Di Silverio Franco, Sciarra Alessandro, Gentile Vincenzo
Department of Urology, University of Rome, Rome, Italy.
Urology. 2008 May;71(5):947-51. doi: 10.1016/j.urology.2007.09.033. Epub 2008 Feb 15.
To verify whether in patients with biochemical progression after radical prostatectomy (RRP), the administration of a cyclooxygenase-2 (COX-2) inhibitor during the off-phases of intermittent androgen deprivation (IAD) may increase the effectiveness and off-therapy time of intermittent therapy.
This is a comparative, prospective study. A total of 44 patients with biochemical progression after RRP were included in a clinical protocol for IAD once prostate-specific antigen (PSA) levels progressed over 0.4 ng/mL. The 44 cases were randomly assigned to receive two different treatment strategies: group A received IAD therapy using bicalutamide 150 mg once daily in the on-phases and no therapy in the off-phases; group B received IAD therapy using bicalutamide 150 mg once daily in the on-phases and etoricoxib 60 mg once daily in the off-phases.
Median follow-up was 62 weeks. In group A 5 of 22 (22.7%) cases and in group B 2 of 22 (9.1%) cases failed to respond to IAD (P >0.05). Comparing the two groups, in all three cycles of IAD the time of the cycles and the time of the off-phases were significantly (P <0.0001) longer in group B than in group A. The highest PSA value reached during the off-phases in each cycle was significantly (P <0.001) lower in group B than in group A. Withdrawal from treatment owing to side effects was not necessary in any of the 44 patients.
In patients with biochemical progression after RRP, we showed that the use of a COX-2 inhibitor in the off-phases of IAD is able to increase the off-treatment time significantly.
验证在根治性前列腺切除术(RRP)后出现生化进展的患者中,在间歇性雄激素剥夺(IAD)的非治疗阶段给予环氧化酶-2(COX-2)抑制剂是否可提高间歇性治疗的有效性及延长非治疗时间。
这是一项对比性前瞻性研究。共有44例RRP后出现生化进展的患者纳入临床IAD方案,一旦前列腺特异性抗原(PSA)水平超过0.4 ng/mL。44例患者随机分配接受两种不同治疗策略:A组在治疗阶段每日一次服用150 mg比卡鲁胺进行IAD治疗,在非治疗阶段不进行治疗;B组在治疗阶段每日一次服用150 mg比卡鲁胺进行IAD治疗,在非治疗阶段每日一次服用60 mg依托考昔。
中位随访时间为62周。A组22例中有5例(22.7%)、B组22例中有2例(9.1%)对IAD无反应(P>0.05)。比较两组,在所有三个IAD周期中,B组的周期时间和非治疗阶段时间均显著长于A组(P<0.0001)。B组每个周期非治疗阶段达到的最高PSA值显著低于A组(P<0.001)。44例患者中无一例因副作用而停药。
在RRP后出现生化进展的患者中,我们发现IAD非治疗阶段使用COX-2抑制剂能够显著延长非治疗时间。