Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study

André Manuel Da Silva Lopes,Sara Colomer-Lahiguera,Nuria Mederos Alfonso,Veronica Aedo-Lopez,Gilliosa Spurrier-Bernard,Lærke Kjær Tolstrup,Helle Pappot,Sandrine Aspeslagh,Anne Rogiers,Bart Neyns,John B Haanen,Sandra A Mitchell,Alfredo Addeo,Olivier Michielin,Manuela Eicher

doi:10.1016/j.ejca.2021.08.026

Abstract

BackgroundImmune-related adverse events (IrAEs) associated with the use of immune checkpoint inhibitors (ICIs) may not be fully covered by existing measures like the PRO-CTCAE™. Selecting PRO-CTCAE™ items for monitoring symptomatic adverse events is hindered by the heterogeneity and complexity of IrAEs, and no standardised selection process exists.We aimed to reach expert consensus on the PRO-CTCAE™ symptom terms relevant for cancer patients receiving ICIs and to gather preliminary expert opinions about additional symptom terms reflecting ICI symptomatic toxicities. Additionally, we gathered expert consensus about a core set of priority symptom terms for prospective surveillance and monitoring. DesignThis Delphi study involved an international panel of experts (n = 6 physicians; n = 3 nurses, n = 1 psychiatrist and n = 1 patient advocates). Experts prioritised the relevance and importance of symptom terms to monitor in patients treated with ICIs. ResultsExperts reached a consensus on the relevance of all (n = 80) PRO-CTCAE™ Symptom Terms. Consensus on the importance of these symptom terms for prospective monitoring in patients receiving ICIs was reached for 81% (n = 65) of these terms. Additional symptoms terms (n = 56) were identified, with a consensus that 84% (47/56) of these additional symptom terms should also be considered when monitoring symptomatic IrAEs. ConclusionThis study identified a prioritised list of symptom terms for prospective surveillance for symptomatic IrAEs in patients receiving ICI treatment. Our results indicate the need to strengthen the validity of PRO measures used to monitor patients receiving ICIs. While these results provided some support for the content validity of the PRO CTCAE™ and resulted in a preliminary set of salient symptomatic adverse events related to the use of ICIs, broader international agreement and patient involvement are needed to further validate our initial findings.

Highlights

The growing complexity of cancer care motivates efforts to improve the safety, effectiveness and tolerability of cancer treatments
This study identified a prioritised list of symptom terms for prospective surveillance for symptomatic immune-related adverse events (IrAEs) in patients receiving immune checkpoint inhibitors (ICIs) treatment
While these results provided some support for the content validity of the patient-reported outcomes (PROs) CTCAEä and resulted in a preliminary set of salient symptomatic adverse events related to the use of ICIs, broader international agreement and patient involvement are needed to further validate our initial findings. a 2021 The Authors

Summary

Introduction

The growing complexity of cancer care motivates efforts to improve the safety, effectiveness and tolerability of cancer treatments. PROs are defined as ‘any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else’ [11]. Their use in clinical trials to track symptomatic toxicities of cancer treatments can improve the management of those symptoms, thereby preserving the health-related quality of life, and allowing patients to remain in treatment for longer, and decreasing emergency department visits [12,13]. Using PROs can enhance patient-clinician communication, allowing for a complete discussion of therapy side effects during office visits [13,14]

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