ASCO, SITC Release Recommendations for Immuno-Oncology Clinical Trial Reporting, Assessment

11/08/18

The American Society of Clinical Oncology (ASCO) and the Society for Immunotherapy of Cancer (SITC) released a statement with twelve clinical trial reporting and assessment recommendations that address the efficacy, toxicity, and combination/sequencing aspects of immuno-oncology treatments.

The recommendations were published in the Journal of Clinical Oncology (doi:10.1200/JCO.18.00145) and the Journal of ImmunoTherapy of Cancer.

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A working group was convened in 2016 to address the need for immuno-oncology specific clinical trial reporting guidance. Members of the group included medical oncologists, immunologists, clinical researchers, biostatisticians, industry, and government representatives. The resulting recommendations were crafted to improve the completeness and consistency of reporting of immuno-oncology trial efficacy and toxicity endpoints, as well as combination and sequencing studies to better facilitate interpretation and comparison of trial data in the available literature.

The recommendations are categorized into three sections: efficacy and reporting standard for immuno-oncology trials (1-6), toxicity reporting standards for immuno-oncology trials (7-11), and combination or sequencing of immunotherapies reporting standards (12).

  1. Report the criteria used to evaluate response to therapy and the rationale for the selected criteria.
     
  2. Include spider plots or swimmer plots in efficacy descriptions to better report kinetics of response for non-randomized trials.
     
  3. Report how disease control rate is defined and how its components are assessed.
  4. Report criteria that allow patients to continue treatment beyond disease progression.
  5. Report the number (proportion) of patients who are treated beyond progression, as well as the treatment beyond progression duration, emergence of new toxicity, and efficacy after initial progression.
  6. Report progression-free survival and overall survival using Kaplan-Meier analyses.
  7. Differentiate between the clinical diagnoses of immuno-oncology toxicity and the specific symptoms that led to the diagnoses.
  8. If the pre-specified clinical diagnoses used in data collection belong to categories such as “immune-related adverse events” or “adverse events of special interest,” report how these terms are defined and why these categories were selected for trial reporting.
  9. Report all toxicity by specific grade.
  10. Report clinical interventions used to manage immuno-oncology toxicity.
  11. Report time of onset and duration of immuno-oncology toxicity.
  12. Report the scientific hypothesis for the combination or sequence, as well as the rationale for the selection of the particular dose and sequence of agents.

“Given the rapid expansion of the number of immuno-oncology clinical trials and ongoing improvements to the evidence base supporting the use of immuno-oncology treatments in clinical care, these recommendations will likely need regular revision as the immuno-oncology field develops,” authors of the recommendations concluded.—Zachary Bessette