Manni A, Santen R J, Boucher A E, Lipton A, Harvey H, Simmonds M, Gordon R, Rohner T, Drago J, Wettlaufer J
Department of Medicine, Milton S. Hershey Medical Center, Pennsylvania State University, Hershey 17033.
J Steroid Biochem. 1987;27(1-3):551-6. doi: 10.1016/0022-4731(87)90353-0.
Seventy-five patients with stage D-2 prostate cancer refractory to orchiectomy have been entered in a controlled trial to test whether androgen priming enhances the efficacy of chemotherapy. All patients are treated with aminoglutethimide and hydrocortisone as a means of achieving medical adrenalectomy and are given cyclic i.v. chemotherapy with cytoxan, adriamycin and 5-fluorouracil. Patients in the stimulation arm (N = 39) receive, in addition, fluoxymesterone (5 mg p.o. b.i.d.) for 3 days before and on the day of chemotherapy. A similar response rate was observed in the stimulation and control arm (83% vs 74% respectively) when the analysis was restricted to evaluable patients. When all patients were included, a significantly higher response rate was observed in the control arm (64% vs 49%, P less than 0.05) as a result of the larger fraction of unevaluable patients in the stimulation arm (41% vs 14%). Median duration of response is 9 months in the stimulation and 10 months in the control arm. Median overall survival in the stimulation and control group is 12 months and 16 months respectively. Significant toxicity consisting of exacerbation of bone pain and, in two patients, development of reversible spinal cord compression was observed following androgen priming. Our results suggest that combined medical adrenalectomy and chemotherapy are highly effective in the treatment of advanced prostate cancer. Thus far, no additional benefit has been observed with androgen priming.
75例睾丸切除术后难治的D-2期前列腺癌患者进入一项对照试验，以测试雄激素预处理是否能提高化疗疗效。所有患者均接受氨鲁米特和氢化可的松治疗以实现药物性肾上腺切除，并接受环磷酰胺、阿霉素和5-氟尿嘧啶的静脉化疗。刺激组（N = 39）的患者在化疗前3天及化疗当天还额外口服氟甲睾酮（5 mg，每日2次）。当分析仅限于可评估患者时，刺激组和对照组的缓解率相似（分别为83%和74%）。当纳入所有患者时，由于刺激组中不可评估患者的比例较大（41%对14%），对照组的缓解率显著更高（64%对49%，P<0.05）。刺激组的中位缓解持续时间为9个月，对照组为10个月。刺激组和对照组的中位总生存期分别为12个月和16个月。雄激素预处理后观察到明显的毒性反应，包括骨痛加重，两名患者出现可逆性脊髓压迫。我们的结果表明，药物性肾上腺切除联合化疗在晚期前列腺癌治疗中非常有效。迄今为止，未观察到雄激素预处理有额外益处。
