PDF(Pubmed)
Abstract：
Nivolumab is used to treat several different types of cancers. Although it is generally considered to be effective and well-tolerated, it has been associated with adverse effects requiring discontinuation of treatment, like many other drugs used for cancer. A 70-year-old male was switched from sunitinib to nivolumab for renal cell carcinoma. The patient developed persistent hypothyroidism, onycholysis, and pneumonitis at nivolumab cycle 6, 10, and 11, respectively. Using the Naranjo causality method, the likelihood of causality was deemed \"probable\" for pneumonitis and hypothyroidism and \"possible\" for onycholysis. Nivolumab was eventually discontinued due to disease progression, rather than safety concerns. Eudravigilance, the European pharmacovigilance database, was searched for all nivolumab-related individual case safety reports from Malta, up to September 4, 2023. Six reports were identified in Malta, although the 3 events identified in this case report were not reported, suggesting under-reporting in Malta. This case report identified an uncommon nivolumab adverse drug reaction (ADR), onycholysis and showed how, despite the occurrence of 3 ADRs, it was its lack of efficacy rather than its safety which led to its discontinuation in this particular patient.
摘要：
Nivolumab用于治疗几种不同类型的癌症。虽然它通常被认为是有效的和良好的耐受性，它与需要停止治疗的不良反应有关，就像许多其他治疗癌症的药物一样。一名70岁的男性从舒尼替尼改用nivolumab治疗肾细胞癌。病人出现持续性甲状腺功能减退,甲状腺溶解症,和肺炎分别在nivolumab第6、10和11周期。使用Naranjo因果关系方法，因果关系的可能性被认为是肺炎和甲状腺功能减退症的“可能”和甲状腺溶解的“可能”。Nivolumab最终因疾病进展而停用，而不是安全问题。Eudra警惕，欧洲药物警戒数据库,从马耳他搜索所有与nivolumab相关的个体病例安全性报告，到2023年9月4日。在马耳他发现了六份报告，尽管本病例报告中确定的3个事件没有报告，建议在马耳他漏报。该病例报告确定了罕见的纳武单抗不良反应（ADR），并展示了如何，尽管发生了3次ADR，是其缺乏疗效而非安全性导致该患者停药.
