Literature DB >> 34643935

The Importance of Disease-Free Survival as a Clinical Trial Endpoint: A Qualitative Study Among Canadian Survivors of Lung Cancer.

Andrea Bever1, Jackie Manthorne2, Tissa Rahim1, Layla Moumin2, Shelagh M Szabo3.   

Abstract

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.
© 2021. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

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Year:  2021        PMID: 34643935     DOI: 10.1007/s40271-021-00552-w

Source DB:  PubMed          Journal:  Patient        ISSN: 1178-1653            Impact factor:   3.883


  29 in total

1.  End points for adjuvant therapy trials: has the time come to accept disease-free survival as a surrogate end point for overall survival?

Authors:  Sharlene Gill; Daniel Sargent
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2.  Canadian consensus: a new systemic treatment algorithm for advanced EGFR-mutated non-small-cell lung cancer.

Authors:  B Melosky; S Banerji; N Blais; Q Chu; R Juergens; N B Leighl; G Liu; P Cheema
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Review 3.  Recurrence after surgery in patients with NSCLC.

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Review 4.  Disease-free survival as an end-point in the treatment of solid tumours--perspectives from clinical trials and clinical practice.

Authors:  Andrew G Robinson; Christopher M Booth; Elizabeth A Eisenhauer
Journal:  Eur J Cancer       Date:  2014-06-12       Impact factor: 9.162

Review 5.  Endpoints in adjuvant treatment trials: a systematic review of the literature in colon cancer and proposed definitions for future trials.

Authors:  Cornelis J A Punt; Marc Buyse; Claus-Henning Köhne; Peter Hohenberger; Roberto Labianca; Hans J Schmoll; Lars Påhlman; Alberto Sobrero; Jean-Yves Douillard
Journal:  J Natl Cancer Inst       Date:  2007-06-27       Impact factor: 13.506

6.  Surrogate clinical endpoints to predict overall survival in non-small cell lung cancer trials-are we in a new era?

Authors:  Jeffrey M Clarke; Xiaofei Wang; Neal E Ready
Journal:  Transl Lung Cancer Res       Date:  2015-12

Review 7.  Which Metrics Are Appropriate to Describe the Value of New Cancer Therapies?

Authors:  Peter Johnson; Wolfgang Greiner; Imad Al-Dakkak; Samuel Wagner
Journal:  Biomed Res Int       Date:  2015-06-16       Impact factor: 3.411

Review 8.  The emerging treatment landscape of targeted therapy in non-small-cell lung cancer.

Authors:  Min Yuan; Li-Li Huang; Jian-Hua Chen; Jie Wu; Qing Xu
Journal:  Signal Transduct Target Ther       Date:  2019-12-17

9.  Disease-free survival as a surrogate for overall survival in patients with HER2-positive, early breast cancer in trials of adjuvant trastuzumab for up to 1 year: a systematic review and meta-analysis.

Authors:  Everardo D Saad; Pierre Squifflet; Tomasz Burzykowski; Emmanuel Quinaux; Suzette Delaloge; Dimitris Mavroudis; Edith Perez; Martine Piccart-Gebhart; Bryan P Schneider; Dennis Slamon; Norman Wolmark; Marc Buyse
Journal:  Lancet Oncol       Date:  2019-01-29       Impact factor: 41.316

10.  Surrogate endpoints for overall survival in chemotherapy and radiotherapy trials in operable and locally advanced lung cancer: a re-analysis of meta-analyses of individual patients' data.

Authors:  Audrey Mauguen; Jean-Pierre Pignon; Sarah Burdett; Caroline Domerg; David Fisher; Rebecca Paulus; Samithra J Mandrekar; Chandra P Belani; Frances A Shepherd; Tim Eisen; Herbert Pang; Laurence Collette; William T Sause; Suzanne E Dahlberg; Jeffrey Crawford; Mary O'Brien; Steven E Schild; Mahesh Parmar; Jayne F Tierney; Cécile Le Pechoux; Stefan Michiels
Journal:  Lancet Oncol       Date:  2013-05-14       Impact factor: 41.316

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