Weekly administration of docetaxel in combination with estramustine and celecoxib in patients with advanced hormone-refractory prostate cancer: final results from a phase II study.

Weekly administration of docetaxel in combination with estramustine and celecoxib in patients with advanced hormone-refractory prostate cancer: final results from a phase II study.
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DOI:
10.1038/sj.bjc.6604030
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发表时间:
2007-11-05
影响因子:
8.8
通讯作者:
Tello, J. M.
Tello, J. M.
中科院分区:
医学1区
文献类型:
--
作者:
Carles, J.;Font, A.;Mellado, B.;Domenech, M.;Gallardo, E.;Gonzalez-Larriba, J. L.;Catalan, G.;Alfaro, J.;del Alba, A. Gonzalez;Nogue, M.;Lianes, P.;Tello, J. M.

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本研究的目的是评价每周一次的多西紫杉醇、雌激素胺和塞来昔布治疗激素不敏感的晚期前列腺癌患者的疗效和安全性。4 8例患者用多西紫杉醇35 mg m−2,每周3次,每4周1次,雌孕酮2 80 mg,每日2次,第1~3天,第8~10天,第15~17天,塞来昔布400 mg,每日2次,直至病情进展或出现毒性反应。每28天重复一次周期,至少6个周期。对患者进行了反应和毒性评估。患者接受治疗的中位数为4个周期(范围:1-9个)。在意向治疗分析中,48例患者中有28例前列腺特异性抗原(PSA)下降超过50%(总有效率:58%,95%可信区间(CI):44-72),PSA应答的中位持续时间为8.0个月(95%可信区间:6.9-9.0)。中位随访11.3个月,中位进展时间7.1个月,中位总生存期19.2个月。最常见的严重毒性是乏力(15%的患者)、腹泻和口腔炎(各8%的患者)。2例患者出现3/4度中性粒细胞减少。在研究期间,由于胃穿孔而中毒死亡。塞来昔布每周联合多西紫杉醇和雌激素钠是激素抵抗前列腺癌患者的有效和安全的治疗方法,但它似乎没有增加多西紫杉醇的任何好处。
The objective of this study was to evaluate the efficacy and safety profile of weekly docetaxel, estramustine and celecoxib in patients with advanced hormone-refractory prostate cancer. Forty-eight patients received 35 mg m−2 of weekly docetaxel for 3 out of every 4 weeks, 280 mg of estramustine twice daily on days 1–3, 8–10, 15–17 and 400 mg of celecoxib twice daily until progression or toxicity. Cycles were repeated every 28 days for at least six cycles. Patients were evaluated for response and toxicity. Patients received a median of four cycles (range: 1–9). On an intention-to-treat analysis, prostate-specific antigen (PSA) was decreased greater than 50% in 28 out of 48 patients (overall response rate: 58%, 95% confidence interval (CI): 44–72) and median duration of PSA response was 8.0 months (95% CI: 6.9–9.0). After a median follow-up of 11.3 months, the median time to progression was 7.1 months and the median overall survival was 19.2 months. The most frequent severe toxicity was asthenia (15% of patients), diarrhoea and stomatitis (8% of patients, each). Grade 3/4 neutropenia was reported in two patients. There was a toxic death during the study due to a gastric perforation. Celecoxib with weekly docetaxel and estramustine is an effective and safe treatment for patients with hormone-refractory prostate cancer, but it does not seem to add any benefit to docetaxel.
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