Gao Weimin, Xia Zhigang, Zhou Tingfeng, Dong Youlin
Department of Otolaryngology, The Second Affiliated Hospital of Jiaxing University, Jiaxing, China.
Department of Otolaryngology, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.
Front Pharmacol. 2025 Jun 24;16:1602276. doi: 10.3389/fphar.2025.1602276. eCollection 2025.
Head and neck squamous cell carcinoma (HNSCC) remains a significant global health concern, with treatment outcomes for advanced or metastatic stages being suboptimal despite the availability of various targeted therapies and immunotherapies. This study evaluates five FDA-approved anti-HNSCC drugs-cetuximab, pembrolizumab, nivolumab, atezolizumab, and durvalumab-focusing on the adverse drug reactions (ADRs) associated with their use as reported in the WHO VigiAccess database.
A retrospective analysis was conducted on ADR reports from the WHO-VigiAccess database, focusing on demographic information (age, gender, and geographical distribution) and ADR classification. The disproportionality analysis was used to identify ADRs through Reporting Odds Ratios (ROR) and Proportional Reporting Ratios (PRR). ADRs were categorized into 27 system organ classes (SOCs) for comparison across the five drugs.
A total of 145,678 ADR reports were analyzed. Cetuximab exhibited the highest incidence of skin and subcutaneous tissue disorders (20.88%), while durvalumab showed elevated respiratory system disorders (18.53%). Pembrolizumab and nivolumab had notable immune-related adverse events, with malignant neoplasm progression reported at 5.56% and 4.23%, respectively. Atezolizumab was primarily associated with blood and lymphatic system disorders (5.51%). Disproportionality analysis revealed significant safety concerns for each drug, such as skin toxicity for cetuximab, respiratory complications for durvalumab, and reproductive system risks for nivolumab.
This comparative pharmacovigilance study highlights the diverse safety profiles of the five anti-HNSCC drugs. Clinicians should consider these ADRs when treating patients, especially elderly individuals or those with comorbidities. Personalized monitoring strategies should be developed to minimize risks and optimize therapeutic outcomes for HNSCC patients.
头颈部鳞状细胞癌（HNSCC）仍然是一个重大的全球健康问题，尽管有各种靶向治疗和免疫治疗方法，但晚期或转移性阶段的治疗效果仍不尽人意。本研究评估了五种美国食品药品监督管理局（FDA）批准的抗HNSCC药物——西妥昔单抗、帕博利珠单抗、纳武利尤单抗、阿替利珠单抗和度伐利尤单抗——重点关注世界卫生组织药物不良反应数据库（WHO VigiAccess database）中报告的与这些药物使用相关的药物不良反应（ADR）。
对WHO-VigiAccess数据库中的ADR报告进行回顾性分析，重点关注人口统计学信息（年龄、性别和地理分布）以及ADR分类。采用不成比例分析，通过报告比值比（ROR）和比例报告比值（PRR）来识别ADR。ADR被分为27个系统器官类别（SOC），以便对这五种药物进行比较。
共分析了145,678份ADR报告。西妥昔单抗的皮肤和皮下组织疾病发生率最高（20.88%），而度伐利尤单抗的呼吸系统疾病发生率较高（18.53%）。帕博利珠单抗和纳武利尤单抗有显著的免疫相关不良事件，分别报告有5.56%和4.23%的恶性肿瘤进展。阿替利珠单抗主要与血液和淋巴系统疾病相关（5.51%）。不成比例分析揭示了每种药物的重大安全问题，如西妥昔单抗的皮肤毒性、度伐利尤单抗的呼吸系统并发症以及纳武利尤单抗的生殖系统风险。
这项比较性药物警戒研究突出了这五种抗HNSCC药物不同的安全性特征。临床医生在治疗患者时，尤其是老年患者或有合并症的患者时，应考虑这些ADR。应制定个性化的监测策略，以将风险降至最低，并优化HNSCC患者的治疗效果。
