ENZAMET
Trial question
What is the role of enzalutamide addition to testosterone suppression in patients with metastatic hormone-sensitive prostate cancer?
Study design
Multi-center
Open label
RCT
Population
1125 male patients.
Inclusion criteria: male patients with metastatic hormone-sensitive prostate cancer.
Key exclusion criteria: prostate cancer with significant sarcomatoid or spindle cell or neuroendocrine small cell components; history of seizure; significant CVD within the last 3 months; life expectancy of < 12 months.
Interventions
N=563 enzalutamide (testosterone suppression plus enzalutamide at a dose of 160 mg daily).
N=562 standard care (testosterone suppression plus standard nonsteroidal antiandrogen drug).
Primary outcome
Overall survival
81.9%
74.6%
81.9 %
61.4 %
41.0 %
20.5 %
0.0 %
Enzalutamide
Standard
care
Significant
increase ▲
NNT = 13
Significant increase in overall survival (81.9% vs. 74.6%; HR 1.5, 95% CI 1.2 to 1.9).
Secondary outcomes
Significant increase in progression-free survival at 3 years (67% vs. 37%; HR 2.6, 95% CI 2.1 to 3).
Significant increase in clinical progression-free survival at 3 years (68% vs. 41%; HR 2.5, 95% CI 2 to 3).
Safety outcomes
No significant difference in febrile neutropenia.
Significant difference in grade 2 fatigue (25% vs. 14%).
Conclusion
In male patients with metastatic hormone-sensitive prostate cancer, enzalutamide was superior to standard care with respect to overall survival.
Reference
Ian D Davis, Andrew J Martin, Martin R Stockler et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N Engl J Med. 2019 Jul 11;381(2):121-131.
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