The Journal of urology · 2025
Treatment of High-Risk Biochemically Recurrent Prostate Cancer With Enzalutamide in Combination With Leuprolide: Secondary End Points From the EMBARK Trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Shore Neal D, Gleave Martin, De Giorgi Ugo, Rannikko Antti, Pieczonka Christopher M, Sridharan Swetha, Brasso Klaus, Woo Henry H, Gómez Caamaño Antonio, Saranchuk Jeff W, Nordquist Luke T, Ferreira Ubirajara, Tang Yiyun, Rosbrook Brad, Haas Gabriel P, Rosales Matt, Zohren Fabian, Tarazi Jamal, Freedland Stephen J
Аннотация
PURPOSE: The primary analysis of EMBARK reported improved metastasis-free survival for enzalutamide plus leuprolide (enzalutamide combination) vs leuprolide plus placebo (leuprolide alone) in patients with high-risk biochemical recurrence while maintaining quality of life. Here, we present secondary efficacy end points for enzalutamide combination vs leuprolide alone.
MATERIALS AND METHODS: EMBARK is a global, multicenter, randomized, controlled, phase 3 trial. Patients were randomized (1:1:1) to enzalutamide combination, leuprolide alone, or enzalutamide monotherapy. Non-key secondary end points reported herein include time to distant metastasis, resumption of any hormonal therapy, castration resistance, symptomatic progression, and first symptomatic skeletal event. Hormonal treatment-related symptoms were assessed using the Quality-of-Life Questionnaire-Prostate 25. Time-to-event end points were summarized using the Kaplan-Meier method, with nominal P values.
RESULTS: Enzalutamide combination vs leuprolide alone was associated with increased 5-year probabilities (95% CI) for remaining free of distant metastasis (91.0% [87.1-93.7] vs 81.5% [76.3-85.7]), resumption of any hormonal therapy after treatment suspension (14.9% [10.8-19.6] vs 7.8% [4.4-12.3]), castration resistance (96.6% [93.9-98.1] vs 67.8% [62.4-72.6]), symptomatic progression (70.9% [65.5-75.6] vs 53.3% [47.6-58.6]), and first symptomatic skeletal event (97.8% [95.4-98.9] vs 91.5% [87.8-94.1]). Time to confirmed clinically meaningful deterioration of hormonal treatment-related symptoms favored leuprolide alone vs enzalutamide combination, although the median difference was small (0.03 months).
CONCLUSIONS: Combined with the primary findings from EMBARK, data from non-key secondary efficacy end points strengthen support for enzalutamide combination as a new standard of care for patients with high-risk biochemical recurrence.
CLINICAL TRIAL REGISTRATION NUMBER: NCT02319837.
MATERIALS AND METHODS: EMBARK is a global, multicenter, randomized, controlled, phase 3 trial. Patients were randomized (1:1:1) to enzalutamide combination, leuprolide alone, or enzalutamide monotherapy. Non-key secondary end points reported herein include time to distant metastasis, resumption of any hormonal therapy, castration resistance, symptomatic progression, and first symptomatic skeletal event. Hormonal treatment-related symptoms were assessed using the Quality-of-Life Questionnaire-Prostate 25. Time-to-event end points were summarized using the Kaplan-Meier method, with nominal P values.
RESULTS: Enzalutamide combination vs leuprolide alone was associated with increased 5-year probabilities (95% CI) for remaining free of distant metastasis (91.0% [87.1-93.7] vs 81.5% [76.3-85.7]), resumption of any hormonal therapy after treatment suspension (14.9% [10.8-19.6] vs 7.8% [4.4-12.3]), castration resistance (96.6% [93.9-98.1] vs 67.8% [62.4-72.6]), symptomatic progression (70.9% [65.5-75.6] vs 53.3% [47.6-58.6]), and first symptomatic skeletal event (97.8% [95.4-98.9] vs 91.5% [87.8-94.1]). Time to confirmed clinically meaningful deterioration of hormonal treatment-related symptoms favored leuprolide alone vs enzalutamide combination, although the median difference was small (0.03 months).
CONCLUSIONS: Combined with the primary findings from EMBARK, data from non-key secondary efficacy end points strengthen support for enzalutamide combination as a new standard of care for patients with high-risk biochemical recurrence.
CLINICAL TRIAL REGISTRATION NUMBER: NCT02319837.