title: Patient-reported outcomes as end points and outcome indicators in solid tumours.
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.
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: Angeles A
authors.initials: AA
authors.lastname: Secord
authors.affiliation: Department of Gynecologic Oncology and Reproductive Medicine, Unit 1362, MD Anderson Cancer Center, P.O. Box 301439, Houston, TX 77230-1439, USA.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Coleman
authors.affiliation: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: Laura J
authors.initials: LJ
authors.lastname: Havrilesky
authors.affiliation: Division of Medical Oncology, Duke Cancer Institute, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: Amy P
authors.initials: AP
authors.lastname: Abernethy
authors.affiliation: Department of Biostatistics and Bioinformatics, Duke Cancer Institute, Duke University Medical Center, Durham, NC 27710, USA.
authors.forename: Gregory P
authors.initials: GP
authors.lastname: Samsa
authors.affiliation: Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 633 N. St Clair, Suite 1900, Chicago, IL 60611, USA.
authors.forename: David
authors.initials: D
authors.lastname: Cella
mesh_terms: D002986:Clinical Trials as Topic; D005544:Forecasting; D006801:Humans; D009369:Neoplasms / Q000401:mortality / Q000628:therapy*; D063868:Patient Outcome Assessment; D018802:Patient-Centered Care; D011788:Quality of Life; D057566:Self Report; D016019:Survival Analysis; D016896:Treatment Outcome