Prognostic value of systemic inflammatory markers in avelumab maintenance for advanced urothelial carcinoma: the multicentric SAILOR analysis

Systemic inflammatory indices have been proposed as prognostic biomarkers in several malignancies; however, their role in patients receiving avelumab maintenance for advanced urothelial carcinoma (aUC) remains poorly defined. This study aimed to evaluate the prognostic impact of inflammatory markers in this context and to develop a composite score for outcome stratification. We retrospectively analyzed patients with aUC who were treated with avelumab maintenance therapy. Systemic inflammatory markers - including the neutrophil-to-lymphocyte ratio (NLR), neutrophil-to-eosinophil ratio (NER), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte ratio (PLR), and the systemic immune-inflammation index (SII) - were collected at baseline and after treatment initiation (cycle 3), and changes from baseline to cycle three were analyzed (increase versus stability/decrease). Overall survival (OS), the primary endpoint, was evaluated using Kaplan-Meier and Cox models. A prognostic score was created from the multivariable analysis. Time-dependent Receiver operating characteristics (ROC) analysis was employed to evaluate model discrimination at 6, 12, and 24 months. The prognostic impact on disease control rate (DCR - secondary endpoint) was assessed using logistic regression and ROC curves. A total of 358 patients were included in the study. In the multivariable analysis, high NLR, high NER, low LMR, increasing NLR trend, bone and liver metastases were independently associated with worse OS. These variables were incorporated into a 0-6 point prognostic score, which demonstrated good discrimination (C-index 0.76; AUC at 6, 12, and 24 months: 0.87, 0.75, and 0.73, respectively). The score remained prognostic across subgroups and following sensitivity analyses. High LMR, low NER, the absence of liver metastases, and the absence of bone metastases were independently associated with higher DCR. A response-associated score combining these variables showed a decreasing DCR from 69% (score 0) to 25% (score 4). Baseline and dynamic inflammatory markers may serve as prognostic factors for OS in patients with aUC undergoing avelumab maintenance therapy. A composite score that integrates laboratory and clinical features could allow for clinically meaningful stratification of survival and response outcomes, with potential applications in clinical practice. However, a prospective evaluation is necessary.

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Journal
Scientific Reports
Published
2026-06-17
DOI
https://doi.org/10.1038/s41598-026-56672-6
Primary Topic
Inflammatory Biomarkers in Disease Prognosis
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article
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article

Prognostic value of systemic inflammatory markers in avelumab maintenance for advanced urothelial carcinoma: the multicentric SAILOR analysis

Francesco Ciccimarra, Lorenzo Antonuzzo, Martina Catalano, Massimo Di Maïo et al.
Scientific Reports
Inflammatory Biomarkers in Disease Prognosis
article

Prognostic value of systemic inflammatory markers in avelumab maintenance for advanced urothelial carcinoma: the multicentric SAILOR analysis

Francesco Ciccimarra, Lorenzo Antonuzzo, Martina Catalano, Massimo Di Maïo, Martina Fanelli, Linda Cerbone, Matteo Santoni, Michela Roberto, Francesca Vignani, Marco Maruzzo, Marco Pisino, Michele Dionese, Maria Cossu Rocca, Giandomenico Roviello, Gian Paolo Spinelli, Vincenza Conteduca, Simona Secondino, Antonio Doronzo, Mimma Rizzo, Sara Elena Rebuzzi, Palma Fedele, Daniele Galanti, Valentina Guadalupi, Federico Paolieri, Brigida Anna Maiorano, Antonello Veccia, Mariella Sorarů, Alessia Cavo, Pierangela Sepe, Elisabetta Gambale, Daniele Santini, Alessia Mennitto, Marco Messina, Alessandro Rizzo, Roberto Filippi, Carlo Messina, Vincenzo Emanuele Chiuri, Andrea Necchi, Francesco Pierantoni
article en

Abstract

Systemic inflammatory indices have been proposed as prognostic biomarkers in several malignancies; however, their role in patients receiving avelumab maintenance for advanced urothelial carcinoma (aUC) remains poorly defined. This study aimed to evaluate the prognostic impact of inflammatory markers in this context and to develop a composite score for outcome stratification. We retrospectively analyzed patients with aUC who were treated with avelumab maintenance therapy. Systemic inflammatory markers - including the neutrophil-to-lymphocyte ratio (NLR), neutrophil-to-eosinophil ratio (NER), lymphocyte-to-monocyte ratio (LMR), platelet-to-lymphocyte ratio (PLR), and the systemic immune-inflammation index (SII) - were collected at baseline and after treatment initiation (cycle 3), and changes from baseline to cycle three were analyzed (increase versus stability/decrease). Overall survival (OS), the primary endpoint, was evaluated using Kaplan-Meier and Cox models. A prognostic score was created from the multivariable analysis. Time-dependent Receiver operating characteristics (ROC) analysis was employed to evaluate model discrimination at 6, 12, and 24 months. The prognostic impact on disease control rate (DCR - secondary endpoint) was assessed using logistic regression and ROC curves. A total of 358 patients were included in the study. In the multivariable analysis, high NLR, high NER, low LMR, increasing NLR trend, bone and liver metastases were independently associated with worse OS. These variables were incorporated into a 0-6 point prognostic score, which demonstrated good discrimination (C-index 0.76; AUC at 6, 12, and 24 months: 0.87, 0.75, and 0.73, respectively). The score remained prognostic across subgroups and following sensitivity analyses. High LMR, low NER, the absence of liver metastases, and the absence of bone metastases were independently associated with higher DCR. A response-associated score combining these variables showed a decreasing DCR from 69% (score 0) to 25% (score 4). Baseline and dynamic inflammatory markers may serve as prognostic factors for OS in patients with aUC undergoing avelumab maintenance therapy. A composite score that integrates laboratory and clinical features could allow for clinically meaningful stratification of survival and response outcomes, with potential applications in clinical practice. However, a prospective evaluation is necessary.

Scientific Reports
University of Foggia (IT), Università degli Studi del Piemonte Orientale “Amedeo Avogadro” (IT), University of Udine (IT), AOL (United States) (US), Vita-Salute San Raffaele University (IT), Policlinico Umberto I (IT), CTO Hospital (IT), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), Ospedale Santa Chiara (IT), Istituto di Istruzione Secondaria Superiore "V. Lilla" Francavilla Fontana - Oria (IT), Azienda Universitaria Ospedaliera Consorziale - Policlinico Bari (IT), Ospedale di Rivoli (IT), Ospedale Sacro Cuore Don Calabria (IT), Ospedale San Carlo (IT), Azienda Ospedaliero Universitaria Ospedali Riuniti (IT), Istituto Oncologico Veneto (IT), Azienda Ospedaliero-Universitaria Careggi (IT), Ospedale Santa Maria (IT), Azienda Ospedaliero Universitaria Maggiore della Carita (IT), A. O. Ordine Mauriziano di Torino (IT), Istituto Tumori Bari (IT), National Cancer Institute (MY), Policlinico San Matteo Fondazione (IT), Ospedale Vito Fazzi (IT), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Fondazione IRCCS Istituto Nazionale dei Tumori (IT), Villa Torri Hospital (IT), Ospedale Buccheri la Ferla Fatebenefratelli (IT), Hospital of Prato (IT), Ospedale di Macerata, University of Florence (IT), University of Macerata (IT), University of Turin (IT), European Institute of Oncology (IT), Misericordia University (US), Sapienza University of Rome (IT)
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