Caffo Orazio, Sava Teodoro, Comploj Evi, Fariello Annamaria, Zustovich Fable, Segati Romana, Sacco Cosimo, Valduga Francesco, Cetto Gianluigi, Galligioni Enzo
Medical Oncology Department, University of Verona, Verona, Italy.
BJU Int. 2008 Nov;102(9):1080-5. doi: 10.1111/j.1464-410X.2008.07779.x. Epub 2008 May 15.
To report the results of a randomized phase II trial of docetaxel with and without estramustine phosphate (EP) in patients with hormone-refractory prostate cancer (HRPC).
Patients with progressive HRPC were randomized to receive docetaxel 70 mg/m(2) on day 1 (arm A), or docetaxel 70 mg/m(2) on day 2 plus oral EP three times daily, at a total daily dose of 840 mg, on days 1-5 (arm B). The primary objective of the trial was to evaluate the activity of the treatments in terms of the response in prostate-specific antigen (PSA) level.
Forty-five of the 49 patients centrally randomized to arm A and 44 of the 46 in arm B were evaluable for activity. The PSA level decreased by > or =50% in 40% of the patients in arm A and in 75% of those in arm B. The median time to PSA progression was 20 weeks in arm A and 30 weeks in arm B. The patients in arm B had an improvement in pain over time.
These data support the existence of a possible advantage in combining docetaxel and EP, which should be verified in a specific randomized phase III study.
报告多西他赛联合或不联合磷酸雌莫司汀（EP）治疗激素难治性前列腺癌（HRPC）患者的随机II期试验结果。
将病情进展的HRPC患者随机分为两组，A组在第1天接受多西他赛70mg/m²治疗；B组在第2天接受多西他赛70mg/m²治疗，并在第1 - 5天口服EP，每日3次，每日总剂量840mg。该试验的主要目的是根据前列腺特异性抗原（PSA）水平的反应评估治疗效果。
A组49例集中随机分组患者中的45例以及B组46例中的44例可评估疗效。A组40%的患者和B组75%的患者PSA水平下降≥50%。A组PSA进展的中位时间为20周，B组为30周。B组患者的疼痛随时间推移有所改善。
这些数据支持多西他赛与EP联合使用可能存在优势，这应在特定的随机III期研究中得到验证。
