Department of Internal Medicine I, Divison of Oncology, Comprehensive Cancer Center and Gaston H. Glock Research Center, Medical University of Vienna, Vienna, Austria.
Department of Gynecology and Gynecological Oncology, Medical University of Innsbruck, Innsbruck, Austria.
Breast. 2020 Apr;50:64-70. doi: 10.1016/j.breast.2020.01.035. Epub 2020 Jan 31.
STEPAUT, an Austrian non-interventional study, evaluated the safety and efficacy of everolimus plus exemestane in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) recurring/progressing on/after nonsteroidal aromatase inhibitors (NSAIs) in routine clinical practice.
Postmenopausal women with HR+, HER2- ABC progressing on/after NSAIs receiving everolimus plus exemestane in accordance with routine practice and the current version of Summary of Product Characteristics were eligible. Planned individual observation period corresponded to the duration of treatment until formal study end.
Overall, 236 patients (median age: 65 years) were enrolled at 17 sites across Austria. The median progression-free survival (mPFS) in the overall population was 9.5 months (95% confidence interval [CI]: 8.6-10.7 months). The mPFS (95% CI) in patients who received everolimus 10 and 5 mg was 9.9 months (7.3-11.5 months) and 8 months (4.7-10.7 months), respectively. The median time to progression was numerically longer in patients who had a therapy break (11.9 months, 95% CI: 10.0-14.6 months) versus those who did not have any therapy break (10.7 months, 95% CI: 8.9-12.6 months). Patients experienced grade 1 (53.7%), grade 2 (35.9%), grade 3 (9.9%), grade 4 (0.2%) adverse events (AEs). The most common AEs of any grade were stomatitis, mucositis (53.8%), rash, exanthema (29.7%), loss of appetite, nausea (28.4%).
Real-world safety and efficacy data from STEPAUT were consistent with results from BOLERO-2, supporting everolimus plus exemestane as a suitable treatment option for HR+, HER2- ABC recurring/progressing on/after NSAIs.
奥地利的非干预性研究 STEPAUT 评估了依维莫司联合依西美坦在激素受体阳性（HR+）、人表皮生长因子受体 2 阴性（HER2-）晚期乳腺癌（ABC）患者中的安全性和疗效，这些患者在接受非甾体芳香化酶抑制剂（NSAI）治疗后或治疗过程中疾病进展/复发。
符合以下条件的绝经后 HR+、HER2-ABC 患者有资格接受依维莫司联合依西美坦治疗：正在接受 NSAI 治疗，且病情进展/复发；按照常规治疗方案和当前版产品特性摘要使用依维莫司联合依西美坦。计划的个体观察期与治疗持续时间相对应，直至研究结束。
共有 236 名患者（中位年龄：65 岁）在奥地利的 17 个地点入组。总体人群的中位无进展生存期（mPFS）为 9.5 个月（95%置信区间[CI]：8.6-10.7 个月）。接受依维莫司 10mg 和 5mg 治疗的患者 mPFS（95%CI）分别为 9.9 个月（7.3-11.5 个月）和 8 个月（4.7-10.7 个月）。有治疗中断的患者中位进展时间（11.9 个月，95%CI：10.0-14.6 个月）长于无治疗中断的患者（10.7 个月，95%CI：8.9-12.6 个月）。患者发生 1 级（53.7%）、2 级（35.9%）、3 级（9.9%）、4 级（0.2%）不良反应（AE）。任何级别最常见的 AE 是口腔炎、黏膜炎（53.8%）、皮疹、皮疹（29.7%）、食欲下降、恶心（28.4%）。
STEPAUT 的真实世界安全性和疗效数据与 BOLERO-2 的结果一致，支持依维莫司联合依西美坦作为 HR+、HER2-ABC 在接受 NSAI 治疗后或治疗过程中疾病进展/复发的一种合适的治疗选择。
