March 31, (), Publish Date: August 9, Common documentation of AE names on Case Report Forms. The CTCAE v Available at Accessed March 20, Nexavar spackage insert]. West Haven, CT: Bayer Pharmaceuticals. (£mma Resources – Multinational Association of Supportive Care in Cancer: Therapy Evaluation Program: National .

Author: Vigul Samukree
Country: Sweden
Language: English (Spanish)
Genre: Spiritual
Published (Last): 23 April 2014
Pages: 205
PDF File Size: 17.57 Mb
ePub File Size: 2.37 Mb
ISBN: 804-2-60937-493-4
Downloads: 99052
Price: Free* [*Free Regsitration Required]
Uploader: Kall

No protocol for this study exists. The present study provides evidence of poor reporting of toxicity in clinical trials. Our study provides cctcaev3 of poor reporting of toxicity in clinical trials. The standardized AE lexicon was required and was assigned five points in our scoring system, as it comprises the major part of CTCAE v3.

Journal of Clinical Oncology. We anticipated that the NCI-sponsored trials in this analysis would have higher total scores, but in fact, these trials were similar to other trials in their poor adherence to CTCAE v3. National Center for Biotechnology InformationU. Formss article has been cited by other articles in PMC.

If multiple publications were identified from the same trial, the initial publication was used for the analysis.

Use and misuse of common terminology criteria for adverse events in cancer clinical trials

A phase II study. However, the current literature is still primarily composed of studies using version 3. Finding Appropriate AE Terms.

Reproducible and systematic reporting of toxicity allows studies to be more easily compared with one another [ 2 — 4 ] and facilitates the generation of toxicity-related meta-analyses and other secondary analyses [ 5 — 7 ].


EHY was achieved by arranging capacitive electrodes with a deep hypothermia radiofrequency field of Treatment-related mortality with bevacizumab in cancer patients: Response assessment Bidimensional tumor measurements were performed at baseline and every eight weeks one cycleaccording to RECIST, by computed tomography or magnetic resonance imaging.

Open in a separate window.

Use and misuse of common terminology criteria for adverse events in cancer clinical trials

Journal List Oncotarget v. Results Characteristics of selected RCTs From articles screened initially, publications describing RCTs were included in the present analysis. Is there room for improvement in adverse event reporting in the era of targeted therapies? Hemorrhage, GI-colon Should be more specific; for example: The mean score for AE terms was only 0. The median time to radiological progression was 5. Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology.

Flowchart of screening of randomized clinical trials included in this analysis. The main goal of clinical investigators writing a manuscript might be to report only the adverse events that they consider meaningful for their readers often clinicians.

Forty-three percent of the trials were positive based on the stated primary froms. Received Apr 4; Accepted Aug J Cancer Res Ther. Likewise, in some reports, Alopecia was given a grade of 3 or more, while the maximum grade for this term is 2 in Ctcaev v3. Not an AE term. An AE is a term that is a unique representation of a specific event used for medical documentation and scientific analyses.

Etoposide and cisplatin versus irinotecan and cisplatin in patients with limited-stage small-cell lung cancer treated with etoposide and cisplatin plus concurrent accelerated hyperfractionated thoracic radiotherapy JCOG Publications were limited to trials exploring pharmacologic interventions in patients with solid tumors.


Sorafenib BAY in hepatocellular carcinoma patients: For this type of term, one word should be selected from the words listed after the Supra-ordinate term to make it more specific e.

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

The standard treatment for advanced hepatocellular carcinoma HCC is sorafenib, a multikinase inhibitor of tumor cell proliferation and angiogenesis. The findings from RCTs enable clinicians to make treatment recommendations, describe the risks and benefits of various treatments, and facilitate shared decision-making [ 1 ]. This article is mentioned in: One point was deducted for each misused AE term.

The mean score for this section was 0.

All patients were evaluable for toxicity. Our results further extended these findings, specifically evaluating the quality of reporting toxicity in the context of CTCAE v3. In the design of medical interventions, it is critical to strike a balance between efficacy and toxicity, ctcadv3 many anticancer drugs may be so toxic that they become less beneficial [ 9 ].

All authors read and approved the final manuscript. Hyperthermia inhibits angiogenesis by a plasminogen activator inhibitor 1-dependent mechanism. Common Terminology Criteria for Adverse Events v3.

British Journal of Cancer. Quality of reporting of modern randomized controlled trials in medical oncology: Cancer Microenvironment and Therapeutic Implications.

The use of and adherence to CTCAE v in cancer clinical trial publications

Detailed information is described in the Result section. Quality of reporting of serious adverse drug events to an institutional review board: Statistical analyses were performed in SAS version 9. We only analyzed publications from the past two years from randomized phase III trials of solid tumor treatments, although phase II trials, hematologic malignancy trials and multimodality treatment trials for instance, studies of radiation therapy should also be required to adhere to CTCAE v3.


Author information Article notes Copyright and License information Disclaimer. These results compare favorably with the sorafenib phase II study conducted by Abou-Alfa et al 17 in patients with advanced HCC; three 2.