{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T16:21:48Z","timestamp":1790266908875,"version":"4.1.0"},"reference-count":38,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"15","content-domain":{"domain":["ascopubs.org"],"crossmark-restriction":true},"short-container-title":["JCO"],"published-print":{"date-parts":[[2023,5,20]]},"abstract":"<jats:sec>\n                    <jats:title>PURPOSE<\/jats:title>\n                    <jats:p>To investigate the efficacy and safety of trastuzumab deruxtecan, an antibody-drug conjugate targeting human epidermal growth factor receptor 2 (HER2) with a topoisomerase I inhibitor payload, in patients with uterine carcinosarcoma (UCS) expressing HER2.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>PATIENTS AND METHODS<\/jats:title>\n                    <jats:p>Patients with recurrent UCS with HER2 immunohistochemistry scores \u22651+ previously treated with chemotherapy were included. Patients were assigned to the HER2-high (immunohistochemistry score \u22652+; n = 22) or low (immunohistochemistry score of 1+; n = 10) groups for primary and exploratory analyses, respectively. Trastuzumab deruxtecan 6.4 or 5.4 mg\/kg was administered intravenously once every 3 weeks until unacceptable toxicity or disease progression. Dose modification was based on the updated recommended phase II dose for breast cancer to be 5.4 mg\/kg. The primary end point was the objective response rate by central review in the HER2-high group. Secondary end points included the overall response rate (ORR) in the HER2-high group by investigator assessment, ORR in the HER2-low group, progression-free survival (PFS), overall survival (OS), and safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>The ORR by central review in the HER2-high and HER2-low groups were 54.5% (95% CI, 32.2 to 75.6) and 70.0% (95% CI, 34.8 to 93.3) and those by investigator assessments were 68.2% and 60.0%, respectively. The median PFS and OS in the HER2-high and HER2-low groups were 6.2 and 13.3 months and 6.7 months and not reached, respectively. Grade \u2265 3 adverse events occurred in 20 patients (61%). Grades 1-2 and 3 pneumonitis\/interstitial lung disease occurred in eight (24%) and one (3%) patient, respectively.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSION<\/jats:title>\n                    <jats:p>Trastuzumab deruxtecan has efficacy in patients with UCS, regardless of HER2 status. The safety profile was generally consistent with that previously reported. Toxicities were manageable with appropriate monitoring and treatment.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.22.02558","type":"journal-article","created":{"date-parts":[[2023,3,30]],"date-time":"2023-03-30T11:03:26Z","timestamp":1680174206000},"page":"2789-2799","update-policy":"https:\/\/doi.org\/10.1200\/crossmark","source":"Crossref","is-referenced-by-count":129,"title":["Trastuzumab Deruxtecan for Human Epidermal Growth Factor Receptor 2\u2013Expressing Advanced or Recurrent Uterine Carcinosarcoma (NCCH1615): The STATICE Trial"],"prefix":"10.1200","volume":"41","clinical-trial-number":[{"clinical-trial-number":"umin000029506","registry":"10.18810\/umin-japan"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2606-4208","authenticated-orcid":true,"given":"Tadaaki","family":"Nishikawa","sequence":"first","affiliation":[{"name":"Department of Medical Oncology, National Cancer Center Hospital, Tokyo, 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