Meet-URO Score Validation in Real-world Patients with Metastatic Renal Cell Carcinoma Receiving First-line Pembrolizumab Plus axitinib A Subanalysis of the Prospective ProPAXI Study
Main Article Content
Keywords
Immunotherapy, Prognostic factors, Prognostic score, Renal Cell Carcinoma, Tyrosine kinase inhibitor
Abstract
The Meet-URO score provided a more accurate prognostication than the international metastatic RCC database consortium (IMDC) risk group classification for patients with metastatic renal cell carcinoma (mRCC) by incorporating the pretreatment neutrophil-to-lymphocyte ratio (NLR) and the presence of bone metastases in different settings of the disease. To additionally validate the Meet-URO score on overall survival (OS) in a cohort of mRCC patients treated with first-line pembrolizumab plus axitinib, a post hoc analysis of the observational prospective ProPAXI study was conducted. Progression-free survival (PFS) was also considered. Harrell’s C-index was used to compare the discriminative ability on OS and PFS. Overall, the ProPAXI study included 170 patients. Both the five- and the three-risk group Meet-URO score were evaluated to account for the small sample size. The five Meet-URO risk group score showed a mOS of 27.1 months (p = 0.064) and 10.3 (p = 0.014) months for group 4 and group 5, respectively, while it was not reached for the other groups (p < 0.01). Although a worsening of PFS was observed with increasing the risk group, these differences were not statistically significant (p =0.19). Similar results were observed fot the three-risk group Meet-URO score. Both five and the three Meet-URO risk groups showed a better C-index for OS (0.69 and 0.66, respectively) compared to IMDC (0.62) and for PFS (0.60 and 0.59, respectively) compared to IMDC (0.56). These findings suggest that the Meet-URO score may provide more accurate prognostic stratification than IMDC alone in mRCC patients treated with first-line pembrolizumab and axitinib.
References
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2. Motzer R, Alekseev B, Rha SY, Porta C, Eto M, Powles T, et al. Lenvatinib plus pembrolizumab or everolimus for advanced renal cell carcinoma. The New England Journal of Medicine. 2021;384:1289–300. https://doi.org/10.1056/NEJMoa2035716
3. Choueiri TK, Powles T, Burotto M, Escudier B, Bourlon MT, Zurawski B, et al. Nivolumab plus cabozantinib versus sunitinib for advanced renal-cell carcinoma. The New England Journal of Medicine. 2021;384:829–41. https://doi.org/10.1056/NEJMoa2026982
4. Heng DYC, Xie W, Regan MM, Warren MA, Golshayan AR, Sahi C, et al. Prognostic factors for overall survival in patients with metastatic renal cell carcinoma treated with vascular endothelial growth factor–targeted agents: results from a large, multicenter study. Journal of Clinical Oncology. 2009;27:5794–9. https://doi.org/10.1200/JCO.2008.21.4809
5. Heng DY, Xie W, Regan MM, Harshman LC, Bjarnason GA, Vaishampayan UN, et al. External validation and comparison with other models of the international metastatic renal-cell carcinoma database consortium prognostic model: a population-based study. Lancet Oncology. 2013;14:141–8. https://doi.org/10.1016/S1470-2045(12)70559-4 6. Rizzo A, Mollica V, Santoni M, Rosellini M, Marchetti A, Ricci AD, et al. Comparative effectiveness of first-line immune checkpoint inhibitors plus tyrosine kinase inhibitors according to IMDC risk groups in metastatic renal cell carcinoma: a meta-analysis. Immunotherapy 2021;13:783–93. https://doi.org/10.2217/imt-2021-0005
7. Powles T, Plimack ER, Soulières D, Waddell T, Stus V, Gafanov R, et al. Pembrolizumab plus axitinib versus sunitinib monotherapy as first-line treatment of advanced renal cell carcinoma (KEYNOTE-426): extended follow-up from a randomised, open-label, phase 3 trial. Lancet Oncol ogy. 2020;21:1563–73. https://doi.org/10.1016/S1470-2045(20)30436-8
8. Motzer RJ, Powles T, Burotto M, Escudier B, Bourlon MT, Shah AY, et al. Nivolumab plus cabozantinib versus sunitinib in first-line treatment for advanced renal cell carcinoma (CheckMate 9ER): long-term follow-up results from an open-label, randomised, phase 3 trial. Lancet Oncology. 2022;23:888–98. https://doi.org/10.1016/S1470-2045(22)00290-X
9. Choueiri TK, Eto M, Motzer R, De Giorgi U, Buchler T, Basappa NS, et al. Lenvatinib plus pembrolizumab versus sunitinib as first-line treatment of patients with advanced renal cell carcinoma (CLEAR): extended follow-up from the phase 3, randomised, open-label study. Lancet Oncology. 2023;24:228–38. https://doi.org/10.1016/S1470-2045(23)00049-9
