Abiraterone acetate plus Prednisone/Prednisolone compared with Enzalutamide in metastatic castration resistant prostate cancer before or after chemotherapy: A retrospective study of real-world data (ACES)

Prantik Das; Sarah Taylor; James Price; Michael Jones; Cristina Martin-Fernandez; Akram Ali; Thangrarajh Mugunthan; Chandrani Mallik; Colin Ward

doi:10.1002/bco2.11

Abiraterone acetate plus Prednisone/Prednisolone compared with Enzalutamide in metastatic castration resistant prostate cancer before or after chemotherapy: A retrospective study of real-world data (ACES)

BJUI Compass. 2020 Mar 27;1(1):21-31. doi: 10.1002/bco2.11. eCollection 2020 Mar.

Authors

Prantik Das^{1

2}, Sarah Taylor¹, James Price¹, Michael Jones¹, Cristina Martin-Fernandez³, Akram Ali¹, Thangrarajh Mugunthan¹, Chandrani Mallik¹, Colin Ward¹

Affiliations

¹ University Hospitals of Derby NHS Trust Derby UK.
² School of Medicine University of Nottingham Derby UK.
³ Janssen-Cilag Limited High Wycombe UK.

PMID: 35474912
PMCID: PMC8988641
DOI: 10.1002/bco2.11

Abstract

Background: Abiraterone acetate combined with Prednisone/Prednisolone (AA+P) and Enzalutamide (ENZ) have proven survival benefit in men with metastatic castration-resistant prostate cancer (mCRPC) in chemotherapy-naïve and prior chemotherapy patients. There have been no studies directly comparing the effectiveness of ENZ to AA+P in mCRPC patients.

Methods: A retrospective, survival analysis study of 143 real-world mCRPC patients (90 in AA+P and 53 in ENZ group) was conducted. Patients who started their treatment between February 2012 and May 2016 were included. The primary end point was biochemical progression-free survival (bPFS). Secondary end points were radiological progression-free survival (rPFS) and overall survival (OS). Toxicity data were also collected. Data were analyzed using Cox proportional hazards (PH) models, adjusting for covariates: prior radical treatment; Gleason score; prostate-specific antigen; age; and chemotherapy naïve or not.

Results: After median follow-up of 15 months (interquartile range 7 to 23), 112 events of biochemical progression were observed (71 in AA+P and 41 in ENZ). About 41% in AA+P group and 30% patients in ENZ group received prior chemotherapy. The chance of biochemical progression was significantly lower among ENZ patients than AA+P patients, when adjusting for all covariates in the Cox PH model (hazard ratio [HR] 0.54, 95% confidence interval [CI] 0.35 to 0.82, P = .004). There was a trend implying the chance of rPFS could be higher among ENZ patients than AA+P patients (HR 1.24, 95% CI 0.76 to 2.02, P = .4). There is no difference in OS between ENZ and AA+P patients, when adjusting for all covariates in the Cox PH model (HR 0.91, 95% CI 0.59 to 1.41, P = .7). About 38% of ENZ patients reported fatigue compared to 16% of AA+P patients, while hypertension was reported slightly more in AA+P patients.

Conclusions: This study showed a statistically significant difference in bPFS, favoring ENZ, but no significant difference in rPFS or OS.

Keywords: Enzalutamide; abiraterone; castrate resistant; overall survival; progression free survival; prostate cancer.