| アブストラクト | BACKGROUND: Cetuximab (chimeric monoclonal antibody to human epidermal growth factor receptor) is used to treat colorectal and head and neck cancers. Due to cross-reactivity with galactose-alpha-1,3-galactose (alpha-gal), it can induce hypersensitivity even at first administration. We aimed to determine the incidence and clinical manifestation of cetuximab-induced anaphylaxis, and to establish a means of predicting its incidence in patients ahead of treatment. METHODS: Nationwide and single-center pharmacovigilance data from 2010 to 2017 were collected from the Korea Institute of Drug Safety-Korea Adverse Event Reporting System and Severance Regional Pharmacovigilance Center. Patients scheduled for cetuximab administration were enrolled prospectively. A skin prick test was carried out and serum IgE specific to cetuximab and cross-reactive allergens were measured. Reactions were monitored after cetuximab infusion. RESULTS: Over 8 years, there were 23 reports of anaphylaxis nationwide. In a single-center study, incidence of cetuximab-induced anaphylaxis was 1.1%. Most anaphylaxis occurred at first injection (93.3%), even under pretreatment with anti-allergic drugs. Four of 64 patients (6.3%) experienced severe anaphylaxis. The median cetuximab-specific IgE titer was 6.9 kUA/L in patients experiencing anaphylaxis and 0 kUA/L in those who did not (P < 0.001). The results of alpha-gal, beef sIgE, and cetuximab skin prick testing were similar to those of cetuximab sIgE. Patients who did not experience hypersensitivity were negative in all 4 allergy tests. Its positive and negative predictive values were 100%. CONCLUSIONS: Specific IgE detection of cetuximab or alpha-gal can accurately predict cetuximab-induced anaphylaxis prior to first administration. |
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| 投稿日 | 2021/7/15 |
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| 投稿者 | Park, Kyung Hee; Lee, Jongsun; Beom, Seung Hoon; Shin, Sang Joon; Ahn, Joong Bae; Kim, Sung-Ryeol; Lee, Jae-Hyun; Park, Jung-Won |
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| ジャーナル名 | The World Allergy Organization journal |
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| 組織名 | Division of Allergy and Immunology, Department of Internal Medicine, Yonsei;University College of Medicine, Seoul, Republic of Korea.;Institute of Allergy, Yonsei University College of Medicine, Seoul, Republic of;Korea.;Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of;Medicine, Seoul, Republic of Korea. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/34257795/ |
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