Nivolumab Safety in Renal Cell Carcinoma: A Case Report

IF 1.1 Q4 PHARMACOLOGY & PHARMACY Journal of Pharmacy Technology Pub Date : 2023-12-15 DOI:10.1177/87551225231218164
James Debono, D. Balzan, John-Joseph Borg, Stephen Falzon, Dania al-Haddad, Benjamin Micallef, Janet Sultana
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引用次数: 0

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.
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尼妥珠单抗在肾细胞癌中的安全性:病例报告
Nivolumab 用于治疗多种不同类型的癌症。虽然人们普遍认为它有效且耐受性良好,但与许多其他治疗癌症的药物一样,它也与需要中断治疗的不良反应有关。一名 70 岁的男性患者因患肾细胞癌从舒尼替尼转为使用 nivolumab。该患者分别在 nivolumab 第 6、10 和 11 周期出现了持续性甲状腺功能减退、甲状腺肿和肺炎。采用纳兰霍因果关系法,认为肺炎和甲状腺功能减退的因果关系为 "可能",甲状腺肿大的因果关系为 "可能"。Nivolumab最终因疾病进展而停药,而非安全性问题。在欧洲药物警戒数据库 Eudravigilance 中搜索了截至 2023 年 9 月 4 日马耳他所有与尼夫单抗相关的个体病例安全报告。在马耳他发现了六份报告,但本病例报告中发现的三起事件并未报告,这表明马耳他的报告不足。本病例报告确定了一种不常见的 nivolumab 药物不良反应 (ADR)--甲状旁腺溶解症,并说明了尽管发生了 3 例 ADR,但导致该特定患者停药的原因是其缺乏疗效而非安全性。
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来源期刊
Journal of Pharmacy Technology
Journal of Pharmacy Technology PHARMACOLOGY & PHARMACY-
CiteScore
1.50
自引率
0.00%
发文量
49
期刊介绍: For both pharmacists and technicians, jPT provides valuable information for those interested in the entire body of pharmacy practice. jPT covers new drugs, products, and equipment; therapeutic trends; organizational, legal, and educational activities; drug distribution and administration; and includes continuing education articles.
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