ORIGINAL ARTICLE The Prognostic Role of Quality of Life Assessment in Breast Cancer Edgar D. Staren, MD, PhD, MBA, Digant Gupta, MD, MPH, and Donald P. Braun, PhD Office of Clinical Research, Cancer Treatment Centers of America Ò (CTCA) at Midwestern Regional Medical Center, Zion, Illinois n Abstract: While the use of quality of life (QoL) assessments has been increasing in oncology, few studies have exam- ined the prognostic significance of QoL in breast cancer. We investigated the association between QoL at presentation and survival in breast cancer. We examined 1,511 breast cancer patients treated at two single-system cancer centers between January 2001 and December 2008. QoL was evaluated using the validated survey instrument EORTC-QLQ-C30. Patient survival was defined as the time interval between the date of first patient visit and the date of death from any cause ⁄ date of last contact. Univariate and multivariate Cox regression analyses were performed to evaluate the prognostic significance of QoL after controlling for the effects of age, tumor stage, and prior treatment history. Mean age at presentation was 52.5 years. There were 590 analytic and 921 non-analytic patients. Patient stage of disease at diagnosis was I, 335; II, 591; III, 290; IV, 159; and 136 indeterminate. Median overall survival was 32.8 months (95% CI: 27.6–38.0). On univariate analysis, QoL function and symptom scales that were predictive of survival were physical (p < 0.001), role (p < 0.001), cog- nitive (p = 0.003), social (p < 0.001), fatigue (p < 0.001), nausea ⁄ vomiting (p < 0.001), pain (p < 0.001), dyspnea (p < 0.001), loss of appetite (p < 0.001), and constipation (p < 0.001). On multivariate analyses, only role function (degree of impairment of work and ⁄ or leisure ⁄ hobby related activities) was significantly associated with survival. This study suggests that baseline QoL (in particular, the role function) provides useful prognostic information in breast cancer. n Key Words: breast cancer, prognosis, quality of life Q uality of life (QoL) is a multidimensional con- struct. A growing consensus among health care providers and researchers is that treatment efficacy should be judged by effects on both quantity and quality of life; this has led to the inclusion of QoL assessment as a primary endpoint in cancer clinical tri- als along with traditional endpoints of tumor response and survival. Most studies measuring QoL in cancer patients compare the effects of different treatments or assess the effect of a single treatment longitudinally. There is general agreement in the medical and sci- entific research community that patients are the best source of information regarding their QoL. Conse- quently, the use of self-reported QoL assessment has become a valuable tool for both clinical practice and research. There are extensive data in the literature showing that QoL tools measuring the activities of daily life can predict survival in several different types of cancers independent of the extent of the disease and other clinical prognostic factors (1–19). These studies have used different combinations of clinical and QoL factors in multivariate models evaluating the prognostic significance on clinical outcomes. Although there are several studies that demonstrate the relationship between QoL and survival in patients with breast cancer (2–4,6,9,12,14,20–26), there is no ‘‘gold standard’’ QoL questionnaire available. Rather, the selection of a QoL questionnaire for any particular study is governed by the research goals of the study. The most commonly used instrument for evaluating the QoL of cancer patients is the European Organiza- tion for the Research and Treatment of Cancer Core Quality of Life Questionnaire (QLQ-C30), which emphasizes a patient’s capacity to function well. In the current study, we have employed the QLQ-C30 to investigate its efficacy in predicting survival in breast cancer patients treated in an integrative model combining surgery, radiation, and chemotherapy as Address correspondence and reprint requests to: Edgar D. Staren, MD, PhD, MBA, CTCA Operations Center, 2610 Sheridan Road, Zion, IL 60099, USA, or e-mails: edgar.staren@ctca-hope.com; gupta_digant@yahoo.com. DOI: 10.1111/j.1524-4741.2011.01151.x Ó 2011 Wiley Periodicals, Inc., 1075-122X/11 The Breast Journal, Volume 17 Number 6, 2011 571–578