2. ONCOLOGYEDUCATION.COM ARTICLE SUMMARIES
Enzalutamide in Metastatic Prostate Cancer Before Chemotherapy
Beer T.M., et al., New England Journal of Medicine, doi: /NEJMoa

3. BACKGROUND
The recently-published COU-AA-302 trial established the superiority of abiraterone/prednisone over placebo/prednisone in patients with metastatic CRPC prior to chemotherapy. The PREVAIL study tested enzalutamide in this setting.
Beer T.M., et al., New England Journal of Medicine, doi: /NEJMoa

4. Enzalutamide 160mg po daily
STUDY DESIGN
Primary Outcome: Radiographic PFS and OS
N = 1717
Enzalutamide 160mg po daily
All had metastatic prostate cancer, and had progressed despite androgen suppression (with either an LHRH analog or surgical castration), ECOG 0/1 and had adequate organ function.
Placebo
Patients with bone or visceral METs were accepted. The use of previous antiandrogens, such as bicalutamide, was allowed but not required. Patients could not have received any previous ketoconazole, abiraterone, or cytotoxic chemotherapy.
Beer T.M., et al., New England Journal of Medicine, doi: /NEJMoa

5. RESULTS - EFFICACY Enzalutamide Placebo Hazard Ratio p-Value
1 yr Radiographic PFS
65%
14%
0.19 ( )
p < 0.001
mOS
32.4 mo
30.2 mo
0.71 ( )
p <
Beer T.M., et al., New England Journal of Medicine, doi: /NEJMoa

6. All-grade Hypertension
RESULTS – SAFETY
Enzalutamide
Placebo
All-grade Hypertension
13% 4%
Fatigue
36%
26%
Hot flushes
18% 8%
Beer T.M., et al., New England Journal of Medicine, doi: /NEJMoa

7. COMMENTARY
The PREVAIL study shows that enzalutamide is effective for patients with mCRPC in the pre-docetaxel setting.
Both enzalutamide and abiraterone/prednisone have now shown that they are effective in improving OS in the pre-docetaxel setting.
Beer T.M., et al., New England Journal of Medicine, doi: /NEJMoa