Breast Cancer Treatment with Everolimus and Exemestane for Er+ Women - Results of the 2Nd Interim Analysis of the Non-Interventional Trial Brawo

Abstract

ABSTRACT Aim: BRAWO is a German non-interventional study of 3000 patients (pts) with advanced or metastatic, hormone-receptor-positive and HER2-negative breast cancer treated with everolimus (EVE) and exemestane (EXE). Data is collected at about 400 sites. Main objectives are to extend the knowledge on a) the impact of physical activity on efficiency and quality of life, b) prophylaxis and management of stomatitis in clinical routine, and c) the sequence of therapy, when EVE is used in daily clinical practice. We report the results of the 2nd preplanned interim analysis (IA) which was defined to take place 12 months after the inclusion of the 500th patient into the documentation. Methods: The 2nd interim analysis (data cut-off 08 Jul 2014) covers data of the first 500 documented patients (pts) and evaluated for the first time progression free survival (PFS). Furthermore, baseline data, safety data and the tumor status were analyzed. Results: At the time of data cut-off, 409 pts had discontinued the study, 91 were still ongoing. Baseline characteristics: Median age: 66 yrs; median BMI: 25.9; ECOG 0-1: 377 (89.8%); visceral metastases: 53.7%; bone only metastases: 26.3%. 26.2% pts received EVE and EXE as first treatment (first line), 28.8% as second line, 18.8% as third line and 26.2% as fourth or later line in the advanced setting. 18.6% of pts had received EXE earlier in their treatment history. The median PFS was 8.0 months (6.7; 9.1; 95% CI). For pts receiving EVE/EXE as first treatment for the advanced setting (N = 131) median PFS was 10.1 months (6.7; 17.6). 41.6% of these 500 pts had at least one stomatitis event: 19.8 % grade 1, 15.8% grade 2 and 3.4% grade 3. 86.8% of pts received recommendations regarding stomatitis prevention from their physician. The general safety profile was consistent with previously reported safety findings. Conclusions: Here we present for the first time efficacy data on EVE/EXE under real world conditions. The data confirm the efficacy results of the pivotal phase 3 trial BOLERO-2 (median PFS vs placebo +EXE: 7.8 months vs 3.2 months, respectively by local radiologic assessment). Disclosure: P.A. Fasching: Consulting Fees: Novartis Speakers' Bureau: Pfizer, Roche, Novartis, Genomic Health Grant/Research Support: Novartis, Amgen; T. Decker: Consulting Fees: Novartis PI/Lead investigator: Novartis; A. Schneeweiss: Consulting Fees: Roche, Celgene, Novartis Honoraria: Astra, Roche, Celgene, Eisai, Medac, GlaxoSmithKline, Pfizer; C. Uleer: Consulting Fees: Novartis Honoraria: Novartis, Roche, AstraZeneca, Amgen; P. Wimberger: Honoraria scientific lectures Novartis; C.M. Kurbacher: Consulting Fees: CFL Contracted Research: Amgen, Novartis, Hexal, Roche, Teva Honoraria: Teva, Amgen; N. Harbeck, W. Bloch, H. Tesch and F. Schutz: Consulting Fees: Novartis Honoraria: Novartis; S. Kummel: Consulting Fees: Roche; M. Muth and J. Kreuzeder: Employee of Novartis Pharma GmbH, Germany; D. Luftner: Consulting Fees: Novartis Contracted Research: Novartis Honoraria: Novartis; C. Jackisch: Consulting Fees: Novartis. All other authors have declared no conflicts of interest.