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已发表论文
膀胱癌中抗体药物偶联物的风险信号：一项基于真实世界 FAERS 数据的研究
Authors Liu J , Li G, Yang J , Sun B, Guo S
Received 13 July 2025
Accepted for publication 13 November 2025
Published 28 November 2025 Volume 2025:17 Pages 995—1009
DOI https://doi.org/10.2147/CLEP.S553420
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Professor Henrik Sørensen
Jinming Liu,1– 3,* Guowang Li,1,2,* Jia Yang,1– 3 Binxu Sun,1– 3 Shanqi Guo1– 3
1Department of Oncology, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China; 2National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China; 3Tianjin Cancer Institute of Traditional Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Binxu Sun, Department of Oncology, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, 300380, People’s Republic of China, Email sunbinxu@126.com Shanqi Guo, Department of Oncology, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, 300380, People’s Republic of China, Email shanqi.guo@tmu.edu.cn
Background: Antibody-drug conjugates (ADCs) represent a transformative class of therapeutics for advanced bladder cancer. However, their real-world safety profiles are not yet fully characterized.
Methods: This retrospective pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2024. Disproportionality analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN), were used to detect significant adverse drug event (ADE) signals for four ADCs in bladder cancer treatment: enfortumab vedotin (EV), sacituzumab govitecan (SG), trastuzumab deruxtecan (DS-8201), and trastuzumab emtansine (T-DM1).
Results: Among 494 analyzed reports, EV constituted the majority (91.7%). Distinct safety signals were identified for each ADC: EV was strongly associated with skin disorders and metabolic disturbances; SG was primarily linked to gastrointestinal events, with emerging signals of renal abnormalities; DS-8201 was associated with systemic administration-related issues; and T-DM1 showed signals for respiratory and bleeding events. Notably, oral candidiasis related to EV was not explicitly highlighted in the current prescribing information.
Conclusion: This study delineates the safety profiles of ADC therapies for bladder cancer, confirming known risks and identifying potential new signals. The findings highlight the need for ADC-specific monitoring strategies and proactive management protocols to mitigate toxicities, thereby providing essential evidence for clinical decision-making.
Keywords: FAERS database, antibody-drug conjugate, bladder cancer, adverse drug event, disproportionality analysis, real-world study
1Department of Oncology, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China; 2National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China; 3Tianjin Cancer Institute of Traditional Chinese Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Binxu Sun, Department of Oncology, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, 300380, People’s Republic of China, Email sunbinxu@126.com Shanqi Guo, Department of Oncology, First Teaching Hospital, Tianjin University of Traditional Chinese Medicine, Tianjin, 300380, People’s Republic of China, Email shanqi.guo@tmu.edu.cn
Background: Antibody-drug conjugates (ADCs) represent a transformative class of therapeutics for advanced bladder cancer. However, their real-world safety profiles are not yet fully characterized.
Methods: This retrospective pharmacovigilance study analyzed data from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2024. Disproportionality analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), and Bayesian confidence propagation neural network (BCPNN), were used to detect significant adverse drug event (ADE) signals for four ADCs in bladder cancer treatment: enfortumab vedotin (EV), sacituzumab govitecan (SG), trastuzumab deruxtecan (DS-8201), and trastuzumab emtansine (T-DM1).
Results: Among 494 analyzed reports, EV constituted the majority (91.7%). Distinct safety signals were identified for each ADC: EV was strongly associated with skin disorders and metabolic disturbances; SG was primarily linked to gastrointestinal events, with emerging signals of renal abnormalities; DS-8201 was associated with systemic administration-related issues; and T-DM1 showed signals for respiratory and bleeding events. Notably, oral candidiasis related to EV was not explicitly highlighted in the current prescribing information.
Conclusion: This study delineates the safety profiles of ADC therapies for bladder cancer, confirming known risks and identifying potential new signals. The findings highlight the need for ADC-specific monitoring strategies and proactive management protocols to mitigate toxicities, thereby providing essential evidence for clinical decision-making.
Keywords: FAERS database, antibody-drug conjugate, bladder cancer, adverse drug event, disproportionality analysis, real-world study