In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 1061-1061
Abstract:
1061 Background: BRAWO is a German 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. Methods: In this update on the results of the 3rd interim analysis (data cut-off 18-Oct-2016) we analyzed under real world conditions the first 1.078 patients followed up until disease progression for their progression-free survival (PFS) events. A two-stage process based on a Cox regression model was used to check the relevance of the start dose on PFS. In the first step potentially relevant covariates defined by medical experts were evaluated for relevance. In the second step start dose and all covariates showing a p-value of at most 0.1 in first step including all two-interaction of start dose with these parameters were included into the model. Results: Our multivariate analysis support the evidence that predictive factors, such as body mass index (BMI, p-value: 〈 0.001), therapeutic line (1st vs. 2nd+3rd vs. ≥4th; p-value: 0.013), presence of visceral metastases (p-value: 〈 0.001) and ECOG (Eastern Cooperative Oncology Group, p-value: 〈 0.001) status at the beginning of the therapy correlated significantly with the PFS. 283 patients started with 5mg and 795 Patients started with 10 mg. Starting dose had no significant impact on the PFS (neither as main effect nor within interactions, p-value: 0.44-0.88). Conclusions: Even though the approved and recommended starting dose for treatment with EVE is 10 mg, physicians sometimes start EVE-treatment with a lower starting dose, trying subsequently to increase the dose to the recommended dose of 10mg to allow the patient’s organism to adapt to the therapeutic. As the study was not powered to detect possible differences in PFS by starting dose, the result of showing no detrimental effect of a lower start dose may be the result of limited power. Clinical trial information: EUPAS9462.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/JCO.2017.35.15_suppl.1061
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2017
detail.hit.zdb_id:
2005181-5
