Toxicity‐related immunotherapy discontinuation and outcome in patients with advanced renal cell carcinoma treated with immune‐based combinations ( <scp>ARON</scp> ‐1 study)
(2025) International Journal of Cancer — Vol. 158, n° 5, p. 1396-1405 (2025)
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Intl Journal of Cancer - 2025 - Molina%E2%80%90Cerrillo - Toxicity%E2%80%90related immunotherapy discontinuation and outcome in patients.pdf
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- Authors
Molina‐cerrillo, Javier 
Roviello, Giandomenico
- Abstract
- The advent of immunotherapy (IO) has revolutionized the therapeutic landscape of advanced renal cell carcinoma (RCC). The aim of this study is to analyze clinical outcomes in patients who discontinued IO in metastatic RCC first line in a real-world setting. We retrospectively collected data about 1077 patients aged ≥18 years with a histologically confirmed diagnosis of clear cell RCC and histologically or radiologically confirmed metastatic disease, treated in 52 centers from 20 countries, between January 1, 2016 and April 1, 2024, from all three International metastatic renal cell carcinoma (mRCC) Database Consortium risk groups (favorable, intermediate, and poor). Each patient was treated in front-line with IO + Tirosine Kinase Inhibitor or IO + IO combinations. In this study we analyzed survival outcomes comparing patients who interrupted IO versus patients who continuously received it and multivariable analysis. We analyzed the clinical behavior of 185 patients who interrupted IO treatment due to SAE, 127 patients with IO-tyrosine kinase inhibitor, 58 patients with IO–IO versus 892 patients who do not discontinue IO treatment. No significant differences in OS were found in patients who discontinue treatment versus no discontinuation. Moreover, time to discontinuation seemed to be an OS predictor, being inferior in patients who interrupted IO in the first to third month versus patients who discontinued treatment after this time data. The ARON-1 study offers a comprehensive examination of toxicity-related IO discontinuation in advanced RCC, contributing to a better understanding of balancing treatment efficacy with tolerability.
- Affiliations
Hospital Ramón y Cajal, Madrid Department of Medical Oncology University of Florence Department of Health Sciences, Section of Clinical Pharmacology and Oncology Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran, Mexico City Department of Hemato-Oncology Escuela de Medicina, Mexico City Universidad Panamericana Palacký University, Olomouc, Czech Republic Department of Oncology, Faculty of Medicine and Dentistry Charles University, Pilsen, Czech Republic Department of Oncology and Radiotherapeutics, Faculty of Medicine and University Hospital in Pilsen Charles University, Pilsen, Czech Republic Biomedical Center, Faculty of Medicine in Pilsen San Camillo Forlanini Hospital, Rome, Italy Department of Medical Oncology Maria Sklodowska-Curie National Research Institute of Oncology, Warsaw, Poland Department of Uro-Oncology Tawam Hospital, Al Ain, UAE Medical Oncology Grande Ospedale Metropolitano Niguarda, Milan, Italy Medical Oncology, Niguarda Cancer Center NHS Foundation Trust Royal Marsden NHS Foundation Trust, London, UK University Hospital of Parma, Parma, Italy Medical Oncology Unit University of Parma, Parma, Italy Department of Medicine and Surgery Ankara University Faculty of Medicine, Ankara, Türkiye Department of Medical Oncology AORN“A. Cardarelli”, Naples, Italy Department of Medical Oncology University of Kansas Cancer Center, Westwood, Ksansas, USA Division of Medical Oncology, Department of Internal Medicine Tampere University, Tampere, Finland Department of Oncology, Tampere University Hospital, Tampere Cancer Center, Faculty of Medicine and Health Technology Sungkyunkwan University Samsung Medical Center, Seoul, South Korea Department of Hematology and Oncology Azienda Ospedaliera Universitaria Consorziale Policlinico di Bari, Bari, Italy Medical Oncology Unit Carol Davila University of Medicine and Pharmacy, Bucharest, Romania Department of Oncology-Radiotherapy, Prof. Dr. Alexandru Trestioreanu Institute of Oncology Pesaro y Urbino, Italy Azienda Ospedaliera“Ospedali Riuniti Marche Nord” Saint Joseph University of Beirut, Beirut, Lebanon Hematology-Oncology Department, Faculty of Medicine University“Politecnica delle Marche”, Ancona, Italy Anatomic Pathology, Department of Biomedical Sciences and Public Health LACOG, Porto Alegre, Brazil Latin American Cooperative Oncology Group Hospital Israelita Albert Einstein, Sao Paulo, SP, Brazil Oncology Unit IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy Medical Oncology University of Bologna, Bologna, Italy Department of Medical and Surgical Sciences (DIMEC) Hospital Sírio Libanês, Brasília, Brazil Oncology and Hematology Department MD Anderson Cancer Center Madrid, Madrid, Spain Department of Medical Oncology University of Bari“Aldo Moro”, Bari, Italy Chair of Oncology, Interdisciplinary Department of Medicine Azienda Ospedaliera Santa Maria, Terni, Italy Medical Oncology Macerata Hospital, Macerata, Italy Medical Oncology Unit
Citations
Molina‐cerrillo, J., Roviello, G., Bourlon, M., Studentova, H., Fiala, O., Cerbone, L., Kucharz, J., Ansari, J., Zeppellini, A., Taha, T., Buti, S., Ürün, Y., Scagliarini, S., Li, H., Sunela, K., Park, S., Rizzo, M., Zgura, A., Chiari, R., & Seront, E. (2025). Toxicity‐related immunotherapy discontinuation and outcome in patients with advanced renal cell carcinoma treated with immune‐based combinations ( <scp>ARON</scp> ‐1 study). International Journal of Cancer, 158(5), 1396-1405. https://doi.org/10.1002/ijc.70228 (Original work published 2025)