Enzalutamide in patients with castration-resistant prostate cancer. retrospective, multicenter, real life study

BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) is the final stage of pCa history and represents a clinically relevant phenotype with an elevated burden of mortality. The aim of the present study is to evaluate the efficacy and safety of enzalutamide in a "real-life" setting in mCRPC patients.METHODS: Data about all mCRPC patients treated with enzalutamide from September 2017 to September 2018 were collected. Demographics, comorbidities, clinical parameters, outcomes, toxicity, overall survival and progression free survival were analyzed.RESULTS: Overall 158 patients were enrolled. Mean age was 75.8 (±8.7) years with a baseline median PSA of 16.5 (IQR 7.4-47.8) ng/mL. The median follow-up lasted 7.7 (IQR 4-14.1) months. Of all the 10.1% of patients reported grade 3-4 adverse events. 43.7% of patients experienced a progression. Overall the 6 and 12 months PFS rates were 69.5% (95% CI: 61.7-78.3%) and the 45.6% (95% CI: 36.5-57.1%); a median baseline PSA >16 ng/mL (HR:2.0, 95% CI: 1.2-3.3, p=0.005), the use of opioid (HR:3.1, 95% CI 1.9-5.0, p<0.001), a previous treatment (abiraterone, docetaxel or abiraterone + docetaxel) were significantly associated with higher rates of cancer progression. Conversely, a brief pain questionnaire of 0-1 (HR: 0.4, 95% CI: 0.2-0.7, p<0.001), a 12 weeks 50% PSA reduction (HR: 0.4, 95% CI: 0.2-0.8, p=0.006) and a longer time to mCRPC (HR: 0.4, 95% CI: 0.3-0.7, p=0.002) were related to lower cancer progression rates.CONCLUSIONS: Our data shows an effective and safe profile of enzalutamide in a "realworld" perspective in patients with mcRPC.