Overall adverse events of drugs for metastatic renal cell carcinoma: real world reporting patterns from eudra vigilance database

INTRODUCTION AND OBJECTIVE: Aim of our study was to analyze adverse events (AEs) associated with drugs approved for the treatment of metastatic renal cell carcinoma reported in the eudra-vigilance database METHODS: Eudra-Vigilance (EV) database is the system for managing and analyzing information on suspected adverse reactions to medicines which have been authorized or being studied in clinical trials in the European Economic Area (EEA). AEs were analyzed for the following drugs Axitinib, Cabozantinib, Ipilimumab, Nivolumab, Pazopanib, Pembrolizumab and Sunitinib up to September 2019.Adverse events were evaluated for different age groups (<65 vs 65-85 vs >85 years) and by severity.Pooled Relative Risk (PRR) were used to compare data RESULTS: Overall more than 90% of AEs reported in the EV database are defined as serious. Adverse events are reported in table 1. Axitinib treatment resulted in 1620/9503 (17%) fatal events, older patients presented a higher risk of cardiac disorders (PRR=2,05-2,99, p=0,01) and of ear and labyrinth disorders (PRR=4,8-5,94,p=0,01). Cabozantinib treatment resulted in 233/3226 (7%) fatal events, older patients presented a higher risk of nervous system (PRR=2,15-3,29,p=0,01) and psychiatric disorders (PRR=4,44-6,24,p=0,01). Ipilimumab treatment resulted in 2094/18085 (12%) fatal events, older patients presented a higher risk of gastrointestinal disorders (PRR=1,17-1,47,p=0,01). Nivolumab treatment resulted in 6851/46750 (15%) fatal events, older patients presented a higher risk of musculoskeletal disorders (PRR=1,40-1,60,p=0,01). Pazopanib treatment resulted in 2911/18658 (16%) fatal events, older patients presented a higher risk of gastrointestinal disorders (PRR=3,05-4,99, p=0,01) Pembrolizumab treatment resulted in 3428/24442 (14%) fatal events, older patients presented a higher risk of ear disorders (PRR=3,68-4,25,p=0,01) while a lower risk of blood disorders (PRR=0,51-0,83,p=0,01). Sunitinib treatment resulted in 11001/63749 (17%) fatal events, older patients presented a higher risk of psychiatric disorders (PRR=2,25-3,02,p=0,01) CONCLUSIONS: Real life data suggest several and severe AEs in patients treated with drugs for metastatic kidney cancer. Frail elderly patients (>85 years) presented a different AEs profile when compared to younger patients