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I-II期化学预防试验中的生物标志物：来自美国国立癌症研究所经验的教训。

Biomarkers in phase I-II chemoprevention trials: lessons from the NCI experience.

作者信息

Szabo Eva

机构信息

Lung and Upper Aerodigestive Cancer Research Group, Division of Cancer Prevention, National Cancer Institute, National Institutes of Health, 9609 Medical Centre Drive, Room 5E-102, Bethesda, MD 20892, USA.

出版信息

Ecancermedicalscience. 2015 Nov 24;9:599. doi: 10.3332/ecancer.2015.599. eCollection 2015.

DOI:10.3332/ecancer.2015.599
PMID:26635903
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4664504/
Abstract

Early phase clinical trials are an essential component of chemopreventive drug development to identify signals of drug efficacy that can subsequently be explored definitively in phase III trials. Whereas phase I trials focus on safety and identification of optimal dose and schedule for cancer prevention, phase II trials focus on intermediate endpoints that are variably related to cancer development. The United States National Cancer Institute supports a programme devoted to early phase cancer prevention clinical trials. The experience, along with the benefits and limitations of the range of biomarker endpoints used in these studies, are reviewed here.

摘要

早期临床试验是化学预防药物开发的重要组成部分，用于识别药物疗效信号，随后可在III期试验中进行明确探索。I期试验侧重于安全性以及确定癌症预防的最佳剂量和给药方案，而II期试验则侧重于与癌症发展有不同关联的中间终点。美国国立癌症研究所支持一项致力于早期癌症预防临床试验的计划。本文回顾了这些研究中使用的一系列生物标志物终点的经验以及利弊。

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