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, multicentre 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 favourable 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 anaemia 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 favourable outcomes, similar to those reported by other studies.

Keywords: Carcinoma de células renales metastásico; Checkpoint inhibitors; Immunotherapy; Inhibidores de puntos de control; Inmunoterapia; Metastatic renal cell carcinoma; Nivolumab; Safety; Seguridad; Tolerabilidad; Tolerability.