| アブストラクト | BACKGROUND/AIM: Anti-human epidermal growth factor receptor 2 (HER2) antibody-drug conjugates have incompletely characterized safety profiles. Therefore, we compared the adverse events for trastuzumab emtansine (T-DM1) and trastuzumab deruxtecan (T-DXd) using the Japanese Adverse Drug Event Report (JADER) database and U.S. Food and Drug Administration Adverse Event Reporting System (FAERS). PATIENTS AND METHODS: We analyzed the JADER (April 2004-April 2025) and FAERS (Q1 1997-Q1 2025) databases for the target drugs T-DM1 and T-DXd, with trastuzumab and pertuzumab as comparators. All reported cases were included regardless of severity grade. RESULTS: Hepatobiliary disorder signals were detected for T-DM1, whereas hematotoxicity- and infection-related signals were prominent for T-DXd, including sepsis and Pneumocystis jirovecii pneumonia (PJP). Interstitial lung disease was observed for both agents. Signals for cardiac disorders were detected for trastuzumab, pertuzumab and T-DM1, but not for T-DXd. T-DXd-associated nausea and myelosuppression were frequently reported within 40 days of treatment initiation, whereas PJP was reported later, with a median time to onset of 90 days. CONCLUSION: Analyses using JADER and FAERS revealed the adverse event profiles of HER2 antibody-drug conjugates. Hepatobiliary disorders were characteristic of T-DM1, whereas hematotoxicity and infection-related events were characteristic of T-DXd. Interstitial lung disease was detected for both agents. These findings were consistent with those of clinical trials. Infection-related events associated with T-DXd were identified as potential signals, highlighting the clinical relevance of PJP, with a median time to onset of approximately 90 days. |
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| ジャーナル名 | In vivo (Athens, Greece) |
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| Pubmed追加日 | 2026/7/1 |
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| 投稿者 | Hosonaka, Kousuke; Yamaoka, Kenta; Uchida, Mayako; Uesawa, Yoshihiro; Takahashi, Kazushige; Shimizu, Tadashi |
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| 組織名 | School of Pharmacy, Hyogo Medical University, Kobe, Japan.;Department of Pharmacy, Osaka-fu Saiseikai Noe Hospital, Osaka, Japan.;Department of Pharmacy, Kobe City Medical Center General Hospital, Kobe, Japan.;Department of Pharmacy, Kyushu University Hospital, Fukuoka, Japan.;Department of Medical Molecular Informatics, Meiji Pharmaceutical University,;Tokyo, Japan.;School of Pharmacy, Hyogo Medical University, Kobe, Japan;;shimizu-t@hyo-med.ac.jp. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/42379740/ |
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