| アブストラクト | OBJECTIVES: The objective of this study is to illustrate the adverse events secondary to cetuximab therapy for head and neck cancer and elucidate risk factors for serious outcomes. MATERIALS AND METHODS: This retrospective study was conducted using the FDA Adverse Event Reporting System (FAERS). The predictor variables were patient characteristics, country of treatment, and adverse events. The outcome variable was the rate of serious outcomes. Multivariate logistic regression was created to identify all significant risk factors of the outcome. P < 0.05 was considered statistically significant. RESULTS: The final sample consisted of 3,086 reports of adverse events from cetuximab therapy in head and neck cancer treatment, of which 2,746 reports were considered serious (89.0%) per the FAERS criteria. Mucosal inflammation was the most common adverse event. The strongest risk factor for a serious outcome was cetuximab therapy in countries outside the US (OR 105.2, P < 0.01). Polytherapy (OR 7.6, P < 0.01) was also a risk factor for serious outcome. CONCLUSIONS: Health-care providers should be aware of potential complications following cetuximab administration, particularly when administered in countries outside the US and in conjunction with other medications. |
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| 組織名 | Columbia University College of Dental Medicine, New York, NY, United States.;Electronic address: ds3840@cumc.columbia.edu.;Division of Oral and Maxillofacial Pathology, Columbia University Irving Medical;Center, New York, NY, United States.;Section of Oral Oncology, Head and Neck Surgery Fellowship Program Director,;Department of Oral and Maxillofacial Surgery, University of Alabama at;Birmingham, AL, United States.;Department of Surgery, Division of Oral and Maxillofacial Surgery, Head and Neck;Surgical Oncology & Microvascular Reconstructive Surgery, University of Miami;Miller School of Medicine/Jackson Memorial Hospital System, Miami, FL, United;States.;Department of Oral and Maxillofacial Surgery, University of Pennsylvania, School;of Dental Medicine, Philadelphia, PA, United States; Brockton Oral and;Maxillofacial Surgery Inc., Department of Oral and Maxillofacial Surgery, Good;Samaritan Medical Center, Brockton, MA, United States; Department of Oral and;Maxillofacial Surgery, Kaohsiung Medical University, School of Dentistry,;Kaohsiung, Taiwan.;Head and Neck Surgical Oncology & Microvascular Reconstructive Surgery,;Department of Surgery, Division of Oral and Maxillofacial Surgery, University of;Miami/Jackson Health System, Miami, FL, United States. |
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