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Comparative Study
. 2025 Jul;14(7):e250023.
doi: 10.57264/cer-2025-0023. Epub 2025 May 9.

Overall survival in patients with metastatic castration-sensitive prostate cancer treated with apalutamide versus abiraterone acetate: a head-to-head analysis of real-world patients in the USA

Benjamin Lowentritt  1 , Mehmet A Bilen  2 , Ibrahim Khilfeh  3 , Carmine Rossi  4 , Shawn Du  3 , Frederic Kinkead  4 , Lilian Diaz  4 , Dominic Pilon  4 , Lorie Ellis  3 , Neal D Shore  5
Affiliations
Comparative Study

Overall survival in patients with metastatic castration-sensitive prostate cancer treated with apalutamide versus abiraterone acetate: a head-to-head analysis of real-world patients in the USA

Benjamin Lowentritt et al. J Comp Eff Res. 2025 Jul.

Abstract

Aim: Head-to-head studies of survival outcomes associated with different androgen receptor pathway inhibitor (ARPI) treatments for metastatic castration (hormone)-sensitive prostate cancer have not been conducted. The purpose of this study was to compare 24-month overall survival among ARPI-naive patients with metastatic castration-sensitive prostate cancer (mCSPC) who initiated apalutamide or abiraterone acetate. Materials & methods: Linked de-identified clinical and claims healthcare databases were used to compare overall survival between patients with mCSPC initiating apalutamide or abiraterone acetate treated in community-based urology practices in the USA. Overall survival at 24 months post-treatment initiation (primary analyses) was compared between apalutamide and abiraterone acetate initiators using weighted Cox proportional hazards models (exploratory analyses used all available follow-up). Results: Overall, 1879 and 2073 patients had initiated apalutamide or abiraterone acetate, respectively (both cohorts: weighted mean age 72 years, 62% were white, and 66% had bone metastasis). At 24 months post-index, patients in the apalutamide cohort had a 26% lower risk of mortality compared with those in the abiraterone acetate cohort (hazard ratio: 0.74; 95% confidence interval: 0.59, 0.93; p = 0.010), with the difference maintained when outcomes were evaluated using all available follow-up (hazard ratio: 0.72; 95% confidence interval: 0.59, 0.88; nominal p < 0.001). Conclusion: In this nationally representative, real-world head-to-head analysis of nearly 4000 ARPI-naive patients with mCSPC, apalutamide was associated with a 26% reduction in the risk of mortality compared with abiraterone acetate by 24 months post-treatment initiation.

Keywords: androgen receptor pathway inhibitors; comparative effectiveness research; prostatic neoplasms.

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Conflict of interest statement

Competing interests disclosure

B Lowentritt is an employee of Chesapeake Urology and has received consulting fees from Johnson & Johnson, Dendreon, Astellas Pharma, Bayer, AstraZeneca/MedImmune, Merck, Tolmar, Abbvie, Pfizer and Myovant Sciences. MA Bilen has acted as a paid consultant for and/or as a member of the advisory boards of Exelixis, Bayer, BMS, Eisai, Pfizer, AstraZeneca, Johnson & Johnson, Calithera Biosciences, Genomic Health, Nektar, EMD Serono, SeaGen and Sanofi and has received grants to his institution from Merck, Xencor, Bayer, Bristol-Myers Squibb, Genentech/Roche, SeaGen, Incyte, Nektar, AstraZeneca, Tricon Pharmaceuticals, Genome & Company, AAA, Peloton Therapeutics and Pfizer for work performed outside of the current study. I Khilfeh and S Du are employees and stockholders of Johnson & Johnson. C Rossi, F Kinkead, L Diaz and D Pilon are employees of Analysis Group, Inc., a consulting company that has provided paid consulting services to Johnson & Johnson. L Ellis was an employee of Johnson & Johnson at the time the study was conducted. ND Shore is an employee of the Carolina Urologic Research Center and has received consulting fees from Johnson & Johnson, Bayer, Dendreon, Tolmar, Ferring, Medivation/Astellas, Amgen, Pfizer, AstraZeneca, Astellas Pharma, AbbVie, Merck, Bristol Myers Squibb/Sanofi, Exact Imaging, FerGene, InVitae, MDxHealth, Myriad Genetics, Propella Therapeutics, Genzyme, Sanofi, CG Oncology, Genesis Cancer Care, Urogen pharma, Speciality Networks, PeerView, Clarity Pharmaceuticals, Lantheus Medical Imaging, Lilly, Photocure, Telix Pharmaceuticals, AIkido Pharma, Arquer Diagnostics, Asieris Pharmaceuticals, Minomic, Novartis, PlatformQ Health, Promaxo, Protara Therapeutics, Fize Medical, Accord Research, Antev, Aura Biosciences, Bioprotect and Sumitomo Pharma Oncology. ND Shore has received research funding from AbbVie, Amgen, Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb/Pfizer, Boston Scientific, Clovis Oncology, Dendreon, Exact Imaging, Ferring, Foundation Medicine, InVitae, Johnson & Johnson, MDxHealth, Merck, Myovant Sciences, Myriad Genetics, Nymox, Pfizer, Sanofi, Sesen Bio, Tolmar, CG Oncology, DisperSol, FORMA Therapeutics, Guardant Health, Jiangsu Yahong Meditech, Novartis, Pacific Edge, POINT Biopharma, Propella Therapeutics, SeaGen, MT Group, Theralase, Veru, Zenflow, Advantagene, Aragon Pharmaceuticals, Endocyte, Exelixis, FKD Therapies, Genentech, Istari Oncology, Medivation, OncoCellMDx, ORIC Pharmaceuticals, Palette Life Sciences, Plexxikon, RhoVac, Steba Biotech, Urogen pharma, Urotronic, US Biotest and Vaxiion for work performed outside of the current study. The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

The authors have no other competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript apart from those disclosed.

Figures

Graphical abstract comparing 24-month overall survival in ARPI-naïve mCSPC patients, showing a 26% mortality risk reduction with apalutamide versus abiraterone acetate; includes study design, baseline characteristics and survival curves.
Graphical abstract
Figure 1.
Figure 1.. Sample selection.
ARPI: Androgen receptor pathway inhibitor; mCSPC: Metastatic castration-sensitive prostate cancer; PARP: Poly ADP-ribose polymerase.
Figure 2.
Figure 2.. Overall survival between patients who initiated apalutamide versus abiraterone acetate.
aPropensity scores were generated using probability estimates from a logistic regression models using the following predictors: age (continuous), race, geographic region, payer type, year of index date, time between metastasis and index date (continuous and categorical), time between PC diagnosis and index date (continuous), de novo PC, ADT use overlapping with index date, first-generation androgen receptor pathway inhibitor use, chemotherapy use, metastases location (bone, nodal, visceral and metastasis in multiple sites), Quan–Charlson Comorbidity Index (continuous), most recent prostate-specific antigen level (categorical) and earliest Gleason score (categorical). Each patient was attributed an inverse-probability of treatment weight that was defined as follows: 1/(propensity score) for the apalutamide cohort and 1/(1-propensity score) for the abiraterone acetate cohort. Normalized inverse-probability of treatment weights were truncated at the 95th percentiles. bAn HR <1 indicates that the apalutamide cohort had a lower rate of death compared with the abiraterone acetate cohort. *Significant at the 5% level. ADT: Androgen deprivation therapy; CI: Confidence interval; HR: Hazard ratio; PC: Prostate cancer.
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