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A paradigm shift in tumour response evaluation of targeted therapy: The assessment of novel drugs in exploratory clinical trials

机译:靶向治疗的肿瘤反应评估模式转变:探索性临床试验中新药的评估

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Purpose of Review: To describe the difficulty in assessing the biological activity of a novel agent in phase II trials. Recent Findings: Two major fields of research provide interesting new potential endpoints: endpoints based on new imaging techniques (e.g. PET or spectral imaging that explore tumour metabolism, dynamic contrast enhanced (DCE) ultrasonography or DCE-MRI that explore tumour vascularization and tumour growth inhibition) and endpoints integrating assessment of tumour burden across time, such as the growth modulation index. Summary: Most of the recently described techniques appear attractive, but require formal validation.
机译:审查目的:描述在II期临床试验中评估新型药物生物学活性的困难。最新发现:两个主要的研究领域提供了有趣的新潜在终点:基于新成像技术(例如,探索肿瘤代谢的PET或光谱成像,探索肿瘤血管形成和肿瘤生长抑制的动态对比增强(DCE)超声检查或DCE-MRI) )和整合了跨时间的肿瘤负荷评估的终点,例如生长调节指数。简介:最近描述的大多数技术似乎很有吸引力,但是需要正式的验证。

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