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一项关于戈舍瑞林和氟他胺对比睾丸切除术治疗晚期前列腺癌患者的III期试验。

A phase III trial of zoladex and flutamide versus orchiectomy in the treatment of patients with advanced carcinoma of the prostate.

作者信息

Iversen P, Christensen M G, Friis E, Hornbøl P, Hvidt V, Iversen H G, Klarskov P, Krarup T, Lund F, Mogensen P

机构信息

Department of Urology, Hvidovre Hospital, Denmark.

出版信息

Cancer. 1990 Sep 1;66(5 Suppl):1058-66. doi: 10.1002/cncr.1990.66.s5.1058.

DOI:10.1002/cncr.1990.66.s5.1058
PMID:2144207
Abstract

In a multicenter Phase III trial 264 patients with advanced prostatic cancer were randomized to either bilateral orchiectomy or treatment with zoladex supplemented by flutamide. Presently, median follow-up time is 30 months. A small difference in objective response was recorded in favor of the combination therapy, whereas no statistically significant difference was found in subjective response to therapy, time to progression, and overall survival. Adverse effects were more commonly encountered in the pharmacologically treated patients. It is concluded that the combination of zoladex plus flutamide is not clinically superior to orchiectomy in the treatment of patients with advanced carcinoma of the prostate.

摘要

在一项多中心III期试验中,264例晚期前列腺癌患者被随机分为双侧睾丸切除术组或戈舍瑞林辅以氟他胺治疗组。目前,中位随访时间为30个月。记录到客观反应存在微小差异,支持联合治疗,但在治疗的主观反应、疾病进展时间和总生存期方面未发现统计学上的显著差异。药物治疗组更常出现不良反应。结论是,在治疗晚期前列腺癌患者方面,戈舍瑞林加氟他胺的联合治疗在临床上并不优于睾丸切除术。

相似文献

1
A phase III trial of zoladex and flutamide versus orchiectomy in the treatment of patients with advanced carcinoma of the prostate.一项关于戈舍瑞林和氟他胺对比睾丸切除术治疗晚期前列腺癌患者的III期试验。
Cancer. 1990 Sep 1;66(5 Suppl):1058-66. doi: 10.1002/cncr.1990.66.s5.1058.
2
Zoladex plus flutamide vs. orchidectomy for advanced prostatic cancer. Danish Prostatic Cancer Group (DAPROCA).
Eur Urol. 1990;18 Suppl 3:41-4. doi: 10.1159/000463979.
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Zoladex and flutamide versus bilateral orchiectomy. A randomized phase III EORTC 30853 study. The EORTC GU Group.
Cancer. 1990 Sep 1;66(5 Suppl):1045-57. doi: 10.1002/cncr.1990.66.s5.1045.
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Zoladex and flutamide versus orchiectomy in the treatment of advanced prostatic cancer. A combined analysis of two European studies, EORTC 30853 and DAPROCA 86.
Cancer. 1990 Sep 1;66(5 Suppl):1067-73. doi: 10.1002/cncr.1990.66.s5.1067.
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Orchidectomy vs. Zoladex plus flutamide in patients with metastatic prostate cancer. The EORTC GU Group.
Eur Urol. 1990;18 Suppl 3:34-40. doi: 10.1159/000463978.
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Total androgen blockade with Zoladex plus flutamide vs. Zoladex alone in advanced prostatic carcinoma: interim report of a multicenter, double-blind, placebo-controlled study.戈舍瑞林联合氟他胺与单纯戈舍瑞林进行全雄激素阻断治疗晚期前列腺癌:一项多中心、双盲、安慰剂对照研究的中期报告
Eur Urol. 1990;18 Suppl 3:45-7. doi: 10.1159/000463980.
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EORTC protocol 30853: orchidectomy versus zoladex plus flutamide in the management of metastatic carcinoma of the prostate. Interim statistical analysis of the side effects of treatment.欧洲癌症研究与治疗组织(EORTC)30853号方案:睾丸切除术与戈舍瑞林加氟他胺治疗前列腺转移性癌的对比。治疗副作用的中期统计分析。
Cancer. 1990 Sep 1;66(5 Suppl):1022-4. doi: 10.1002/cncr.1990.66.s5.1022.
8
Zoladex with or without flutamide in the treatment of locally advanced or metastatic prostate cancer: interim analysis of an ongoing PONCAP study. Italian Prostatic Cancer Project (PONCAP).戈舍瑞林联合或不联合氟他胺治疗局部晚期或转移性前列腺癌:一项正在进行的PONCAP研究的中期分析。意大利前列腺癌项目(PONCAP)
Eur Urol. 1990;18 Suppl 3:48-53. doi: 10.1159/000463981.
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Long-term results of Danish Prostatic Cancer Group trial 86. Goserelin acetate plus flutamide versus orchiectomy in advanced prostate cancer.
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Phase III studies to compare goserelin (Zoladex) with orchiectomy and with diethylstilbestrol in treatment of prostatic carcinoma.
Urology. 1989 May;33(5 Suppl):45-52. doi: 10.1016/0090-4295(89)90106-4.

引用本文的文献

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Maximal androgen blockade for the treatment of metastatic prostate cancer--a systematic review.最大雄激素阻断治疗转移性前列腺癌的系统评价。
Curr Oncol. 2006 Jun;13(3):81-93. doi: 10.3747/co.v13i3.85.
2
Maximal androgen blockade for advanced prostate cancer.晚期前列腺癌的最大雄激素阻断疗法
Cochrane Database Syst Rev. 2000;1999(2):CD001526. doi: 10.1002/14651858.CD001526.
3
Controversies in the management of advanced prostate cancer.晚期前列腺癌治疗中的争议
Br J Cancer. 1999 Jan;79(1):146-55. doi: 10.1038/sj.bjc.6690024.
4
Goserelin. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in prostate cancer.戈舍瑞林。其药效学和药代动力学特性以及在前列腺癌治疗中的疗效综述。
Drugs Aging. 1995 Apr;6(4):324-43. doi: 10.2165/00002512-199506040-00007.
5
Drug therapy of prostatic cancer.前列腺癌的药物治疗
Drugs Aging. 1991 Sep-Oct;1(5):353-63. doi: 10.2165/00002512-199101050-00003.
6
Flutamide. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in advanced prostatic cancer.
Drugs Aging. 1991 Mar;1(2):104-15. doi: 10.2165/00002512-199101020-00003.
7
Goserelin. A review of its pharmacodynamic and pharmacokinetic properties, and clinical use in sex hormone-related conditions.戈舍瑞林。对其药效学和药代动力学特性以及在性激素相关病症中的临床应用的综述。
Drugs. 1991 Feb;41(2):254-88. doi: 10.2165/00003495-199141020-00008.