500mg氟维司群治疗绝经后雌激素受体阳性转移性乳腺癌患者的疗效和安全性  

Efficacy and safety of 500 mg fulvestrant treatment for postmenopausal patients with ER-positive metastatic breast cancer

作　　者：赵燕南[1] 张淑娟 陈潇雨[1] 张剑[1] 张盛[1] 王中华[1] 吕方芳[1] 曹君[1] 邵志敏[3] 胡夕春[1] 王碧芸[1] 

机构地区：[1]复旦大学附属肿瘤医院肿瘤内科,上海200032 [2]新疆维吾尔自治区喀什地区第二人民医院肿瘤科,844000 [3]复旦大学附属肿瘤医院乳腺外科,上海200032

出　　处：《中华乳腺病杂志（电子版）》2015年第5期292-297,共6页Chinese Journal of Breast Disease(Electronic Edition)

摘　　要：目的 评价500 mg氟维司群对绝经后激素受体阳性转移性乳腺癌患者的疗效和安全性。方法 回顾性分析2012年2月至2014年8月复旦大学附属肿瘤医院收治的61例接受500 mg氟维司群治疗的绝经后ER阳性转移性乳腺癌患者的临床资料。评估氟维司群的临床疗效、影响因素和不良反应,并利用Kaplan-Meire生存分析、Log-rank检验、COX比例风险回归模型进行生存分析。结果 中位随访17.2个月（2.0~32.7个月）时,本组患者中位无进展生存期（PFS）为6.4个月,临床获益率为37.7%（23/61）,客观缓解率为8.2%（5/61）,中位OS为27.0个月。单因素分析（Log-rank检验）显示,500 mg氟维司群治疗后,患者的PFS与癌转移后接受内分泌治疗、既往使用他莫昔芬、仅有骨转移及内脏转移显著相关（χ2=3.963、5.197、5.115、5.479,P=0.047、0.024、0.023、0.019）。COX比例风险回归分析显示,治疗后患者的PFS与癌转移后接受内分泌治疗及内脏转移有关（HR=3.1,95%CI：1.1~8.8,P=0.036;HR=2.3,95%CI：1.2~4.3,P=0.013）,癌转移后接受内分泌治疗者疾病进展的风险是未接受者的3.1倍,伴内脏转移者疾病进展的风险是不伴者的2.3倍。本组患者使用500 mg氟维司群后未出现Ⅲ度及以上不良反应,且未发生治疗相关性死亡。结论 500 mg氟维司群治疗绝经后ER阳性转移性乳腺癌患者的疗效和安全性值得肯定。Objective To evaluate the efficacy and safety of 500 mg fulvestrant for the treatment of postmenopausal patients with ER-positive metastatic breast cancer. Methods We retrospectively analyzed the clinical data of 61 metastatic breast cancer patients treated with 500 mg fulvestrant in Fudan University Shanghai Cancer Center from February 2012 to August 2014. Clinical efficacy, influencing factors and adverse effect were evaluated. Kaplan-Meire analysis, Log-rank test and Cox proportional hazard regression model were used for survival analysis. Results After the median follow-up of 17. 2 months （ 2.0 - 32. 7 months ）, median progression free survival （PFS） was 6.4 months, clinical benefit rate was 37.7% （23/61）, objective response rate was 8.2% （5/61） and median OS was 27. 0 months. Log-rank test showed that after the treatment of 500 mg fulvestrant, PFS was significantly correlated with endocrine therapy after metastasis, prior tamoxifen use, bone metastasis alone and visceral metastasis （ X2 = 3. 963,5. 197,5. 115,5.479; P = 0. 047,0. 024, 0. 023,0. 019）. COX proportional hazard regression analysis indicated that PFS was correlated with relevant endocrine therapy after metastasis and visceral metastasis respectively （ fir = 3.1, 95% CI： 1.1 - 8.8, P= 0. 036 ;HR = 2. 3, 95% CI： 1.2-4. 3 ,P= O. 013 ）. The patients receiving endocrine therapy had the risk of disease progression 3.1 times of that in those receiving no hormonal therapy. The patients with visceral metastasis had the risk of disease progression 2. 3 times of that in patients without visceral metastasis. Conclusion The treatment of 500 mg fulvestrant has a favorable efficacy and safety for postmenopausal patients with ER-positive metastatic breast cancer.

关 键 词：绝经期 雌激素受体 雌激素受体调节剂 乳腺肿瘤 肿瘤转移 

分 类 号：R737.9[医药卫生—肿瘤]