Department of Urology, UC Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Medical Oncology Division, University of Washington/Seattle Cancer Care Alliance, Seattle, WA, USA.
Eur Urol. 2016 Oct;70(4):675-683. doi: 10.1016/j.eururo.2016.03.017. Epub 2016 Mar 19.
Enzalutamide, an oral androgen receptor inhibitor, significantly improved overall survival (OS) and radiographic progression-free survival (rPFS) versus placebo in the PREVAIL trial of men with chemotherapy-naïve metastatic castration-resistant prostate cancer.
To assess the effects of enzalutamide versus placebo in patients from PREVAIL based on site and extent of baseline disease.
DESIGN, SETTING, AND PARTICIPANTS: One thousand seven hundred and seventeen asymptomatic or minimally symptomatic patients were randomized to enzalutamide (n=872) or placebo (n=845). Subgroup analyses included nonvisceral (only bone and/or nodal; n=1513), visceral (lung and/or liver; n=204), low-volume bone disease (<4 bone metastases; n=867), high-volume bone disease (≥4 bone metastases; n=850), lymph node only disease (n=195).
Oral enzalutamide (160mg) or placebo once daily while continuing androgen deprivation therapy.
Coprimary endpoints (rPFS, OS) were prospectively evaluated in nonvisceral and visceral subgroups. All other efficacy analyses were post hoc.
Enzalutamide improved rPFS versus placebo in patients with nonvisceral disease (hazard ratio [HR], 0.18; 95% confidence interval [CI], 0.14-0.22), visceral disease (HR, 0.28; 95% CI, 0.16-0.49), low- or high-volume bone disease (HR, 0.16; 95% CI, 0.11-0.22; HR, 0.22; 95% CI, 0.16-0.29, respectively), and lymph node only disease (HR, 0.09; 95% CI, 0.04-0.19). For OS, HRs favored enzalutamide (<1) across all disease subgroups, although 95% CI was >1 in patients with visceral disease (HR, 0.82; 95% CI, 0.55-1.23). Enzalutamide was well tolerated in patients with or without visceral disease.
Enzalutamide provided clinically significant benefits in men with chemotherapy-naïve metastatic castration-resistant prostate cancer, with or without visceral disease, low- or high-volume bone disease, or lymph node only disease.
Patients with metastatic castration-resistant prostate cancer-including those with or without visceral disease or widespread bone disease-benefitted from enzalutamide, an active well-tolerated therapy.
在化疗初治转移性去势抵抗性前列腺癌男性患者的 PREVAIL 试验中，与安慰剂相比，口服雄激素受体抑制剂恩扎卢胺显著改善了总生存期（OS）和影像学无进展生存期（rPFS）。
根据基线疾病的部位和范围，评估恩扎卢胺与安慰剂在 PREVAIL 患者中的疗效。
设计、地点和参与者：1717 例无症状或轻度症状患者被随机分配至恩扎卢胺（n=872）或安慰剂（n=845）组。亚组分析包括非内脏（仅骨和/或淋巴结；n=1513）、内脏（肺和/或肝；n=204）、低骨量疾病（<4 处骨转移；n=867）、高骨量疾病（≥4 处骨转移；n=850）、仅淋巴结疾病（n=195）。
口服恩扎卢胺（160mg）或安慰剂，每日一次，同时继续雄激素剥夺治疗。
非内脏和内脏亚组前瞻性评估了主要终点（rPFS、OS）。所有其他疗效分析均为事后分析。
与安慰剂相比，恩扎卢胺改善了非内脏疾病患者的 rPFS（风险比 [HR]，0.18；95%置信区间 [CI]，0.14-0.22）、内脏疾病患者（HR，0.28；95%CI，0.16-0.49）、低或高骨量疾病患者（HR，0.16；95%CI，0.11-0.22；HR，0.22；95%CI，0.16-0.29）和仅淋巴结疾病患者（HR，0.09；95%CI，0.04-0.19）。对于 OS，所有疾病亚组中 HR 均有利于恩扎卢胺（<1），但内脏疾病患者的 95%CI>1（HR，0.82；95%CI，0.55-1.23）。恩扎卢胺在有或无内脏疾病的患者中均耐受良好。
恩扎卢胺为化疗初治转移性去势抵抗性前列腺癌患者带来了有临床意义的获益，无论是否存在内脏疾病、低或高骨量疾病或仅淋巴结疾病。
转移性去势抵抗性前列腺癌患者（包括有或无内脏疾病或广泛骨疾病的患者）从恩扎卢胺治疗中获益，该药物为一种有效且耐受良好的治疗方法。
