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Bouchard LC, Aaronson N, Gondek K, et al. Cancer symptom response as an oncology clinical trial end point. Expert Rev Qual Life Cancer Care. 2018;3(2):35-46doi: 10.1080/23809000.2018.1483193.
Bouchard, L. C., Aaronson, N., Gondek, K., & Cella, D. (2018). Cancer symptom response as an oncology clinical trial end point. Expert review of quality of life in cancer care, 3(2), 35-46. https://doi.org/10.1080/23809000.2018.1483193
Bouchard, Laura C, et al. "Cancer symptom response as an oncology clinical trial end point." Expert review of quality of life in cancer care vol. 3,2 (2018): 35-46. doi: https://doi.org/10.1080/23809000.2018.1483193
Bouchard LC, Aaronson N, Gondek K, Cella D. Cancer symptom response as an oncology clinical trial end point. Expert Rev Qual Life Cancer Care. 2018;3(2):35-46. doi: 10.1080/23809000.2018.1483193. Epub 2018 Jun 07. PMID: 31020045; PMCID: PMC6476191.
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Expert Rev Qual Life Cancer Care. 2018;3(2):35-46. doi: 10.1080/23809000.2018.1483193. Epub 2018 Jun 07.

Cancer symptom response as an oncology clinical trial end point.

Expert review of quality of life in cancer care

Laura C Bouchard, Neil Aaronson, Kathleen Gondek, David Cella

Affiliations

  1. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL USA.
  2. Division of Psychosocial Research & Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
  3. Outcomes Research and Epidemiology, Shire Pharmaceuticals, Cambridge, MA USA.

PMID: 31020045 PMCID: PMC6476191 DOI: 10.1080/23809000.2018.1483193

Abstract

INTRODUCTION: A critical challenge in oncology is interpreting clinical trial results to inform clinical decision making. Clinical trials typically focus on overall survival (OS) and progression-free survival (PFS) as primary endpoints, which do not reflect early signs of meaningful patient benefit or harm.

AREAS COVERED: CSR requires careful consideration of its measurement and interpretation to facilitate integration into clinical practice. We describe considerations for the evaluation, analysis, and interpretation of CSR in clinical trials. To illustrate the potential clinical value of CSR, we performed a retrospective analysis of a three-arm randomized cooperative-group clinical trial.

EXPERT COMMENTARY: Evaluation of CSR provides a meaningful assessment of early cancer treatment effects. It can act as an early signal of disease progression and death and thus can identify which patients with stable disease will have a more favorable prognosis. Future research will include development of methods for more accurate assessment of CSR, reduction of the number of symptoms used as signals for disease progression or survival by tumor type, and statistical methods that effectively correct for missing data and informative censoring.

Keywords: cancer symptom response; clinical trial endpoints; quality of life

Conflict of interest statement

Financial and competing interest disclosure: All authors declare that they have no conflicts of interest.

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