Medical University of Brandenburg Theodor Fontane, Campus Rüdersdorf and Immanuel Hospital Märkische Schweiz, Buckow, Germany.
University Hospital Heidelberg, Heidelberg, Germany.
Int J Cancer. 2024 Jul 1;155(1):128-138. doi: 10.1002/ijc.34912. Epub 2024 Mar 6.
BRAWO, a real-world study, assessed the efficacy, quality of life (QoL) and safety of EVE + EXE in postmenopausal women with HR+/HER2- advanced breast cancer (ABC) in routine clinical practice. Postmenopausal women with HR+/HER2-ABC with recurrence or progression after a NSAI were included. Primary Observation parameters included the evaluation of the effectiveness of EVE + EXE. A multivariate-analysis using Cox proportional hazard model was built to identify predictors of progression. Overall, 2100 patients were enrolled (August 2012-December 2017); 2074 were evaluable for efficacy and safety analyses. Majority of patients (60.6%) received EVE + EXE as first (28.7%) or second-line (31.9%) therapy. Visceral metastases were present in 54.1% patients. Median progression-free survival (mPFS) reported as 6.6 months (95%CI: 6.3-7.0). Multivariate-analysis in a subset of patients (n = 1837) found higher body mass index (BMI) and non-visceral metastases to be independent predictors of favorable PFS. Patients with a BMI of 20 to <25 had a mPFS of 6.0 (95%CI: 5.4-6.4) and those with a BMI ≥30 had mPFS of 8.5 (95%CI: 6.9-9.9). 41.2% patients achieved stable disease and 7.3% partial response. No major changes were observed QoL; 86.4% patients received stomatitis prophylaxis and 41.4% experienced EVE related AEs of stomatitis, mainly low grade. AEs occurred in 91.2% of patients, of which stomatitis (42.6%) and fatigue (19.8%) were most frequent. The BRAWO study provides real-world evidence of efficacy and safety of EVE + EXE in patients with HR+, HER2- ABC. A high BMI and the absence of visceral metastases were independent predictors of PFS in this cohort of patients.
BRAWO 是一项真实世界研究,评估了 EVE+EXE 在绝经后 HR+/HER2-晚期乳腺癌(ABC)女性中的疗效、生活质量(QoL)和安全性。该研究纳入了 HR+/HER2-ABC 患者,这些患者在 NSAI 治疗后复发或进展。主要观察参数包括 EVE+EXE 的疗效评估。采用 Cox 比例风险模型进行多变量分析,以确定进展的预测因素。该研究共纳入 2100 例患者(2012 年 8 月至 2017 年 12 月);2074 例患者可进行疗效和安全性分析。大多数患者(60.6%)接受 EVE+EXE 作为一线(28.7%)或二线(31.9%)治疗。54.1%的患者存在内脏转移。中位无进展生存期(mPFS)为 6.6 个月(95%CI:6.3-7.0)。对一组患者(n=1837)的多变量分析发现,较高的体重指数(BMI)和非内脏转移是有利 PFS 的独立预测因素。BMI 为 20-<25 的患者 mPFS 为 6.0(95%CI:5.4-6.4),BMI ≥30 的患者 mPFS 为 8.5(95%CI:6.9-9.9)。41.2%的患者病情稳定,7.3%的患者部分缓解。QoL 无明显变化;86.4%的患者接受了口腔炎预防治疗,41.4%的患者出现了 EVE 相关口腔炎不良反应,主要为低级别。91.2%的患者出现了不良反应,其中最常见的是口腔炎(42.6%)和疲劳(19.8%)。BRAWO 研究提供了 EVE+EXE 在 HR+、HER2-ABC 患者中的疗效和安全性的真实世界证据。在该患者队列中,较高的 BMI 和无内脏转移是 PFS 的独立预测因素。