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  • Review Article
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Patient-reported outcomes as end points and outcome indicators in solid tumours

Nature Reviews Clinical Oncology volume 12, pages 358–370 (2015)Cite this article

Subjects

Key Points

  • Patient-reported outcomes (PROs) are associated with tumour-response outcomes and are prognostic for survival outcomes in a variety of adult solid cancers

  • Composite end points that consider multiple components, such as tumour-related and patient-centric end points, might delineate the total clinical benefit beyond mere survival

  • The development of patient-centric composite end points in oncological clinical trials might better reflect the realities of differing outcomes and meaning of those outcomes to real people afflicted with cancer

  • Further evaluation is required to identify reliable, disease-specific composite end points

Abstract

Patient-reported outcome (PRO) measures, such as quality of life, have been associated with relevant clinical end points and are prognostic for survival outcomes in a variety of solid cancers in adults. In the past few years, PROs have garnered a greater influence as established and clinically relevant measures that could alter the current paradigm of practice-changing therapeutic advances, as it has been recognized that classic clinical end points do not accurately portray a full appreciation of the benefits, risks and costs of therapy. In this Review, we comprehensively assess the correlation of PROs with treatment response and survival, and explore tumour-related and patient-centric composite end points in patients with cancer participating in clinical trials. Comparisons or composite end points that consider tumour-related and PRO components might help health-care providers, patients with cancer and decision makers to better understand the total clinical benefit of therapeutic interventions.

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Figure 1: The schema depicts the determination of a novel composite end point, OTU, used in the FOCUS2 trial.38

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Authors and Affiliations

  1. Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, 27710, NC, USA

    Angeles A. Secord & Laura J. Havrilesky

  2. Division of Medical Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, 27710, NC, USA

    Amy P. Abernethy

  3. Department of Biostatistics and Bioinformatics, Duke Cancer Institute, Duke University Medical Center, Durham, 27710, NC, USA

    Gregory P. Samsa

  4. Department of Gynecologic Oncology and Reproductive Medicine, Unit 1362, MD Anderson Cancer Center, P.O. Box 301439, Houston, 77230-1439, TX, USA

    Robert L. Coleman

  5. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St Clair, Suite 1900, Chicago, 60611, IL, USA

    David Cella

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Contributions

A.A.S. and D.C. wrote the main manuscript text, and A.A.S. prepared Tables 1–2 and Figure 1. All authors reviewed/edited the manuscript before submission, discussed content and researched data for the article.

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Correspondence to Angeles A. Secord.

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Competing interests

A.A.S. has received research funding from Astellas Pharma, Astex Pharmaceuticals, Boerhinger Ingelheim, Bristol–Myers Squibb (BMS), Eisai-Morphotek, Genentech, Incyte, Precision Therapeutics, and Sanofi–Aventis. A.A.S. has served on Advisory Boards for Boerhinger Ingelheim, Genentech, GSK and Precision Therapeutics. R.L.C. has served on the Scientific Steering Committee for Amgen, Amo Therapeutics, Astellas Pharma Global Dev., BioMarin Pharmaceutical, Clovis Oncology, Eisai-Morphotek, Esperance Pharmaceuticals, Genentech, GSK, Janssen, Oxygene, Precision Therapeutics and Sanofi–Aventis. R.L.C. has served on an Independent Data Monitoring Committee for a trial sponsored by Johnson & Johnson, and has received research funding from Abbott Laboratories, Amgen, Array Bio, Clovis, EMD-Serono, Merck, Merrimack, Millennium, Novartis, Oncomed, and Sanofi-Aventis. A.P.A has received research funding from the Celgene; DARA; Dendreon; GSK; Helsinn; National Institute of Nursing Research, National Cancer Institute, Agency for Healthcare Research and Quality; and Pfizer. Since 2011 she has had nominal consulting agreements with or received honoraria from BMS, Novartis and Pfizer. Further consulting with BMS is pending in 2014, for a role as Co-Chair of a Scientific Advisory Committee. A.P.A. has a paid leadership role with American Academy of Hospice & Palliative Medicine (President) and has corporate leadership responsibility in Advoset (an education company), athenahealth (health information technology (IT) company), and Orange Leaf Associates (an IT development company). D.C. has received research funding from GlaxoSmithKline (GSK) and Pfizer. He has also served as a consultant for Clovis Oncology, Genentech and GSK. L.J.H. and G.P.S. declare no competing interests.

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Secord, A., Coleman, R., Havrilesky, L. et al. Patient-reported outcomes as end points and outcome indicators in solid tumours. Nat Rev Clin Oncol 12, 358–370 (2015). https://doi.org/10.1038/nrclinonc.2015.29

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