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Background <p>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.</p> Patients and methods <p>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&#xa0;<i>P</i>&#xa0;values were two-sided, and those &lt; 0.05 were considered statistically significant. Results were contextualized with key clinical experiences involving nivolumab monotherapy in aRCC.</p> Results <p>With a median follow-up of 14.6&#xa0;months, median overall survival (OS) was 18.1&#xa0;months (95% confidence interval [CI], 14.2–23.7&#xa0;months), and median progression-free survival (PFS) was 4.96&#xa0;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.</p> Conclusion <p>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.</p>

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Real-world evidence of nivolumab monotherapy in advanced renal cell carcinoma from a multicenter retrospective cohort study by the Spanish Genitourinary Oncology Group

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  • 发表日期：

    2025年11月28日

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  • Natalia Fernández-Díaz,
  • María Mateos-González,
  • Ana Pertejo-Fernández,
  • Juan Diego Cacho-Lavín,
  • María José Juan-Fita,
  • Isabel Chirivella-González,
  • Mikel Arruti-Ibarbia,
  • Ovidio Fernández-Calvo,
  • Natalia Fernández-Núñez,
  • María José Méndez-Vidal,
  • Martín Lázaro-Quintela,
  • Aurea Molina-Díaz,
  • Nieves Del Pozo-Alonso,
  • Olatz Etxaniz-Ulazia,
  • Silvia Margarita García-Acuña,
  • Yoel Z. Betancor,
  • Ainara Azueta-Etxebarria,
  • Ana Calatrava-Fons,
  • Helena Lombardía-Rodríguez,
  • Lorena Alarcón-Molero,
  • Leire Etxegarai-Ganboa,
  • Abraham Antón-Cameselle,
  • José Antonio Bello-Giz,
  • Carlos Manuel Neira-De Paz,
  • Teresa Cabaleiro,
  • Teresa González-Serrano,
  • José Antonio Ortiz-Rey,
  • Felipe Sacristán-Lista,
  • Silvia García-Rubín,
  • Elisa Ortega,
  • Cristina Carrato-Moñino,
  • Santiago Aguín-Losada,
  • Luis León-Mateos,
  • Jorge García-González,
  • Álvaro Pinto-Marín,
  • Ignacio Duran,
  • Rafael López-López,
  • Urbano Anido-Herranz,
  • Juan Ruiz-Bañobre

摘要

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.