| 摘要: |
| 目的 观察氟维司群联合依西美坦治疗非甾体类芳香化酶抑制剂（NSAIs）治疗后进展的绝经后激素受体阳性晚期乳腺癌的疗效及安全性。方法 选择平顶山市第一人民医院肿瘤科于2014-10-10—2016-10-20间收治的符合标准的晚期乳腺癌患者47例，研究组24例，d0、d14、d28分别予以氟维司群500 mg肌肉注射给药，此后每28d为1周期，联合依西美坦2.5mg/d；对照组23例,口服依西美坦单药2.5 mg/d，分析两组患者的疾病控制率、无进展生存时间、不良事件发生率。结果 中位随访时间8.6个月，研究组和对照组的疾病控制率分别为54.2%和21.7%，差异有统计学意义（χ2=5.23,P=0.023）；中位PFS分别为6.5个月（95%CI=3.86-9.14）和3.0个月（95%CI=2.37-3.63），差异有统计学意义（P=0.044）；两组的常见不良事件差异无统计学意义。结论 氟维司群联合依西美坦治疗NSAIs治疗失败的绝经后激素受体阳性晚期乳腺癌，可显著提高疾病控制率及无进展生存时间，具有良好的耐受性和安全性。 |
| 关键词: 氟维司群 依西美坦 芳香化酶抑制剂 晚期乳腺癌 |
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| Abstract: |
| [Objectives ] To observe the efficacy and safety of fulvestrant plus exemestane in the treatment of hormone receptor-positive recurrent or metastatic breast cancer progressing on prior nonsteroidal aromatase inhibitors (NSAIs). [Methods] 2014.10.10- 2016.10.20 47 eligible patients were randomly assigned to experimental arm(24caes) and control arm(23cases) . Patients in the experimental arm received fulvestrant 500mg at d0,d14,d28，then every 28 days , plus exemestane 2.5 mg per day; in the control arm patients received exemestane 2.5 mg/day only. The primary end point was progression-free survival(PFS). [Results] The disease control rate(DCR) in the experimental arm and control arm were 54.2% and 21.7% respectively, with statistical difference (p =0.023); the median PFS were 6.5 months (95% CI=3.86-9.14) and 3.0 months (95%CI= 2.37 -3.63) respectively, with statistically difference(p=0.046); there were no statistical difference of common adverse events were observed between the two arms. [Conclusion] Fulvestrant plus exemestane can significantly improve the DCR and PFS in hormone receptor-positive, recurrent or metastatic breast cancer progressing on prior NSAIs with reasonable tolerance. |
| Key words: fulvestrant exemestane aromatase inhibitors metastatic breast caner |
