Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: A final report of CALGB 9780
Phase II study of docetaxel, estramustine, and low-dose hydrocortisone in men with hormone-refractory prostate cancer: A final report of CALGB 9780
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DOI：
10.1200/jco.2001.19.9.2509
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发表时间：
2001-05-01
影响因子：
45.3
通讯作者：
Vogelzang, NJ
中科院分区：
文献类型：
--
作者：
Savarese, DM;Halabi, S;Vogelzang, NJ
目的：探讨多西紫杉醇、雌二醇（EM）和小剂量氢化可的松联合治疗激素难治性前列腺癌（HRPC）的疗效。患者和方法：EM与其他抗有丝分裂药物（如多西他赛）联合在体外具有协同作用，并在HRPC患者中显示出显着的临床活性。我们研究了在初始激素治疗后出现进展的HRPC患者静脉注射多西他赛70 mg/m(2)、口服雌二醇和每日低剂量氢化可的松。结果：在这个多中心合作组研究的47名男性中，46名可评估反应和/或毒性。在24例可测量疾病患者中，有3例完全缓解和9例部分缓解，可测量疾病缓解率为50%（24例患者中有12例；95%置信区间[CI]， 27%至73%）。在预处理前列腺特异性抗原（PSA）升高的44例患者中，30例（68%）患者PSA下降50%或以上，25例（57%）患者PSA下降75%或以上。在所有46例可评估的患者中，可测量的疾病和生化反应的综合发生率为54%（3例完全缓解，22例部分缓解，95% CI， 37%至71%）。主要毒性是中性粒细胞减少症，26%的患者为3级，30%为4级粒细胞减少症；无发热性中性粒细胞减少发作。其他常见但轻微的不良反应包括不适/疲劳、外周水肿和高血糖，治疗期间血栓栓塞事件的发生率为9%。中位随访为17个月，中位生存期为20个月。所有患者到疾病进展的中位时间为8个月，可测量疾病的患者为10个月。结论：该疗法在HRPC中有效且耐受性良好，应与米托蒽醌和强的松进行三期试验比较。中华临床杂志（英文版）：2509-2576。(C) 2001年美国临床肿瘤学会。
Purpose: To investigate the combination of docetaxel, estramustine (EM), and low-dose hydrocortisone in men with hormone-refractory prostate cancer (HRPC).Patients and Methods: Combinations of EM with other antimitotic agents such as docetaxel are synergistic in vitro and show significant clinical activity in patients with HRPC. We studied intravenous administration of docetaxel 70 mg/m(2), oral estramustine, and low-dose daily hydrocortisone in men with HRPC who demonstrated progression after initial hormone therapy.Results: Of the 47 men enrolled onto this multicenter cooperative group study, 46 were assessable for response and/or toxicity. In the 24 patients with measurable disease, there were three complete and nine partial responses for a measurable disease response rate of 50% (12 of 24 patients; 95% confidence interval [CI], 27% to 73%. In the 44 patients in whom pretreatment prostate-specific antigen (PSA) was elevated, 30 (68%) had a 50% or greater decrease, and 25 (57%) had a 75% or greater decrease in PSA. The combined measurable disease and biochemical response rate in all 46 assessable patients was 54% (three complete responses, 22 partial responses, 95% CI, 37% to 71%). The predominant toxicity was neutropenia, with 26% of patients having grade 3 and 30% having grade 4 granulocytopenia; there were no episodes of febrile neutropenia. Other common but mild adverse effects included malaise/fatigue, peripheral edema, and hyperglycemia, The incidence of thromboembolic events during therapy was 9%. With a median follow-up of 17 months, the median survival was 20 months. The median time to disease progression was 8 months for all patients, and 10 months for those with measurable disease.Conclusion: This therapy is efficacious and moderately well tolerated in HRPC and should be compared in a phase III trial with mitoxantrone and prednisone. J Clin Oncol 19:2509-2576. (C) 2001 by American Society of Clinical Oncology.