Immune checkpoint inhibitors (ICIs) have been employed in the adjuvant and metastatic setting of renal cell carcinoma (RCC) treatment. Among ICIs, combined immunotherapy has the highest risk for immune-related adverse events (irAEs). We aimed to document the incidence of irAEs in RCC patients treated with nivolumab and ipilimumab as data from the European population remain limited.
We analysed data from 88 RCC patients treated with nivolumab + ipilimumab between May 2022 and June 2024 across six high-volume oncology units in Poland. We reviewed irAEs and estimated their impact on survival parameters via univariate and multivariate Cox proportional hazards regression models, along with log-rank tests.
With a median follow-up of 11.3 months, the median overall survival (OS) was not reached, whereas the median progression-free survival (PFS) was 12.8 months (6.3-19.3). A total of 74 irAEs were recorded in 50 patients. The most frequent events were endocrine (n = 20, 27%), hepatic (n = 15, 17%), general (n = 12, 13.6%), and cutaneous (n = 11, 12.5%). The occurrence of irAEs was associated with a 60% lower risk of disease progression (hazard ratio 0.44, 95% confidence interval 0.2-0.87, p = 0.018) without impacting OS and higher disease control rate (n = 45, 90% vs. n = 24, 63.2%, p = 0.004). In contrast, patients with hepatotoxicity had poorer outcomes, with a 2.6-fold greater risk of death (p = 0.05).
IrAEs may serve as a predictive factor for the efficacy of the nivolumab + ipilimumab regimen in RCC patients. Special attention is needed for hepatotoxicity, as it can significantly impact survival outcomes.
BMC cancer. 2024 Nov 15*** epublish ***
Renata Pacholczak-Madej, Artur Drobniak, Łukasz Stokłosa, Anna Bidas, Jolanta Dobrzańska, Aleksandra Grela-Wojewoda, Agnieszka Roman, Daria Tusień-Małecka, Jerzy Walocha, Paweł Blecharz, Mirosława Puskulluoglu
Department of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland. ., Department of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland., Department of Clinical Oncology, Holy Cross Cancer Center, Kielce, Poland., Department of Oncology, Jagiellonian University Medical College, Krakow, Poland., Department of Clinical Oncology, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow Branch, Krakow, Poland., Department of Clinical Oncology, Ludwik Rydygier Hospital, Krakow, Poland., Clinical and Experimental Oncology Clinic, Institute of Oncology, Karol Marcinkowski Medical University, Poznań, Poland., Department of Anatomy, Medical College, Jagiellonian University, Krakow, Poland., Department of Gynecological Oncology, Krakow Branch, Maria Sklodowska-Curie National Research Institute of Oncology, Garncarska 11 Street, Krakow, 31-115, Poland.