Division of Breast Surgery, The University of Nottingham, Nottingham City Hospital, Hucknall Road, Nottingham, NG5 1PB, UK.
Department of Breast Cancer, Affiliated Hospital of Academy of Military Medical Sciences, No. 8 Dongda Street, Fengtai District, Beijing, 100071, China.
Breast Cancer. 2019 Nov;26(6):703-711. doi: 10.1007/s12282-019-00973-4. Epub 2019 May 11.
Fulvestrant, a selective estrogen receptor degrader, is approved for first- and second-line treatment of postmenopausal women with hormone receptor-positive advanced breast cancer (ABC).
Meta-analysis of randomized controlled trials (RCTs) evaluating fulvestrant 500 mg in postmenopausal hormone receptor-positive ABC, to evaluate differences in clinical benefit rate (CBR; proportion of patients experiencing best overall response of complete response, partial response, or stable disease for ≥ 24 weeks) between fulvestrant 500 mg and comparator endocrine therapies. Odds ratios (OR) and 95% confidence intervals (CI) for CBR were calculated; fixed effects (FE) models were constructed (first- and second-line data, alone and combined).
Six RCTs were included. Four studies evaluated fulvestrant 500 mg vs. fulvestrant 250 mg; two evaluated fulvestrant 500 mg vs. anastrozole 1 mg. In total, 1054 and 534 patients were included (first- and second-line treatment, respectively). Analysis of OR and 95% CI of CBR by therapy line favored fulvestrant 500 mg vs. comparator therapy. Assessing all results combined in the FE model indicated significant improvement in CBR with fulvestrant 500 mg vs. comparator treatments (OR 1.33; 95% CI 1.13-1.57; p = 0.001). Restricting the FE model to therapy line demonstrated significant improvement in CBR vs. comparator treatments (OR 1.33; 95% CI 1.02-1.73; p = 0.035) for first-line, and a trend to improvement vs. comparator treatments (OR 1.27; 95% CI 0.90-1.79; p = 0.174) for second-line.
In postmenopausal patients with hormone receptor-positive ABC, fulvestrant 500 mg first-line was associated with significantly greater CBR (more patients benefiting from treatment) vs. comparator endocrine therapy.
氟维司群是一种选择性雌激素受体降解剂，已获批用于治疗绝经后激素受体阳性的晚期乳腺癌（ABC）的一线和二线治疗。
对评估氟维司群 500mg 治疗绝经后激素受体阳性 ABC 的随机对照试验（RCT）进行荟萃分析，以评估氟维司群 500mg 与对照内分泌治疗之间在临床获益率（CBR；经历完全缓解、部分缓解或疾病稳定≥24 周的患者比例）方面的差异。计算了 CBR 的优势比（OR）和 95%置信区间（CI）；构建了固定效应（FE）模型（单独和联合使用一线和二线数据）。
纳入了 6 项 RCT。四项研究评估了氟维司群 500mg 与氟维司群 250mg 的疗效，两项研究评估了氟维司群 500mg 与阿那曲唑 1mg 的疗效。共有 1054 名和 534 名患者分别纳入一线和二线治疗组。按治疗线评估 OR 和 95%CI 的 CBR 倾向于氟维司群 500mg 优于对照治疗。在 FE 模型中综合评估所有结果表明，氟维司群 500mg 与对照治疗相比，CBR 显著改善（OR 1.33；95%CI 1.13-1.57；p=0.001）。将 FE 模型限制在治疗线，显示氟维司群 500mg 与对照治疗相比，CBR 显著改善（OR 1.33；95%CI 1.02-1.73；p=0.035），而二线治疗有改善的趋势（OR 1.27；95%CI 0.90-1.79；p=0.174）。
在绝经后激素受体阳性 ABC 患者中，氟维司群 500mg 一线治疗与对照内分泌治疗相比，CBR（更多患者受益于治疗）显著提高。
