Abstract
BackgroundThe Common Terminology Criteria for Adverse Events, Version 3.0 (CTCAE v3.0) was released in 2003, and has been widely used as the predominant set of toxicity criteria for cancer clinical trials and scientific meetings. However, the degree to which the elements of CTCAE v3.0 are followed in oncology publications has not been comprehensively evaluated.MethodsWe reviewed phase III randomized clinical trials evaluating systemic cancer therapies, published between Jan 1, 2012 and December 31, 2013, to identify eligible studies that explicitly mentioned using CTCAE v3.0 as the toxicity criteria. A 10-point score based on adherence to CTCAE v3.0 was used to assess the studies. Multivariate linear regression was used to identify features associated with improved adherence.ResultsIn total, 104 publications reporting data on 86,957 patients were included in this analysis. The mean total score for adherence to all four elements of CTCAE v3.0 was 4.03 on a 10-point scale (range, 1 to 9), with 16 publications (15%) having total scores ≤2. Highly heterogeneous and unstandardized adverse event terms were frequently used. In addition, Supra-ordinate terms, terms using ‘Other, specify’, and Grades were often used incorrectly. The multivariate regression model revealed that the absence of a placebo (P=0.003) and a higher total number of AE terms in the table (P<0.001) were independent predictors of a lower total score.ConclusionGiven the importance of understanding the toxicity of new treatments, better adherence to CTCAE v3.0 should be encouraged to ensure the consistency and comparability of toxicity data across different studies.
Highlights
Phase III randomized clinical trials (RCTs) are the ideal way to evaluate medical treatments, and their results enable clinicians to work together to recommend appropriate treatments with an understanding of their benefits and risks
Though the Common Terminology Criteria for Adverse Events (CTCAE) was originally intended for the oncology field, this lexicon is frequently used by physicians making routine care decisions, such as the appropriate dosages of drugs or modes of supportive care
The first required element of CTCAE v3.0 that we evaluated was the use of the standardized adverse event (AE) lexicon
Summary
Phase III randomized clinical trials (RCTs) are the ideal way to evaluate medical treatments, and their results enable clinicians to work together to recommend appropriate treatments with an understanding of their benefits and risks. As oncology treatments are often highly toxic, more sophisticated methods and standards for reporting the extent and severity of adverse effects are needed in the oncology field than in other fields. Considering that most cancer therapies have limited therapeutic indexes, it should be easier to compare cancer studies with one another than non-cancer studies www.impactjournals.com/oncotarget. The Common Terminology Criteria for Adverse Events, Version 3.0. (CTCAE v3.0) was released in 2003, and has been widely used as the predominant set of toxicity criteria for cancer clinical trials and scientific meetings. The degree to which the elements of CTCAE v3.0 are followed in oncology publications has not been comprehensively evaluated
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