CTCAE v3.0: development of a comprehensive grading system for the adverse effects of cancer treatment

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Abstract

Multiple systems have been developed for grading the adverse effects (AEs) of cancer treatment. The National Cancer Institute Common Toxicity Criteria (CTC) system has substantially evolved since its inception in 1983. The most recent version, CTCAE v3.0 (Common Terminology Criteria for Adverse Events version 3.0) represents the first comprehensive, multimodality grading system for reporting the acute and late effects of cancer treatment. The new CTC requires changes in the application of AE criteria including new guidelines regarding late effects, surgical and pediatric effects, multimodality issues, and for reporting the duration of an effect. It builds on the strengths of previous systems, represents a considerable effort among hundreds of participants, and signifies an international collaboration and consensus of the oncology research community. This article updates recent progress in the evolution of adverse effects grading systems and reviews the development of CTCAE v3.0.

Section snippets

Evolution of the CTC

The evolution of various AE grading systems and the history of their modality origins have been reviewed elsewhere.3 Table 1 summarizes the most widely used systems over the last 20 years. In 1998, the NCI released a revised and markedly expanded version of the CTC (CTC v2.0) designed to update the original CTC. Among the changes was greater specificity in criteria language and the systematic inclusion of criteria for grading the acute effects of radiotherapy. This revision did not include

New principles of CTCAE v3.0

A number of new principles were established at the workshop regarding the need for fundamental changes in the methods of grading and reporting adverse effects.

Late effects and acute effects criteria will be merged into a single uniform system and applied without a predetermined time-based designation. In an era of complex multimodality integration, the designation of acute versus late effects (or subacute, consequential, and so on) will be a determination made by the investigator(s) upon

CTCAE v3.0

The third version of the CTC has been renamed as Common Terminology Criteria for Adverse Events v3.0 (CTCAE v3.0). The purpose of renaming is to move away from the term toxicity, which implies causation and does not fit the jargon commonly used across all modalities. It is scheduled for full distribution to NCI-sponsored organizations in the Spring of 2003 and will be available on the CTEP web site (http://ctep.info.nih.gov/CTC3/ctc/htm).10 It is anticipated that after October 2003 all

Summary

CTCAE v3.0 represents the first comprehensive, multimodality grading system to include both acute and late effects. We believe that it will greatly facilitate the standardized reporting of AEs, comparison of outcomes between trials and institutions, and promote a more complete recognition and reporting of adverse effects. This document has evolved over 20 years of use and has substantially matured in recent years to become a vital multimodality clinical trials tool. The development of CTCAE

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Supported by NCI R13 CA 93030-01.

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