Sandro Pitigliani Medical Oncology Department, Hospital of Prato, Istituto Toscano Tumori, Via Suor Niccolina 20, Prato 59100, Italy.
CHU Sart Tilman Liège and Liège University, Avenue de L'Hôpital 1, 4000 Liège, Belgium.
Breast. 2018 Apr;38:144-149. doi: 10.1016/j.breast.2017.12.016. Epub 2018 Jan 8.
The double-blind, phase III CONFIRM study (NCT00099437) evaluated fulvestrant 500 mg vs fulvestrant 250 mg in postmenopausal women with hormone receptor-positive locally advanced/metastatic breast cancer (LA/MBC). This post-hoc analysis investigated the efficacy and safety of fulvestrant given either first-line or second-line for advanced disease.
MATERIALS & METHODS: Progression-free survival (PFS) and overall survival (OS) with fulvestrant 500 mg vs fulvestrant 250 mg was evaluated using unadjusted log-rank tests in patients treated in the first- (progression during or within 12 months after completing adjuvant endocrine therapy; n = 387) and second-line (following endocrine therapy for LA/MBC; n = 343) settings.
First-line fulvestrant 500 mg significantly prolonged PFS vs fulvestrant 250 mg (median PFS 5.6 vs 4.2 months; hazard ratio [HR] 0.80; 95% confidence interval [CI] 0.64-1.00; p = .047). Median PFS was numerically greater with second-line fulvestrant 500 mg vs fulvestrant 250 mg (7.9 vs 6.3 months; HR 0.80; 95% CI 0.64-1.02; p = .068). At data cut-off (75.5% maturity), median OS with first-line fulvestrant 500 mg was 23.2 vs 22.1 months with fulvestrant 250 mg (HR 0.87; 95% CI 0.70-1.10; p = .251), and 29.2 vs 22.8 months, respectively, in the second-line (HR 0.75; 95% CI 0.58-0.96; p = .020). The safety profile was broadly comparable between dose groups and across treatment lines, and consistent with the overall patient population.
The superiority of fulvestrant 500 mg over fulvestrant 250 mg in patients with LA/MBC in CONFIRM was consistent in both the first- and second-line settings for PFS, and numerically greater in both settings for OS.
CONFIRM 是一项双盲、III 期研究（NCT00099437），评估了氟维司群 500mg 与氟维司群 250mg 治疗激素受体阳性局部晚期/转移性乳腺癌（LA/MBC）绝经后女性的疗效。本事后分析评估了氟维司群一线或二线治疗晚期疾病的疗效和安全性。
无调整对数秩检验比较了氟维司群 500mg 与氟维司群 250mg 在一线（辅助内分泌治疗期间或结束后 12 个月内进展；n=387）和二线（LA/MBC 内分泌治疗后；n=343）患者中的无进展生存期（PFS）和总生存期（OS）。
氟维司群 500mg 一线治疗显著延长了 PFS，优于氟维司群 250mg（中位 PFS 5.6 个月 vs 4.2 个月；风险比 [HR] 0.80；95%置信区间 [CI] 0.64-1.00；p=0.047）。氟维司群 500mg 二线治疗的中位 PFS 也略长于氟维司群 250mg（7.9 个月 vs 6.3 个月；HR 0.80；95% CI 0.64-1.02；p=0.068）。数据截止时（75.5%成熟度），氟维司群 500mg 一线治疗的中位 OS 为 23.2 个月，氟维司群 250mg 为 22.1 个月（HR 0.87；95% CI 0.70-1.10；p=0.251），氟维司群 500mg 二线治疗的中位 OS 为 29.2 个月，氟维司群 250mg 为 22.8 个月（HR 0.75；95% CI 0.58-0.96；p=0.020）。安全性特征在剂量组和治疗线之间基本一致，与总体患者人群一致。
在 CONFIRM 中，氟维司群 500mg 一线治疗 LA/MBC 的疗效优于氟维司群 250mg，这种优势在 PFS 方面在一线和二线治疗中均一致，在 OS 方面在二线治疗中略优。
