📃 Paper Title: EMBARK Trial: Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer
🧍 Author: Freedland
🕒 Year: 2023
📚 Journal: The New England Journal of Medicine
🌎 Country: United States
ㅤContext to the study:
How to manage adults with prostate cancer with high-risk biochemical recurrence after definitive radical prostatectomy or radiation therapy?
ㅤ✅ Take-home message of study:
Enzalutamide monotherapy or in combination with leuprolide may improve 5-year metastasis-free survival compared to leuprolide alone in adults with prostate cancer with high-risk biochemical recurrence after definitive radical prostatectomy or radiation therapy.
ㅤ International, randomized, phase 3 trial
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Study participants:
1068 patients underwent randomization: 355 were assigned to the combination group, 358 to the leuprolide-alone group, and 355 to the monotherapy group.
Followed for a median of 60.7 months
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Key study outcomes:
Primary outcome: Metastasis-free survival, defined as time to imaging-based disease progression or all-cause death. Secondary endpoints: Metastasis-free survival in the monotherapy group as compared with the leuprolide-alone group; patient-reported outcomes; safety.
At 5 years, metastasis-free survival was 87.3% (95% confidence interval [CI], 83.0 to 90.6) in the combination group, 71.4% (95% CI, 65.7 to 76.3) in the leuprolide-alone group, and 80.0% (95% CI, 75.0 to 84.1) in the monotherapy group.
For metastasis-free survival, enzalutamide plus leuprolide was superior to leuprolide alone (hazard ratio for metastasis or death, 0.42; 95% CI, 0.30 to 0.61; P<0.001); enzalutamide monotherapy was also superior to leuprolide alone (hazard ratio for metastasis or death, 0.63; 95% CI, 0.46 to 0.87; P=0.005).
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Study Limitations:
Overall survival data; Underrepresentation of non-White patients (<20%).
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What are the estimated 5-year metastasis-free survival and progression-free survival rates for patients treated with leuprolide alone compared to those treated with enzalutamide alone?
For 5-year PSA progression-free survival:
Enzalutamide alone: 88.9%
Leuprolide alone: 70%