CRITICAL REVIEW
Common toxicity criteria: version 2.0. an improved reference for grading the acute effects of cancer treatment: impact on radiotherapy

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Abstract

In 1997, the National Cancer Institute (NCI) led an effort to revise and expand the Common Toxicity Criteria (CTC) with the goal of integrating systemic agent, radiation, and surgical criteria into a comprehensive and standardized system. Representatives from the Radiation Therapy Oncology Group (RTOG) participated in this process in an effort to improve acute radiation related criteria and to achieve better clarity and consistency among modalities. CTC v. 2.0 replaces the previous NCI CTC and the RTOG Acute Radiation Morbidity Scoring Criteria and includes more than 260 individual adverse events with more than 100 of these applicable to acute radiation effects. One of the advantages of the revised criteria for radiation oncology is the opportunity to grade acute radiation effects not adequately captured under the previous RTOG system. A pilot study conducted by the RTOG indicated the new criteria are indeed more comprehensive and were preferred by research associates. CTC v. 2.0 represents an improvement in the evaluation and grading of acute toxicity for all modalities.

Introduction

The recognition and grading of toxicity caused by cancer treatment is an important aspect of radiation oncology practice and a critical endpoint in clinical trials. Prior to 1985, the radiotherapy literature carried a variety of inconsistent descriptions and ad hoc terminology for radiation-related toxicity. A similar problem existed in the chemotherapy literature. In 1982, the National Cancer Institute (NCI) created the Common Toxicity Criteria (CTC) for chemotherapy-related effects and the Radiation Therapy Oncology Group (RTOG) developed the Acute Radiation Morbidity Scoring Criteria for radiation effects. Separate criteria were also developed for the late effects of radiation (1).

These systems have now been in place for more than 15 years and have been crucial to the identification and reporting of toxicity in clinical trials. However, as new toxicities were observed, CTC users found it necessary to create new criteria or modify old criteria for specific purposes, leading to inconsistencies and confusion in grading among investigators and cooperative groups. In addition, some of the original criteria included descriptions of multiple adverse events within the same item, making it impossible to tell which specific event had occurred. It was therefore recognized that an expanded and improved set of criteria for acute effects were needed. This report will describe the revised Common Toxicity Criteria and its impact on toxicity grading in radiotherapy.

Section snippets

Methods

In 1997, the NCI Cancer Therapy Evaluation Program (CTEP) led an effort to revise and expand the CTC and to merge systemic, radiation, and surgical criteria into one comprehensive and standardized system. Representatives from the U.S. cooperative groups, many international cooperative groups, the pharmaceutical industry, and the World Health Organization (WHO) participated in the process. The RTOG appointed a panel consisting of Disease Site Chairs charged with suggesting revisions to the RTOG

Results

A full reproduction of the most recent version of CTC v. 2.0 is included at the end of this report (Appendix A). CTC v. 2.0 is also available on the NCI/CTEP web site (2). It is considered a “dynamic” document and will be updated regularly as necessary. Readers are urged to view the web site for the most up-to-date version. A complete description of all modifications in the previous RTOG or CTC criteria is beyond the scope of this report, but an overview with a few significant changes and

Discussion

CTC v. 2.0 is a more comprehensive and improved reference for the grading of acute toxicity for all modalities. It has been in use for all NCI-sponsored trials since March 1998. Additional changes and improvements will be made on a regular basis. Readers are urged to view the NCI/CTEP web site for the most up-to-date version (3). Discussions are underway between the NCI and the newly created American College of Surgeons Oncology Group to consider additional revisions and expansion of surgically

Acknowledgements

Thanks also to Joyce Neading, R.N., Bonnie Sauder, R.N., and Anne Wooten, R.N., who assisted in the data collection comparison study.

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