Clinical models for testing chemopreventative agents in prostate cancer and overview of SELECT: the Selenium and Vitamin E Cancer Prevention Trial.

Clinical models for testing chemopreventative agents in prostate cancer and overview of SELECT: the Selenium and Vitamin E Cancer Prevention Trial.
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测试前列腺癌化学预防药物的临床模型和 SELECT 概述:硒和维生素 E 癌症预防试验。

DOI:
10.1007/978-3-642-55647-0_19
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发表时间:
2003
期刊:
Recent results in cancer research. Fortschritte der Krebsforschung. Progres dans les recherches sur le cancer
影响因子:
--
通讯作者:
E. Klein
E. Klein
中科院分区:
--
文献类型:
--
作者:
E. Klein

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化学预防试验的目标人群应包括那些由明确的流行病学和遗传标准定义的前列腺癌发生风险高于平均水平的人群。这些人群包括没有癌症的组织学或临床证据的“一级预防”组,以及“二级预防”的几种临床模型,包括在确定性治疗之前具有临床明显疾病的那些和基于组织学和/或生物化学状态在治疗后具有高复发风险的那些。每个风险组和临床模型都有潜在的优点和缺点,并且每个组中疾病发展和进展的机制可能是独特的。这些观察结果引起了许多潜在的特定药物的临床试验。这些试验还应包括收集对疾病发展和进展的潜在混杂影响的数据。临床前、流行病学和II期数据表明,硒和维生素E在预防前列腺癌方面具有潜在功效。前列腺癌预防试验(PCPT)的经验表明了健康男性对癌症预防长期研究的兴趣和奉献精神。SELECT,硒和维生素E癌症预防试验,是一项组间III期,随机,双盲,安慰剂对照,基于人群的临床试验,旨在测试硒和维生素E单独和联合预防前列腺癌的疗效,其建立在对其他癌症的大规模化学预防试验的二次分析和PCPT的教训基础上。
Target populations for chemoprevention trials should include those at higher than average risk for the development of prostate cancer as defined by explicit epidemiologic and genetic criteria. Such populations include a "primary prevention" group without histologic or clinical evidence of cancer, and several clinical models of "secondary prevention," including those with clinically evident disease prior to definitive therapy and those at high risk of recurrence after therapy based on histology and/or biochemical status. Each risk group and clinical model has potential advantages and disadvantages, and the mechanisms which underlie disease development and progression in each group may be unique. These observations give rise to many potential clinical trials of specific agents. These trials should also include collection of data on potentially confounding influences on disease development and progression. Preclinical, epidemiologic, and Phase II data suggest that both selenium and vitamin E have potential efficacy in prostate cancer prevention. The experience of the Prostate Cancer Prevention Trial (PCPT) demonstrates the interest and dedication of healthy men to long-term studies of cancer prevention. SELECT, the Selenium and Vitamin E Cancer Prevention Trial, is an intergroup phase III, randomized, double-blind, placebo-controlled, population-based clinical trial designed to test the efficacy of selenium and vitamin E alone and in combination in the prevention of prostate cancer which builds on secondary analyses of large-scale chemoprevention trials for other cancers and the lessons of PCPT.
DOI: 10.1093/jnci/82.11.941
发表时间: 1990-06-06
影响因子: 10.3
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