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首页> 外文期刊>Journal of Clinical Oncology >Phase II trial of oral estramustine, oral etoposide, and intravenous paclitaxel in hormone-refractory prostate cancer.
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Phase II trial of oral estramustine, oral etoposide, and intravenous paclitaxel in hormone-refractory prostate cancer.

机译：口服雌莫司汀，口服依托泊苷和静脉内紫杉醇用于激素难治性前列腺癌的II期试验。

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PURPOSE: To evaluate the combination of intravenous (IV) paclitaxel, oral estramustine, and oral etoposide in patients with advanced hormone-refractory prostate cancer. PATIENTS AND METHODS: Forty patients with carcinoma of the prostate that was progressing despite hormonal therapy and who had undergone antiandrogen withdrawal (if previously treated with an antiandrogen) were enrolled onto this phase II trial. Patients were treated with oral estramustine 280 mg tid and oral etoposide 100 mg/d for 7 days, with paclitaxel 135 mg/m(2) IV over 1 hour on day 2 of each 21-day treatment cycle. Patients received a maximum of six cycles of therapy. RESULTS: Thirty-seven patients were assessable for response. Twenty-two had measurable disease at baseline; response was not assessable in six of these patients. Overall response was 45% (10 of 22 patients; 95% confidence interval [CI], 24% to 68%), and response was 63% (10 of 16) in assessable patients. Twenty-six patients had a > or = 50% decrease from their baseline prostate-specific antigen levels during therapy, for a response rate of 65% (95% CI, 48% to 79%) by this criterion. Median duration of response was 3.2 months, with an estimated median survival of 12.8 months. Major toxicities of therapy were leukopenia (eight patients had > or = grade 4 leukopenia) and anemia. Hematologic toxicity seemed to be associated with liver metastases. Serial measurements in 24 patients using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) showed no significant change in quality of life (QOL) as a result of therapy. CONCLUSION: The combination of IV paclitaxel, oral estramustine, and oral etoposide is active in patients with advanced prostate cancer. The regimen is tolerable and does not have a significant impact on QOL as measured by the FACT-P in a limited sample of patients.
机译：目的：评估晚期激素难治性前列腺癌患者的静脉（IV）紫杉醇，口服雌莫司汀和口服依托泊苷的组合。患者与方法：40例尽管接受激素治疗但仍在进展中且已接受抗雄激素治疗（如果先前已接受抗雄激素治疗）的前列腺癌患者参加了该II期试验。在每个21天的治疗周期的第2天，在1个小时内用口服雌莫司汀280 mg tid和口服依托泊苷100 mg / d治疗7天，并用紫杉醇135 mg / m（2）静脉内治疗1天。患者最多接受六个疗程。结果：37例患者的反应可评估。 22名患者在基线时可测量的疾病。这些患者中有6例的反应没有评估。在可评估患者中，总缓解率为45％（22名患者中的10名; 95％置信区间[CI]，为24％至68％），缓解率为63％（16名中的10名）。 26名患者在治疗期间比其基线前列腺特异性抗原水平降低了>或= 50％，根据该标准，其缓解率为65％（95％CI，48％至79％）。中位反应持续时间为3.2个月，估计中位生存期为12.8个月。治疗的主要毒性是白细胞减少症（8名患者≥4级白细胞减少症）和贫血。血液学毒性似乎与肝转移有关。使用前列腺癌功能评估（FACT-P）对24例患者进行的连续测量显示，治疗后生活质量（QOL）没有明显变化。结论：IV紫杉醇，口服雌莫司汀和口服依托泊苷联合使用对晚期前列腺癌患者有效。 FACT-P在有限的患者样本中，该方案是可以耐受的，并且对QOL没有明显影响。

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