Klotz L, Gleave M, Goldenberg S L
Sunnybrook Health Science Center, University of Toronto, Toronto, Ontario, Canada.
Mol Urol. 2000 Fall;4(3):233-7;discussion 239.
The Canadian Urologic Oncology Group has carried out three studies of neoadjuvant hormonal therapy (NHT) in prostate cancer. The first, a study of 3 months of cyproterone acetate (CPA) 100 mg TID in patients undergoing external-beam radiation therapy, showed a benefit with respect to time to biochemical progression. There are no survival or clinical progression data available from this study. The second study involved 3 months of CPA prior to radical prostatectomy compared with radical prostatectomy alone and enrolled 200 patients. The probability of biochemical progression at 36 months was similar in the two groups (CPA 40%; surgery alone 30%; P = 0.3233). More recently, we have carried out a randomized trial of 3 v 8 months of leuprolide plus flutamide prior to radical prostatectomy in 547 patients. Patients were stratified by clinical stage, Gleason grade, and serum prostate specific antigen (PSA) concentration. In the 3- and 8-month groups, presurgery PSA concentrations were <0.1 ng/mL in 35% v 73%, and >0.3 ng/mL in 37% v 10%, respectively. In the 3- and 8-month groups, the positive margin rates were 17% and 5% and the organ-confined rates 71% and 91% (P < 0.01). One-year follow-up is now available on the entire cohort. Data regarding time to biochemical and clinical progression and overall and disease-specific survival will be required to determine whether this change in the pathologic findings translates into a patient benefit.
加拿大泌尿外科肿瘤学组开展了三项前列腺癌新辅助激素治疗（NHT）研究。第一项研究针对接受外照射放疗的患者，给予醋酸环丙孕酮（CPA）100mg每日三次，共3个月，结果显示在生化进展时间方面有获益。该研究没有生存或临床进展数据。第二项研究是在根治性前列腺切除术前行3个月的CPA治疗，并与单纯根治性前列腺切除术进行比较，纳入了200例患者。两组在36个月时生化进展的概率相似（CPA组40%；单纯手术组30%；P = 0.3233）。最近，我们对547例患者在根治性前列腺切除术前行3个月与8个月的亮丙瑞林加氟他胺进行了随机试验。患者按临床分期、Gleason分级和血清前列腺特异性抗原（PSA）浓度进行分层。在3个月组和8个月组中，术前PSA浓度<0.1ng/mL的比例分别为35%和73%，>0.3ng/mL的比例分别为37%和10%。在3个月组和8个月组中，切缘阳性率分别为17%和5%，器官局限性率分别为71%和91%（P < 0.01）。目前整个队列已有1年的随访数据。需要有关生化和临床进展时间以及总生存和疾病特异性生存的数据，以确定病理结果的这种变化是否能给患者带来益处。
