Abstract
Introduction
The purpose of this study was to investigate the association between baseline androgen concentrations and outcomes in men with metastatic castration-resistant prostate cancer (mCRPC) treated with first-line enzalutamide or abiraterone acetate plus prednisone (AAP).
Materials and Methods
We previously randomized men with mCRPC to enzalutamide or AAP to compare side-effects and measured androgen concentrations. In this post-hoc analysis, patients were grouped in quartiles (Q) based on their serum androgen values. Kaplan-Meier and Cox regression were used to analyze progression-free and overall survival for baseline androgen groups, treatment subgroups and their interaction. The trial was registered at clinicaltrialsregister.eu (2017-000099-27).
Results
Eighty-four patients received enzalutamide and 85 AAP. Overall, higher (Q4) compared with lower (Q1) baseline serum testosterone was associated with longer progression-free survival (24.8 vs. 10.7 months, hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.33; 0.84) and overall survival (52.8 vs. 31.5 months, HR 0.49, 95% CI 0.28; 0.85). The risk reduction in death seemed to be treatment dependent (treatment subgroup interaction P = .04). For men in the AAP subgroup, the Q4 compared with Q1 group had a significant lower risk of death (HR 0.30, 95% CI 0.13; 0.73), while no difference was found for enzalutamide (HR 0.77, 95% CI 0.35; 1.69). Similar results were found for the other androgens.
Conclusion
Pre-treatment serum testosterone levels may be a clinically useful biomarker for predicting mCRPC treatment responses and guiding treatment selection.
The purpose of this study was to investigate the association between baseline androgen concentrations and outcomes in men with metastatic castration-resistant prostate cancer (mCRPC) treated with first-line enzalutamide or abiraterone acetate plus prednisone (AAP).
Materials and Methods
We previously randomized men with mCRPC to enzalutamide or AAP to compare side-effects and measured androgen concentrations. In this post-hoc analysis, patients were grouped in quartiles (Q) based on their serum androgen values. Kaplan-Meier and Cox regression were used to analyze progression-free and overall survival for baseline androgen groups, treatment subgroups and their interaction. The trial was registered at clinicaltrialsregister.eu (2017-000099-27).
Results
Eighty-four patients received enzalutamide and 85 AAP. Overall, higher (Q4) compared with lower (Q1) baseline serum testosterone was associated with longer progression-free survival (24.8 vs. 10.7 months, hazard ratio [HR] 0.52, 95% confidence interval [CI] 0.33; 0.84) and overall survival (52.8 vs. 31.5 months, HR 0.49, 95% CI 0.28; 0.85). The risk reduction in death seemed to be treatment dependent (treatment subgroup interaction P = .04). For men in the AAP subgroup, the Q4 compared with Q1 group had a significant lower risk of death (HR 0.30, 95% CI 0.13; 0.73), while no difference was found for enzalutamide (HR 0.77, 95% CI 0.35; 1.69). Similar results were found for the other androgens.
Conclusion
Pre-treatment serum testosterone levels may be a clinically useful biomarker for predicting mCRPC treatment responses and guiding treatment selection.
| Originalsprog | Engelsk |
|---|---|
| Artikelnummer | 102200 |
| Tidsskrift | Clinical Genitourinary Cancer |
| Vol/bind | 22 |
| Udgave nummer | 6 |
| Antal sider | 8 |
| ISSN | 1558-7673 |
| DOI | |
| Status | Udgivet - 2024 |
Bibliografisk note
Funding Information:This trial was mainly supported by funding from Copenhagen University Hospital, Herlev and Gentofte . Additional grants were received from the following independent foundations: Scandinavian Prostate Cancer Group research fund, Herlev and Gentofte internal research fund, \u2018Torben og Alice Frimodts\u2019 foundation, and \u2018Christina Larsen og Dommer Ellen Larsen\u2019 Scholarship. None of the grant providers had any role in design and conduct of the study, collection of data, management of the data, analysis, interpretation of the data, preparation, review or approval of the manuscript. Treatment with enzalutamide and AAP was financed through the Danish healthcare system as per the standard of care.
Funding Information:
This trial was mainly supported by funding from Copenhagen University Hospital, Herlev and Gentofte. Additional grants were received from the following independent foundations: Scandinavian Prostate Cancer Group research fund, Herlev and Gentofte internal research fund, \u201CTorben og Alice Frimodts\u201D foundation, and \u2018Christina Larsen og Dommer Ellen Larsen\u2019 Scholarship. None of the grant providers had any role in design and conduct of the study, collection of data, management of the data, analysis, interpretation of the data, preparation, review or approval of the manuscript. Treatment with enzalutamide and AAP was financed through the Danish healthcare system as per the standard of care.
Publisher Copyright:
© 2024 The Author(s)