氟维司群多线治疗激素受体阳性晚期乳腺癌的疗效和安全性分析

Efficacy and safety of fulvestrant in multi-line endocrine therapy on hormone receptor positive metastatic breast cancer

目的探讨氟维司群(fulvestrant,FUL)在激素受体(hormone receptor,HR)阳性晚期乳腺癌多线内分泌治疗中的疗效与安全性。方法收集解放军总医院2010年6月-2013年12月收治的60例既往行规范内分泌治疗的HR阳性晚期乳腺癌患者的临床资料,并对FUL疗效、影响因素与安全性进行回顾性分析。结果本组60例患者中位年龄为54.5岁,确诊时Ⅰ/Ⅱ期患者23例,Ⅲ/Ⅳ期为18例,47例术后曾行辅助内分泌治疗,50例曾接受晚期化疗。接受氟维司群治疗后客观有效率(objective response rate,ORR)为6.7%,临床获益率(clinical benefit response rate,CBR;CR+PR+SD≥24周)为30.0%,中位疾病进展时间(time to progression,TTP)为4.6个月,中位总生存期(overall survival,OS)为30.1个月。29例他莫昔芬及芳香化酶抑制剂均耐药的患者FUL治疗的ORR为6.9%,CBR(≥24周)为13.8%,中位TTP为4.0个月,中位OS为19.3个月。FUL的疗效与DFS、既往内分泌治疗与化疗、FUL剂量等因素相关。主要不良反应为注射部位不适、头痛、恶心、乏力、潮红等总体发生率较低。结论氟维司群对激素受体阳性的晚期乳腺癌内分泌治疗疗效可靠,安全性良好。

Objective To evaluate the efficacy and safety of fulvestrant（FUL） in multi-line endocrine therapy on hormone receptor（HR） positive metastatic breast cancer. Methods A total of 60 patients with HR positive metastatic breast cancer were treated with fulvestrant in our hospital from June 2010 to December 2013. Their clinical data, the efficacy of FUL, influencing factors and safety were retrospectively analyzed. Results Of the 60 patients with median age of 54.5 years, 23 cases were in stage Ⅰ / Ⅱ, 18 cases were in stage Ⅱ / Ⅳ, 47 cases received adjuvant endocrine therapy, and 50 cases received chemotherapy after recurrence. The ORR and CBR after FUL treatment（ ≥ 24 weeks） was 6.7%, 30.0%, respectively, and the median TTP was 4.6 months with median OS of 30.1 months. Twenty-nine out of 60 cases with both tmoxifen and aromatase inhibitor resistance achieved ORR of 6.9% and CBR（ ≥ 24 weeks） of 13.8% with median TTP of 4.0 months and median OS of 19.3 months. The efficacy of FUL was related to DFS, previous endocrine therapy and chemotherapy, and the dose of FUL. The main adverse events were injection site reaction, headache, gastrointestinal disturbance, weakness and hot flush. Most adverse events were moderate and reversible.Conclusion Fulvestrant is safe and effective in treatment of hormone receptor positive metastatic breast cancer.