Boccardo F, Decensi A U, Guarneri D, Martorana G, Fioretto L, Mini E, Macaluso M P, Giuliani L, Santi L, Periti P
Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
Cancer Detect Prev. 1991;15(6):501-3.
Between March 1986 and March 1987, 48 patients with stage D prostate carcinoma were entered into a multicentric pilot study using the pure nonsteroidal antiandrogen nilutamide (Anandron--RU 23908) at the dose of 100 mg t.i.d. as the only therapy until disease progression or the occurrence of toxicity. Minimum follow-up was 15 months. Median age of patients was 72 (56 to 83) and median initial Performance Status (PS) was 1 (0 to 3). Of the 48 patients, 29 were untreated, while 19 patients were progressing following treatment by orchiectomy, LHRH analogs, or other endocrine therapies. According to the National Prostatic Cancer Project (NPCP) criteria, 43 patients were evaluable for response. Overall best response in untreated patients was partial response (PR), 41.6%; stationary disease (SD), 54.1%; 73.6% of pretreated patients achieved SD. Median progression-free survival and overall survival in untreated patients were 325 and 696 days, respectively, and 174 and 447 days, respectively, in pretreated patients. The more common side effects were G.I. toxicity (65%), hemeralopia (27%), and alcohol intolerance (6.2%). Results of this study suggest that Anandron may be a safe and effective treatment for patients with advanced prostatic cancer.
1986年3月至1987年3月期间，48例D期前列腺癌患者进入一项多中心试点研究，使用纯非甾体抗雄激素药物尼鲁米特（安鲁米特--RU 23908），剂量为每日3次，每次100毫克，作为唯一治疗方法，直至疾病进展或出现毒性反应。最短随访时间为15个月。患者的中位年龄为72岁（56至83岁），初始中位体能状态（PS）为1（0至3）。48例患者中，29例未接受过治疗，19例在接受睾丸切除术、促性腺激素释放激素（LHRH）类似物或其他内分泌治疗后病情进展。根据国家前列腺癌项目（NPCP）标准，43例患者可评估疗效。未接受治疗患者的总体最佳疗效为部分缓解（PR），占41.6%；病情稳定（SD），占54.1%；73.6%的接受过治疗的患者病情稳定。未接受治疗患者的无进展生存期和总生存期的中位数分别为325天和696天，接受过治疗的患者分别为174天和447天。较常见的副作用为胃肠道毒性（65%）、夜盲症（27%）和酒精不耐受（6.2%）。本研究结果表明，安鲁米特可能是晚期前列腺癌患者的一种安全有效的治疗方法。
