Optimal treatment duration is unknown in metastatic renal cell carcinoma (mRCC) responding to immune checkpoint inhibitors (ICPIs). Prolonged treatment can lead to late toxicity, burden for day clinics and financial impact.
This multicenter retrospective study included mRCC patients responding to ipilimumab/nivolumab in first-line or nivolumab in later lines, who were treated for at least 21 months and did not stop for toxicity. Progression-free survival (PFS), overall survival (OS), and cancer-specific survival (CSS) were modeled non- and semi-parametrically. The effect of elective ICPI discontinuation (i.e. treatment interruption at the clinician's discretion) between 21 and 25 months on PFS was assessed by a causal inference approach using artificial censoring along with inverse probability of censoring weighting.
Ninety-five patients were included with a median follow-up of 62.1 (95% confidence interval [CI]: 57.3-67.5) months. Fifty-four received ipilimumab/nivolumab, whereas 41 patients received nivolumab, for a median treatment duration of 33.8 (95% CI: 28.5-39.6) months. Fifty-seven patients discontinued ICPIs electively. Three-year PFS after discontinuation was 57.1% (95% CI: 34.3-95.1), 3-year OS 67.5% (95% CI: 37.0-100.0), and 3-year CSS 90.0% (95% CI: 73.2-100.0). Fifteen (15.8%) patients discontinued ICPIs between 21 and 25 months. Compared to 80 patients who were treated longer, they had more often a metachronous metastatic pattern (p = 0.048) and a complete response (p = 0.045). Elective ICPI stop between 21 and 25 months did not significantly impact the hazard for progression/death (adjusted HR 1.08, 95% CI: 0.64-1.84, p = 0.766).
Among mRCC patients responding to ICPI, elective therapy discontinuation approximately 24 months after initiation does not appear to compromise outcomes compared to continuing therapy.
Acta oncologica (Stockholm, Sweden). 2025 Jul 30*** epublish ***
Alexander Decruyenaere, Gennigens Christine, Rottey Sylvie, Laenen Annouschka, Emmanuel Seront, Els Everaert, Philip R Debruyne, Heidi Van Den Bulck, Julie Bastin, Verbiest Annelies, Christof Vulsteke, Peter Schatteman, Daisy Luyten, Sandrine Aspeslagh, Nieves Martinez-Chanza, Marlies De Bock, Thomas Meyskens, Jolanda Verheezen, Barbara Brouwers, Benoit Beuselinck
Department of Medical Oncology, Ghent University Hospital, Gent, Belgium., Department of Medical Oncology, CHU Liège, Liège, Belgium., Biostatistics and Statistical Bioinformatics Center, Leuven, Belgium., Oncologie Médicale, UCL St-Luc, Bruxelles, Belgium., Medische Oncologie, VITAZ, St Niklaas, Belgium., Kortrijk Cancer Centre, General Hospital AZ Groeninge, Kortrijk, Belgium; Medical Technology Research Centre (MTRC), School of Allied Health and Social Care, Anglia Ruskin University, Chelmsford, UK; School of Nursing and Midwifery, University of Plymouth, Plymouth, UK., Medische Oncologie, AZ Imelda, Bonheiden, Belgium., Medische Oncologie, Heilig Hart ziekenhuis, Lier, Belgium., Department of Oncology, Multidisciplinary Oncological Center Antwerp, Antwerp University Hospital, Edegem, Belgium; Center for Oncological Research (CORE), Antwerp University, AntwerpMedische Oncologie, UZAntwerpen, Antwerpen, Belgium., Center for Oncological Research (CORE), Antwerp University, Antwerp Medische Oncologie, UZAntwerpen, Antwerpen, Belgium; Medische Oncologie, Maria Middelares ziekenhuis, Gent, Belgium., Uro Onco Unit, Urology, AZORG, Aalst, Belgium., Medische Oncologie, Jessa ziekenhuis, Hasselt, Belgium., Medische Oncologie, UZBrussel, Brussel, Belgium., Department of Medical Oncology, Institut Jules Bordet - Hôpital Universitaire de Bruxelles, Université Libre de Bruxelles (ULB), Brussels, Belgium., Medische Oncologie, AZ Delta, Roeselare, Belgium., Medische Oncologie, Klina, Brasschaat, Belgium., Medische Oncologie, Trudo Ziekenhuis, St Truiden, Belgium., Medische Oncologie, St Jan ziekenhuis, Brugge, Belgium., General Medical Oncology, University Hospital Leuven, Leuven, Belgium. .
PubMed http://www.ncbi.nlm.nih.gov/pubmed/40734572