Medical Oncology Department, Santa Chiara Hospital, Trento, Italy.
Urol Oncol. 2010 Mar-Apr;28(2):152-6. doi: 10.1016/j.urolonc.2008.07.033. Epub 2008 Oct 10.
Although docetaxel (DOC) plus prednisone is currently the treatment of choice for hormone-refractory prostate cancer (HRPC), no standard therapy is available for those patients who progress during DOC treatment. The aim of this study was to evaluate whether the addition of estramustine (E) can overcome DOC resistance.
Patients who had not responded to DOC in a previous randomised phase II trial received a one-hour intravenous infusion of DOC 70 mg/m(2) on day 2 in combination with oral E 840 mg/day divided into three daily administrations on days 1-5. The primary endpoint was a >50% decrease in PSA; the secondary endpoints were biochemical progression-free survival, overall survival, the objective response rate, and toxicity.
A biochemical response was observed in 52% of the 25 patients evaluable for response. The only grade 4 event was a cerebral stroke that occurred a few days after the administration of the first treatment course. Treatment discontinuation due to worsened compliance was observed in the patients who received a higher cumulative number of courses.
Our findings suggest that the addition of E may be useful in selected HRPC patients resistant to DOC alone.
尽管多西他赛（DOC）联合泼尼松目前是治疗激素难治性前列腺癌（HRPC）的首选方法，但对于那些在 DOC 治疗期间进展的患者，尚无标准疗法。本研究旨在评估是否添加雌莫司汀（E）可以克服 DOC 的耐药性。
在之前的一项随机 II 期试验中对未对 DOC 产生反应的患者，在第 2 天给予 70mg/m²的静脉输注 DOC，同时在第 1-5 天每天口服 840mg 的 E，分为 3 次。主要终点为 PSA 下降>50%；次要终点为生化无进展生存期、总生存期、客观缓解率和毒性。
25 例可评估反应的患者中，有 52%观察到生化反应。唯一的 4 级事件是在第一个疗程治疗后几天发生的脑卒。那些接受更高累积疗程数的患者因依从性恶化而停药。
我们的研究结果表明，在单独对 DOC 耐药的选择 HRPC 患者中，添加 E 可能是有用的。
