Fernández-Díaz, Natalia (N);Mateos-González, María (M);Pertejo-Fernández, Ana (A);Cacho-Lavín, Juan Diego (JD);Juan-Fita, María José (MJ);Chirivella-González, Isabel (I);Arruti-Ibarbia, Mikel (M);Fernández-Calvo, Ovidio (O);Fernández-Núñez, Natalia (N);Méndez-Vidal, María José (MJ);Lázaro-Quintela, Martín (M);Molina-Díaz, Aurea (A);Del Pozo-Alonso, Nieves (N);Etxaniz-Ulazia, Olatz (O);García-Acuña, Silvia Margarita (SM);Betancor, Yoel Z (YZ);Azueta-Etxebarria, Ainara (A);Calatrava-Fons, Ana (A);Lombardía-Rodríguez, Helena (H);Alarcón-Molero, Lorena (L);Etxegarai-Ganboa, Leire (L);Antón-Cameselle, Abraham (A);Bello-Giz, José Antonio (JA);Neira-De Paz, Carlos Manuel (CM);Cabaleiro, Teresa (T);González-Serrano, Teresa (T);Ortiz-Rey, José Antonio (JA);Sacristán-Lista, Felipe (F);García-Rubín, Silvia (S);Ortega, Elisa (E);Carrato-Moñino, Cristina (C);Aguín-Losada, Santiago (S);León-Mateos, Luis (L);García-González, Jorge (J);Pinto-Marín, Álvaro (Á);Duran, Ignacio (I);López-López, Rafael (R);Anido-Herranz, Urbano (U);Ruiz-Bañobre, Juan (J);

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BMC Cancer.2025 Nov 28;25(1):1835.doi:10.1186/s12885-025-15264-9

Abstract

BACKGROUND: The efficacy of nivolumab for advanced renal cell carcinoma (aRCC) has been evaluated in real-world evidence (RWE) studies across several European countries, yet data from Spain have been lacking.

PATIENTS AND METHODS: We conducted a multicenter, retrospective study of 222 previously treated aRCC patients to assess the efficacy of nivolumab and the influence of pre-treatment factors on clinical outcomes across 13 Spanish centers. Eligible patients had received at least one dose of nivolumab in routine clinical practice. Demographic, clinical, and laboratory data were extracted from electronic records. Efficacy endpoints were overall survival (OS), progression-free survival (PFS), disease control rate (DCR), and overall response rate (ORR). Survival estimates were calculated by the Kaplan-Meier method, and groups were compared with the log-rank test. The Cox proportional hazards regression model was used to evaluate factors independently associated with OS. Factors associated with disease control (DC) and response were tested with logistic regression in univariable and multivariable analyses. Comparisons between patient and disease characteristics were carried out using Fisher's exact test. All P values were two-sided, and those < 0.05 were considered statistically significant. Results were contextualized with key clinical experiences involving nivolumab monotherapy in aRCC.

RESULTS: With a median follow-up of 14.6 months, median overall survival (OS) was 18.1 months (95% confidence interval [CI], 14.2-23.7 months), and median progression-free survival (PFS) was 4.96 months (95% CI, 3.98-7.13). The disease control rate was 51% (95% CI, 45-58%), and the objective response rate was 23% (95% CI, 18-30%). Poor International Metastatic RCC Database Consortium (IMDC) risk score was independently associated with shorter OS, while prior nephrectomy predicted improved OS. Poor IMDC risk and ≥ 3 metastatic sites were independently associated with shorter PFS; ≥ 3 metastatic sites also correlated with reduced disease control.

CONCLUSION: Consistent with previous clinical trials and RWE studies, our findings reinforce the efficacy of nivolumab in routine clinical practice for an unselected cohort of previously treated aRCC patients in Spain.