Janknegt R A, Abbou C C, Bartoletti R, Bernstein-Hahn L, Bracken B, Brisset J M, Da Silva F C, Chisholm G, Crawford E D, Debruyne F M
Department of Urology, University Hospital Maastricht, The Netherlands.
J Urol. 1993 Jan;149(1):77-82; discussion 83. doi: 10.1016/s0022-5347(17)36003-2.
The efficacy and tolerance of the nonsteroidal antiandrogen nilutamide in the treatment of prostatic cancer were studied in a large double-blind clinical trial initiated in 1986. Patients with metastatic prostatic cancer without prior endocrine manipulation underwent orchiectomy and were randomized to 1 of 2 groups receiving nilutamide (225 patients) or placebo (232). Nilutamide and placebo were evaluated for efficacy in 207 and 216 patients, respectively. Progression-free survival was significantly longer in the nilutamide group (median time to progression 20.8 months on nilutamide and 14.9 months on placebo, p = 0.005). Median time to death from prostatic cancer was 30.0 months in the placebo group and 37 months in the nilutamide group. Objective regressions were higher in the nilutamide group (41%) than in the placebo group (24%). Significant differences in favor of the nilutamide group were found at several intervals for bone pain, prostatic acid phosphatase, prostate specific antigen, alkaline phosphatase and bone scan isotope uptake. Nilutamide and orchiectomy constitute a more effective treatment for metastatic prostatic cancer than orchiectomy alone, and the adverse effects of nilutamide, usually minor, are outweighed by the significant improvements in most disease measures and progression-free survival.
1986年启动了一项大型双盲临床试验，研究非甾体类抗雄激素药物尼鲁米特治疗前列腺癌的疗效和耐受性。未接受过内分泌治疗的转移性前列腺癌患者接受了睾丸切除术，并随机分为两组，分别接受尼鲁米特治疗（225例患者）或安慰剂治疗（232例）。分别对207例和216例患者评估了尼鲁米特和安慰剂的疗效。尼鲁米特组的无进展生存期显著更长（尼鲁米特组的疾病进展中位时间为20.8个月，安慰剂组为14.9个月，p = 0.005）。安慰剂组前列腺癌死亡的中位时间为30.0个月，尼鲁米特组为37个月。尼鲁米特组的客观缓解率（41%）高于安慰剂组（24%）。在多个时间点，尼鲁米特组在骨痛、前列腺酸性磷酸酶、前列腺特异性抗原、碱性磷酸酶和骨扫描同位素摄取方面均有显著优势。与单纯睾丸切除术相比，尼鲁米特联合睾丸切除术是治疗转移性前列腺癌更有效的方法，尼鲁米特的不良反应通常较小，在大多数疾病指标和无进展生存期方面的显著改善超过了这些不良反应。
