Presentation Authors: Cosimo De Nunzio*, Giorgia Tema, Riccardo Lombardo, Olivia Voglino, Valeria Baldassarri, Fabiana Cancrini, Angela Sica, Antonio Nacchia, Andrea Tubaro, Rome, Italy
Introduction: To analyze age influence on adverse events (AEs) associated with Enzaliutamide (ENZ), Abiraterone (AAP) and Radium223. Real life data from Eudra-Vigilance.
Methods: Eudra-Vigilance 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). We explored the effect of age on AES in patients treated with AAP, ENZ and Radium223. Patients were divided in three groups by age: 85 yo, between 65 and 85 and < 65 yo. Pooled Relative Risk (PRR) were used to compare groups.
Results: Data from Eudra Vigilance indicates that AA, Radium and ENZ treatment is well tolerated with few significant differences in the different age groups. Particularly, patients with age between 65 and 85 years old treated with AAP had a statistically significant higher risk of cardiac and metabolism disorders while a lower risk of musculoskeletal, hepatobiliary and connective tissue diseases (PRR>1). As well patients 85 yo treated with AAP had a statistically significant higher risk of cardiac, general, infectious, metabolism and nutrition disorders when compared to younger patients ( < 65 yo) while a lower risk of eye and hepatobiliary disorders (PRR < 1). Patients with age between 65 and 85 yo treated with ENZ had a statistically significant higher risk of cardiac, gastrointestinal, infectious and metabolism disorders when compared to younger patients ( < 65). As well patients 85 years old treated with AAP had a statistically significant higher risk of cardiac and infectious disorders while a lower risk of gastrointestinal disorders when compared to younger patients ( < 65 yo) while a lower risk of eye disorders, hepatobiliary disorders and neoplasms (PRR < 1).
Conclusions: Real life data suggest that older patients have different AEs profiles when treated with AAP and ENZ while no real differences are seen in Radium 223 treated patients. Although Eudra vigilance data suggest an acceptable tolerability in all the three different age groups, clinicians should always consider a different AA or ENZ safety profile according to patientsâ€™ age.