Enzalutamide may offer more benefits to patients with mCRPC who have not been previously exposed to abiraterone or chemotherapy
Enzalutamide (ENZA) is known to be an androgen receptor inhibitor that has already demonstrated efficacy and safety in patients with metastatic castration-resistant prostate cancer (mCRPC) in randomized clinical trials. PREMISE (NCT02495974) – a long-term, prospective, observational European study presented at the 35th Congress of the European Association of Urology (EAU) 2020 – evaluated ENZA in these patients now in a real-world setting.
Patients with mCRPC who received ENZA as part of standard clinical practice entered one of the following four cohorts:
1) virgin abiraterone (ABI) and chemotherapy virgin (QT) patient;
2) previous use of abiraterone (post-ABI), however virgin from QT;
3) ABI virgin, but post-QT;
4) post-ABI and post-QT;
The primary outcome measure was the time to treatment failure (time to treatment failure, TTF), defined as the time from the start of treatment to discontinuation for any reason. Secondary outcomes included time free from prostate specific antigen (PSA) and time free from disease progression. The safety analysis included treatment-emergent adverse events, treatment modifications due to adverse events (AEs) and death. Data were collected from patients for up to 18 months.
A total of 1,760 patients from 16 European countries were enrolled, of whom 1732 started treatment. Baseline demographic characteristics and patient history were similar between cohorts.
The median TTF was longer in cohort 1 when compared to cohorts 2-4, with similar results in other secondary parameters. The incidence of treatment-emergent adverse events was higher in cohort 4. Treatment-related adverse events were similar in all cohorts, with fatigue being the most frequent (14–20%). The most common adverse event that led to the discontinuation of ENZA was fatigue (3%) in cohort 1, asthenia (5%) in cohort 2 and tumor progression in cohorts 3 and 4 (4% and 9%, respectively).
These unselected data suggest that ENZA may offer more benefits to patients with mCRPC who were not exposed to ABI or QT.
European Urology Open Science, 2020, 19 (2): e883-e884.