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Phase I trials as valid therapeutic options for patients with cancer.
Nature Reviews Clinical Oncology ( IF 78.8 ) Pub Date : 2019-09-02 , DOI: 10.1038/s41571-019-0262-9
Jacob J Adashek 1 , Patricia M LoRusso 2 , David S Hong 3 , Razelle Kurzrock 4
Affiliation  

For many years, oncology phase I trials have been referred to as 'toxicity trials' and have been believed to have low clinical utility other than that of establishing the adverse event profile of novel therapeutic agents. The traditional distinction of clinical trials into three phases has been challenged in the past few years by the introduction of targeted therapies and immunotherapies into the routine management of patients with cancer. This transformation has especially affected early phase trials, leading to the current situation in which response rates are increasingly reported from phase I trials. In this Perspectives, we highlight key elements of phase I trials and discuss how each one of them contributes to a new paradigm whereby preliminary measurements of the clinical benefit from a novel treatment can be obtained in current phase I trials, which can therefore be considered to have a therapeutic intent.

中文翻译:

I 期试验作为癌症患者的有效治疗选择。

多年来,肿瘤学 I 期试验一直被称为“毒性试验”,并被认为除了确定新型治疗药物的不良事件概况外,临床效用较低。在过去几年中,将靶向疗法和免疫疗法引入癌症患者的常规管理中,传统的将临床试验分为三个阶段的做法受到了挑战。这种转变尤其影响了早期试验,导致目前 I 期试验报告的反应率越来越多。在这个观点中,
更新日期:2019-09-03
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