Michaelis Laura C, Ratain Mark J
Section of Hematology/Oncology, University of Chicago, 5841 S. Maryland Avenue, MC 2115, Chicago, Illinois 60637, USA.
Nat Rev Cancer. 2006 May;6(5):409-14. doi: 10.1038/nrc1883.
The unprecedented pace of therapeutic development in oncology has created a climate in which the traditional methods of evaluating agent activity might no longer be adequate. How is the field transitioning to new endpoints in early drug development and what are the difficulties in this transition? Here, we will explore the historical context for the current criteria for tumour response evaluation and some of the pitfalls in using these standards when testing newer anticancer agents for activity. We will argue that the current drug development environment dictates different outcome measurements and therefore more imaginative and rigorous early-phase trial designs.
肿瘤治疗发展的空前速度营造了一种氛围，在这种氛围下，评估药物活性的传统方法可能不再适用。该领域在早期药物研发中如何向新的终点指标转变，以及这种转变存在哪些困难？在此，我们将探讨当前肿瘤反应评估标准的历史背景，以及在测试新型抗癌药物活性时使用这些标准所存在的一些缺陷。我们认为，当前的药物研发环境决定了需要不同的结果测量方法，因此需要更具想象力和严谨性的早期试验设计。
