Ferrari P, Castagnetti G, Ferrari G, Baisi B, Dotti A
Department of Urology, Civic Hospital, Modena, Italy.
Urol Int. 1996;56 Suppl 1:13-7. doi: 10.1159/000282863.
Androgen deprivation based on hormone manipulation is the treatment of choice in advanced prostatic cancer. The unequivocal role of adrenal androgens in the growth of prostatic cancer after medical or surgical castration requires a new logical approach (complete androgen blockade) in the treatment of advanced prostate cancer. One hundred and fifty patients with biopsy-proven advanced prostatic cancer were randomized into two groups. One group (74 patients) received leuprolide + flutamide (complete androgen blockade); the second group (76 patients) received only leuprolide and, during the first 3 weeks of treatment, cyproterone acetate (150 mg/day) to prevent flare-up phenomena. The aim of the study was to evaluate the differences between the two groups on overall survival and time to progression (log-rank test). One hundred and twenty-five patients were evaluable, 62 in the leuprolide-only group and 63 in the leuprolide + flutamide group. Median duration of follow-up was 102 weeks. No statistical difference between the two groups was observed in overall survival, in time to disease progression, and in time to treatment failure. In the combination (leuprolide + flutamide) treatment group, a positive trend for overall survival and in time to progression was observed in a subgroup of patients with good performance status and no bone metastases. We observed mild gastrointestinal toxicity (diarrhea, nausea) in the group treated with leuprolide + flutamide. The aim of this study was to compare the effectiveness of total androgen withdrawal with medical testicular suppression in advanced prostatic cancer. No significant statistical difference was observed between the two groups in overall survival and in time to progression, but probably too few patients were enrolled in each treatment arm to give a statistical interpretation of our results. We conclude that there is a positive trend in the combination treatment arm in patients with good prognostic factors.
基于激素操控的雄激素剥夺疗法是晚期前列腺癌的首选治疗方法。在药物或手术去势后，肾上腺雄激素在前列腺癌生长中的明确作用要求在晚期前列腺癌治疗中采用一种新的合理方法（完全雄激素阻断）。150例经活检证实为晚期前列腺癌的患者被随机分为两组。一组（74例患者）接受亮丙瑞林+氟他胺（完全雄激素阻断）治疗；第二组（76例患者）仅接受亮丙瑞林治疗，且在治疗的前3周给予醋酸环丙孕酮（150毫克/天）以预防病情突然加重现象。该研究的目的是评估两组在总生存期和疾病进展时间方面的差异（对数秩检验）。125例患者可进行评估，仅用亮丙瑞林组62例，亮丙瑞林+氟他胺组63例。中位随访时间为102周。两组在总生存期、疾病进展时间和治疗失败时间方面未观察到统计学差异。在联合（亮丙瑞林+氟他胺）治疗组中，在身体状况良好且无骨转移的患者亚组中观察到总生存期和疾病进展时间呈积极趋势。我们在接受亮丙瑞林+氟他胺治疗的组中观察到轻度胃肠道毒性（腹泻、恶心）。本研究的目的是比较晚期前列腺癌中完全雄激素撤退与药物性睾丸抑制的有效性。两组在总生存期和疾病进展时间方面未观察到显著统计学差异，但可能每个治疗组纳入的患者太少，无法对我们的结果进行统计学解释。我们得出结论，在具有良好预后因素的患者中，联合治疗组有积极趋势。
