Bertagna C, De Géry A, Hucher M, François J P, Zanirato J
International Development, Roussel Uclaf, Romainville, France.
Br J Urol. 1994 Apr;73(4):396-402. doi: 10.1111/j.1464-410x.1994.tb07603.x.
To review the efficacy of the combination of the anti-androgen nilutamide (Anandron) plus orchidectomy in patients with stage D prostate cancer who had received no previous treatment.
The results of seven randomized double-blind trials were analysed. In these studies patients were followed up until progression of disease or withdrawal for other reasons. Bone pain, urinary symptoms, performance status, levels of prostatic acid phosphatase (PAP) and alkaline phosphatase (AP) were evaluated before treatment and after 1, 3, 6, 12 and 18 months of treatment. Bone scans and X-rays were taken every 6 months. The best objective response, the time of progression and the time of death were recorded. The changes from baseline in symptoms and levels of tumour markers at month six and the percentages of objective regressions in the two treatment groups were compared using the Cochran-Mantel-Haenszel test stratified by study. Peto's method was used for the analysis of time to progression and of survival.
Of the 1191 patients enrolled in all the original trials, 1056 were eligible. In the group of patients treated with nilutamide 50% had complete or partial regression of disease compared with 33% of those who were given a placebo (P < 0.001); bone pain and levels of PAP and AP were improved or returned to normal significantly more frequently (P < 0.01); the odds of disease progression were significantly reduced (odds ratio 0.84, P = 0.05); the odds of death from cancer and from other causes were reduced but the difference was not statistically significant.
The combination of nilutamide and orchidectomy has a beneficial effect on pain of metastatic origin, levels of tumour markers, the objective response of disease and the time to disease progression. This treatment combination might also improve survival.
回顾抗雄激素药物尼鲁米特（安鲁米特）联合睾丸切除术对未经任何治疗的D期前列腺癌患者的疗效。
分析了7项随机双盲试验的结果。在这些研究中，对患者进行随访直至疾病进展或因其他原因退出研究。在治疗前以及治疗1、3、6、12和18个月后，评估骨痛、泌尿系统症状、身体状况、前列腺酸性磷酸酶（PAP）和碱性磷酸酶（AP）水平。每6个月进行一次骨扫描和X线检查。记录最佳客观反应、疾病进展时间和死亡时间。使用按研究分层的Cochran-Mantel-Haenszel检验比较两组治疗6个月时症状和肿瘤标志物水平相对于基线的变化以及客观缓解率。采用Peto法分析疾病进展时间和生存期。
在所有原始试验纳入的1191例患者中，1056例符合条件。接受尼鲁米特治疗的患者组中，50%的患者疾病完全或部分缓解，而接受安慰剂治疗的患者组这一比例为33%（P<0.001）；骨痛以及PAP和AP水平改善或恢复正常的频率显著更高（P<0.01）；疾病进展的几率显著降低（优势比0.84，P=0.05）；癌症死亡和其他原因死亡的几率降低，但差异无统计学意义。
尼鲁米特与睾丸切除术联合应用对转移性疼痛、肿瘤标志物水平、疾病客观反应及疾病进展时间具有有益影响。这种治疗组合可能还会改善生存期。
