Phase II trial of 96-hour paclitaxel plus oral estramustine phosphate in metastatic hormone-refractory prostate cancer
Phase II trial of 96-hour paclitaxel plus oral estramustine phosphate in metastatic hormone-refractory prostate cancer
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DOI：
10.1200/jco.1997.15.9.3156
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发表时间：
1997-09-01
影响因子：
45.3
通讯作者：
McAleer, C
中科院分区：
文献类型：
--
作者：
Hudes, GR;Nathan, F;McAleer, C
目的：评估 96 小时紫杉醇和每日口服雌莫司汀磷酸盐 (EMP) 对转移性激素难治性前列腺癌 (HRPC) 患者的抗肿瘤活性。 患者和方法：34 名在一种或多种激素治疗和抗雄激素戒断试验后进展的前列腺腺癌患者被纳入这项 II 期试验。患者在每个 21 天周期的第 1 至 4 天接受紫杉醇 120 mg/m(2) 96 小时静脉 (IV) 输注，同时每日口服 EMP 600 mg/m(2)/d，连续。结果：9 名患者中的 4 名在肝脏（两名患者）或淋巴结（两名患者）中出现可测量的疾病客观反应（一名完全缓解 [CR] 和三名部分缓解 [PR]）2、6、 8、20个月的持续时间。在 25 名可评估的转移仅限于骨的患者中，14 名患者治疗前前列腺特异性抗原 (PSA) 水平持续 6 周下降大于或等于 50%，7 名下降大于或等于 80%。总体而言，治疗前 PSA 水平升高的 32 名患者中，有 17 名 (53.1%) 的 PSA 下降大于或等于 50%，9 名 (28.1%) 的下降大于或等于 80%。主要毒性（大于或等于2级）是恶心、体液潴留和疲劳，发生率分别为33%、33%和24.2%。根据 PSA 水平升高和其他临床标准，进展的中位时间为 22.5 周。预计中位总生存时间为69周。结论：EMP联合96小时紫杉醇是HRPC患者的积极治疗方案。这些结果进一步支持了通过互补机制联合损害微管功能的药物的治疗策略。 (C) 1991 年美国临床肿瘤学会。
Purpose: To evaluate the antitumor activity of 96-hour paclitaxel and daily oral estramustine phosphate (EMP) in patients with metastatic hormone-refractory prostate cancer (HRPC).Patients and Methods: Thirty-four patients with adenocarcinoma of the prostate that progressed after one or more hormonal therapies and a trial of antiandrogen withdrawal were enrolled onto this phase II trial. patients received paclitaxel 120 mg/m(2) by 96-hour intravenous (IV) infusion on days 1 through 4 of each 21-day cycle, together with daily oral EMP 600 mg/m(2)/d, continuously.Results: Four of nine patients with measurable disease objective responses (one complete response [CR] and three partial responses [PRs]) in liver (two patients) or nodes (two patients) of 2, 6, 8, and 20 months' duration. Of 25 assessable patients with metastases limited to bone, 14 had a greater than or equal to 50% decline in pretreatment prostate-specific antigen (PSA) level sustain 6 weeks and seven had a greater than or equal to 80% decline. Overall, 17 of 32 patients (53.1%) with elevated pretreatment PSA levels had a greater than or equal to 50% decline of PSA and nine (28.1%) had a greater than or equal to 80% decrease. The main toxicities (greater than or equal to grade 2) were nausea, fluid retention, and fatigue, which occurred in 33%, 33%, and 24.2% of patients. Median time to progression, based on increasing PSA level and other clinical criteria, was 22.5 weeks. The estimated median overall survival time is 69 weeks.Conclusion: The combination of EMP and 96-hour paclitaxel an active regimen for patients with HRPC. These results further support the therapeutic strategy of combining agents that impair microtubule function by complementary mechanisms. (C) 1991 by American Society of Clinical Oncology.