Research Papers:

The use of and adherence to CTCAE v3.0 in cancer clinical trial publications

Sheng Zhang _, Qiang Chen and Qing Wang

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Oncotarget. 2016; 7:65577-65588. https://doi.org/10.18632/oncotarget.11576

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Sheng Zhang1, Qiang Chen2, Qing Wang3

1Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China

2Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, China

3Department of Clinical Laboratory, Affiliated Hospital of Qingdao University, China

Correspondence to:

Sheng Zhang, email: [email protected]

Keywords: adverse event, CTC, randomized clinical trial

Received: April 04, 2016    Accepted: August 12, 2016    Published: August 24, 2016


Background: 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. However, the degree to which the elements of CTCAE v3.0 are followed in oncology publications has not been comprehensively evaluated.

Methods: We 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.

Results: In 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.

Conclusion: Given 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.

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