Hospital Universitario Clínico San Cecilio, Complejo Hospitalario Universitario, C/Dr. Oloriz, 16, 18012, Granada, Spain.
Hospital Clinic de Barcelona, illarroel, 170, 08036, Barcelona, Spain.
Clin Transl Oncol. 2018 Jul;20(7):862-869. doi: 10.1007/s12094-017-1797-9. Epub 2017 Nov 24.
This study aimed to describe the efficacy of fulvestrant 500 mg in postmenopausal women with estrogen receptor (ER)-positive advanced/metastatic breast cancer who had disease progression after receiving anti-estrogen therapy in clinical practice, getting real-world data.
Multicenter, retrospective, observational study conducted in Spain. Postmenopausal women with locally advanced/metastatic ER-positive breast cancer who received treatment with fulvestrant 500 mg after progression with a previous anti-estrogen therapy were eligible. The primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), clinical benefit rate (CBR), duration of clinical benefit (DoCB), and safety profile.
A total of 263 women were evaluated (median age, 65.8 years). At a median follow-up of 21.5 months, median PFS and OS were 10.6 and 43.2 months, respectively. PFS according to 1st, 2nd, 3rd, and ≥ 4th lines were 11.5, 10.6, 9.9, and 8.5 months, respectively (p = 0.0245). PFS in patients with visceral involvement was 10 months vs 10.6 months in patients without visceral involvement (p = 0.6604), 9.6 months in patients with high Ki67 vs 10 months in patients with low Ki67 (p = 0.7224), and 10.2 months in HER2+ patients vs 10.3 months in HER2- patients (p = 0.6809). The CBR was 56.5% and the DoCB was 18.4 months. The most frequently adverse events were injection site pain (10.3%) and musculoskeletal disorders (7.6%).
Fulvestrant 500 mg administered in clinical practice was shown to be effective (PFS, 10.6 months; CBR, 56.5%) and well tolerated, in accordance with previous trials.
本研究旨在描述在临床实践中，接受抗雌激素治疗后疾病进展的雌激素受体（ER）阳性晚期/转移性乳腺癌绝经后妇女使用氟维司群 500mg 的疗效，获得真实世界的数据。
这是一项在西班牙进行的多中心、回顾性、观察性研究。符合条件的患者为接受氟维司群 500mg 治疗的局部晚期/转移性 ER 阳性乳腺癌绝经后妇女，这些患者在先前的抗雌激素治疗进展后接受了该治疗。主要终点为无进展生存期（PFS）；次要终点包括总生存期（OS）、临床获益率（CBR）、临床获益持续时间（DoCB）和安全性特征。
共评估了 263 名女性（中位年龄 65.8 岁）。中位随访 21.5 个月时，中位 PFS 和 OS 分别为 10.6 和 43.2 个月。第 1、2、3 和≥4 线的 PFS 分别为 11.5、10.6、9.9 和 8.5 个月，差异有统计学意义（p=0.0245）。有内脏转移的患者的 PFS 为 10 个月，无内脏转移的患者为 10.6 个月（p=0.6604）；Ki67 高的患者为 9.6 个月，Ki67 低的患者为 10 个月（p=0.7224）；HER2+的患者为 10.2 个月，HER2-的患者为 10.3 个月（p=0.6809）。CBR 为 56.5%，DoCB 为 18.4 个月。最常见的不良反应是注射部位疼痛（10.3%）和肌肉骨骼疾病（7.6%）。
氟维司群 500mg 在临床实践中的应用被证明是有效的（PFS 为 10.6 个月；CBR 为 56.5%），且耐受性良好，与先前的试验一致。
