In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. e12547-e12547
Abstract:
e12547 Background: BRAWO is a non-interventional study, which enrolled more than 2400 patients (pts) with advanced/metastatic, hormone-receptor-positive and HER2-negative breast cancer treated with EVE and EXE. Main objectives are a) the impact of physical activity on efficacy 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 updated data of the 3 rd interim analysis, including PFS. Methods: This updated analysis (data cut-off 18 Oct 2016) covers data of the first 1345 documented pts with at least one follow up under therapy. Here we describe the baseline characteristics, safety and PFS as well as response rates. PFS was estimated using Kaplan-Meier estimator. Results: At the time point of this data cut-off 1289 pts (93.9%) had discontinued the documentation. The median time for pts since primary diagnosis was 7.1 yrs and 2.2 yrs, since first sign of relapse (local recurrence or metastases). At baseline, 54.1% presented with visceral metastases. 49.2% had an ECOG performance status of 0 and 74.8% of pts started with 10mg EVE, while 24.5% started with 5mg EVE. According to treatment lines we found 27% 1L (359 pts), 32% 2L (426 pts), 19% 3L (253 pts), 11% 4L (153 pts) and 11% 5L (154 pts) in our cohort Additional baseline and safety data will be presented. The Kaplan Meier estimate of the overall PFS is 6.9 months (95%CI 6.3-7.4). 2.2% (18 pts) of the pts experienced a complete and 17.8% (147 pts) a partial remission, while 57.4% (475 pts) remained stable as their best overall responses during the documentation period. 52.3% (718 pts) discontinued the treatment due to a progressive disease and 25.5% (350 pts) due to adverse events. 67.1% (902 pts) continued the antineoplastic treatment with a subsequent therapy. Conclusions: Here we report the PFS of pts treated with EVE + EXE in a real world scenario. The PFS of 6.9 months observed in our series matches somewhat perfect with the PFS of 7.8 months from the randomized Bolero-2 trial suggesting that these findings might be valid and useful for everyday routine. Clinical trial information: EUPAS9462.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.15_suppl.e12547
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5
