Kotake T, Usami M, Sonoda T, Matsuda M, Okajima E, Osafune M, Isurugi K, Akaza H, Saitoh Y
Centre for Adult Diseases, Osaka University, Japan.
Am J Clin Oncol. 1988;11 Suppl 2:S108-11. doi: 10.1097/00000421-198801102-00026.
Ninety patients with advanced prostatic cancer (15 with stage B, 23 with stage C, and 52 with stage D) were randomized to receive 0.9, 1.8, or 3.6 mg, respectively, of Zoladex depot subcutaneous injection every 28 days for 12 weeks. The serum levels of LH, FSH, and testosterone were elevated after the first injection, and followed by a significant decrease. The suppression of testosterone levels in the blood to castrate levels was observed in all patients except two treated with 0.9 mg. Objective response (CR and PR) was seen in 63.6% (0.9 mg), 47.8% (1.8 mg), and 68% (3.6 mg) of patients according to the Japanese Prostatic Group Criteria. Subjective improvement (performance status, analgesic consumption) was also observed in 75-88% of patients but without a statistically significant difference between each dose group. Only minor adverse effects were found during the treatments. The drug was detected dose dependently in the blood by radioimmunoassay. These results suggest that endocrine therapy with Zoladex depot in doses of 3.6 mg subcutaneously every 4 weeks is a useful alternative to surgical castration in patients with prostatic cancer.
90例晚期前列腺癌患者（15例B期、23例C期和52例D期）被随机分组，分别每28天接受0.9毫克、1.8毫克或3.6毫克的诺雷德长效皮下注射，共12周。首次注射后，血清促黄体生成素（LH）、促卵泡生成素（FSH）和睾酮水平升高，随后显著下降。除2例接受0.9毫克治疗的患者外，所有患者血液中的睾酮水平均被抑制至去势水平。根据日本前列腺癌研究组标准，分别有63.6%（0.9毫克组）、47.8%（1.8毫克组）和68%（3.6毫克组）的患者出现客观缓解（完全缓解和部分缓解）。75%-88%的患者也出现了主观改善（体能状态、镇痛药使用量），但各剂量组之间无统计学显著差异。治疗期间仅发现轻微不良反应。通过放射免疫测定法在血液中检测到该药物呈剂量依赖性。这些结果表明，每4周皮下注射3.6毫克诺雷德长效进行内分泌治疗，是前列腺癌患者手术去势的一种有效替代方法。
