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Understanding these risks is crucial for effective management and safe administration of T-DXd. Therefore, we conducted a postmarketing surveillance study in Japan to investigate the incidence of ILD and related factors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>All patients with human epidermal growth factor receptor 2-positive unresectable or recurrent breast cancer who initiated T-DXd in Japan between May 25, 2020, and November 30, 2021, were included. The primary outcome was the incidence of adjudicated drug-related ILD, and its associated factors were investigated using a Cox proportional hazards model.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The safety analysis set included 1,731 patients with a median (range) age of 60 (27\u201387) years. The median (range) duration of T-DXd treatment was 9.4 (0.7\u201317.9) months. A total of 24 (1.4%) and 11 (0.6%) patients had ILD as a medical history and comorbidity, respectively. The incidence of any Grade, Grade\u2009\u2265\u20093, and Grade 5 adjudicated drug-related ILD was 16.1%, 3.0%, and 1.0%, respectively. The median (range) time from the first T-DXd treatment to the first onset of ILD was 5.1 (0.5\u201317.3) months. Male sex, higher body mass index (\u2265\u2009median [21.3\u00a0kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ]), history\/comorbidity of ILD, and impaired renal function were identified as baseline factors potentially associated with an increased risk of drug-related ILD.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The incidence of adjudicated drug-related ILD in the real-world setting was similar to that observed in clinical trials.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s12282-025-01814-3","type":"journal-article","created":{"date-parts":[[2026,1,31]],"date-time":"2026-01-31T06:48:24Z","timestamp":1769842104000},"page":"346-358","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Real-world analysis of interstitial lung disease\/pneumonitis in Japanese patients with breast cancer receiving trastuzumab deruxtecan"],"prefix":"10.1007","volume":"33","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6260-6943","authenticated-orcid":false,"given":"Junji","family":"Tsurutani","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kengo","family":"Noguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayumi","family":"Tanabe","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,1,31]]},"reference":[{"key":"1814_CR1","unstructured":"World Health Organization. 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