Effectiveness of nivolumab-based immunotherapy and prognostic stratification by the Meet-URO score in real-world older patients with metastatic renal cell carcinoma
- PMID: 40803027
- DOI: 10.1016/j.jgo.2025.102336
Effectiveness of nivolumab-based immunotherapy and prognostic stratification by the Meet-URO score in real-world older patients with metastatic renal cell carcinoma
Abstract
Introduction: The incidence of renal cell carcinoma (RCC) increases with age, yet older patients (≥70 years) are underrepresented in clinical trials. Evidence on the efficacy of immune checkpoint inhibitors (ICIs) and on reliable prognostic tools for this population remains limited. We aimed to evaluate the effectiveness of nivolumab-based immunotherapy in older patients with metastatic RCC (mRCC) and assess the prognostic accuracy of the International Metastatic RCC Database Consortium (IMDC) and Meet-URO scores.
Materials and methods: This multicenter study included 889 patients with mRCC treated with nivolumab alone or in combination with ipilimumab, using data from the Meet-URO 15 study and the Italian Expanded Access Program. Progression-free survival (PFS), overall survival (OS), and prognostic factors were analyzed by age group (<70 and ≥ 70 years) using Kaplan-Meier curves and multivariate models.
Results: Median OS and PFS were similar between younger and older patients (mOS: 23.5 vs. 25.1 months, HR: 1.02, p = 0.82; mPFS: 6.28 vs. 7.82 months, HR: 0.93, p = 0.40). The Meet-URO score outperformed the IMDC score in prognostic accuracy (p < 0.001), particularly in older patients. Non-clear cell histology was linked to shorter PFS (HR: 1.37, p = 0.05), while prior nephrectomy improved OS (HR: 0.55, p = 0.001). Limitations include the retrospective design and treatment heterogeneity. Prospective validation is needed.
Discussion: In this large real-world cohort, outcomes in older patients with mRCC receiving nivolumab-based immunotherapy were comparable to those in younger patients. The Meet-URO score improved prognostic stratification and supported clinical decision-making.
Keywords: Elderly; Immunotherapy; Ipilimumab; Meet-URO; Metastatic renal cell carcinoma; Nivolumab; Prognostic.
Copyright © 2025 Elsevier Ltd. All rights reserved.
Conflict of interest statement
Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: UB received honoraria for Advisory Board role from PFIZER; NOVARTIS; ASTRA ZENECA, Johnson & Johnson; Travel grants from IPSEN, ASTELLAS, EISAI, MSD, MERCK. LF received honoraria as a speaker at scientific events and advisory role by BMS, Pfizer, MSD, Ipsen, Novartis. SB (NB: S. Buti) received honoraria for speaking at scientific events and advisory roles from AstraZeneca, Bristol Myers Squibb, Ipsen, Astellas, Merck, Eisai, MSD, Novartis, Gentili, and Pfizer and research funding from Novartis and Pfizer, outside the present work. SB (NB: S Bracarda) received honoraria as a speaker at scientific events and advisory role by BMS, Pfizer, MSD, Ipsen, Roche, Eli Lilly, AstraZeneca, Pierre-Fabre, Novartis. SB served as an Advisory Board or Steering Committee member for Bayer, Astellas, Janssen, Pfizer, BMS, MSD, Roche-Genentech, Ipsen, Novartis (AAA), Astrazeneca, Merck, Gilead, Indicon, Genenta and congress travel accommodation from MSD, Pfizer, Bayer, Ipsen and Merck. MM received honoraria as a speaker at scientific events and advisory role by Recordati, EISAI, MSD, Merck Serono, Bayer, Ipsen, Astellas, Johnson & Johnson, AstraZeneca. MM served as Steering Committee member for BMS. MM received congress travel accommodation from Ipsen, Johson & Johnson and Merck Serono. (MARUZZO MARCO). UDG, financial interests, personal, advisory board: Pfizer, BMS, MSD, PharmaMar, Astellas, Bayer, Ipsen, Novartis, EISAI, Janssen; financial interests, personal, invited speaker: Roche, BMS, Clovis Oncology, AstraZeneca; financial interests, institutional, research grant: AstraZeneca, Sanofi, Roche. SC received honoraria as speaker/consultant by BMS, MSD, Ipsen, Pierre-Fabre, Novartis, Bayer and congress travel accomodation from Gentili, Recordati, BMS, MSD, Ipsen, Pierre-Fabre, Novartis, Roche. PAZ reports outside the submitted work personal fees for advisory role, speaker engagements and travel and accommodation expenses from Merck Sharp & Dohme (MSD), Astellas, Janssen, Sanofi, Ipsen, Pfizer, Novartis, Bristol Meyer Squibb, Amgen, AstraZeneca, Roche, and Bayer. MR received honoraria as a speaker/consultant by MSD, Bristol-Myers Squibb, Astrazeneca, Johnson & Johnson, Eisai, Gilead, Ipsen, Merck Serono and congress travel accommodation from Merck Serono, MSD, Johnson & Johnson, Ipsen. DG served as an advisory board for Sanofi and received consulting fee from Amgen. All other authors have declared no conflicts of interest. GP services advisory boards/consulting for Astellas, AstraZeneca, BMS, Janssen, IPSEN, Merk, MSD, Novartis, Pfizer. PR services advisory boards for MSD, AstraZeneca and Janssen. GF served as an advisory board member for Astellas, Janssen, Pfizer, Bayer, MSD, Merck and received travel accommodation from Astellas, Janssen, Bayer. DG served as an advisory board for Sanofi and received consulting fee from Amgen. All other authors have declared no conflicts of interest. SER received honoraria as a speaker at scientific events and travel accommodation from Amgen, GSK, BMS, MSD. GLB reported personal fees from Astellas, Astrazeneca, Amgen, Bayer, Merck, Pfizer. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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