Two large randomized clinical trials (RCT), LATITUDE and STAMPEDE, demonstrated an increased overall survival by addition of the androgen receptor targeted agent abiraterone acetate to gonadotropin-releasing hormone (GnRH) agonist treatment in men with de novo castration sensitive metastatic prostate cancer (mCSPC) [1,2]. In LATITUDE, the median time on treatment with abiraterone and prednisone for men with high-risk mCSPC was 26 months (inter-quartile range [IQR] 12 to 49). In STAMPEDE, the median time on treatment in the subgroup with metastatic disease, or nonmetastatic disease with no radiotherapy planned, was 33 months (IQR 14 to Not reported).
Subsidized use of abiraterone for the treatment of men with de novo mCSPC not suitable for treatment with docetaxel was approved in June 2018 in Sweden [3]. Since men treated in clinical practice often are older and have more comorbidity than men in RCTs, it is relevant to study drug utilization in routine care to detect signals suggesting a potentially different effectiveness in clinical practice compared to what is expected from the efficacy estimated in the pivotal randomized controlled trials.
The aim of this study was to describe patient characteristics and time on treatment in a nation-wide population-based cohort of men with de novo mCSPC treated with abiraterone in clinical practice.