Abstract P5-19-12: Subgroup analysis on efficacy in the routine treatment - Results of the 2nd interim analysis of BRAWO, the non-interventional trial "Breast Cancer Treatment with Everolimus and Exemestane for HR+ Women"

Abstract

Introduction BRAWO is a German non-interventional study of 3000 patients (pts) with advanced or metastatic, hormone-receptor-positive, HER2-negative breast cancer treated with everolimus (EVE) and exemestane (EXE). We report results of the 2nd preplanned interim analysis (IA) with a data cut-off on 8th July 2014. Methods BRAWO collects data on the routine clinical treatment with EVE and EXE at about 400 sites. Main objectives are to extend the knowledge on a) the efficacy in the clinical routine and the impact of physical activity on efficacy and quality of life, b) prophylaxis and management of stomatitis, and c) the sequence of therapy in the clinical routine. The 2nd IA was defined to take place 12 months after the inclusion of the 500. patient into the documentation. Results Efficacy data will be reported for the first 500 documented pts. Apart from data on the total study population we will present the PFS results for subgroups including pts with or without prior EXE therapy, with or without prior chemotherapy for the advanced setting, with or without visceral metastasis and with regard to the line of treatment in the advanced setting and the extent of physical activity. The respective summary of adverse events for these patients will be presented as well as results on treatment compliance and dosing. Baseline characteristics and medical history as well as insights into treatment sequences before EVE and EXE will further be shown for all enrolled patients with valid baseline documentation (approx. 1200). Conclusion This subgroup analysis will provide insights into the treatment efficacy in the clinical routine and will add to a more comprehensive understanding of the treatment with EVE/EXE. Citation Format: Christian Jackisch, Eva-Maria Grischke, Andreas Schneeweiss, Thomas Decker, Christoph Uleer, Frank Förster, Oliver Tomé, Pauline Wimberger, Christian M Kurbacher, Bettina Mueller, Nadia Harbeck, Christoph Mundhenke, Sherko Kuemmel, Mathias Muth, Julia Kreuzeder, Wilhelm Bloch, Hans Tesch, Diana Lüftner, Florian Schütz, Peter A Fasching. Subgroup analysis on efficacy in the routine treatment - Results of the 2nd interim analysis of BRAWO, the non-interventional trial "Breast Cancer Treatment with Everolimus and Exemestane for HR+ Women" [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P5-19-12.

Efficacy and safety of everolimus plus exemestane in patients with HR+, HER2− advanced breast cancer progressing on/after prior endocrine therapy in routine clinical practice: Primary results from the non-interventional study, STEPAUT

“…Furthermore, for patients who had an everolimus dose escalation from 5 to 10 mg, the median time to the first occurrence of stomatitis was longer than those who started and maintained the everolimus 5 mg or 10 mg dose. The frequency of the AE was higher in the everolimus 10 mg group compared with the everolimus 5 mg group, similar to that reported in the BRAWO study [ 15 ]. Treatment interruption was more effective than dose reduction for managing AEs.…”

“…The safety profile of everolimus observed in this study was similar to the known safety profile of the drug in both clinical and real-world settings [ 10 , 15 , 16 ]. Most of the AEs were manageable, with only 10% of the AEs being in the grade 3 category.…”

“…Jackisch et al. reported similar results in the BRAWO study when the combination was administered in the first-line setting [ 15 ].…”

Efficacy and tolerance of everolimus in 123 consecutive advanced ER positive, HER2 negative breast cancer patients. A two center retrospective study

“…The present series included a large majority of very advanced but fit patients, treated for slowly evolving ER positive, HER2 negative breast cancer, as shown in Table 1. Despite these characteristics, the present population compares favorably with the population of patients of the Bolero-2 and BRAWO trials [16], as suggested in Tables 1 and 2. Briefly, median age, performance status, disease bulk and delay to everolimus therapy were quite similar.…”

Efficacy and safety of everolimus plus exemestane in postmenopausal women with hormone receptor‐positive, human epidermal growth factor receptor 2‐negative locally advanced or metastatic breast cancer: Results of the single‐arm, phase IIIB 4EVER trial

“…As might be expected based on the more heavily pretreated patient population, the ORR with everolimus plus exemestane in 4EVER (8.9% [95% CI: 5.8–12.9] within the first 24 weeks of treatment) was lower than in other trials with the combination in this setting (BOLERO‐2: ORR for the everolimus plus exemestane arm was 12.6% [95% CI: 9.8–15.9] at median 18‐month follow‐up; BRAWO: ORR for everolimus plus exemestane was 19.4% at the second interim analysis [12‐month follow‐up]) . In contrast to BOLERO‐2 and BRAWO, tumor assessments as per the study protocol were only performed at 24 and 48 weeks/EOT in 4EVER.…”