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.

中文翻译：

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依维莫司加依西美坦治疗激素受体阳性、HER-2 阴性晚期乳腺癌患者的疗效和安全性：开放标签、多中心、非干预性 BRAWO 研究的结果

BRAWO 是一项真实世界研究，在常规临床实践中评估了 EVE + EXE 对患有 HR+/HER2- 晚期乳腺癌 (ABC) 的绝经后女性的疗效、生活质量 (QoL) 和安全性。纳入 NSAI 后复发或进展的 HR+/HER2-ABC 绝经后女性。主要观察参数包括EVE+EXE有效性的评估。建立了使用 Cox 比例风险模型的多变量分析来确定进展的预测因素。总体而言，2100 名患者入组（2012 年 8 月至 2017 年 12 月）；2074 例可进行有效性和安全性分析评估。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) 报告为 6.6 个月 (95% CI: 6.3–7.0)。对一部分患者进行多变量分析（n= 1837）发现较高的体重指数（BMI）和非内脏转移是良好 PFS 的独立预测因素。BMI 为 20 至 <25 的患者的 mPFS 为 6.0 (95%CI: 5.4–6.4)，BMI ≥30 的患者的 mPFS 为 8.5 (95%CI: 6.9–9.9)。41.2% 的患者疾病稳定，7.3% 部分缓解。未观察到生活质量发生重大变化；86.4% 的患者接受了口腔炎预防，41.4% 的患者经历了 EVE 相关的口腔炎 AE，主要是低度不良事件。91.2%的患者发生不良事件，其中口腔炎（42.6%）和疲劳（19.8%）最常见。BRAWO 研究提供了 EVE + EXE 对 HR+、HER2− ABC 患者的有效性和安全性的真实世界证据。高 BMI 和无内脏转移是该患者队列中 PFS 的独立预测因素。