The Importance of Disease-Free Survival as a Clinical Trial Endpoint: A Qualitative Study Among Canadian Survivors of Lung Cancer.
Journal
The patient
ISSN: 1178-1661
Titre abrégé: Patient
Pays: New Zealand
ID NLM: 101309314
Informations de publication
Date de publication:
05 2022
05 2022
Historique:
accepted:
19
09
2021
pubmed:
14
10
2021
medline:
18
5
2022
entrez:
13
10
2021
Statut:
ppublish
Résumé
In lung cancer trials, overall survival is a well-validated and widely used endpoint; yet, in the context of adjuvant or curative intent treatments, disease-free survival (DFS) may be a better indicator of transformative patient outcomes. Although use of DFS is growing, patient perceptions of its relevance have not been established. We aimed to understand the importance of DFS as a trial endpoint, from the perspective of survivors of lung cancer. Web-based qualitative interviews were conducted with Canadian survivors of stage Ib-IIIa lung cancer. Participants described their experiences of cancer diagnosis and treatment, including their treatment goals and priorities. Participants then provided their perspectives on DFS and overall survival, and how well each aligned with their treatment priorities. Thematic analysis was used to explore patterns in responses. Among the 18 participants (mean age, 64 years), 83% were female, most (89%) had received surgery, and 56% received chemotherapy. Most participants viewed DFS as an intrinsically meaningful treatment outcome, for reasons such as alignment with treatment goals, and the perception that DFS would help maintain a high quality of life. One individual was interested in DFS only as a potential surrogate for overall survival. Participants desired access to new treatments that improve DFS and emphasized this within the context of promoting patient agency in treatment decision making. These findings suggest DFS is a meaningful endpoint from the perspective of survivors of lung cancer; and may help inform decisions regarding regulatory approval and reimbursement of new treatments based on DFS data.
Sections du résumé
BACKGROUND
In lung cancer trials, overall survival is a well-validated and widely used endpoint; yet, in the context of adjuvant or curative intent treatments, disease-free survival (DFS) may be a better indicator of transformative patient outcomes. Although use of DFS is growing, patient perceptions of its relevance have not been established.
OBJECTIVE
We aimed to understand the importance of DFS as a trial endpoint, from the perspective of survivors of lung cancer.
METHODS
Web-based qualitative interviews were conducted with Canadian survivors of stage Ib-IIIa lung cancer. Participants described their experiences of cancer diagnosis and treatment, including their treatment goals and priorities. Participants then provided their perspectives on DFS and overall survival, and how well each aligned with their treatment priorities. Thematic analysis was used to explore patterns in responses.
RESULTS
Among the 18 participants (mean age, 64 years), 83% were female, most (89%) had received surgery, and 56% received chemotherapy. Most participants viewed DFS as an intrinsically meaningful treatment outcome, for reasons such as alignment with treatment goals, and the perception that DFS would help maintain a high quality of life. One individual was interested in DFS only as a potential surrogate for overall survival. Participants desired access to new treatments that improve DFS and emphasized this within the context of promoting patient agency in treatment decision making.
CONCLUSIONS
These findings suggest DFS is a meaningful endpoint from the perspective of survivors of lung cancer; and may help inform decisions regarding regulatory approval and reimbursement of new treatments based on DFS data.
Identifiants
pubmed: 34643935
doi: 10.1007/s40271-021-00552-w
pii: 10.1007/s40271-021-00552-w
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
307-316Informations de copyright
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.
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