ASCO, SITC Release Recommendations for Clinical Trial Reporting of Immunotherapy Adverse Events

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The authors focused on 3 key areas of reporting standards to adjust: efficacy, toxicity, and the combination or sequencing of immunotherapies.
The authors focused on 3 key areas of reporting standards to adjust: efficacy, toxicity, and the combination or sequencing of immunotherapies.

As immunotherapies have become more prevalent in clinical trials for treatments against cancer, the American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC) have together developed recommendations for trial reporting standards, which they recently published as a joint statement in the Journal of Clinical Oncology.

Involving the immune system in the mechanisms of action for cancer therapies can result in adverse events manifesting differently compared with other forms of treatment, necessitating an updated approach to reporting of events.

The authors focused on 3 key areas of reporting standards to adjust: efficacy, toxicity, and the combination or sequencing of immunotherapies.

The recommendations suggest efficacy reporting should include criteria for response evaluation and reasons for the criteria, explanation of disease control rate assessment, and criteria involved in continuation of treatment beyond disease progression.

Analytic or visualization methods are recommended to include use of spider or swimmer plots to show response kinetics, along with Kaplan-Meier analyses to report overall survival and progression-free survival.

In addition to reporting all grades of toxicity, the statement recommended including timing and duration of toxicity and its management. Another recommendation was to distinguish between diagnoses of toxicity and the symptoms contributing to diagnoses. Attribution of diagnoses to specific adverse event categories also merits definition of terms and rationales for their usage.

Because immunotherapies are often used in combinations or with specific sequencing approaches, the recommendations urge that data-based scientific hypotheses behind the use of these strategies also be reported.

The authors noted these recommendations will likely be revised with time but intended these as a starting point to ensure proper interpretations of immuno-oncology trial data. 

Reference

Tsimberidou AM, Levit LA, Schilsky RL, et al. Trial reporting in immuno-oncology (TRIO): an American Society of Clinical Oncology-Society for Immunotherapy of Cancer statement [published online October 19, 2018]. J Clin Oncol. doi: 10.1200/JCO.18.00145

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