Safety of nivolumab in metastatic renal cell carcinoma patients: A real-life experience in a Spanish urology setting

Abstract

Introduction and objectivesNivolumab 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 methodsRetrospective, 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. ResultsThe 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%). ConclusionIn the real-life clinical setting, nivolumab shows favorable outcomes, similar to those reported by other studies.