Evidence map›Paper›PMID 41316036›Full record

ArticleBMC cancer2025

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

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 and 29 more

Abstract readMulticenter Study
In one paragraph

Article in BMC cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

39 authors.

Natalia Fernández-DíazDepartment of Medical Oncology, University Clinical Hospital of Santiago de Compostela (SERGAS), Santiago de Compostela, Spain.ORCID http://orcid.org/0000-0002-6804-9746
María Mateos-GonzálezDepartment of Medical Oncology, University Clinical Hospital of Santiago de Compostela (SERGAS), Santiago de Compostela, Spain.
Ana Pertejo-FernándezDepartment of Medical Oncology, Hospital Universitario La Paz - IdiPAZ, Madrid, Spain.
Juan Diego Cacho-LavínDepartment of Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
María José Juan-FitaDepartment of Medical Oncology, Fundación Instituto Valenciano de Oncología (IVO), Valencia, Spain.
Isabel Chirivella-GonzálezDepartment of Medical Oncology, INCLIVA Biomedical Research Institute, University of Valencia, Valencia, Spain.
Mikel Arruti-IbarbiaDepartment of Medical Oncology, Hospital Galdakao-Usansolo, Bizkaia, Spain.
Ovidio Fernández-CalvoDepartment of Medical Oncology, Complejo Hospitalario Universitario de Ourense, Ourense, Spain.
Natalia Fernández-NúñezDepartment of Medical Oncology, Hospital Universitario Lucus Augusti, Lugo, Spain.
María José Méndez-VidalDepartment of Medical Oncology, Hospital Universitario Reina Sofía, Maimonides Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, Spain.
Martín Lázaro-QuintelaDepartment of Medical Oncology, Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
Aurea Molina-DíazDepartment of Medical Oncology, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.
Nieves Del Pozo-AlonsoDepartment of Medical Oncology, Hospital Universitario del Vinalopó, Elche, Alicante, Spain.
Olatz Etxaniz-UlaziaDepartment of Medical Oncology, Catalan Institute of Oncology (ICO), Hospital Germans Trias I Pujol, Badalona, Barcelona, Spain.
Silvia Margarita García-AcuñaDepartment of Pathology, University Clinical Hospital of Santiago de Compostela (SERGAS), University of Santiago de Compostela (USC), Santiago de Compostela, Spain.
Yoel Z BetancorTranslational Medical Oncology Group (ONCOMET), Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.
Ainara Azueta-EtxebarriaDepartment of Pathology, Hospital Universitario Marques de Valdecilla, IDIVAL, Santander, Spain.
Ana Calatrava-FonsDepartment of Pathology, Fundación Instituto Valenciano de Oncología (IVO), Valencia, Spain.
Helena Lombardía-RodríguezTranslational Medical Oncology Group (ONCOMET), Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.
Lorena Alarcón-MoleroDepartment of Pathology, Hospital Clínico Universitario de Valencia, Valencia, Spain.
Leire Etxegarai-GanboaDepartment of Pathology, Hospital Galdakao-Usansolo, Bizkaia, Spain.
Abraham Antón-CameselleTranslational Medical Oncology Group (ONCOMET), Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.
José Antonio Bello-GizDepartment of Pathology, Complejo Hospitalario Universitario de Ourense, Ourense, Spain.
Carlos Manuel Neira-De PazDepartment of Pathology, Hospital Universitario Lucus Augusti, Lugo, Spain.
Teresa CabaleiroFundación Pública Galega Instituto de Investigación Sanitaria de Santiago de Compostela, University Clinical Hospital of Santiago de Compostela, Santiago de Compostela, Spain.
Teresa González-SerranoDepartment of Pathology, Hospital Universitario Reina Sofía, Maimonides Institute for Biomedical Research of Córdoba (IMIBIC), Córdoba, Spain.
José Antonio Ortiz-ReyDepartment of Pathology, Complejo Hospitalario Universitario de Vigo, Vigo, Spain.
Felipe Sacristán-ListaDepartment of Pathology, Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.
Silvia García-RubínTranslational Medical Oncology Group (ONCOMET), Health Research Institute of Santiago de Compostela (IDIS), Santiago de Compostela, Spain.
Elisa OrtegaDepartment of Pathology, Hospital Universitario del Vinalopó, Elche, Alicante, Spain.
Cristina Carrato-MoñinoDepartment of Pathology, Hospital Germans Trias I Pujol, Badalona, Barcelona, Spain.
Santiago Aguín-LosadaDepartment of Medical Oncology, University Clinical Hospital of Santiago de Compostela (SERGAS), Santiago de Compostela, Spain.
Luis León-MateosDepartment of Medical Oncology, University Clinical Hospital of Santiago de Compostela (SERGAS), Santiago de Compostela, Spain.
Jorge García-GonzálezDepartment of Medical Oncology, University Clinical Hospital of Santiago de Compostela (SERGAS), Santiago de Compostela, Spain.
Álvaro Pinto-MarínDepartment of Medical Oncology, Hospital Universitario La Paz - IdiPAZ, Madrid, Spain.
Ignacio DuranDepartment of Medical Oncology, Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.
Rafael López-LópezDepartment of Medical Oncology, University Clinical Hospital of Santiago de Compostela (SERGAS), Santiago de Compostela, Spain.
Urbano Anido-HerranzDepartment of Medical Oncology, University Clinical Hospital of Santiago de Compostela (SERGAS), Santiago de Compostela, Spain.
Juan Ruiz-BañobreDepartment of Medical Oncology, University Clinical Hospital of Santiago de Compostela (SERGAS), Santiago de Compostela, Spain. juan.ruiz.banobre@sergas.es.ORCID http://orcid.org/0000-0003-0755-4295

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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

methodsWe 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.

resultsWith 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.

conclusionConsistent 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.

Indexed as

Antineoplastic Agents, ImmunologicalCarcinoma, Renal CellKidney NeoplasmsNivolumabAdultAgedAged, 80 and overFemaleHumansMaleMiddle AgedProgression-Free SurvivalRetrospective StudiesSpainTreatment OutcomeAntineoplastic Agents, ImmunologicalNivolumabImmunotherapyKidney cancerNivolumabReal-world evidenceRenal cell carcinoma

Identifiers

PMID41316036
PMCPMC12664163

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