Multicenter Retrospective Analysis of Nivolumab Monotherapy Outcomes in Advanced Renal Cell Carcinoma by the Spanish Genitourinary Oncology Group - Report - MDSpire

Multicenter Retrospective Analysis of Nivolumab Monotherapy Outcomes in Advanced Renal Cell Carcinoma by the Spanish Genitourinary Oncology Group

  • By

  • 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

  • November 28, 2025

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Outcomes of Nivolumab Monotherapy in Advanced Renal Cell Carcinoma: Spanish Multicenter Study

Overview

This multicenter retrospective study evaluated nivolumab monotherapy in 222 advanced renal cell carcinoma patients treated in routine clinical practice across Spain. Results demonstrated meaningful overall survival and disease control rates consistent with prior clinical trials, with patient and disease characteristics influencing outcomes.

Background

Advanced renal cell carcinoma (aRCC) treatment has evolved from cytokine therapies to targeted agents like tyrosine kinase inhibitors and mTOR inhibitors. Despite initial benefits, resistance to these therapies is common, necessitating new options. Nivolumab, an anti-PD-1 antibody, was approved for aRCC after prior anti-angiogenic therapy based on improved survival in clinical trials. However, real-world data are needed to confirm its effectiveness in broader patient populations.

Data Highlights

CharacteristicValue
Number of patients222
Median age (years)65 (range 22–87)
Sex27% female, 73% male
ECOG Performance Status0: 20%, 1: 70%, ≥2: 10%
IMDC risk scoreFavorable: 20%, Intermediate: 59%, Poor: 19%
Prior nephrectomy90%
Histologic subtypeClear cell RCC: 85%
Common metastasis sitesLungs: 63%, Lymph nodes: 57%

Key Findings

  • Nivolumab was administered as second-line or later therapy in a real-world cohort of 222 aRCC patients.
  • Median patient age was 65 years, with a predominance of male patients and good performance status (ECOG 0-1 in 90%).
  • Most patients had intermediate or poor IMDC risk scores, reflecting a heterogeneous population.
  • Clear cell histology was the most common subtype (85%), and prior nephrectomy was performed in 90% of patients.
  • Lung and lymph node metastases were the most frequent metastatic sites.

Clinical Implications

Nivolumab monotherapy demonstrates effectiveness in a diverse, real-world aRCC population, supporting its use beyond controlled clinical trial settings. Patient selection considering performance status and risk scores remains important to optimize outcomes. These findings reinforce nivolumab as a valuable treatment option in routine practice for previously treated aRCC patients.

Conclusion

This retrospective multicenter analysis confirms that nivolumab monotherapy provides meaningful clinical benefit in advanced renal cell carcinoma patients treated in routine practice, with outcomes aligned with pivotal clinical trials. Real-world data support its continued integration into aRCC treatment paradigms.

References

  1. Motzer et al. 2015 -- Nivolumab versus Everolimus in Advanced Renal-Cell Carcinoma
  2. FDA Approval 2015 -- Nivolumab for aRCC
  3. EMA Approval 2016 -- Nivolumab for aRCC

Original Source(s)

Multicenter Retrospective Analysis of Nivolumab Monotherapy Outcomes in Advanced Renal Cell Carcinoma by the Spanish Genitourinary Oncology Group

  • by 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

  • November 28, 2025

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