Debono James, Balzan Dustin, Borg John Joseph, Falzon Stephen, Al-Haddad Dania, Micallef Benjamin, Sultana Janet
Oncology Department, Sir Anthony Mamo Oncology Centre, Mater Dei Hospital, Msida, Malta.
Pharmacy Directorate, Mater Dei Hospital, Msida, Malta.
J Pharm Technol. 2024 Apr;40(2):112-117. doi: 10.1177/87551225231218164. Epub 2023 Dec 15.
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.
纳武利尤单抗用于治疗多种不同类型的癌症。尽管它通常被认为有效且耐受性良好,但与许多其他用于癌症的药物一样,它也会出现需要停药的不良反应。一名70岁男性因肾细胞癌从舒尼替尼改用纳武利尤单抗。该患者分别在纳武利尤单抗治疗的第6、10和11周期出现持续性甲状腺功能减退、甲床分离和肺炎。采用Naranjo因果关系法,肺炎和甲状腺功能减退的因果关系可能性被判定为“很可能”,甲床分离为“可能”。最终,纳武利尤单抗因疾病进展而非安全问题停药。检索了欧洲药物警戒数据库Eudravigilance中截至2023年9月4日来自马耳他的所有与纳武利尤单抗相关的个体病例安全报告。在马耳他共识别出6份报告,尽管本病例报告中识别出的3例事件未被报告,这表明马耳他存在报告不足的情况。本病例报告识别出一种不常见的纳武利尤单抗药物不良反应(ADR),即甲床分离,并展示了尽管出现了3例ADR,但在该特定患者中导致停药的原因是其缺乏疗效而非安全性。