{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,6]],"date-time":"2026-07-06T13:29:43Z","timestamp":1783344583116,"version":"3.54.6"},"reference-count":24,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2019,12,11]],"date-time":"2019-12-11T00:00:00Z","timestamp":1576022400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2020,3,15]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Although initial trabectedin (1.2\u00a0mg\/m<jats:sup>2<\/jats:sup>) is safe and effective for patients with translocation\u2010related sarcoma (TRS) in Japan, its efficacy in other types of soft\u2010tissue sarcomas (STSs) remains unknown. This study retrospectively investigated its efficacy and safety through postmarketing surveillance of trabectedin in patients with unresectable and relapsed STS.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>One hundred forty patients received intravenous trabectedin (1.2\u00a0mg\/m<jats:sup>2<\/jats:sup> on day 1 every 21\u00a0days) over the course of 24\u00a0hours. The primary endpoint was the efficacy and safety of trabectedin.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Grade 3 or higher adverse events occurred in 100 patients (71%) and included hepatotoxicity (37.8%), neutropenia (32.8%), and rhabdomyolysis (3.6%). Patients at high risk for grade 3 or higher rhabdomyolysis (36%) were classified by height (\u2265170.3\u00a0cm) and age (\u226432\u00a0years) through a classification and regression tree model (area under the curve, 0.9). The overall median progression\u2010free survival (PFS) was 3.7\u00a0months; with respect to the histological type, the median PFS was 17.4\u00a0months for myxoid liposarcoma, 4.9\u00a0months for leiomyosarcoma, 5.6\u00a0months for synovial sarcoma, and 3.7\u00a0months for dedifferentiated liposarcoma. Histological type (liposarcoma\/leiomyosarcoma [L\u2010sarcoma] and TRS) and grade 3 neutropenia (but not grade 4) were associated with significantly improved PFS after trabectedin treatment (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.003, <jats:italic>P<\/jats:italic>\u00a0=\u00a0.04, and <jats:italic>P<\/jats:italic>\u00a0=\u00a0.001). The median growth modulation index (GMI) was 0.91; 37 patients (36.7%) experienced a GMI\u00a0&gt;\u00a01.33, and among patients with solitary fibrous tumors and undifferentiated pleomorphic sarcoma, 60% and 42.9%, respectively, had a GMI\u00a0&gt;\u00a01.33. The median overall survival (OS) was 16.4\u00a0months. A GMI\u00a0&gt;\u00a01.33 was associated with significantly improved OS (<jats:italic>P<\/jats:italic>\u00a0=\u00a0.0006).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Initial trabectedin at 1.2\u00a0mg\/m<jats:sup>2<\/jats:sup> has clinically meaningful benefits for patients with L\u2010sarcoma and certain histological subtypes of TRS.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.32661","type":"journal-article","created":{"date-parts":[[2019,12,11]],"date-time":"2019-12-11T09:32:02Z","timestamp":1576056722000},"page":"1253-1263","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Efficacy and safety of trabectedin for patients with unresectable and relapsed soft\u2010tissue sarcoma in Japan: A Japanese Musculoskeletal Oncology Group study"],"prefix":"10.1002","volume":"126","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-8060-7309","authenticated-orcid":false,"given":"Hiroshi","family":"Kobayashi","sequence":"first","affiliation":[{"name":"Department of Orthopaedic Surgery The University of Tokyo Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2024-514X","authenticated-orcid":false,"given":"Shintaro","family":"Iwata","sequence":"additional","affiliation":[{"name":"Division of Orthopedic Surgery National Cancer Center Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3073-0595","authenticated-orcid":false,"given":"Toru","family":"Wakamatsu","sequence":"additional","affiliation":[{"name":"Department of Musculoskeletal Oncology Service Osaka International Cancer Institute Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keiko","family":"Hayakawa","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgical Oncology Cancer Institute Hospital Japanese Foundation for Cancer Research Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tsukasa","family":"Yonemoto","sequence":"additional","affiliation":[{"name":"Division of Orthopedic Surgery Chiba Cancer Center Chiba Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Junji","family":"Wasa","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery Shizuoka Cancer Center Hospital Shizuoka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroyuki","family":"Oka","sequence":"additional","affiliation":[{"name":"Department of Medical Research and Management for Musculoskeletal Pain, 22nd Century Medical and Research Center, Faculty of Medicine The University of Tokyo Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takafumi","family":"Ueda","sequence":"additional","affiliation":[{"name":"Department of Orthopedic Surgery National Hospital Organization Osaka National Hospital Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sakae","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery The University of Tokyo Hospital Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,11]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/jso.24112"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(16)00010-3"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2017.0087"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)60651-5"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(15)01283-0"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(15)70098-7"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2015.62.4734"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1158\/1535-7163.MCT-10-0263"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2004.05.210"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2004.02.098"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.01.180"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.32117"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2012.05.012"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10637-014-0094-5"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mds470"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-015-1697-8"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12885-016-2511-y"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2011.01.016"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(05)70255-2"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1007\/s10147-018-1370-8"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00432-013-1447-8"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.2147\/DDDT.S92395"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00280-007-0583-8"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2014.11.008"}],"container-title":["Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcncr.32661","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.32661","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cncr.32661","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.32661","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T10:30:28Z","timestamp":1760265028000},"score":1,"resource":{"primary":{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/10.1002\/cncr.32661"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12,11]]},"references-count":24,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2020,3,15]]}},"alternative-id":["10.1002\/cncr.32661"],"URL":"https:\/\/doi.org\/10.1002\/cncr.32661","archive":["Portico"],"relation":{},"ISSN":["0008-543X","1097-0142"],"issn-type":[{"value":"0008-543X","type":"print"},{"value":"1097-0142","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12,11]]},"assertion":[{"value":"2019-09-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-11-20","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-12-11","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}