OBJECTIVES : Androgen receptor inhibitors apalutamide and enzalutamide have been approved for the treatment of nmCRPC in France. Other anti-androgens (AA) may be used off-label, while use of darolutamide is currently limited in this setting. Objectives of this real-world study were to describe nmCRPC patients, treatment patterns, and management of AEs among such patients receiving abiraterone, apalutamide, bicalutamide or enzalutamide.

METHODS : This retrospective chart review study was conducted in 35 nmCRPC-treating sites in France. Clinically diagnosed nmCRPC patients starting AA therapy between January-December 2018 were included and their AEs recorded. Detailed chart data were then collected in a subset of patients experiencing ≥1 AE to better understand AE severity and actions taken to manage them. Results were summarized using descriptive statistics.

RESULTS : Thirty-five physicians reported similar use of AA across their practices (nmCRPC patients treated with apalutamide, 22.0%; enzalutamide, 21.8%; abiraterone, 23.0%; bicalutamide, 25.3%). A total of 270 patients were included, of which 59.3% were reported to have ≥1 AE. Most common AEs were asthenia/fatigue (39.6%), hot flush (18.9%) and hypertension (11.5%). Among the 107 patient-subset who had ≥1 AE (abiraterone, 28; apalutamide, 16; bicalutamide, 29; enzalutamide, 34) mean age was 74 years, 89.7% had ECOG 0-1 at nmCRPC diagnosis, PSA-doubling time (PSA-DT) was only available in 11.2% of patients (of these, 58.3% had PSA-DT ≤6 months), majority (50.5%) initiated therapy to prevent/delay metastasis, and 31.8% progressed to metastasis by end-of-study (median follow-up: 1.5 years from therapy initiation). Actions taken to manage AEs included AE treatment (32.7%), therapy discontinuation (14.0%), AE-related hospitalization (7.5%), and dose reduction (5.6%).

CONCLUSIONS : Retrospective chart reviews from France showed that more than half of treated nmCRPC patients experienced AEs and one third required treatment of the AEs. These findings highlight the AE burden of treating nmCRPC, and hence the need for effective therapies with a favorable safety and tolerability profile.