Results Of The 3rd Interim Analysis Of The Non-Interventional Trial Brawo - Subanalysis Of Patients < 70 Years And >= 70 Years

Background BRAWO is a German non-interventional study of 3000 patients (pts) with advanced/metastatic, hormone-receptor-positive and HER2-negative breast cancer treated with everolimus and exemestane (EVE+EXE). The pivotal BOLERO-2 trial demonstrated that adding EVE to EXE improved PFS over EXE and was generally well tolerated in elderly patients with HR+ advanced breast cancer (u003e65 years as well as u003e70 years). Here we describe data of elderly patients treated with EVE+EXE in daily clinical routine. Methods We report data of the 3rd preplanned interim analysis (IA) of the first 1300 pts documented in BRAWO. Patient and disease characteristics in elderly patients (≥ 70 years, n=485) and patients Results At time of data cut-off, 71% pts had discontinued the study, 29% were still ongoing. Patient and disease characteristics were comparable in both groups except for: median age (60y (range: 20-69y) vs. 75y (range 70-93y)), median time since 1st diagnosis (6.4y More patients in the older group received fulvestrant (20.6% vs. 16.2%), in the younger group more patients received chemotherapy (20.3% vs. 14.2%) as last antineoplastic therapy. In general, more patients in the older subgroup did not receive any chemotherapy as pretreatment (53.6% vs 40.2%). More patients in the subgroup ≥70y received 5mg EVE as starting dose (30.3% vs. 20.8%) and had 5mg as end dose (37.9% vs. 26.9%). Median PFS was 7.1 months in the overall population, 7.0 months (6.5, 8.0; 95%CI) for pts Table 1: Incidence and severity of stomatitis Discussion The data described here show that EVE+EXE treatment is effective and safe for elderly patients in daily clinical routine. This is consistent with data from an exploratory analysis of the pivotal BOLERO-2 trial, where the same differences in baseline characteristics were observed for elderly pts compared to younger pts as in BRAWO. Efficacy was also comparable to elderly pts in BOLERO-2 (mPFS 6.8 months for EVE+EXE in pts ≥70 years). Citation Format: Tesch H, Grischke E-M, Fasching PA, Decker T, Uleer C, Schneeweiss A, Salat C, Wimberger P, Mundhenke C, Forster F, Kluth-Pepper B, Schubert J, Bloch W, Jackisch C, Schutz F, Luftner D. Results of the 3rd interim analysis of the non-interventional trial BRAWO – Subanalysis of patients