Abstract P4-13-06: Results of the 3rd interim analysis of the non-interventional trial BRAWO – Subanalysis of patients &lt;70 years and ≥ 70 years
Authors: Tesch H , Grischke E-M , Fasching PA , Decker T , Uleer C , Schneeweiss A , Salat C , Wimberger P , Mundhenke C , Förster F , Kluth-Pepper B , Schubert J , Bloch W , Jackisch C , Schütz F , Lüftner D 
Published: May 2016

Abstract
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 (&gt;65 years as well as &gt;70 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 &lt;70 years (n=813) are described. Furthermore, safety and efficacy data for both subgroups are described.
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 &lt;70y vs. 8.8y ≥70 y), ECOG performance status 0 (56.6% &lt;70y vs. 37.0% ≥70 y), and younger pts seemed to have less comorbidities (charlson comorbidity index (CCI)=0: 80.9% vs. 67.4%). The distribution of patients by therapy line was similar as well as tumor grading, hormone receptor status, Ki67-status and metastasis localization.
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 &lt;70y and 7.3 months (6.3, 8.6; 95%CI) for pts ≥70y. Kaplan Meier estimates for median treatment duration were longer for younger pts (167.0 days (155.0, 191.0; 95%CI vs. 128.0 days (112.0, 152.0; 95%CI)). Incidence and severity of stomatitis were comparable across subgroups (Table 1). Quality of life analysis revealed no significant differences between older and younger pts.
Table 1: Incidence and severity of stomatitis
Patient Characteristics&lt; 70 years (n=813)≥ 70 years (n=485)Stomatitis Number of patients with at least one Stomatitis Event (based on stomatitis questionnaires)339 (41.7%)200 (41.2%)Grade 1181 (22.3%)95 (19.6%)Grade 2119 (14.6%)79 (16.3%)Grade 319 (2.3%)11 (2.3%)unknown20 (2.5%)15 (3.1%)Number of Stomatitis Events431 (100.0%)252 (100%)Grade 1237 (55.0%)125 (49.6%)Grade 2136 (31.6%)87 (34.5%)Grade 319 (4.4%)13 (5.2%)
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, Förster F, Kluth-Pepper B, Schubert J, Bloch W, Jackisch C, Schütz F, Lüftner D. Results of the 3rd interim analysis of the non-interventional trial BRAWO – Subanalysis of patients &lt;70 years and ≥ 70 years. [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 P4-13-06.