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首页> 外文期刊>Urologic oncology >Phase II trial of thalidomide and daily oral dexamethasone for treatment of hormone refractory prostate cancer progressing after chemotherapy.
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Phase II trial of thalidomide and daily oral dexamethasone for treatment of hormone refractory prostate cancer progressing after chemotherapy.

机译：沙利度胺和每日口服地塞米松治疗化疗后激素难治性前列腺癌的II期试验。

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摘要

BACKGROUND: Responses to monotherapy corticosteroid or thalidomide have been described in prostate cancer, in chemotherapy naive subjects. METHODS: A total of 39 men with hormone refractory, metastatic prostate cancer who had progression during or after at least 1 conventional cytotoxic drug were treated on a single-arm Phase II trial with dexamethasone, 0.75 mg twice a day plus thalidomide, 100-400 mg/day. RESULTS: Best-observed responses included >50% prostate-specific antigen (PSA) reduction with no radiologic progression: 10 of 39 (26%; 95% confidence interval 13% to 42%). An additional 14 of 39 had decreased PSA but then with radiologic or other progression by 12 weeks. Median progression-free survival was 84 days. Toxicity appeared treatable; there were 5 nonfatal thromboses. There was 1 subject who had complete PSA and radiologic response; 4 responders tolerated treatment without progression for more than 1 year. CONCLUSIONS: PSA responses were frequent. Mostly, these were not durable, but some lasted more than a year. Further investigation on determinants of response durability for these or related compounds should be considered. The response rate of the present data does not support Phase III testing of this regimen for this population.
机译：背景：在前列腺癌中，初次化疗的受试者中已经描述了对单药皮质类固醇或沙利度胺的反应。方法：在39例患有激素难治性转移性前列腺癌的男性中，至少在1种常规细胞毒性药物治疗期间或之后进展，在单组II期试验中接受地塞米松0.75 mg每天两次，联合沙利度胺100-400毫克/天。结果：最佳观察到的反应包括> 50％的前列腺特异性抗原（PSA）降低，无放射学进展：39/10（26％; 95％置信区间13％至42％）。 39例中有14例的PSA降低，但放射学或其他进展持续12周。中位无进展生存期为84天。毒性似乎可以治愈;有5例非致命性血栓形成。有1名受试者具有完整的PSA和放射学反应; 4名反应者耐受治疗且无进展超过1年。结论：PSA反应频繁。大多数情况下，这些都不耐用，但有些可以使用一年以上。应该考虑进一步研究这些或相关化合物的响应持久性决定因素。当前数据的响应率不支持针对该人群的该方案的III期测试。

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