","family":"Hirao","sequence":"additional","affiliation":[{"name":"Department of Surgery National Hospital Organization Osaka National Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Makoto","family":"Tahara","sequence":"additional","affiliation":[{"name":"Department of Head and Neck Medical Oncology National Cancer Canter Hospital East  Kashiwa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satoru","family":"Iwasa","sequence":"additional","affiliation":[{"name":"Department of Experimental Therapeutics National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasuyoshi","family":"Sato","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology The Cancer Institute Hospital of Japanese Foundation for Cancer Research  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuya","family":"Hamakawa","sequence":"additional","affiliation":[{"name":"Department of Surgery National Hospital Organization Osaka National Hospital  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5196-3630","authenticated-orcid":false,"given":"Kohei","family":"Shitara","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology and Gastrointestinal Oncology National Cancer Canter Hospital East Kashiwa  Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9090-801X","authenticated-orcid":false,"given":"Hidehito","family":"Horinouchi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keisho","family":"Chin","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology The Cancer Institute Hospital of Japanese Foundation for Cancer Research  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7302-0278","authenticated-orcid":false,"given":"Norikazu","family":"Masuda","sequence":"additional","affiliation":[{"name":"Department of Surgery, Breast Oncology, National Hospital Organization Osaka National Hospital, Osaka, Japan; Current position: Department of Breast and Endocrine Surgery Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuya","family":"Suzuki","sequence":"additional","affiliation":[{"name":"Japan and Asia Clinical Development Department Oncology Business Group, Eisai Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shiori","family":"Okumura","sequence":"additional","affiliation":[{"name":"Japan and Asia Clinical Development Department Oncology Business Group, Eisai Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takao","family":"Takase","sequence":"additional","affiliation":[{"name":"Clinical Data Science Department Medicine Development Center, Eisai Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Reiko","family":"Nagai","sequence":"additional","affiliation":[{"name":"Clinical Data Science Department Medicine Development Center, Eisai Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kan","family":"Yonemori","sequence":"additional","affiliation":[{"name":"Department of Breast and Medical Oncology National Cancer Center Hospital  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2022,7,21]]},"reference":[{"key":"e_1_2_12_2_1","unstructured":"Eisai Co Ltd.Halaven (eribulin mesylate) [package insert].2020."},{"key":"e_1_2_12_3_1","volume-title":"HALAVEN 0.44 Mg\/ml Solution for Injection [Summary of Product Characteristics]","author":"Eisai GmbH","year":"2021"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60070-6"},{"key":"e_1_2_12_5_1","unstructured":"Eisai Inc.Halaven (eribulin mesylate) [package insert]. Woodcliff Lake NJ2021."},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijpharm.2013.01.010"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.3390\/pharmaceutics9020012"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.3390\/nano10020190"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41416-019-0377-x"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdz242.043"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.62.3488"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1111\/1759-7714.13022"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-020-06864-8"},{"key":"e_1_2_12_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-020-05603-w"},{"key":"e_1_2_12_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(18)30739-3"},{"key":"e_1_2_12_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31827-5"},{"key":"e_1_2_12_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/hed.25020"},{"key":"e_1_2_12_18_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.18.01859"},{"key":"e_1_2_12_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2020.08.697"}],"container-title":["Cancer Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cam4.4996","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cam4.4996","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cam4.4996","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,19]],"date-time":"2023-08-19T13:47:40Z","timestamp":1692452860000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/cam4.4996"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,7,21]]},"references-count":18,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2023,1]]}},"alternative-id":["10.1002\/cam4.4996"],"URL":"https:\/\/doi.org\/10.1002\/cam4.4996","archive":["Portico"],"relation":{},"ISSN":["2045-7634","2045-7634"],"issn-type":[{"value":"2045-7634","type":"print"},{"value":"2045-7634","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,7,21]]},"assertion":[{"value":"2022-01-14","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-06-23","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-07-21","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}