Real-world experience on the use of nivolumab monotherapy for advanced renal cell carcinoma: a multicenter retrospective cohort study in Spain

The safety and efficacy of nivolumab in treating advanced renal cell carcinoma (aRCC) patients have been evaluated in real-world evidence (RWE) studies across various European countries, but no such data from Spain have been reported until now. We conducted a multicenter, retrospective study on 222 previously treated aRCC patients to assess the efficacy of nivolumab and the impact of pre-treatment factors on therapy outcomes in a real-world clinical practice scenario in Spain. Our results were then compared with other significant clinical experiences involving aRCC patients treated with nivolumab monotherapy. With a median follow-up of 14.6 months, the median overall survival (OS) was 18.1 months (95% confidence interval [CI], 14.2-23.7 months), and the median progression-free survival (PFS) was 4.96 months (95% CI, 3.98-7.13 months). The disease control rate was 51% (95% CI, 45-58%) and the objective response rate 23% (95% CI, 18-30%). Poor IMDC risk score was independently associated with worse OS, while prior nephrectomy with better OS. Poor IMDC risk score and ≥3 metastatic sites were independently associated with worse PFS; ≥3 metastatic sites was also associated with lower disease control. Consistent with prior clinical trials and RWE studies, this research confirms the efficacy and safety of nivolumab in daily clinical practice for a cohort of unselected previously treated aRCC patients in Spain.