Decensi A, Guarneri D, Paoletti M C, Lalanne J M, Merlo F, Boccardo F
Department of Clinical Oncology, National Institute for Cancer Research, Genoa, Italy.
Eur J Cancer. 1991;27(9):1100-4. doi: 10.1016/0277-5379(91)90301-s.
The activity of the pure non-steroidal antiandrogen nilutamide as a single agent was evaluated in 44 patients with metastatic carcinoma of the prostate. Objective (partial) response rates (95% confidence limits) were 38.5 (18.7)% in 26 previously untreated patients and 5.5 (11%) in 18 patients progressing on primary androgen suppressive procedures. The most frequent side-effects were decreased adaptation to darkness (29.5%), slight nausea (31.8%) and alcohol intolerance (18.2%). In addition, treatment was discontinued in 3 patients because of gastrointestinal symptoms. A non-significant increase in testosterone levels was shown in the untreated group during the first month of treatment, after which the levels remained stable. About half of the sexually active men claimed the maintenance of libido and sexual potency during treatment. Although our study confirms a significant incidence of visual disturbances, the activity data coupled with the ability of maintaining sexual interest suggest that single therapy with non-steroidal antiandrogens may deserve comparison to conventional endocrine treatment in controlled trials.
对44例前列腺癌转移患者评估了单纯非甾体类抗雄激素药物尼鲁米特的活性。26例先前未接受过治疗的患者的客观（部分）缓解率（95%置信区间）为38.5（18.7）%，18例在初始雄激素抑制治疗过程中病情进展的患者的客观（部分）缓解率为5.5（11）%。最常见的副作用是暗适应能力下降（29.5%）、轻度恶心（31.8%）和酒精不耐受（18.2%）。此外，3例患者因胃肠道症状而停药。未治疗组在治疗的第一个月睾酮水平有非显著性升高，此后水平保持稳定。约一半有性活动的男性称在治疗期间性欲和性功能得以维持。尽管我们的研究证实视觉障碍的发生率较高，但活性数据以及维持性兴趣的能力表明，在对照试验中，非甾体类抗雄激素药物单药治疗可能值得与传统内分泌治疗进行比较。
