Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer
Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer
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DOI：
10.1056/nejmoa041318
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发表时间：
2004-10-07
影响因子：
158.5
通讯作者：
Crawford, ED
中科院分区：
文献类型：
--
作者：
Petrylak, DP;Tangen, CM;Crawford, ED
背景：基于Mitoxantrone的化学疗法会导致疼痛疼痛，而无需延长与雄激素独立前列腺癌的男性的生存率。我们比较了多西他赛加雌氨司汀与Mitoxantrone和Mitoxantrone和泼尼松在转移性，激素独立的前列腺癌中进行了比较。Methods：我们将770名男性随机分配给两种治疗方法之一，每次以21天的自行车进行：280 mg的雌激素：280 mg的Estramustine三次第2天的1至5，60毫克每平方米的身体表面面积和60毫克多西他赛前三分剂量的地塞米松，或每天两次，每平方米12毫克每平方米的Mitoxantrone每天两次。主要终点是总体生存。次要终点是无进展的生存率，客观反应率和治疗后血清前列腺特异性抗原（PSA）级别的下降至少50％。回报：在674名合格的患者中，有338名被分配接受多西昔二氏菌和雌激素和雌激素336接收Mitoxantrone和泼尼松。在意向性治疗分析中，给定的多西他赛和雌二指的组中位总生存期比给定的mitoxantrone和泼尼松的组中的总生存期更长（17.5个月，15.6个月，p = 0.02，按日志秩检验）和死亡的相应危害比为0.80（95％的置信区间，0.67至0.97）。在给定的多西他赛和雌马的组中，进展的中位时间为6.3个月，在给定米托氨基酮和泼尼松的组中，该组的中位时间为3.2个月（P
BACKGROUND:Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer. We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic, hormone-independent prostate cancer.METHODS:We randomly assigned 770 men to one of two treatments, each given in 21-day cycles: 280 mg of estramustine three times daily on days 1 through 5, 60 mg of docetaxel per square meter of body-surface area on day 2, and 60 mg of dexamethasone in three divided doses before docetaxel, or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily. The primary end point was overall survival; secondary end points were progression-free survival, objective response rates, and post-treatment declines of at least 50 percent in serum prostate-specific antigen (PSA) levels.RESULTS:Of 674 eligible patients, 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone. In an intention-to-treat analysis, the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone (17.5 months vs. 15.6 months, P=0.02 by the log-rank test), and the corresponding hazard ratio for death was 0.80 (95 percent confidence interval, 0.67 to 0.97). The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone (P