依维莫司联合依西美坦治疗激素受体阳性、HER2阴性复发转移性乳腺癌的安全性及有效性分析

目的:观察依维莫司联合依西美坦治疗非甾体类芳香化酶抑制剂（NSAIs）耐药的激素受体阳性、HER2阴性绝经后晚期乳腺癌的安全性及疗效。方法:2014年8月10日至2016年9月20日收治的绝经后激素受体阳性、HER2阴性，NSAIs治疗后进展的晚期乳腺癌患者46例，随机进入研究组和对照组。研究组23例口服依维莫司10 mg/d及依西美坦2.5 mg/d；对照组23例口服依西美坦单药2.5 mg/d，分析两组患者的肿瘤控制率(DCR)、不良反应发生率、无进展生存期（PFS）。结果:中位随访时间9.5个月，研究组和对照组的DCR率分别为65.2%和34.8%，差异具有统计学意义（P=0.038）。研究组最常见的不良反应为口腔炎（65.2%）和乏力（47.8%）与对照组差异具有统计学意义（P＜0.05）。研究组和对照组的中位PFS分别为6.5个月(95%CI=4.8~8.2)和3.5个月(95%CI=2.7~4.3)，差异有统计学意义（P=0.02）。结论:依维莫司联合依西美坦治疗绝经后NSAIs耐药的激素受体阳性、HER2阴性晚期乳腺癌的不良反应可控，可显著提高DCR率及PFS。

Safety and efficacy of everolimus plus exemestane in the treatment of hormone receptor-positive,HER2-negative locally advanced or metastatic breast cancer

Objective:To observe the safety and efficacy of everolimus plus exemestane in postmenopausal hormone receptor-positive,HER2-negative locally advanced or metastatic breast cancer progressing on prior nonsteroidal aromatase inhibitors (NSAIs).Methods:From 10th August,2014 to 20th September,2016,46 eligible patients were randomly assigned to experimental group(23 cases) and control group(23 cases).Patients in the experimental group received everolimus 10 mg/d plus exemestane 2.5 mg/d,and in the control group all patients received exemestane 2.5 mg/d.The primary end point was progression-free survival(PFS).Results:The disease control rate(DCR) in the experimental group and control group were 65.2% and 34.8% respectively,with statistical difference (P=0.038).There were more stomatitis (65.2%) and fatigue (47.8%) in the experimental group,with statistical difference compared with control (P＜0.05).The median PFS were 6.5 months (95%CI=4.8~8.2) and 3.5 months (95%CI=2.7~4.3)respectively in the two group,with statistically difference(P=0.02).Conclusion:Everolimus plus exemestane can be delivered safely with careful monitor in hormone receptor-positive,HER2-negative locally advanced or metastatic breast cancer progressing on prior NSAIs,can significantly improve the DCR and PFS.