A CONTROLLED TRIAL OF LEUPROLIDE WITH AND WITHOUT FLUTAMIDE IN PROSTATIC-CARCINOMA
A CONTROLLED TRIAL OF LEUPROLIDE WITH AND WITHOUT FLUTAMIDE IN PROSTATIC-CARCINOMA
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DOI：
10.1056/nejm198908173210702
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发表时间：
1989-08-17
影响因子：
158.5
通讯作者：
GOODMAN, PJ
中科院分区：
文献类型：
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作者：
CRAWFORD, ED;EISENBERGER, MA;GOODMAN, PJ
为了验证最大限度的雄激素阻断可以提高前列腺癌治疗效果的假设，我们在弥散性、未经治疗的前列腺癌（D2期）患者中进行了一项随机双盲试验。所有603名男性均接受leuprolide治疗，leuprolide是一种促性腺激素释放激素的类似物，可抑制促性腺激素的释放，与安慰剂或氟他胺联合使用，氟他胺是一种非甾体抗雄激素，可抑制雄激素与细胞核的结合。与接受leuprolide和安慰剂治疗的300例患者相比，随机分配接受leuprolide和氟他胺治疗的303例患者无进展生存期更长（16.5个月对13.9个月，P = 0.039），中位生存期增加（35.6个月对28.3个月，P = 0.035）。两种治疗方法之间的差异在病情轻微且表现良好的男性中尤为明显；然而，该亚组还需要进一步的研究。在联合雄激素阻断治疗的前12周，症状改善最大，此时单独使用leuprolide通常会引起疾病的疼痛发作。我们的结论是，在晚期前列腺癌患者中，左连用氟他胺治疗优于单用左连用。
To test the hypothesis that maximal androgen blockade improves the effectiveness of the treatment of prostatic cancer, we conducted a randomized, double-blind trial in patients with disseminated, previously untreated prostate cancer (stage D2). All 603 men received leuprolide, an analogue of gonadotropin-releasing hormone that inhibits the release of gonadotropins, in combination with either placebo or flutamide, a nonsteroidal antiandrogen that inhibits the binding of androgens to the cell nucleus. As compared with the 300 patients receiving leuprolide and placebo, the 303 patients randomly assigned to receive leuprolide and flutamide had a longer progression-free survival (16.5 vs. 13.9 months; P = 0.039) and an increase in the median length of survival (35.6 vs. 28.3 months; P = 0.035). The differences between the treatments were particularly evident for men with minimal disease and good performance status; however, further studies should be conducted in this subgroup. Symptomatic improvement was greatest during the first 12 weeks of the combined androgen blockade, when leuprolide alone often produces a painful flare in the disease. We conclude that in patients with advanced prostate cancer, treatment with leuprolide and flutamide is superior to treatment with leuprolide alone.