Adverse Events Related to Abiraterone and Enzalutamide Treatment

[Balsam01]

TAKE-HOME MESSAGE

•The aim of this study was to analyze adverse events (AEs) associated with enzalutamide and abiraterone using real-life data from a European database. More than 90% of the reported AEs were defined as serious for both drugs. Older patients (>85 and 65–85 years) treated with abiraterone or enzalutamide were at increased risk of cardiac, infectious, metabolic, and respiratory disorders compared with younger patients (<65 years). According to phase III studies, the most frequent AEs in patients treated with abiraterone were hepatobiliary disorders, whereas the most frequent AEs in patients treated with enzalutamide were psychiatric and vascular disorders.

•Based on these data, real-world AEs of oral oncolytics in prostate cancer appear to be different than those in clinical trial data. Clinicians should consider these data when treating cancer patients with abiraterone and enzalutamide.

– Gautam Jayram, MD

BACKGROUND

Data from clinical trials do not always provide adequate information to judge the impact of new treatments when used in a real-world setting. The aim of our study was to analyze adverse events (AEs) associated with enzalutamide (ENZ) and abiraterone (ABI) using real-life data from the EudraVigilance (EV) database.

METHODS

The EV database is the system for managing and analyzing information on suspected adverse reactions to medicines, which have been authorized or are being studied in clinical trials in the European Economic Area. We recorded the number of AEs for ABI and ENZ per category and severity from January 2013 to January 2019. In addition, we recorded AEs per age group. A meta-analysis of AEs reported in registrational phase III studies (AFFIRM, PREVAIL, COU-AA) was performed.

RESULTS

The number of individual cases identified in EV database was 13,562 for ABI and 40,599 for ENZ. Over 90% of the reported AEs were defined as serious for both drugs. Older patients (>85 years and 65-85 years) treated with ABI or ENZ are at increased risk of cardiac, infectious, metabolic, and respiratory disorders when compared with younger patients (<65). According to registrational phase III studies, the most frequent AEs in patients treated with ABI are hepatobiliary disorders, while the most frequent AEs in patients treated with ENZ are psychiatric and vascular disorders. Several AEs present in the EV database are not reported in the registrational phase III studies. It is important to note that we have no information on the number of patients under treatment in the EV database.

CONCLUSIONS

The EV database highlights several AEs that are not reported in registrational phase III studies as well as different AEs profiles according to age. Clinicians should consider these data when treating patients with castration-resistant prostate cancer with ABI or ENZ.

Prostate Cancer and Prostatic Diseases

Adverse Events Related to Abiraterone and Enzalutamide Treatment: Analysis of the EudraVigilance Database and Meta-Analysis of Registrational Phase III Studies

Prostate Cancer Prostatic Dis. 2020 Jun 01;23(2)199-206, C De Nunzio, R Lombardo, G Tema, O Voglino, A Sica, V Baldassarri, A Nacchia, R Iacovelli, S Bracarda, A Tubaro

[Hidden]

The problem for many of us is that we need these drugs to survive. We are kind of stuck between a rock and hard place because we have to take the chance that there might be some adverse effects rather than die.

Just speaking for myself, I have had no adverse effects from Abiraterone and it has kept my PSA down to undetectable for 2 years now.

And I'd also like to say to anyone reading this: If you need these drugs, discuss these things with your doctor, but don't be intimidated by what you read here.

[Balsam01 in reply to Hidden]

Thanks. My intent in posting stuff is for informational purposes only. To help build the library on this forum. I don't comment on posts because I don't know enough to comment. I appreciate your insights and enjoy reading your comments.

[immunity1]

Looks like a useful summary for reference. Thanks. R