Observational studyThe oncologist2026
Real-world characteristics of trastuzumab deruxtecan-related interstitial lung disease in Japanese patients with breast cancer and gastric cancer.
Observational study in The oncologist, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundInterstitial lung disease (ILD)/pneumonitis is an important adverse drug reaction associated with trastuzumab deruxtecan (T-DXd). This report comprehensively characterized clinical and imaging features of T-DXd-related ILD, systematically evaluated by an independent ILD Adjudication Committee (AC), in Japanese patients with breast/gastric cancer from all-patient post-marketing surveillance studies. PATIENTS AND
methodsThis post hoc analysis evaluated independent ILD AC-adjudicated T-DXd-related ILD cases. Demographics, clinical/radiological features, time to onset, treatment interventions, and outcomes (followed up to 12 months from onset) were analyzed.
resultsAmong 2801 T-DXd-treated patients (breast cancer: 1731; gastric cancer: 1070), 421 potential cases were reviewed: 381 were adjudicated as T-DXd-related ILD (breast cancer: 278; gastric cancer: 103). Median age was 65.0 years, 75.1% were female, and 28.3% had a smoking history. ILD occurred throughout observation (including fatal cases ≥12 months post-initiation) with no specific onset window. Time to onset did not differ across CTCAE grades. Organizing pneumonia was the predominant imaging pattern (67.7%), followed by hypersensitivity pneumonitis (14.2%) and diffuse alveolar damage (DAD, 12.6%). Most cases (78.2%) were worst CTCAE Grade 1-2. Grade 5 ILD occurred in 30 patients (7.9%), with DAD the most common pattern (26 patients). Overall recovery was 83.5%. Corticosteroids were used in 54.6% of cases, with 79.3% responding. High-dose corticosteroids and additional immunosuppressants were ineffective in seven DAD cases.
conclusionsMost T-DXd-related ILD cases were mild/moderate and corticosteroid-responsive; DAD pattern was associated with higher mortality. These findings underscore the importance of vigilant monitoring, early recognition, and prompt corticosteroid treatment to mitigate fatal T-DXd-related ILD.
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