Department of Medical Oncology, National Cancer Centre and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, #17 Panjiayuan Nanli, Beijing, China.
Breast Cancer Res Treat. 2018 Oct;171(3):535-544. doi: 10.1007/s10549-018-4867-y. Epub 2018 Jul 4.
This meta-analysis was conducted to compare the efficacy and safety of fulvestrant with aromatase inhibitors in postmenopausal women with hormone receptor-positive (estrogen and/or progesterone receptor positive) advanced breast cancer.
Electronic databases were searched for randomized controlled trials comparing the efficacy and safety of fulvestrant with three aromatase inhibitors (anastrozole/letrozole/exemestane) published through August 31, 2017. Time to progression/progression-free survival was the primary outcome, while overall survival and safety were the secondary outcomes. Time to progression/progression-free survival was evaluated in subgroups determined on age, hormone receptor status, visceral metastasis, and measurable disease. Hazard ratios with 95% confidence intervals were analyzed by STATA 12.0.
Total of seven randomized controlled trials, with 3168 patients were included for analysis. In the overall population, fulvestrant and aromatase inhibitors had similar time to progression/progression-free survival (Hazard ratio 0.93; 95% confidence interval 0.86-1.01, P = 0.102); however, time to progression/progression-free survival for fulvestrant 500 mg was significantly longer compared with aromatase inhibitors (hazard ratio 0.75; 95% confidence interval 0.62-0.91, P = 0.003). Subgroup analysis revealed significant prolongation of time to progression/progression-free survival with fulvestrant compared with aromatase inhibitors in the patients of estrogen and progesterone receptor-positive (hazard ratio 0.86; 95% confidence interval, 0.75-0.98, P = 0.022) and patients aged ≥ 65 years (hazard ratio 0.81; 95% confidence interval 0.68-0.96, P = 0.014). Overall survival was similar in both groups (hazard ratio 0.89; 95% confidence interval 0.70, 1.13, P = 0.334).
In postmenopausal women with estrogen and/or progesterone receptor-positive advanced breast cancer, fulvestrant 500 mg showed better efficacy than aromatase inhibitor, which was not seen with fulvestrant 250 mg. Compared to aromatase inhibitors, fulvestrant prolonged time to progression/progression-free survival in the subgroups including estrogen and progesterone receptor-positive patients and those aged ≥ 65 years.
本荟萃分析旨在比较氟维司群与芳香化酶抑制剂在激素受体阳性（雌激素和/或孕激素受体阳性）晚期乳腺癌绝经后妇女中的疗效和安全性。
检索电子数据库，以比较截至 2017 年 8 月 31 日发表的氟维司群与三种芳香化酶抑制剂（阿那曲唑/来曲唑/依西美坦）的疗效和安全性的随机对照试验。主要终点为无进展生存期/无进展生存率，次要终点为总生存期和安全性。根据年龄、激素受体状态、内脏转移和可测量疾病，对无进展生存期/无进展生存率进行亚组评估。采用 STATA 12.0 分析风险比和 95%置信区间。
共纳入 7 项随机对照试验，共 3168 例患者进行分析。在总体人群中，氟维司群和芳香化酶抑制剂的无进展生存期/无进展生存率相似（风险比 0.93；95%置信区间 0.86-1.01，P=0.102）；然而，氟维司群 500mg 组的无进展生存期/无进展生存率明显长于芳香化酶抑制剂（风险比 0.75；95%置信区间 0.62-0.91，P=0.003）。亚组分析显示，氟维司群在雌激素和孕激素受体阳性患者（风险比 0.86；95%置信区间 0.75-0.98，P=0.022）和年龄≥65 岁的患者（风险比 0.81；95%置信区间 0.68-0.96，P=0.014）中，无进展生存期/无进展生存率明显延长。两组的总生存期相似（风险比 0.89；95%置信区间 0.70，1.13，P=0.334）。
在雌激素和/或孕激素受体阳性的晚期乳腺癌绝经后妇女中，氟维司群 500mg 比芳香化酶抑制剂更有效，而氟维司群 250mg 则不然。与芳香化酶抑制剂相比，氟维司群延长了包括雌激素和孕激素受体阳性患者以及年龄≥65 岁患者在内的亚组的无进展生存期/无进展生存率。
