Originally published as JCO Early Release 10.1200/JCO.2007.13.3439 on January 28 2008

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The Prognostic Significance of Patient-Reported Outcomes in Cancer Clinical Trials

Carolyn C. Gotay, Crissy T. Kawamoto, Andrew Bottomley, Fabio Efficace

From the Cancer Research Center of Hawaii, University of Hawaii, Honolulu, HI; Quality of Life Unit, European Organization for Research and Treatment of Cancer, Brussels, Belgium; and Health Outcome Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center, Rome, Italy

Corresponding author: Carolyn C. Gotay, PhD, Department of Health Care and Epidemiology, University of British Columbia, 5804 Fairview Ave, Vancouver, British Columbia, V6E 1R7 Canada; e-mail: carolyn.gotay{at}ubc.ca

Purpose Patient-reported outcomes (PROs), routinely collected as a part of cancer clinical trials, have been linked with survival in numerous clinical studies, but a comprehensive critical review has not been reported. This study systematically assessed the impact of PROs on patient survival after a cancer diagnosis within the context of clinical trials.

Design Cancer clinical trials that assessed baseline PROs and mortality were identified through MEDLINE (through December 2006) supplemented by the Cochrane database, American Society of Clinical Oncology/European Society for Medical Oncology abstracts and hand searches. Inclusion criteria were publication in English language and use of multivariate analyses of PROs that controlled for one or more clinical factors. Two raters reviewed each study, abstracted data, and assessed study quality; two additional raters verified abstractions.

Results In 36 of 39 studies (N = 13,874), at least one PRO was significantly associated with survival (P < .05) in multivariate analysis, with varying effect sizes. Studies of lung (n = 12) and breast cancer (n = 8) were most prevalent. The most commonly assessed PRO was quality of life, measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 in 56% of studies. Clinical variables adjusted for included performance status (PS), treatment arm, stage, weight loss, and serum markers. Results indicated that PROs provide distinct prognostic information beyond standard clinical measures in cancer clinical trials.

Conclusion PROs might be considered for stratification purposes in future trials, as they were often better predictors of survival than PS. Studies are needed to determine whether interventions that improve PROs also increase survival and to identify explanatory mechanisms through which PROs relate to survival.

published online ahead of print at www.jco.org on January 28, 2008.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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