Klotz L H, Goldenberg S L, Jewett M, Barkin J, Chetner M, Fradet Y, Chin J, Laplante S
Department of Surgery, University of Toronto Sunnybrook Health Science Centre, Ontario, Canada.
Urology. 1999 Apr;53(4):757-63. doi: 10.1016/s0090-4295(98)00616-5.
To test the hypothesis that neoadjuvant androgen ablation before radical prostatectomy reduces the likelihood of biochemical progression at 36 months.
Two hundred thirteen patients with localized prostate cancer were randomized to radical prostatectomy alone (Sx, n = 101) or a 12-week course of 300 mg of cyproterone acetate daily followed by surgery (CPA, n = 112). Biochemical progression (two consecutive detectable prostate-specific antigen [PSA] values) was determined for the entire group and by baseline PSA, Gleason score, clinical stage, and pathologic stage.
The probability of biochemical progression at 36 months was similar in both groups (CPA 40.2%, Sx 30.1%; P = 0.3233). CPA patients with baseline serum PSA between 25 and 50 ng/mL had a lower probability of biochemical progression (CPA 63.5%, Sx 84.6%; P = 0.0038). No difference in the probability of biochemical progression was seen between groups when analyzed by clinical stage or Gleason score. When analyzed by pathologic margin status, no difference was observed in the probability of biochemical progression in patients with organ-confined disease (P = 0.4484). There was a trend for a higher probability of progression in the neoadjuvant arm in patients with positive and negative surgical margins (P = 0.0105, P = 0.0459; alpha = 0.005 with Bonferroni adjustment).
Neoadjuvant androgen ablation with CPA reduces the positive margin rate significantly but does not result in a difference in biochemical progression at 3 years. This may be due to a lack of sufficient follow-up, insufficient power of the trial to demonstrate a small benefit, or a true lack of benefit of neoadjuvant androgen ablation before radical prostatectomy.
验证根治性前列腺切除术前行新辅助雄激素剥夺治疗可降低36个月时生化进展可能性的假设。
213例局限性前列腺癌患者被随机分为单纯根治性前列腺切除术组（手术组，n = 101）或先接受为期12周、每日300 mg醋酸环丙孕酮治疗随后进行手术的治疗组（醋酸环丙孕酮组，n = 112）。对整个研究组以及根据基线前列腺特异性抗原（PSA）水平、Gleason评分、临床分期和病理分期进行分组后的患者，均测定其生化进展情况（连续两次可检测到PSA值）。
两组在36个月时生化进展的概率相似（醋酸环丙孕酮组40.2%，手术组30.1%；P = 0.3233）。基线血清PSA在25至50 ng/mL之间的醋酸环丙孕酮组患者生化进展概率较低（醋酸环丙孕酮组63.5%，手术组84.6%；P = 0.0038）。按临床分期或Gleason评分分析时，两组间生化进展概率无差异。按病理切缘状态分析时，器官局限性疾病患者的生化进展概率在两组间未观察到差异（P = 0.4484）。手术切缘阳性和阴性的患者中，新辅助治疗组的进展概率有升高趋势（P = 0.0105，P = 0.0459；经Bonferroni校正后α = 0.005）。
醋酸环丙孕酮新辅助雄激素剥夺治疗可显著降低切缘阳性率，但在3年时并未导致生化进展出现差异。这可能是由于随访不足、试验效能不足以显示微小益处，或根治性前列腺切除术前行新辅助雄激素剥夺治疗确实无益处。
