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

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

Background: Immune-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. Design: This 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. Results: Experts 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. Conclusion: This 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.

OriginalsprogEngelsk
TidsskriftEuropean Journal of Cancer
Vol/bind157
Sider (fra-til)225-237
Antal sider13
ISSN0959-8049
DOI
StatusUdgivet - 2021

Bibliografisk note

Funding Information:
This project was supported by the Swiss Institute for Experimental Cancer Research (ISREC) Foundation.The authors declare the following financial interests/personal relationships, which may be considered as potential competing interests: Da Silva Lopes reports grants from Fondation Recherche Cancer (ISREC) Foundation, during the conduct of the study; Dr. Colomer-Lahiguera reports grants from Fondation Recherche Cancer (ISREC) Foundation, during the conduct of the study; Dr. Mederos has nothing to disclose; Dr. Aedo-Lopez has nothing to disclose; Dr. Spurrier-Bernard reports grants from MSD France, grants from Novartis, personal fees from Bayer, other from MPNE, WECAN, outside the submitted work; Dr. Tolstrup has nothing to disclose; Dr. Pappot has nothing to disclose; Dr. Aspeslagh reports and has received speaker fees from Roche, BMS, Novartis, Merck and Pfizer in the last 36 months; Dr. Rogiers has nothing to disclose; Dr. Neyns reports grants and personal fees from Novartis, grants and personal fees from Pfizer, personal fees from BMS, personal fees from MSD, outside the submitted work; Dr. Haanen reports grants and other from BMS, grants and other from MSD, grants and other from Novartis, grants and other from BioNTech, other from Achilles Tx, grants and other from Amgen, other from GSK, other from Immunocore, other from Ipsen, other from Merck Serono, other from Molecular Partners, personal fees from Neogene Tx, other from Pfizer, other from Roche/Genentech, other from Sanofi, other from Seattle Genetics, other from Third Rock Ventures, other from Vaximm, outside the submitted work; Dr. Mitchell has nothing to disclose; Dr. Addeo reports personal fees from BMS, personal fees from MSD, personal fees from AstraZeneca, personal fees from Pfizer, personal fees from Roche, personal fees from Boehringer, personal fees from Ely-Lilly, outside the submitted work; Dr. Michielin reports grants and personal fees from BMS, grants and personal fees from MSD, personal fees from Roche, personal fees from Novartis, grants and personal fees from Pierre-Fabre, grants and personal fees from Amgen, personal fees from GSL, grants from Merck, outside the submitted work; Dr. Eicher reports grants from Fondation Recherche Cancer ISREC, during the conduct of the study; grants and personal fees from Roche, grants and personal fees from BMS, grants from Kaiku Health, personal fees from VIFOR, outside the submitted work.

Funding Information:
This project was supported by the Swiss Institute for Experimental Cancer Research (ISREC) Foundation .

Publisher Copyright:
© 2021 The Authors

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