Adverse Events after Nivolumab and Ipilimumab Combined Immunotherapy in Advanced Renal Cell Carcinoma: A Multicentre Experience in Poland - Beyond the Abstract
However, the potential of immune-related adverse events (irAEs) to serve as biomarkers for treatment efficacy has yet to be fully explored, especially within real-world settings. Our multicenter study in six high-volume referral oncology centers across Poland offers new insights into this area. With a focus on a predominantly Caucasian population, this investigation addresses the existing gap in the literature, as most real-world data on irAEs in RCC patients treated with immunotherapy originate from Japanese centers. Differences in genetic, environmental, and healthcare-related factors between populations underscore the importance of such research. With a median follow-up of 11.3 months, our results reveal critical insights. The occurrence of irAEs correlated with improved progression-free survival (15.5 months vs. 7.2 months, p=0.015) and a higher disease control rate (90% vs. 63%, p=0.004).
Conversely, hepatotoxicity emerged as a major challenge, associated with a 2.6-fold increased risk of death (p=0.05) and the highest treatment discontinuation rate among all irAEs.Notably, 56.8% of patients experienced irAEs, predominantly endocrine (27%) and hepatic (17%). Most irAEs were mild or moderate, and immunosuppressive therapies, primarily steroids, effectively managed these toxicities. Nevertheless, hepatotoxicity underscores the need for heightened vigilance and timely intervention. Our findings highlight key differences from existing studies in Japanese cohorts, where higher rates of endocrine and cutaneous irAEs were reported, and further validate the hypothesis that irAEs may predict immunotherapy efficacy. However, the complex interplay between irAEs and survival outcomes, particularly overall survival, underscores the multifactorial nature of patient prognosis.
Further research, especially prospective studies, is warranted to confirm these observations and refine the management of irAEs in clinical practice. In conclusion, irAEs hold promise as predictive markers for the efficacy of combined immunotherapy in advanced RCC. However, differences between populations and the management of specific toxicities, such as hepatotoxicity, remain critical to optimizing patient outcomes.
Written by: Renata Pacholczak-Madej, MD, PhD, Department of Chemotherapy, The District Hospital, Sucha Beskidzka, Poland; Department of Gynecological Oncology, Krakow Branch, Maria Sklodowska-Curie National Research Institute of Oncology, Krakow, Poland; Department of Anatomy, Medical College, Jagiellonian University, Krakow, Poland
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