Abstract PD08-02: The Impact of Patient Reported Outcomes (PRO) on the Evaluation of Therapy Related Side-Effects and the Improvement of Adherence to Endocrine Treatment in Breast Cancer Patients
Authors: Hubalek M , Oberguggenberger A , Meraner V , Giesinger J , Kemmler G , Sperner-Unterweger B , Beer B , Oberacher H , Marth C , Holzner B. 
Published: April 2011

Abstract
Background: Long term treatment regimen with significant side effects may diminish a patient's quality of life (QOL) and consequently undermine adherence. Endocrine treatment for breast cancer causes various side effects, which can lead to early discontinuation of this effective therapy. Current knowledge on patients’ quality of life (QOL) impairments caused by endocrine therapy originates from clinicians’ impressions and expert ratings. This runs the risk of underestimating the effects of endocrine therapy on patients’ quality of life. Patient reported outcome (PRO) may provide higher accuracy and may therefore essentially contribute to medication evaluation and clinical decision making. In this study, we report on the patient reported outcome (PRO) related to endocrine therapy in early breast cancer.
Methods: Pre-and postmenopausal breast cancer outpatients treated with aromatase inhibitors (AIS) or tamoxifen were approached at their routine control appointment with the treating physician. We conducted a comprehensive PRO assessment comprising the following scales: FACT-B/+ES and HADS (high scores indicate high symptoms). In a short, semi-structured interview data on patients’ general medication intake behavior were collected focusing on the intake of complementary and alternative medicine (CAM)
Results: We analyzed PRO data of 240 patients undergoing endocrine treatment. 66.6% received AI therapy, 71.9% were postmenopausal. We found high levels of symptom burden in this study group: 55.9% had moderate to severe bone pain, 47.8% menopausal symptoms and 49.1% loss of sex drive. Postmenopausal women in the AI group had significantly more symptoms on the endocrine subscale (mean 24.25 vs. 16.42, p=0.045), significantly more anxiety (mean 8.8 vs. 5.11, p=0.036) and depression (mean 8.75 vs. 3.86, p=0.011). In the tamoxifen group premenopausal patients scored significantly higher on all scales. Moreover, patients who used complementary substances had a significant lower physical well-being (22.70 vs. 24.39, p=0.007) and more endocrine symptoms (22.63 vs. 16.30, p=0.004).
Conclusion:The results of our study show a significantly higher assessment of physical side-effects and psychosocial burden on part of the patients than implied by clinicians’ reports and expert ratings. PRO data may therefore provide a more accurate measure for symptom burden and contribute to individualized clinical decision making. It is an important tool to detect and effectively treat therapy related side effect to ultimately preserve adherence to endocrine treatment. According to our findings, it appears mandatory to incorporate PRO data in individualized clinical decision making to arrive at a more accurate assessment of symptom burden.
Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr PD08-02.