Akademik Veri Yönetim Sistemi
ESMO 2025, Berlin, Almanya, 17 Ekim - 21 Kasım 2025, ss.1535, (Özet Bildiri)
Background: Immune checkpoint inhibitors (ICIs) have become a cornerstone in the management of various malignancies; however, their administration in solid organ transplant recipients, particularly kidney transplant patients, remains a significant clinical challenge due to the risk of acute allograft rejection. This study aimed to characterize ICI-associated kidney transplant rejection events reported in the FAERS (FDA Adverse Event Reporting System) database. Methods: A retrospective pharmacovigilance analysis was performed on reports submitted to FAERS between 2012 and March 2025. Cases describing kidney transplant rejection associated with ICIs were included. Demographic variables (age, gender), malignancy type, ICI regimen (monotherapy vs. combination with CTLA-4 inhibitors), geographic origin, reporter characteristics, reporting period (≤2019, 2020—2022, 2023—2024), and adverse event-related mortality were evaluated. Results: Among 99 reported cases, the median age was 68 years (range 40—84), with 43.4% aged ≥65. Male patients constituted the majority (63.6%). Nivolumab (54.5%) and pembrolizumab (24.2%) were the most frequently reported agents. Melanoma (41.4%) was the predominant malignancy. The proportion of combination ICI + CTLA4 use was highest in recent years: 37.5% of reports in 2023—2024 involved combination therapy, compared to 15% in 2020—2022 and 8.6% in ≤2019 (p=0.03), indicating a significant temporal increase. Melanoma was more prevalent in the combination group (84.6% vs. 34.8%, p=0.02). Adverse event-related mortality occurred in 25.3% of cases, numerically higher in monotherapy recipients (27.9% vs. 7.6%, p=0.08). Most reports originated from healthcare professionals (91.9%) and North America (44.4%). Conclusions: ICI-associated kidney transplant rejection appears most frequently with Nivolumab and Pembrolizumab, particularly in melanoma patients. Combination regimens with CTLA-4 inhibitors were more common in recent years and associated with different clinical patterns. These findings highlight the need for heightened vigilance and multidisciplinary decision-making when initiating ICIs in transplant recipients