10. Lee D, Gittleman H, Weinstock C, Suzman D, Bloomquist E, Agrawal S, et al. A U.S. food and drug administration–pooled analysis of frontline combination treatment survival benefits by risk groups in metastatic renal cell carcinoma. European Urology. 2023;84:373–8. https://doi.org/10.1016/j.eururo.2023.05.030
11. Roviello G, Molina-Cerrillo J, Massari F, Cerbone L, Fiala O, Fornarini G, et al. First-line immune-based combinations or sunitinib in favorable-risk metastatic renal cell carcinoma: a real-world retrospective comparison from the ARON-1 study. Cancer Immunology, Immunotherapy. 2025;74:65. https://doi.org/10.1007/s00262-024-03897-x
12. Rebuzzi SE, Fornarini G, Signori A, Rescigno P, Banna GL, Buti S. Banana-shaped survival curves of metastatic renal cell carcinoma treated with first-line immune-combinations, not just a matter of “palateau.” Human Vaccines & Immunotherapeutics. 2024;20. https://doi.org/10.1080/21645515.2024.2351669
13. Rebuzzi SE, Signori A, Banna GL, Maruzzo M, De Giorgi U, Pedrazzoli P, et al. Inflammatory indices and clinical factors in metastatic renal cell carcinoma patients treated with nivolumab: the development of a novel prognostic score (Meet-URO 15 study). Therapeutic Advances in Medical Oncology 2021;13. https://doi.org/10.1177/17588359211019642
14. Rebuzzi SE, Cerbone L, Signori A, Santoni M, Murianni V, De Giorgi U, et al. Application of the Meet-URO score to metastatic renal cell carcinoma patients treated with second- and third-line cabozantinib. Therapeutic Advances in Medical Oncology. 2022;14. https://doi.org/10.1177/17588359221079580
15. Rebuzzi SE, Signori A, Buti S, Banna GL, Murianni V, Damassi A, et al. Validation of the meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian expanded access program. 2022;7:100634. https://doi.org/10.1016/j.esmoop.2022.100634
16. Damassi A, Cremante M, Signori A, Rebuzzi SE, Fornarini G, Giudice GC, et al. Prognostic stratification by the meet-URO score in real-world older patients with metastatic renal cell carcinoma (mRCC) receiving cabozantinib: a subanalysis of the prospective ZEBRA study (Meet-URO 9). Clinical Genitourinary Cancer. 2024;22:126–133.e2. https://doi.org/10.1016/j.clgc.2023.10.001
17. He S, Liu H, Chen J, Zeng H. Validation of the meet-URO score in metastatic clear cell renal cell carcinoma patients receiving second or third-line tyrosine kinase inhibitors-immune checkpoint inhibitors combination therapy. Journal of Translational Medicine. 2024;22:232. https://doi.org/10.1186/s12967-024-05014-z
18. Rescigno P, Ghose A, Brown N, James L, Haywood S, Frazer S, et al. Meet-URO score update in metastatic renal cell carcinoma receiving first-line immune-combinations, The Oncologist. 2025; 30(1, September). https://doi.org/10.1093/oncolo/oyaf248.041
19. Guida A, Gili A, Mosillo C, Maruzzo M, Lai E, Pierantoni F, et al. Efficacy and safety of pembrolizumab plus axitinib combination for metastatic renal cell carcinoma (mRCC) in a real-world scenario: data from the prospective ProPAXI study. Clinical Genitourinary Cancer. 2024:102225. https://doi.org/10.1016/j.clgc.2024.102225
20. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. Journal of Biomedical Informatics. 2009;42:377–81. https://doi.org/10.1016/j.jbi.2008.08.010
21. Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O’Neal L, et al. The REDCap consortium: building an international community of software platform partners. Journal of Biomedical Informatics. 2019;95:103208. https://doi.org/10.1016/j.jbi.2019.103208
22. Han X, Zhang Y, Shao Y. On comparing 2 correlated C indices with censored survival data. Statistics in Medicine. 2017;36:4041–9. https://doi.org/10.1002/sim.7414
23. Rebuzzi SE, Fornarini G, Signori A, Buti S, Procopio G, De Giorgi U, et al. International multicenter real-world REGistry for patients with metastatic renal cell carcinoma—meet-URO 33 study (REGAL study). BMC Cancer. 2024;24:757. https://doi.org/10.1186/s12885-024-12319-1
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Oct 13, 2025
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Meet-URO Score Validation in Real-world Patients with Metastatic Renal Cell Carcinoma Receiving First-line Pembrolizumab Plus axitinib: A Subanalysis of the Prospective ProPAXI Study. (2025). Journal of Kidney Cancer, 12(4), 7-18. https://doi.org/10.15586/jkcvhl.v12i4.403
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Kidney Cancer: Original Articles
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How to Cite
Meet-URO Score Validation in Real-world Patients with Metastatic Renal Cell Carcinoma Receiving First-line Pembrolizumab Plus axitinib: A Subanalysis of the Prospective ProPAXI Study. (2025). Journal of Kidney Cancer, 12(4), 7-18. https://doi.org/10.15586/jkcvhl.v12i4.403