醋酸氯地孕酮联合或不联合促黄体生成素释放激素（LH-RH）激动剂治疗初治局限性或局部进展性前列腺癌激素疗法的早期结果：一项前瞻性随机研究。前列腺癌研究组

Early results of LH-RH agonist treatment with or without chlormadinone acetate for hormone therapy of naive localized or locally advanced prostate cancer: a prospective and randomized study. The Prostate Cancer Study Group.

作者信息

Akaza H, Homma Y, Okada K, Yokoyama M, Moriyama N, Usami M, Hirao Y, Tsushima T, Ohashi Y, Aso Y

机构信息

Department of Urology, Institute of Clinical Medicine, University of Tsukuba, Ibaraki, Japan.

出版信息

Jpn J Clin Oncol. 2000 Mar;30(3):131-6. doi: 10.1093/jjco/hyd035.

DOI:10.1093/jjco/hyd035

PMID:10798540

Abstract

BACKGROUND

The majority of patients with localized and some cases of locally advanced prostate cancer undergo radical prostatectomy. However, radical prostatectomy cannot always be selected for those patients. In this situation, primary hormone therapy is an alternative treatment option. We have designed a prospective randomized study of the effects of primary hormone therapy for such patients.

METHODS

A total of 151 patients with T1b, T1c, T2a, T2b or T3a prostate cancer who were not scheduled for radical prostatectomy were enrolled into this study. Patients were randomly allocated into two groups; Group I received luteinizing hormone-releasing hormone (LH-RH) agonist monotherapy (leuprorelin acetate depot, 3.75 mg monthly) and Group II received LH-RH agonist in combination with chlormadinone acetate (100 mg/day). Effects on serum prostate-specific antigen level, progression-free survival and survival were observed for 2 years.

RESULTS

The reasons why radical prostatectomy was not scheduled were poor risk for surgery (38%), patient's wish (32%) and physician's recommendation (30%). After 12 weeks of treatment, 49% of the patients in both groups showed a complete response (CR). Of the patients showing a partial response (PR) after 12 weeks of treatment, 25% in Group I and 52% in Group II improved to CR 1 year later (p<0.05). Group II showed a longer progression-free survival (p <0.05). Progression-free survival rates were 62% (Group I) and 91% (Group II) in T2b patients and 43% (Group I) and 73% (Group II) in T3 patients. Only one patient in each group died from prostate cancer.

CONCLUSIONS

Early primary hormone therapy is a reasonable treatment option for localized or locally advanced prostate cancer patients if radical prostatectomy was not scheduled. Chlormadinone acetate showed an additive effect with LH-RH agonist, at least in 2 years' observation.

摘要

背景

大多数局限性前列腺癌患者以及部分局部晚期前列腺癌患者会接受根治性前列腺切除术。然而，并非所有这些患者都能选择根治性前列腺切除术。在这种情况下，初始激素治疗是一种替代治疗选择。我们针对此类患者设计了一项关于初始激素治疗效果的前瞻性随机研究。

方法

总共151例未计划接受根治性前列腺切除术的T1b、T1c、T2a、T2b或T3a期前列腺癌患者纳入本研究。患者被随机分为两组；第一组接受促黄体激素释放激素（LH-RH）激动剂单药治疗（醋酸亮丙瑞林长效注射剂，每月3.75毫克），第二组接受LH-RH激动剂联合醋酸氯地孕酮（每日100毫克）治疗。观察两组患者2年的血清前列腺特异性抗原水平、无进展生存期和总生存期变化。

结果

未计划进行根治性前列腺切除术的原因包括手术风险高（38%）、患者意愿（32%）和医生建议（30%）。治疗12周后，两组中49%的患者显示完全缓解（CR）。治疗12周后显示部分缓解（PR）的患者中，第一组25%和第二组52%在1年后改善为CR（p<0.05）。第二组显示出更长的无进展生存期（p<0.05）。T2b期患者的无进展生存率在第一组为62%，第二组为91%；T3期患者在第一组为43%，第二组为73%。每组仅1例患者死于前列腺癌。