Abstract 1686P
Background
Immune-related Adverse Events (IrAEs) present a new challenge to patient safety. The use of Patient-Reported Outcomes (PROs) to monitor adverse events is increasing. Existing measures like the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) do not offer clear guidance how to select the symptoms to monitor in different populations. The wide spectrum of toxicities of more recent treatments such as Immune Checkpoint Inhibitors (ICIs) is not fully covered. We aimed to a) reach expert consensus on PRO-CTCAE™ symptom to be monitored in cancer patients treated with ICIs; b) gather expert opinion on additional symptom terms that could be used to broaden its reach in the ICI toxicity spectrum; and c) reach expert consensus on a set of priority symptom terms to monitor symptomatic IrAEs in this population.
Methods
We conducted a Delphi study with an international panel of eleven experts across four rounds. In round 1, experts assessed the relevance of PRO-CTCAE™ symptom terms and suggested additional terms. Subsequent rounds aimed at consensus on the importance-to-monitor on three levels (level1 = highest; level 3 = lowest) of all relevant symptom terms.
Results
All (n=80) PRO-CTCAE™ Symptom terms were considered relevant. By round 4, consensus on the importance-to-monitor was reached for 82% (n=65). Thirty terms reached consensus on level 1 importance, followed by 33 on level 2 and 2on level 3. Experts agreed on a set of 54 additional symptom terms to be considered to monitor ICI-related toxicities. Consensus on the importance-to-monitor was reached for 87% (n=47) of these terms.
Conclusions
To our knowledge, this is the first consensus of a prioritized list of symptom terms that should be considered for prospective surveillance of ICI-related toxicities. Additionally, they reveal the need to improve existing PRO measures to address the complex nature of IrAEs, and provide a first consensus on what symptom terms should be targeted by future work.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
M. Eicher.
Funding
Swiss Institute for Experimental Cancer Research (ISREC) Foundation.
Disclosure
All authors have declared no conflicts of interest.