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Journal of the National Cancer Institute Advance Access originally published online on February 12, 2008
JNCI Journal of the National Cancer Institute 2008 100(4):240-242; doi:10.1093/jnci/djm324
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Published by Oxford University Press 2008.

COMMENTARY

Is There Room for Improvement in Adverse Event Reporting in the Era of Targeted Therapies?

Maureen Edgerly, Tito Fojo

Affiliation of authors: Center for Cancer Research, National Cancer Institute, Bethesda, MD

Correspondence to: Tito Fojo, MD, PhD, Bldg 10, Rm 12N226, 10 Center Dr, Bethesda, MD 20892-1903 (e-mail: tfojo{at}helix.nih.gov).

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 todays targeted therapies.

Manuscript received September 5, 2007; revised December 19, 2007; accepted December 20, 2007.


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