Tyrrell C J, Kaisary A V, Iversen P, Anderson J B, Baert L, Tammela T, Chamberlain M, Webster A, Blackledge G
Derriford Hospital, Plymouth, UK.
Eur Urol. 1998;33(5):447-56. doi: 10.1159/000019634.
To evaluate the efficacy and tolerability of 'Casodex' monotherapy (150 mg daily) for metastatic and locally advanced prostate cancer.
A total of 1,453 patients with either confirmed metastatic disease (M1), or T3/T4 non-metastatic disease with elevated prostate-specific antigen (M0) were recruited into one of two identical, multicentre, randomised studies to compare 'Casodex' 150 mg/day with castration. The protocols allowed for combined analysis.
At a median follow-up period of approximately 100 weeks for both studies, 'Casodex' 150 mg was found to be less effective than castration in patients with metastatic disease (M1) at entry (hazard ratio of 1.30 for time to death) with a difference in median survival of 6 weeks. In symptomatic M1 patients, 'Casodex' was associated with a statistically significant improvement in subjective response (70%) compared with castration (58%). Analysis of a validated quality-of-life questionnaire proved an advantage for 'Casodex' in sexual interest and physical capacity. 'Casodex' had a substantially lower incidence of hot flushes compared to castration (6-13% compared with 39-44%) and the most commonly reported adverse events were those expected for a potent antiandrogen. However, in patients with M0 disease at entry, the data are still immature with only 13% of M0 patients having died. An initial analysis of this immature data has suggested that the results in these patients may be different to those obtained in patients with M1 disease. A further survival analysis in patients with M0 disease is therefore planned when the data are more mature.
'Casodex' 150 mg is less effective than castration in patients with M1 disease. However, 'Casodex' has shown a benefit in terms of quality of life and subjective response when compared to castration and has an acceptable tolerability profile. Thus 'Casodex' 150 mg monotherapy is an option for patients with M1 prostate cancer for whom surgical or medical castration is not indicated or is not acceptable.
评估“康士得”单药治疗（每日150毫克）转移性和局部晚期前列腺癌的疗效及耐受性。
总共1453例确诊为转移性疾病（M1）或前列腺特异性抗原升高的T3/T4非转移性疾病（M0）的患者被纳入两项相同的多中心随机研究之一，以比较每日150毫克“康士得”与去势治疗。方案允许进行联合分析。
两项研究的中位随访期约为100周，发现对于入组时患有转移性疾病（M1）的患者，150毫克“康士得”的疗效低于去势治疗（死亡时间的风险比为1.30），中位生存期相差6周。在有症状的M1患者中，与去势治疗（58%）相比，“康士得”在主观反应方面有统计学上的显著改善（70%）。对一份经过验证的生活质量问卷的分析证明，“康士得”在性兴趣和身体能力方面具有优势。与去势治疗相比，“康士得”潮热的发生率显著更低（6 - 13%对比39 - 44%），最常报告的不良事件是强效抗雄激素药物预期出现的事件。然而，对于入组时患有M0疾病的患者，数据仍不成熟，仅有13%的M0患者死亡。对这些不成熟数据的初步分析表明，这些患者的结果可能与M1疾病患者的结果不同。因此，计划在数据更成熟时对M0疾病患者进行进一步的生存分析。
对于M1疾病患者，150毫克“康士得”的疗效低于去势治疗。然而，与去势治疗相比，“康士得”在生活质量和主观反应方面显示出益处，且具有可接受的耐受性。因此，对于不适合或无法接受手术或药物去势的M1前列腺癌患者，150毫克“康士得”单药治疗是一种选择。
