Multicenter randomized phase II study of two schedules of docetaxel, estramustine, and prednisone versus mitoxantrone plus prednisone in patients with metastatic hormone-refractory prostate cancer
Multicenter randomized phase II study of two schedules of docetaxel, estramustine, and prednisone versus mitoxantrone plus prednisone in patients with metastatic hormone-refractory prostate cancer
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DOI：
10.1200/jco.2005.12.187
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发表时间：
2005-05-20
影响因子：
45.3
通讯作者：
Poupon, MF
中科院分区：
文献类型：
--
作者：
Oudard, S;Banu, E;Poupon, MF
目的米托蒽醌-糖皮质激素是目前治疗难治性前列腺癌（HRPC）的标准姑息治疗。最近的临床试验证明了紫杉醇-雌莫司汀组合的高活性。我们进行了一项随机II期研究，以评估前列腺特异性抗原（PSA）反应方法将130例转移性HRPC患者随机分为多西他赛组和米托蒽醌-泼尼松组，每组20例，观察两种方案的疗效、主要终点和安全性。（每个21天周期的第2天70 mg/m2或第2天和第9天35 mg/m2）和雌莫司汀（280 mg PO tid，第1 - 5天和第8 - 12天）或米托蒽醌12 mg/m2，每3周一次;结果127例患者可评价PSA反应和安全性。多西他赛组PSA下降≥ 50%的患者比例（67%和63%）高于MP组（18%; P = .0001）。DEP组至PSA进展的中位时间是MP组的5倍（分别为8.8和9.3 vs 1.7个月; P = .000001）。多西他赛组的总生存期（18.6和18.4个月）优于MP组（13.4个月），但差异不显著（P = 0.3）。治疗组间交叉率差异显著（A组、B组和C组分别为16%、10%和48%; P =.00001）。治疗相关毒性反应轻微，主要为血液学毒性反应。
Purpose Mitoxantrone-corticosteroid is currently the standard palliative treatment in hormone-refractory prostate cancer (HRPC) patients. Recent clinical trials documented the high activity of the docetaxel-estramustine combination. We conducted a randomized phase II study to evaluate prostate-specific antigen (PSA) response (primary end point) and safety of two docetaxel-estramustine-prednisone (DEP) regimens and mitoxantrone-prednisone (MP).Patients and Methods One hundred thirty metastatic HRPC patients were randomly assigned to receive docetaxel (70 mg/m(2) on day 2 or 35 mg/m(2) on days 2 and 9 of each 21-day cycle) and estramustine (280 mg PO tid on days 1 through 5 and 8 through 12) or mitoxantrone 12 mg/m(2) every 3 weeks; all patients received prednisone (10 mg daily).Results One hundred twenty-seven patients were assessable for PSA response and safety. A >= 50 % PSA decline was found in a greater percentage of patients in the docetaxel arms (67 % and 63 %) compared with MP (18 %; P = .0001). Median time to PSA progression was five times longer with DEP than with MP (8.8 and 9.3 v 1.7 months, respectively; P = .000001). Overall survival was better in the docetaxel arms (18.6 and 18.4 months) compared with the MP arm (13.4 months), but not significantly so (P = .3). Crossover rates differed significantly among treatment arms (16 %, 10 %, and 48 % in arms A, B, and C, respectively; P =.00001). Treatment-related toxicities were mild and mainly hematologic.Conclusion The results of this randomized phase II study showed significantly higher PSA decline