{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,9]],"date-time":"2026-09-09T22:02:39Z","timestamp":1788991359999,"version":"build-2803163510"},"reference-count":29,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T00:00:00Z","timestamp":1780012800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Oncol."],"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This study aims to mine and analyze adverse event (AE) signals for trastuzumab deruxtecan (T-DXd) using the FAERS database, particularly focusing on AEs that are not fully described in clinical trials and early market surveillance.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>The study selected data from the first quarter of 2020 to the third quarter of 2023, searching with T-DXd as the primary suspected drug. Four advanced signal mining and analysis methods were employed: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Empirical Bayesian Geometric Mean (EBGM), to comprehensively assess the AE signals in the FAERS database.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The study collected 6,703,410 AE reports, of which 4,055 reports involved T-DXd. Through comprehensive analysis, 118 PT signals involving 26 SOCs were identified. The study revealed various newly discovered AEs associated with T-DXd treatment, including immune dysregulation events like Gastroenteritis listeria and Coronavirus pneumonia, hepatobiliary disorders like Pseudocirrhosis and Hepatic failure, and hematological issues like Neutropenia and Thrombocytopenia. Additionally, new safety signals for cardiovascular and ocular problems were found.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>This study confirmed known AEs and identified a range of new AEs, aiding clinicians in making more informed decisions when using T-DXd.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fonc.2026.1778579","type":"journal-article","created":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T04:54:11Z","timestamp":1780030451000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":1,"title":["Mining and analysis of adverse events for trastuzumab deruxtecan based on the FAERS database"],"prefix":"10.3389","volume":"16","author":[{"given":"Anqing","family":"Zhu","sequence":"first","affiliation":[{"name":"Jiangsu Medical College","place":["Yancheng, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rilei","family":"Jiang","sequence":"additional","affiliation":[{"name":"School of Chinese Medicine, Shanghai University of Traditional Chinese Medicine","place":["Shanghai, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chong","family":"Zhou","sequence":"additional","affiliation":[{"name":"Jiangsu Key Laboratory of New Drug Research and Clinical Pharmacy, Xuzhou Medical University","place":["Xuzhou, Jiangsu, China"]},{"name":"Department of Radiotherapy, Xuzhou Central Hospital","place":["Xuzhou, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Dong","sequence":"additional","affiliation":[{"name":"Jiangsu Medical College","place":["Yancheng, Jiangsu, China"]},{"name":"Sheyang Hospital of Traditional Chinese Medicine","place":["Yancheng, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cheng","family":"Huang","sequence":"additional","affiliation":[{"name":"Jiangsu Medical College","place":["Yancheng, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Minjie","family":"Zhu","sequence":"additional","affiliation":[{"name":"Jiangsu Medical College","place":["Yancheng, Jiangsu, China"]},{"name":"Sheyang Hospital of Traditional Chinese Medicine","place":["Yancheng, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianlong","family":"Gu","sequence":"additional","affiliation":[{"name":"Jiangsu Medical College","place":["Yancheng, Jiangsu, China"]},{"name":"Sheyang Hospital of Traditional Chinese Medicine","place":["Yancheng, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Xu","sequence":"additional","affiliation":[{"name":"Jiangsu Medical College","place":["Yancheng, Jiangsu, China"]},{"name":"Sheyang Hospital of Traditional Chinese Medicine","place":["Yancheng, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jianzhong","family":"Ji","sequence":"additional","affiliation":[{"name":"Jiangsu Medical College","place":["Yancheng, Jiangsu, China"]},{"name":"Sheyang Hospital of Traditional Chinese Medicine","place":["Yancheng, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Haohao","family":"Zhu","sequence":"additional","affiliation":[{"name":"Affiliated Mental Health Center of Jiangnan University, Wuxi Central Rehabilitation Hospital","place":["Wuxi, Jiangsu, China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yiting","family":"Cao","sequence":"additional","affiliation":[{"name":"Department of Molecular Biology and Genetics, Weill Institute for Cell and Molecular Biology, Cornell University","place":["Ithaca, NY, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,5,29]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","first-page":"15","DOI":"10.1016\/j.breast.2022.08.010","article-title":"Current and future burden of breast cancer: Global statistics for 2020 and 2040","volume":"66","author":"Arnold","year":"2022","journal-title":"Breast"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2020.106535","article-title":"Breast cancer: Biology, biomarkers, and treatments","volume":"84","author":"Barzaman","year":"2020","journal-title":"Int Immunopharmacol"},{"key":"B3","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1186\/s13058-020-01296-5","article-title":"Triple-negative breast cancer molecular subtyping and treatment progress","volume":"22","author":"Yin","year":"2020","journal-title":"Breast Cancer Res"},{"key":"B4","doi-asserted-by":"publisher","first-page":"84","DOI":"10.1186\/s13058-021-01459-y","article-title":"Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: State of the art and future directions","volume":"23","author":"Ferraro","year":"2021","journal-title":"Breast Cancer Res"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2115022","article-title":"Trastuzumab deruxtecan versus trastuzumab emtansine for breast cancer","volume":"386","author":"Cort\u00e9s","year":"2022","journal-title":"N Engl J Med"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1038\/s41571-021-00470-8","article-title":"Unlocking the potential of antibody\u2013drug conjugates for cancer therapy","volume":"18","author":"Drago","year":"2021","journal-title":"Nat Rev Clin Oncol"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1007\/s40265-020-01281-4","article-title":"Trastuzumab deruxtecan: First approval","volume":"80","author":"Keam","year":"2020","journal-title":"Drugs"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.3390\/ijms22094774","article-title":"Trastuzumab deruxtecan: Changing the destiny of HER2 expressing solid tumors","volume":"22","author":"Indini","year":"2021","journal-title":"Int J Mol Sci"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1080\/13543784.2020.1792443","article-title":"Trastuzumab-deruxtecan: An investigational agent for the treatment of HER2-positive breast cancer","volume":"29","author":"Bartsch","year":"2020","journal-title":"Expert Opin Invest Drugs"},{"key":"B10","doi-asserted-by":"publisher","first-page":"45","DOI":"10.1016\/j.jad.2023.11.076","article-title":"Mining and analysis of adverse event signals of Cariprazine based on the real-world data of FAERS database","volume":"347","author":"Zhu","year":"2024","journal-title":"J Affect Disord"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajp.2023.103828","article-title":"Adverse events of epidiolex: A real-world drug safety surveillance study based on the FDA adverse event reporting system (FAERS) database","volume":"90","author":"Zhou","year":"2023","journal-title":"Asian J Psychiatry"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1007\/s00406-023-01732-5","article-title":"The correlation of Esketamine with specific adverse events: A deep dive into the FAERS database","volume":"275","author":"Jiang","year":"2023","journal-title":"Eur Arch Psychiatry Clin Neurosci"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2023.11.025","article-title":"Safety assessment of Brexpiprazole: Real-world adverse event analysis from the FAERS database","volume":"346","author":"Jiang","year":"2024","journal-title":"J Affect Disord"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2024.03.085","article-title":"Multidimensional assessment of adverse events of bupropion: A large-scale data analysis from the FAERS database","volume":"354","author":"Lu","year":"2024","journal-title":"J Affect Disord"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajp.2024.103968","article-title":"Analysis of the adverse events of Aristada: A real-world study based on FAERS database","volume":"94","author":"Ou","year":"2024","journal-title":"Asian J Psychiatry"},{"key":"B16","doi-asserted-by":"publisher","first-page":"591","DOI":"10.1016\/b978-0-12-396961-3.00006-8","article-title":"Using MedDRA: Implications for risk management","volume":"27","author":"Brown","year":"2004","journal-title":"Drug