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在靶向治疗时代,不良事件报告是否有改进的空间?

Is there room for improvement in adverse event reporting in the era of targeted therapies?

作者信息

Edgerly Maureen, Fojo Tito

机构信息

Center for Cancer Research, National Cancer Institute, Bethesda, MD, USA.

出版信息

J Natl Cancer Inst. 2008 Feb 20;100(4):240-2. doi: 10.1093/jnci/djm324. Epub 2008 Feb 12.

Abstract

The Common Terminology Criteria for Adverse Events (CTCAE), version 3.0, and its predecessors, the Common Toxicity Criteria (CTC) versions 1.0 and 2.0, were developed under the direction of the Cancer Therapy Evaluation Program of the National Cancer Institute (NCI) in an effort to provide standard language for reporting adverse events that occur in NCI-sponsored clinical trials. Each successive version of the CTC has improved the accuracy, precision, and completeness of the criteria in an effort to standardize reporting. We believe that the current version of the CTCAE cannot adequately code the subacute adverse events that commonly occur with today's targeted therapies.

摘要

《不良事件通用术语标准》(CTCAE)3.0版及其前身《通用毒性标准》(CTC)1.0版和2.0版,是在美国国立癌症研究所(NCI)癌症治疗评估项目的指导下制定的,旨在为报告NCI资助的临床试验中发生的不良事件提供标准用语。CTC的每个后续版本都提高了标准的准确性、精确性和完整性,以实现报告的标准化。我们认为,CTCAE的当前版本无法充分编码当今靶向治疗中常见的亚急性不良事件。

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