Emtage L A, Trethowan C, Hilton C, Kelly K, Blackledge G R
Cancer Research Campaign Clinical Trials Unit, Queen Elizabeth Hospital, Birmingham, England.
Am J Clin Oncol. 1988;11 Suppl 2:S173-5. doi: 10.1097/00000421-198801102-00040.
A study comparing Zoladex 3.6 mg depot with diethylstilbestrol (DES) 3 mg/day was initiated in August 1985. One hundred ninety-three patients with histologically confirmed prostate cancer T3/4 or M1 have been randomized up to 31 March 1987: 95 to Zoladex, 98 to DES. No patient had received prior systemic therapy. There is no bias in the treatment groups in terms of baseline characteristics. Median follow-up is 11 months, and the response rate at 12 months from randomization (CR + PR) for Zoladex is 70 +/- 9.4% and 50 +/- 10.1% for DES. Median time to best response is 6 months for Zoladex and 12 months for DES (using the Kaplan-Meier life table method). Subjective responses are 56 +/- 10.2% for Zoladex and 44 +/- 10% for DES. Five increases in bone pain were found after the first Zoladex treatment, as well as one increased ureteric obstruction. None required treatment withdrawal. Seventeen patients on DES were withdrawn due to adverse reaction (chi 2 = 4.33, 1df, p less than 0.05). Overall survival at 31 March 1987 is 84% for the Zoladex group and 78% for the DES group. This study has shown that Zoladex is superior to DES in achieving early tumor response in advanced prostate cancer, without causing serious complications warranting withdrawal of treatment.
1985年8月启动了一项将3.6毫克戈舍瑞林长效注射剂与3毫克/天己烯雌酚（DES）进行对比的研究。截至1987年3月31日，193例经组织学确诊为T3/4期或M1期前列腺癌的患者已被随机分组：95例接受戈舍瑞林治疗，98例接受己烯雌酚治疗。所有患者此前均未接受过全身治疗。治疗组在基线特征方面不存在偏差。中位随访时间为11个月，随机分组后12个月时戈舍瑞林的缓解率（完全缓解+部分缓解）为70±9.4%，己烯雌酚为50±10.1%。戈舍瑞林达到最佳缓解的中位时间为6个月，己烯雌酚为12个月（采用Kaplan-Meier生存表法）。戈舍瑞林的主观缓解率为56±10.2%，己烯雌酚为44±10%。首次使用戈舍瑞林治疗后发现5例骨痛加重，以及1例输尿管梗阻加重。均无需停药。17例接受己烯雌酚治疗的患者因不良反应停药（χ²=4.33，自由度1，p<0.05）。1987年3月31日戈舍瑞林组的总生存率为84%，己烯雌酚组为78%。这项研究表明，在晚期前列腺癌的早期肿瘤反应方面，戈舍瑞林优于己烯雌酚，且不会引起需要停药的严重并发症。