Saf"},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.1002\/pds.1001","article-title":"The reporting odds ratio and its advantages over the proportional reporting ratio","volume":"13","author":"Rothman","year":"2004","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1002\/pds.677","article-title":"Use of proportional reporting ratios (PRRs) for signal generation from spontaneous adverse drug reaction reports","volume":"10","author":"Evans","year":"2001","journal-title":"Pharmacoepidemiol Drug Saf"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.1007\/s002280050466","article-title":"A Bayesian neural network method for adverse drug reaction signal generation","volume":"54","author":"Bate","year":"1998","journal-title":"Eur J Clin Pharmacol"},{"key":"B20","doi-asserted-by":"publisher","DOI":"10.1080\/00031305.1999.10474456","article-title":"Bayesian data mining in large frequency tables, with an application to the FDA spontaneous reporting system","volume":"53","author":"DuMouchel","year":"1999","journal-title":"Am Stat"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.1007\/s10120-021-01196-3","article-title":"Discovery and development of trastuzumab deruxtecan and safety management for patients with HER2-positive gastric cancer","volume":"24","author":"Shitara","year":"2021","journal-title":"Gastric Cancer"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2022.07.256","article-title":"217O Patient-reported outcomes (PROs) from DESTINY-Breast04, a randomized phase III study of trastuzumab deruxtecan (T-DXd) vs treatment of physician's choice (TPC) in patients (pts) with HER2-low metastatic breast cancer (MBC)","volume":"33","author":"Ueno","year":"2022","journal-title":"Ann Oncol"},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.3389\/fonc.2022.947188","article-title":"The link between the microbiota and HER2+ breast cancer: The new challenge of precision medicine","volume":"12","author":"Di Modica","year":"2022","journal-title":"Front Oncol"},{"key":"B24","doi-asserted-by":"publisher","DOI":"10.1080\/14740338.2023.2204228","article-title":"High risks adverse events associated with trastuzumab emtansine and trastuzumab deruxtecan for the treatment of HER2-positive\/mutated Malignancies: A pharmacovigilance study based on the FAERS database","volume":"22","author":"Ma","year":"2023","journal-title":"Expert Opin Drug Saf"},{"key":"B25","doi-asserted-by":"publisher","first-page":"38","DOI":"10.1016\/j.ygyno.2022.12.018","article-title":"Trastuzumab deruxtecan (DS-8201a), a HER2-targeting antibody\u2013drug conjugate with topoisomerase I inhibitor payload, shows antitumor activity in uterine and ovarian carcinosarcoma with HER2\/neu expression","volume":"170","author":"Mauricio","year":"2023","journal-title":"Gynecologic Oncol"},{"key":"B26","doi-asserted-by":"publisher","DOI":"10.1158\/1538-7445.am2024-2599","article-title":"Trastuzumab deruxtecan reprograms immune response by stimulating cGAS-STING pathway in gastric cancer cells","volume":"84","author":"Oh","year":"2024","journal-title":"Cancer Res"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1016\/j.annonc.2019.11.019","article-title":"The art of innovation: Clinical development of trastuzumab deruxtecan and redefining how antibody-drug conjugates target HER2-positive cancers","volume":"31","author":"Yver","year":"2020","journal-title":"Ann Oncol"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2023.101613","article-title":"Incidence of interstitial lung disease and cardiotoxicity with trastuzumab deruxtecan in breast cancer patients: A systematic review and single-arm meta-analysis","volume":"8","author":"Soares","year":"2023","journal-title":"ESMO Open"},{"key":"B29","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1007\/s11912-021-01114-x","article-title":"Cardiovascular toxicity of novel HER2-targeted therapies in the treatment of breast cancer","volume":"23","author":"Dent","year":"2021","journal-title":"Curr Oncol Rep"}],"container-title":["Frontiers in Oncology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fonc.2026.1778579\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T04:54:13Z","timestamp":1780030453000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fonc.2026.1778579\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,5,29]]},"references-count":29,"alternative-id":["10.3389\/fonc.2026.1778579"],"URL":"https:\/\/doi.org\/10.3389\/fonc.2026.1778579","relation":{},"ISSN":["2234-943X"],"issn-type":[{"value":"2234-943X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,29]]},"article-number":"1778579"}}