Alcini E, D'Addessi A, Destito A, Grasso G
Division of Urology, Catholic University of the Sacred Heart, Rome, Italy.
Am J Clin Oncol. 1988;11 Suppl 2:S120-2. doi: 10.1097/00000421-198801102-00030.
The trial drug was ICI 118.630 (Zoladex). Inclusion criteria were histologically confirmed advanced prostate cancer (T greater than 2 or N+ or M+), life expectancy greater than 3 months, and no previous radiotherapy, orchiectomy, or chemotherapy. Treatment started in November 1984; 30 patients were recruited. The period of treatment ranged from 6 to 144 weeks (median of 59.5 weeks). One patient died after 6 weeks of rapidly progressive renal failure. Data were updated to the end of August 1987. The mean age was 67.9 years (53-83 years). Subjective response was evaluated by a mean symptoms score (using daytime micturition, nocturia, dysuria, hesitancy, and flow) and a score of three different items: patients' activity, bone pain, and use of analgesics. Only 7.1% of the patients showed a permanent positive response. Four different objective responses (complete, partial, stable disease, and progression) were possible after evaluating the T category, tumor dimensions, metastases, and prostatic acid phosphatase. Testosterone (T) and plasmatic LH levels rose after administration: T dropped below the castration level (1 ng/ml) within a few days and remained constantly low. The rate of progressive disease was 27.6%; disease control was possible in 72.4% of the patients (PR or SD).
试验药物为ICI 118.630（诺雷德）。纳入标准为经组织学确诊的晚期前列腺癌（T＞2或N+或M+）、预期寿命大于3个月、既往未接受过放疗、睾丸切除术或化疗。治疗于1984年11月开始；招募了30名患者。治疗期为6至144周（中位时间为59.5周）。一名患者在6周后死于快速进展的肾衰竭。数据更新至1987年8月底。平均年龄为67.9岁（53 - 83岁）。主观反应通过平均症状评分（使用日间排尿、夜尿、尿痛、排尿犹豫和尿流情况）以及三个不同项目的评分进行评估：患者活动情况、骨痛和镇痛药使用情况。仅7.1%的患者显示出永久性阳性反应。在评估T类别、肿瘤大小、转移情况和前列腺酸性磷酸酶后，可能出现四种不同的客观反应（完全缓解、部分缓解、疾病稳定和疾病进展）。给药后睾酮（T）和血浆促黄体生成素（LH）水平升高：T在数天内降至去势水平（1 ng/ml）以下并持续保持在低水平。疾病进展率为27.6%；72.4%的患者疾病得到控制（部分缓解或疾病稳定）。
