| アブストラクト | BACKGROUND: Anti-epidermal growth factor receptor monoclonal antibodies like cetuximab and panitumumab have revolutionized colorectal cancer therapy, but their benefits are offset by limiting toxicities that require precise prevention strategies. METHODS: We interrogated the FDA Adverse Event Reporting System (2004 Q1-2025 Q2) to map agent-specific toxicity signatures across age, sex and reporter strata under a multi-algorithm disproportionality framework. Four convergent metrics were required to declare a signal; demographic modifiers (age and sex) and reporter lens (medical vs non-medical personnel) were integrated. RESULTS: 20920 cetuximab and 10280 panitumumab reports with single primary suspect status were identified. Cetuximab generated an early, age-independent AE burst: 54.4 % of events arose within 30 days. Panitumumab showed a protracted profile with only 40.8 % of events in the first month yet 5.4 % reported after one year versus 2.7 % for cetuximab. Panitumumab carried a higher fatality rate and disproportionately intense cutaneous signals, whereas cetuximab dominated radiation-synergy domains such as radiation skin injury. Age stratification revealed >/=65-year panitumumab users faced a 1.5-fold higher hypomagnesaemia ROR than younger patients; women reported higher dermatitis acneiform ROR values on panitumumab compared with cetuximab. Non-medical reporters amplified cetuximab radiation mucositis ROR to 3374.22, whereas panitumumab skin-toxicity ROR climbed to 958.54. CONCLUSION: Cetuximab and panitumumab exhibit divergent, demography-modulated safety narratives. Cetuximab amplifies acute radio-toxicity whereas panitumumab elicits a quantitatively stronger, more persistent mucocutaneous and electrolyte injury that is magnified by female sex, advancing age, and non-medical reporters reporting. These population-specific pharmacovigilance signatures refine risk-benefit assessments and should inform individualized monitoring strategies in precision oncology. |
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| 投稿者 | Mao, Kai-Li; Jin, Liang-Yan; Chen, Guo-Quan; Xie, Jun; Chen, Ping; Sun, Hua-Yu; Li, Liu-Cheng; Zheng, Hong-Liang |
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| 組織名 | The Quzhou Affiliated Hospital of Wenzhou Medical University, Quzhou People's;Hospital, Quzhou, 324000, China. Electronic address: 1258371506@wmu.edu.cn.;Department of Pharmacy, Hangzhou Xixi Hospital, Hangzhou Sixth People's Hospital,;Hangzhou Xixi Hospital Affiliated to Zhejiang Chinese Medical University,;Hangzhou, 310023, China.;Department of Pharmacy, Affiliated Jinhua Hospital, Zhejiang University School of;Medicine, Jinhua, 321000, China.;Hospital, Quzhou, 324000, China.;Department of Pharmacy, Sir Run Run Shaw Hospital, Zhejiang University School of;Medicine, Hangzhou, 310016, China. Electronic address: 3415116@zju.edu.cn.;Hospital, Quzhou, 324000, China. Electronic address: qzrmyyzhl@wmu.edu.cn. |
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