Abstract P4-13-07: Impact of physical activity/exercise on adverse events and quality of life during treatment with everolimus and exemestane for ER+ women - Results of the 3rd interim analysis of BRAWO
Authors: Bloch W , Baumann F , Zimmer P , Grischke E-M , Fasching PA , Decker T , Uleer C , Schneeweiss A , Salat C , Wimberger P , Mundhenke C , Förster F , Kluth-Pepper B , Schubert J , Tesch H , Schütz F , Lüftner D , Jackisch C 
Published: May 2016

Abstract
Introduction
BRAWO is a non-interventional study collecting data of 3000 breast cancer patients treated with everolimus and exemestane (advanced or metastatic, hormone-receptor-positive, HER2-negative breast cancer). We introduce results of the 3rd preplanned interim analysis with data cut-off 08/01/ 2015, including 1300 patients. Since physical activity/exercise was reported to influence side effects as well as quality of life (QoL) of various cancer types and therapies, this analysis focuses on the impact of the physical activity/exercise history, development on adverse effects (AE) of the medical treatment and QoL.
Methods
Patients were asked to complete the EORTC QLQ-C30 QoL questionnaire and visual analogue scales (VAS-KAS) measuring their present-, past ten year- and lifetime physical activity/exercise level. To differentiate between activity/exercise levels, VAS were divided in three equal components (inactive, somewhat active, very active). Questionnaires and information about AE (e. g. stomatitis, fatigue, nausea, diarrhea, etc.) were collected before starting the medical treatment and were repeated each three months. Logistic regression model was used to estimate the impact of baseline physical activity/exercise on AE at any time point of the therapy. ANOVA models were used to calculate the impact of the baseline activity/exercise level on QoL at the last completed data set of each patient.
Results
Median age of patients was 66 years, median weight was 70 kg, median BMI was 25.9, median time since primary diagnosis was 6.2 years, and 54.4% had visceral metastases at baseline. The median PFS for the first 1300 patients was 7.1 months (95% CI, 6.5-8.0). Patients who reported to be very active (exercise) at the week prior to baseline (4.4%) showed significant lower numbers of AE compared to patients who indicate to be somewhat (14.8%) or inactive (80.8%). In contrast to the exercise level, physical activity in everyday life did not affect the AE incidence. Neither lifetime nor past ten year activity/exercise level is associated with the occurrence of AE. Regarding QoL, very active as well as somewhat active women (measured at baseline for almost each time period) showed significant higher QoL values compared to inactive women during the last assessment before death/progress.
Conclusion
Exercise prior to medical treatment with Everolimus and Exemestane may impact AE during therapy. Since physical activity did not show such a relation, this analysis highlights the importance of specific guidelines for preventive/rehabilitative exercise programs. More knowledge about dose-response relationships is needed. Furthermore a livelong healthy, "active" lifestyle may increase QoL, even in patients with advanced and terminal breast cancer disease.
Citation Format: Bloch W, Baumann F, Zimmer P, Grischke E-M, Fasching PA, Decker T, Uleer C, Schneeweiss A, Salat C, Wimberger P, Mundhenke C, Förster F, Kluth-Pepper B, Schubert J, Tesch H, Schütz F, Lüftner D, Jackisch C. Impact of physical activity/exercise on adverse events and quality of life during treatment with everolimus and exemestane for ER+ women - Results of the 3rd interim analysis of BRAWO. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P4-13-07.