ASCO and the Society for Immunotherapy of Cancer (SITC) have released a joint statement with twelve clinical trial reporting recommendations that address the unique efficacy, toxicity, and combination/sequencing aspects of immuno-oncology (IO) treatments. These recommendations, jointly published in the Journal of Clinical Oncology (JCO) and Journal for ImmunoTherapy of Cancer (JITC), will lead to better IO trial reporting and assessment.
The unique efficacy and toxicity effects of IO therapies compared to traditional cancer therapies call for additional considerations for reporting the design, conduct, analysis, and results of IO clinical trials. As the number of IO clinical trials in cancer has rapidly increased, recommendations for reporting this research in biomedical journals will facilitate understanding and comparison across IO trials.
ASCO and SITC convened a working group of experts in 2016 to address the need for IO specific clinical trial reporting guidance. The working group included representation from all specialties that contribute to IO trials including practicing medical oncologists, immunologists, clinical researchers, biostatisticians, industry, and government representatives to develop reporting recommendations.
The work of the group of experts resulted in the Trial Reporting in Immuno-Oncology (TRIO) recommendations, twelve recommendations developed through expert consensus. These recommendations aim to improve the completeness and consistency of reporting of IO trial efficacy and toxicity endpoints, as well as combination and sequencing studies to better facilitate interpretation and comparison of IO trial data in the medical literature.
The twelve recommendations are assembled into three reporting categories to mirror methods currently used to report efficacy, toxicity, and combining or sequencing treatments across IO clinical trials:
EFFICACY REPORTING STANDARDS FOR IO TRIALS
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.
Toxicity Reporting Standards for IO trials
7. Differentiate between the clinical diagnoses of IO 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 IO toxicity.
11. Report time of onset and duration of IO toxicity.
Combination or Sequencing of Immunotherapies Reporting Standard
12. Report the scientific hypothesis for the combination or sequence, as well as the rationale for the selection of the particular dose(s) and sequence of agents.
ASCO is dedicated to supporting and improving clinical trials in ways that take full advantage of today’s scientific and technological opportunities to realize major new advances in cancer prevention, detection, and treatment.