Real-World Incidence of Immune-Related Adverse Events Associated with Nivolumab Plus Ipilimumab in Patients with Advanced Renal Cell Carcinoma: A Retrospective Observational Study

Journal of Clinical Medicine

Hodaka Yamada¹  Satoshi Washino²  Tomoaki Miyagawa²  Masaharu Inoue³  Yukio Kageyama³  Takahiko Soma³  Makoto Kagawa⁴  Satoru Kawakami⁴  Hideki Takeshita⁴ 

[1] Department of Endocrinology, Jichi Medical University Saitama Medical Center, Saitama 330-0834, Japan;Department of Urology, Jichi Medical University Saitama Medical Center, Saitama 330-0834, Japan;Department of Urology, Saitama Cancer Center, Saitama 362-0806, Japan;Department of Urology, Saitama Medical Center Saitama Medical University, Kawagoe 350-8550, Japan;

关键词: nivolumab;    ipilimumab;    hypopituitarism;    thyroid toxicities;    adrenal insufficiency;    renal cell carcinoma;   

DOI  :  10.3390/jcm10204767

来源: DOAJ

【 摘 要 】

Real-world incidence of immune-related adverse events (irAEs) associated with nivolumab plus ipilimumab in patients with renal cell carcinoma (RCC) has been rarely demonstrated. The present study aims to report the safety outcomes of this combination therapy in the real-life population. We conducted a multi-institutional retrospective observational study that assessed the incidence and severity of irAEs associated with nivolumab plus ipilimumab in 41 Japanese patients with metastatic and/or locally advanced RCC. The irAEs were classified into endocrine and non-endocrine irAEs. The median age and follow-up period were 68 years and 13.0 months, respectively. Endocrine irAEs were observed in 66% of patients, including hypopituitarism in 44%, hyperthyroidism in 41%, and primary hypothyroidism in 22%, while non-endocrine irAEs were observed in 54%. All patients experiencing hypopituitarism presented with adrenocorticotropic hormone deficiency, causing secondary adrenal insufficiency, which required permanent corticosteroid replacement therapy. There was an association between the incidence of endocrine irAEs and high-grade non-endocrine irAEs other than skin-related irAEs (p = 0.027). When patients experienced two or more endocrine irAEs, they had a 35% chance of experiencing high-grade non-endocrine irAEs other than skin-related irAEs. Nivolumab plus ipilimumab may lead to a high prevalence of endocrine irAEs in “real-world” patients. Endocrine irAEs may be associated with non-endocrine irAEs other than skin-related irAEs.

【 授权许可】

Unknown