Bilateral orchiectomy with or without flutamide for metastatic prostate cancer
Bilateral orchiectomy with or without flutamide for metastatic prostate cancer
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DOI：
10.1056/nejm199810083391504
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发表时间：
1998-10-08
影响因子：
158.5
通讯作者：
Lowe, BA
中科院分区：
文献类型：
--
作者：
Eisenberger, MA;Blumenstein, BA;Lowe, BA
背景转移性前列腺癌的联合雄激素阻断治疗包括抗雄激素药物加去势。在之前的一项试验中，我们发现，与安慰剂加醋酸亮丙瑞林相比，在醋酸亮丙瑞林（一种合成的促性腺激素释放激素，可导致睾丸功能的医学消融）中加入抗雄激素氟西汀可显著改善生存率。在目前的试验中，我们比较了氟替卡松加双侧睾丸切除术与安慰剂加orchiectomy.Methods我们随机分配的患者谁从来没有接受过抗雄激素治疗和远处转移的前列腺癌治疗与双侧睾丸切除术，氟替卡松或安慰剂。患者分层，根据疾病的程度，并根据性能status.Results的1387例患者谁是在试验中，700人被随机分配到氟替卡松组和687安慰剂组。总体而言，毒性作用的发生率很低;两组之间唯一显著的差异是腹泻和贫血的发生率更高。两组总生存率无显著差异（P=0.14）。与安慰剂相比，氟替卡松的估计死亡风险（风险比）为0.91（90%置信区间为0.81至1.01）。Fluorescent是不相关的增强效益在患者的微小diseases.Conclusions增加fluorescent双侧睾丸切除术并没有导致在临床上有意义的改善，在转移性前列腺癌患者的生存。（N Engl J Med 1998;339：1036-42.）(C)1998年，马萨诸塞州医学会。
Background Combined androgen blockade for the treatment of metastatic prostate cancer consists of an antiandrogen drug plus castration. In a previous trial, we found that adding the antiandrogen flutamide to leuprolide acetate (a synthetic gonadotropin-releasing hormone that results in medical ablation of testicular function) significantly improved survival as compared with that achieved with placebo plus leuprolide acetate. In the current trial, we compared flutamide plus bilateral orchiectomy with placebo plus orchiectomy.Methods We randomly assigned patients who had never received antiandrogen therapy and who had distant metastases from adenocarcinoma of the prostate to treatment with bilateral orchiectomy and either flutamide or placebo. Patients were stratified according to the extent of disease and according to performance status.Results Of the 1387 patients who were enrolled in the trial, 700 were randomly assigned to the flutamide group and 687 to the placebo group. Overall, the incidence of toxic effects was minimal; the only notable differences between the groups were the greater rates of diarrhea and anemia with flutamide. There was no significant difference between the two groups in overall survival (P=0.14). The estimated risk of death (hazard ratio) for flutamide as compared with placebo was 0.91 (90 percent confidence interval, 0.81 to 1.01). Flutamide was not associated with enhanced benefit in patients with minimal disease.Conclusions The addition of flutamide to bilateral orchiectomy does not result in a clinically meaningful improvement in survival among patients with metastatic prostate cancer. (N Engl J Med 1998;339: 1036-42.) (C) 1998, Massachusetts Medical Society.