Improved Outcomes with Enzalutamide in Biochemically Recurrent Prostate Cancer

作者：Stephen J. Freedland, Murilo Luz, Ugo De Giorgi, Martin Gleave, Geoffrey Gotto, Christopher Pieczonka, Gabriel P. Haas, Choung‐Soo Kim, M. Backhaus, Antti Rannikko, Jamal Tarazi, Swetha Sridharan, Jennifer Sugg, Yiyun Tang, Ronald Tutrone, Balaji Venugopal, Arnauld Villers, Henry H. Woo, Fabian Zohren, Neal D. Shore · 发表于：New England Journal of Medicine · 年份：2023 · DOI：10.1056/nejmoa2303974 · 被引用次数：314 · 研究领域：Prostate Cancer Treatment and Research、Prostate Cancer Diagnosis and Treatment、Radiopharmaceutical Chemistry and Applications

BACKGROUND: Patients with prostate cancer who have high-risk biochemical recurrence have an increased risk of progression. The efficacy and safety of enzalutamide plus androgen-deprivation therapy and enzalutamide monotherapy, as compared with androgen-deprivation therapy alone, are unknown. METHODS: In this phase 3 trial, we enrolled patients with prostate cancer who had high-risk biochemical recurrence with a prostate-specific antigen doubling time of 9 months or less. Patients were randomly assigned, in a 1:1:1 ratio, to receive enzalutamide (160 mg) daily plus leuprolide every 12 weeks (combination group), placebo plus leuprolide (leuprolide-alone group), or enzalutamide monotherapy (monotherapy group). The primary end point was metastasis-free survival, as assessed by blinded independent central review, in the combination group as compared with the leuprolide-alone group. A key secondary end point was metastasis-free survival in the monotherapy group as compared with the leuprolide-alone group. Other secondary end points were patient-reported outcomes and safety. RESULTS: A total of 1068 patients underwent randomization: 355 were assigned to the combination group, 358 to the leuprolide-alone group, and 355 to the monotherapy group. The patients were followed for a median of 60.7 months. 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%...