Bono A V, DiSilverio F, Robustelli della Cuna G, Benvenuti C, Brausi M, Ferrari P, Gibba A, Galli L
Ospedale di Circolo e Fondazione Macchi, Varese, Italia.
Urol Int. 1998;60 Suppl 1:18-24. doi: 10.1159/000056541.
In spite of a great amount of data, the hormonal treatment of advanced prostatic carcinoma (CaP) still remains controversial. As a relevant amount of dihydrotestosterone is present within the prostate tissue after castration, complete androgen blockade (CAB), with inhibition of the activity of both testicular and adrenal androgens, has been advocated as up-front treatment of advanced CaP. However, many controlled studies have failed to demonstrate a benefit for CAB in comparison with simple surgical or chemical castration. The present study was performed to bring additional data for a worldwide meta-analysis of all phase III trials comparing castration and CAB.
This is a centrally controlled phase III study in which chemical castration with leuprorelin acetate depot was compared with leuprorelin plus flutamide in stage C and D CaP. Two hundred and forty-one eligible and evaluable patients with histologically proven CaP were recruited for the study (120 treated with castration and 121 with CAB). The diagnostic and staging workup consisted of blood chemistry, general condition assessment, prostate-specific antigen (PSA), abdominal sonography and computed tomography scan, and whole-body isotopic bone scan. End points of the study were survival, time to treatment failure, and time to progression. The patients were followed every 6 months with PSA and sonography.
At a cut-off analysis performed in December 1996, when the mean follow-up period was 43.7 +/- (SD) 24.1 months, no statistical differences in terms of time to treatment failure, time to progression, and death rate could be detected. Also considering the common risk factors, such as basal PSA, haemoglobin, alkaline phosphatase, and Gleason score, the outcome did not show any clear advantage for CAB.
This study appears to confirm that the advantages of first-line CAB in CaP are at best marginal. The final analysis will be performed when the follow-up period has reached 5-years, but it seems unlikely that the present results will change.
尽管有大量数据，但晚期前列腺癌（CaP）的激素治疗仍存在争议。由于去势后前列腺组织中仍存在相当数量的双氢睾酮，因此主张采用完全雄激素阻断（CAB），即抑制睾丸和肾上腺雄激素的活性，作为晚期CaP的一线治疗方法。然而，许多对照研究未能证明CAB与单纯手术或药物去势相比有何益处。本研究旨在为一项全球范围的荟萃分析提供更多数据，该荟萃分析将比较去势和CAB的所有III期试验。
这是一项中央控制的III期研究，在C期和D期CaP患者中，将醋酸亮丙瑞林长效制剂进行药物去势与亮丙瑞林加氟他胺进行比较。招募了241例经组织学证实为CaP的合格且可评估患者进行研究（120例接受去势治疗，121例接受CAB治疗）。诊断和分期检查包括血液化学检查、一般状况评估、前列腺特异性抗原（PSA）、腹部超声和计算机断层扫描，以及全身同位素骨扫描。研究的终点是生存期、治疗失败时间和疾病进展时间。每6个月对患者进行PSA和超声检查随访。
在1996年12月进行的一次截止分析中，平均随访期为43.7±（标准差）24.1个月，在治疗失败时间、疾病进展时间和死亡率方面未发现统计学差异。考虑到常见的风险因素，如基础PSA、血红蛋白、碱性磷酸酶和 Gleason评分，结果也未显示CAB有任何明显优势。
本研究似乎证实，CaP一线CAB的优势充其量微乎其微。随访期达到5年时将进行最终分析，但目前的结果似乎不太可能改变。
