Nelius Thomas, Reiher Frank, Lindenmeir Tobias, Klatte Tobias, Rau Olrik, Burandt Jens, Filleur Stephanie, Allhoff Ernst Peter
Department of Urology, Otto-von-Guericke University Magdeburg, Magdeburg, Germany.
Onkologie. 2005 Nov;28(11):573-8. doi: 10.1159/000088297.
Docetaxel based chemotherapy not only reduces pain and improves quality of life in advanced hormone refractory prostate cancer (HRPC), but it also improves survival. We investigated the combination of docetaxel and estramustine in patients with HRPC regarding efficacy and prognostic parameters.
We conducted a phase-II trial, administering docetaxel (70 mg/m(2) i.v., day 2, every 3 weeks) and estramustine (280 mg 3 times daily p.o., 1 day prior to docetaxel, on 5 consecutive days) to patients with HRPC. Patients were monitored for PSA (prostate-specific antigen) response and toxicity.
62 patients were treated. The median age was 67.5 years, the median PSA was 177.9 ng/ml. The median number of cycles was 6. The median time to progression (TTP) and median survival time were 14 (+/-2) and 24 (+/-5) months, respectively. A = 50% decrease in PSA levels from baseline occurred in 38 (61.3%) patients of whom 25 (40.3%) had a = 75% PSA decrease. The main grade 3-4 hematologic toxicities were neutropenia 34% and anemia 18%.
The combination of docetaxel and estramustine exerts substantial activity in HRPC suggesting an overall survival benefit with manageable toxicity. This trial also demonstrated a survival advantage for patients with early chemotherapeutic intervention. We identified PSA relapse, baseline PSA and hemoglobin as valuable prognostic factors in this setting.
基于多西他赛的化疗不仅能减轻晚期激素难治性前列腺癌（HRPC）患者的疼痛并改善其生活质量，还能提高生存率。我们研究了多西他赛与雌莫司汀联合应用于HRPC患者的疗效及预后参数。
我们开展了一项II期试验，给予HRPC患者多西他赛（70mg/m²静脉注射，第2天，每3周一次）和雌莫司汀（280mg，口服，每日3次，在多西他赛前1天开始，连续5天）。对患者进行前列腺特异性抗原（PSA）反应及毒性监测。
62例患者接受了治疗。中位年龄为67.5岁，中位PSA为177.9ng/ml。中位周期数为6个。中位疾病进展时间（TTP）和中位生存时间分别为14（±2）个月和24（±5）个月。38例（61.3%）患者的PSA水平较基线下降了50%，其中25例（40.3%）患者的PSA下降了75%。主要的3-4级血液学毒性为中性粒细胞减少（34%）和贫血（18%）。
多西他赛与雌莫司汀联合应用在HRPC中显示出显著活性，提示总体生存获益且毒性可控。该试验还证明了早期化疗干预对患者的生存优势。我们确定在这种情况下，PSA复发、基线PSA和血红蛋白是有价值的预后因素。
