Recent real-world studies compared effectiveness and safety of enzalutamide (ENZA) and abiraterone acetate (AA) for metastatic castration-resistant prostate cancer (mCRPC). The growing evidence needs further substantiation with long-term data. This study, the first to use German data, investigated cardiovascular (CV) event risk and overall survival (OS) in patients initiating ENZA or AA. AA (2012) and ENZA (2014) are widely used for mCRPC in Germany.
This retrospective study used data of chemotherapy-naïve patients with mCRPC on ENZA or AA (2012-2020) from two German claims databases (AOK PLUS and GWQ ServicePlus). The primary endpoint was time to first CV event (CV-related hospitalization) analyzed via a meta-analysis of Cox proportional hazard models of propensity score-matched (PSM) intention-to-treat cohorts. Other endpoints were baseline characteristics, CV event rate, number of CV events per patient, and OS.
Of 2240 patients in the total study population (ENZA, 828; AA, 1412), 796 PSM patients were included in each group. ENZA patients were older and had a higher prevalence of some comorbidities, but without meaningful differences after PSM. Further, 386 patients had ≥ 1 CV event (ENZA, 172; AA, 214). ENZA was associated with a significantly lower risk of CV events (hazard ratio [HR] 0.70, 95% confidence interval [CI] 0.57-0.86, p = 0.001, I2 = 0.0%), CV event rate (0.17 vs 0.23 per person-year; event rate ratio 0.75, 95% CI 0.61-0.92, p = 0.006; I2 = 38.0%), fewer recurrent CV events (HR 0.77, 95% CI 0.61-0.96, p = 0.024; I2 = 0.0%), and prolonged OS (HR 0.79, 95% CI 0.71-0.89, p < 0.001) than AA.
The unmatched ENZA cohort had higher average age and more comorbidities than the AA cohort, but no meaningful differences were noted after PSM. ENZA was associated with a significantly lower risk of CV events and improved OS.
This study looked at two treatments for a type of advanced prostate cancer in German patients. The treatments are called enzalutamide (ENZA) and abiraterone acetate (AA). We wanted to see which treatment was safer and more effective, especially in terms of heart-related problems and overall survival. We looked at data from patients who had not received chemotherapy and were treated with either ENZA or AA between 2012 and 2020. We compared the time it took for the first heart-related problem to occur in these patients. We also looked at the number of heart-related problems per each patient and overall survival. The study included 2240 patients (828 treated with ENZA and 1412 treated with AA). An early evaluation found that patients treated with ENZA were older and had a higher prevalence of other health problems. However, after matching the patients in each group based on certain characteristics, we found that these differences were not meaningful. Our results showed that a total of 386 patients had at least one heart-related problem after starting on ENZA or AA. We found that patients treated with ENZA had a lower risk of heart-related problems and lived longer than those treated with AA. In conclusion, even though patients treated with ENZA were older and had more health problems, they had a lower risk of heart-related problems.
Advances in therapy. 2025 Mar 02 [Epub ahead of print]
Axel S Merseburger, Eugen Dornstauder, Carsten-Henning Ohlmann, Armen Aprikian, Sophia Junker, Philipp Hahn, Andrew Chilelli, Matthias Stoelzel, Alexis Serikoff, Stefan G Spitzer
Department of Urology, University Hospital Schleswig-Holstein, Lübeck, Germany. ., Astellas Pharma GmbH, Munich, Germany., Department of Urology, Johanniter Hospital Bonn, Bonn, Germany., Division of Urology, Department of Surgery, McGill University, Montreal, Canada., Cytel Inc., Berlin, Germany., Institute for Pharmacoeconomics and Medication Logistics (IPAM), Wismar, Germany., Astellas Pharma Europe, Addlestone, UK., Astellas Pharma B.V., Leiden, The Netherlands., Praxisklinik Herz und Gefäße Dresden, Akademische Lehrpraxisklinik der TU Dresden, Dresden, Germany.