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Da Silva Lopes AM, Colomer-Lahiguera S, Mederos Alfonso N, et al. Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study. Eur J Cancer. 2021;157:225-237doi: 10.1016/j.ejca.2021.08.026.
Da Silva Lopes, A. M., Colomer-Lahiguera, S., Mederos Alfonso, N., Aedo-Lopez, V., Spurrier-Bernard, G., Tolstrup, L. K., Pappot, H., Aspeslagh, S., Rogiers, A., Neyns, B., Haanen, J. B., Mitchell, S. A., Addeo, A., Michielin, O., & Eicher, M. (2021). Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study. European journal of cancer (Oxford, England : 1990), 157225-237. https://doi.org/10.1016/j.ejca.2021.08.026
Da Silva Lopes, André Manuel, et al. "Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study." European journal of cancer (Oxford, England : 1990) vol. 157 (2021): 225-237. doi: https://doi.org/10.1016/j.ejca.2021.08.026
Da Silva Lopes AM, Colomer-Lahiguera S, Mederos Alfonso N, Aedo-Lopez V, Spurrier-Bernard G, Tolstrup LK, Pappot H, Aspeslagh S, Rogiers A, Neyns B, Haanen JB, Mitchell SA, Addeo A, Michielin O, Eicher M. Patient-reported outcomes for monitoring symptomatic toxicities in cancer patients treated with immune-checkpoint inhibitors: A Delphi study. Eur J Cancer. 2021 Nov;157:225-237. doi: 10.1016/j.ejca.2021.08.026. Epub 2021 Sep 15. PMID: 34536946.
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Eur J Cancer. 2021 Nov;157:225-237. doi: 10.1016/j.ejca.2021.08.026. Epub 2021 Sep 15.

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

European journal of cancer (Oxford, England : 1990)

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

Affiliations

  1. Department of Oncology, Lausanne University Hospital (CHUV), Lausanne, Switzerland; Institute of Higher Education and Research in Healthcare, Faculty of Biology and Medicine, University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland.
  2. Department of Oncology, Lausanne University Hospital (CHUV), Lausanne, Switzerland.
  3. MelanomeFrance, Teilhet, France.
  4. Department of Oncology, Research Unit, Odense University Hospital, Odense, Denmark.
  5. Department of Oncology, Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.
  6. Medical Oncology, University Hospital Brussels, Brussels, Belgium.
  7. Department of Psychiatry, Brugmann University Hospital, Brussels, Belgium.
  8. Department of Medical Oncology, Universitair Ziekenhuis Brussel Oncologisch Centrum, Brussels, Belgium.
  9. Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.
  10. Outcomes Research Branch, Healthcare Delivery Research Program, Division of Cancer Control and Population Sciences, National Cancer Institute, Bethesda, MD, USA.
  11. Department of Oncology, University Hospital of Geneva, Geneva, Switzerland.
  12. Department of Oncology, Lausanne University Hospital (CHUV), Lausanne, Switzerland; Institute of Higher Education and Research in Healthcare, Faculty of Biology and Medicine, University of Lausanne and Lausanne University Hospital, Lausanne, Switzerland. Electronic address: [email protected].

PMID: 34536946 DOI: 10.1016/j.ejca.2021.08.026

Abstract

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.

Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

Keywords: Delphi consensus; Immune checkpoint inhibitors; PRO-CTCAE™; Patient-reported outcomes; Symptomatic immune-related adverse events

Conflict of interest statement

Conflict of interest statement The authors declare the following financial interests/personal relationships, which may be considered as potential competing interests: Da Silva Lopes reports grants fro

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