Abstract GS6-03: Symptoms and health-related quality of life on endocrine therapy alone (E) versus chemoendocrine therapy (C+E): TAILORx patient-reported outcomes results
Authors: Wagner LI , Gray RJ , Garcia S , Whelan TJ , Tevarweerk A , Yanez B , Carlos R , Gareen I , McCaskill-Stevens W , Cella D , Sparano JA , Sledge GW ,   On behalf of the TAILORx Study Team
Published: May 2019

Abstract
Background: TAILORx patient-reported outcomes (PRO) quantify symptoms and health-related quality of life (HRQL) from C+E beyond E alone from the patient's perspective, thus can inform decision-making for women in the intermediate risk group for whom chemotherapy may still be considered.
Methods: TAILORx participants with OncoType DX Recurrence Scores 11-25 were randomly assigned to E or C+E. All TAILORx participants enrolled 1/2010-10/2010 (N=612) completed PROs measuring fatigue, endocrine symptoms, cognitive impairments (PCI), and fear of recurrence at baseline, 3, 6, 12, 24 and 36 months. HRQL was assessed at baseline, 12, and 36 months. Linear regression (LR) examined PRO scores among the per-protocol sample.
Results: Overall, participants reported significantly more fatigue, endocrine symptoms and PCI at 3, 6, 12, 24 and 36 months compared to baseline and those randomized to C+E reported a greater magnitude of change baseline-3 months compared to those randomized to E alone (Table 1). Overall, by 12 months symptoms were comparable between groups. Pre-menopausal women had comparable symptoms at 24 and 36 months. Post-menopausal women randomized to C+E had greater endocrine symptoms at 24 and 36 months and greater fatigue at 6 and 24 months. Fear of recurrence was comparable between arms during treatment and follow-up. Multiple linear regression identified increased fatigue (LR slope β=0.67), endocrine symptoms (β =0.14), and PCI (β=0.11) as significant predictors of decreased HRQL across arms (p&lt; 0.001). HRQL was comparable between E and C+E at 12- and 36-months.
Mean PRO change scores from baseline by treatment arm and menopausal status in per protocol population Months 36122436N=Overall454469458384343n=Pre-menopausal153151150118103n=Post-menopausal301318308266240FACIT-Fatigue Overall sample C+E-8.77-4.37-4.01-4.27-3.67E-2.48-1.97-2.14-1.49-1.83LMED-5.32***-1.55-1.01-1.76-0.90Pre-M C+E-8.01-3.26-2.99-2.45-1.60E-3.87-1.66-1.32-2.52-2.11LMED-3.11-0.82-1.121.021.46Post-M C+E-9.22-4.97-4.55-5.14-4.67E-1.87-2.10-2.52-1.09-1.71LMED-6.42***-1.99*-1.16-3.02*-2.01FACT-Endocrine Symptoms Overall sample C+E-5.56-5.63-6.96-6.81-7.14E-3.61-4.24-5.62-5.31-5.17LMED-1.62*-0.97-1.08-1.05-1.69Pre-M C+E-7.62-8.34-7.94-8.29-8.96E-5.96-6.19-8.95-10.39-10.84LMED-1.44-1.631.062.272.18Post-M C+E-4.39-4.19-6.45-6.10-6.28E-2.55-3.41-4.10-3.23-2.87LMED-1.49-0.45-2.04-2.39*-3.17**Significance between mean change scores *p&lt;0.05;**p&lt;0.01;***p&lt;0.001. LMED=estimated tx difference using linear model regressing score on baseline value and tx
Conclusions: TAILORx is the first trial to examine patient-reported fatigue, endocrine symptoms, PCI and HRQL among breast cancer patients randomized to endocrine therapy alone vs chemoendocrine therapy, thus allowing us to quantify acute and long-term symptoms uniquely attributable to chemotherapy. As expected, chemotherapy is associated with greater fatigue, endocrine symptoms and PCI acutely during treatment, and for post-menopausal women with greater long-term endocrine symptoms. Increased symptoms were associated with poorer HRQL. Long-term HRQL was comparable between groups.
Citation Format: Wagner LI, Gray RJ, Garcia S, Whelan TJ, Tevarweerk A, Yanez B, Carlos R, Gareen I, McCaskill-Stevens W, Cella D, Sparano JA, Sledge, Jr. GW, On behalf of the TAILORx Study Team. Symptoms and health-related quality of life on endocrine therapy alone (E) versus chemoendocrine therapy (C+E): TAILORx patient-reported outcomes results [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr GS6-03.