Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting.
Abstract Introduction and objectives Nivolumab is an immunotherapy agent that has been an approved treatment for previously treated patients with advanced renal cell carcinoma (RCC). Experience in real-life settings, especially regarding immune-related adverse events, is scarce. We present our experience with reference to the safety of nivolumab in patients with metastatic RCC (mRCC) treated in 9 hospitals in Spain. Material and methods Retrospective, multicenter study of patients with mRCC treated with nivolumab between 2016 and 2018. Data on baseline socio-demographic and clinical characteristics and drug-related adverse events were collected. Results The mean age of the 26 patients included was 63.7 ± 11.5 years; 96% were ECOG 0–1 and 78% had favorable or intermediate MSKCC risk scores; 73% had the clear cell histological subtype and 30% metastatic disease. Median follow-up was 9 months (range 1–14). All patients experienced an adverse event at different grades, with fatigue, fever and anemia being the most common (27%). Grade 3 adverse events occurred in 23% of patients. Adverse reactions led to treatment suspension in 3 patients (11%). Conclusion In the real-life clinical setting, nivolumab shows favorable outcomes, similar to those reported by other studies.