Elevated hernia risk in renal cell carcinoma (RCC) patients treated with tyrosine kinase inhibitors (TKIs): A FAERS analysis.

Abstract

e16542 Background: TKIs are the cornerstone of targeted therapy for RCC. However, TKIs may increase the risk of hernia development or complications due to their potential impact on wound healing. This study investigates the association between TKI use and hernia incidence in patients with RCC using the FDA Adverse Event Reporting System (FAERS). Methods: We conducted a retrospective analysis of FAERS data from 2004 to 2024 using the AERS Mine framework. . Reports mentioning both RCC and TKI use were identified, specifically focusing on sunitinib, pazopanib, axitinib, cabozantinib, lenvatinib, bevacizumab, and tivozanib. All hernia terms included except for brain hernia, spinal cord hernia and diaphragmatic hernia. Standard pharmacovigilance metrics and two-way ANOVA testing were used to determine hernia association with TKIs and assess statistical significance across treatment groups. Disproportionality analysis, using the reporting odds ratio (ROR) and its 95% confidence interval (CI), evaluated the association between TKI use and hernia occurrence. Results: Our analysis included a total of 87,593 RCC patients. Of these, 61,128 (70%) were exposed to TKIs, while 26,465 (30%) were not. A total of 272 hernia events were reported across the entire cohort. In the TKI-exposed group, 218 patients (0.36%) experienced hernias. In contrast, the non-TKI exposed group had 54 patients (0.2%) with hernia events. This difference was statistically significant (p < 0.05), suggesting a potential association between TKI exposure and increased hernia incidence (OR: 1.75048, p = 0.000152, 95% CI: 1.2990 - 2.3588). Further analysis within the TKI-exposed group revealed that incisional hernias were less frequent (0.04%) compared to non-incisional hernias (0.11%; OR: 0.3997, p < 0.0001, CI:0.2536 - 0.6300) and unspecified hernias (0.12%; OR: 0.36, p < 0.0001, CI: 1.7695 - 4.3401). We did not observe this same pattern in the non-TKI exposed group. Conclusions: Our FAERS analysis suggests a potential association between TKI use and increased hernia risk in patients with RCC. Further investigation using observational studies is crucial to confirm this association and explore underlying mechanisms. Future research should focus on validating these findings, elucidating the biological mechanisms involved, identifying risk factors, and developing clinical guidelines for hernia prevention and management in this patient population. This knowledge will ultimately contribute to optimizing the care and outcomes of RCC patients receiving TKI therapy. TKI no TKIs (control) OR p CI Total 61,128 (%) 26,465 - - - Hernia 218 (0.36) 54 (0.2) 1.75 0.00015 (1.2990,2.3588) Hernia nos 72 (0.12) 11 (0.04) 2.84 0.00045 (1.5033, 5.3495) Incisional hernia 26 (0.04) 13 (0.05) 0.8657 ns (0.4448, 1.6850) Non-incisional hernia 65 (0.11) 28 (0.11) 1.005 ns (0.64514, 1.5656) RCC patients with and without TKIs.