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

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

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。

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.