戈舍瑞林与己烯雌酚治疗晚期前列腺癌的比较：一项随机多中心试验的结果

A comparison of Zoladex and DES in the treatment of advanced prostate cancer: results of a randomized, multicenter trial.

作者信息

Citrin D L, Resnick M I, Guinan P, al-Bussam N, Scott M, Gau T C, Kennealey G T

机构信息

Section of Medical Oncology, Northwestern University Medical School, Chicago, IL 60611.

出版信息

Prostate. 1991;18(2):139-46. doi: 10.1002/pros.2990180206.

DOI:10.1002/pros.2990180206

PMID:1826048

Abstract

This open, prospective study was conducted to compare ZOLADEX (goserelin acetate implant) and diethylstilbestrol (DES) in the treatment of stage D2 prostate cancer. Sixty-seven patients were allocated to receive 3.6 mg of ZOLADEX every 28 days by subcutaneous injection (n = 48) or 3 mg of DES daily by oral administration (n = 19). Median serum levels of testosterone were reduced to castrate levels (less than 50 ng/dl) within one month of therapy in each group and remained so for up to 120 weeks. According to modified criteria of the National Prostatic Cancer Project, 88% of patients in the ZOLADEX group and 84% in the DES group were objective responders. Time to treatment failure and survival were not significantly different between groups, yet the confidence limits for the hazard ratios were wide. ZOLADEX was better tolerated than DES. We conclude that ZOLADEX is an alternative to DES in patients with stage D2 prostate cancer.

摘要

本开放性前瞻性研究旨在比较戈舍瑞林（醋酸戈舍瑞林植入剂）和己烯雌酚（DES）治疗D2期前列腺癌的效果。67例患者被分配接受皮下注射，每28天注射3.6毫克戈舍瑞林（n = 48），或口服3毫克己烯雌酚，每日一次（n = 19）。每组治疗后一个月内，睾酮的血清中位数水平均降至去势水平（低于50 ng/dl），并在长达120周内维持该水平。根据美国国家前列腺癌项目的修改标准，戈舍瑞林组88%的患者和己烯雌酚组84%的患者为客观缓解者。两组间治疗失败时间和生存率无显著差异，但风险比的置信区间较宽。戈舍瑞林的耐受性优于己烯雌酚。我们得出结论，对于D2期前列腺癌患者，戈舍瑞林是己烯雌酚的替代药物。