Radical or partial nephrectomy followed by adjuvant pembrolizumab is the standard of care for high-risk localized renal cell carcinoma (RCC), yet around 40% of patients relapse within 5 years. We investigated patterns of disease recurrence and the clinical management of RCC patients treated with adjuvant immunotherapy.
We collected patients with high-risk RCC who received adjuvant immunotherapy after radical surgery in our Institution. The primary endpoint was the rate and pattern of disease recurrence. Secondary endpoints were disease-free survival (DFS), overall survival (OS), post-progression survival (OS2) and treatments at recurrence.
From March 2018 to September 2025, 70 patients were included, most received adjuvant pembrolizumab (71%), followed by nivolumab + ipilimumab (16%), and nivolumab monotherapy (13%). 15 patients (21%) experienced recurrence, including 7 (10%) who relapsed on adjuvant treatment. Oligometastatic disease was observed in 10 cases (67%), mainly involving lung (60%), lymph nodes (33%) and renal bed (13%). At recurrence, 9 patients (60%) started first-line therapy, while 5 patients (33%) received loco-regional treatments. After a median follow-up of 30.2 months, 30-month DFS and OS rates were 74% and 94%, respectively, in the overall population. Among patients who progressed, the 24-month OS2 rate was 100% after local therapy alone and 86% with systemic therapy.
High-risk RCC patients treated with adjuvant immunotherapy remain at considerable risk of relapse, frequently with oligometastatic disease. Excellent post-progression outcomes after loco-regional treatment support a multidisciplinary, metastasis-directed approach to recurrence after adjuvant immunotherapy.
Cancer immunology, immunotherapy : CII. 2026 Feb 25*** epublish ***
Chiara Ciccarese, Denis Occhipinti, Daniela Arduini, Davide Di Leo, Alessio Neri, Luigi Roca, Gloria Messina, Paola Troisi, Romina Rose Pedone, Maria Antonia Fucile, Rachele Belletto, Valeria Sardaro, Chiara Ligato, Rexhina Ajdhoni, Fabiana Caliciotti, Chiara Sighinolfi, Luca Tagliaferri, Bernardo Rocco, Giampaolo Tortora, Roberto Iacovelli
Medical Oncology, Department of Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. ., Department of Traslational Medicine and Surgery, Università Cattolica del Sacro Cuore, Rome, Italy., Urology Unit, Department of Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Department of Diagnostic Imaging and Radiation Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy., Medical Oncology, Department of Medical and Surgical Sciences, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/41739194