McLeod David G, Iversen Peter, See William A, Morris Thomas, Armstrong Jon, Wirth Manfred P
Walter Reed Army Medical Center, Washington, DC, USA.
BJU Int. 2006 Feb;97(2):247-54. doi: 10.1111/j.1464-410X.2005.06051.x.
To evaluate, in the ongoing Early Prostate Cancer (EPC) trial programme, the efficacy and tolerability of bicalutamide 150 mg once daily in addition to standard care for localized or locally advanced, nonmetastatic prostate cancer.
The EPC programme comprises three randomized, double-blind, placebo-controlled trials designed for combined analysis. Following standard care, 8113 men with localized (T1-2, N0/Nx) or locally advanced (T3-4, any N; or any T, N+) prostate cancer (all M0) received oral bicalutamide 150 mg once daily or oral placebo. The primary endpoints were progression-free survival (PFS) and overall survival.
The large EPC trial programme is defining men who benefit or do not from early or adjuvant antiandrogen therapy. At a median follow-up of 7.4 years, in localized disease there is no benefit to PFS by adding bicalutamide to standard care, and there is a trend (hazard ratio, HR, 1.16; 95% confidence intervals, CI, 0.99-1.37; P = 0.07) towards decreased survival in patients otherwise undergoing watchful waiting. However, in locally advanced disease, bicalutamide significantly improved PFS irrespective of standard care. Bicalutamide significantly improved overall survival in patients receiving radiotherapy (HR 0.65; 95% CI 0.44-0.95; P = 0.03); this was driven by a lower risk of prostate cancer-related deaths. Bicalutamide produced a trend towards improved overall survival in patients with locally advanced disease otherwise undergoing watchful waiting (HR 0.81; 95% CI 0.66-1.01; P = 0.06). No survival difference was evident in the prostatectomy subgroup.
This ongoing programme is clarifying the role of early or adjuvant antiandrogen therapy in prostate cancer. Patients with localized disease do not appear to derive clinical benefit from added bicalutamide. However, adding bicalutamide 150 mg to standard care provides significant clinical benefits in patients with locally advanced prostate cancer, irrespective of primary therapy.
在正在进行的早期前列腺癌（EPC）试验项目中，评估每日一次口服150mg比卡鲁胺联合标准治疗用于局部或局部晚期、非转移性前列腺癌的疗效和耐受性。
EPC项目包括三项随机、双盲、安慰剂对照试验，旨在进行联合分析。在接受标准治疗后，8113例局部（T1-2，N0/Nx）或局部晚期（T3-4，任何N；或任何T，N+）前列腺癌（均为M0）患者每日一次口服150mg比卡鲁胺或口服安慰剂。主要终点为无进展生存期（PFS）和总生存期。
大型EPC试验项目正在明确哪些男性患者能从早期或辅助抗雄激素治疗中获益或不能获益。在中位随访7.4年时，对于局限性疾病，在标准治疗基础上加用比卡鲁胺对PFS无益处，并且对于原本进行观察等待的患者有生存降低的趋势（风险比，HR，1.16；95%置信区间，CI，0.99-1.37；P = 0.07）。然而，在局部晚期疾病中，无论标准治疗如何，比卡鲁胺均显著改善PFS。比卡鲁胺显著改善了接受放疗患者的总生存期（HR 0.65；95% CI 0.44-0.95；P = 0.03）；这是由较低的前列腺癌相关死亡风险驱动的。比卡鲁胺对于原本进行观察等待的局部晚期疾病患者的总生存期有改善趋势（HR 0.81；95% CI 0.66-1.01；P = 0.06）。在前列腺切除亚组中未观察到生存差异。
正在进行的该项目正在阐明早期或辅助抗雄激素治疗在前列腺癌中的作用。局限性疾病患者似乎未从加用比卡鲁胺中获得临床益处。然而，在标准治疗基础上加用150mg比卡鲁胺为局部晚期前列腺癌患者提供了显著的临床益处，无论初始治疗如何。
