500mg氟维司群治疗既往接受芳香化酶抑制剂治疗的复发转移性乳腺癌患者的回顾性研究  

A retrospective study of 500 mg fulvestrant in recurrent or metastatic breast cancer patients pretreated with the third generation of aromatase inhibitors

作　　者：赵燕南[1] 龚成成 胡夕春[1] 王中华[1] 张剑[1] 王磊苹[1] 曹君[1] 陶中华[1] 王碧芸[1] ZHAO Yannan GONG Chengcheng HU Xichun WANG Zhonghua ZHANG Jian WANG Leiping CAO Jun TAO Zhonghua WANG Biyun(Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, Chin)

机构地区：[1]复旦大学附属肿瘤医院肿瘤内科,复旦大学上海医学院肿瘤学系,上海200032

出　　处：《中国癌症杂志》2016年第9期777-783,共7页China Oncology

摘　　要：背景与目的：第三代芳香化酶抑制剂（aromatase inhibitors，AI）是绝经后激素受体阳性患者内分泌治疗的常规用药。在既往AI治疗后进展的患者中，500 mg氟维司群存在一定获益。该研究旨在探索500 mg氟维司群在既往接受AI治疗的复发转移性乳腺癌患者中临床实际应用时的疗效及安全性。方法：收集2011年7月—2015年12月复旦大学附属肿瘤医院收治的188例经500 mg氟维司群治疗的既往接受AI治疗的激素受体阳性的复发转移性乳腺癌患者的临床资料。主要观察疗效指标为无进展生存时间（progression-free survival，PFS），次要观察疗效指标包括客观缓解率（objective response rate，ORR）、临床获益率（clinical benefit rate，CBR）以及安全性。结果：中位随访 11.3 个月，患者的中位PFS为5.9个月（95%CI：4.2-7.5）；CBR为40.0%，ORR为3.4%。COX多因素分析提示，患者的PFS与转移部位数目（HR=1.92, 95%CI：1.2-2.9，P=0.002）以及既往是否接受转移后化疗（HR=1.52，95%CI：1.0-2.1，P=0.022）有关。6例患者因不良事件停用氟维司群治疗。结论：500 mg氟维司群治疗既往接受AI治疗的复发转移乳腺癌患者的疗效和安全性肯定。Background and purpose： The third generation of aromatase inhibitors （AI） in postmenopausal hormone receptor-positive patients is the routine treatments in endocrine therapy. The 500 mg fulvestrant showed clinical benefits in patients with previous AI treatment. This study aimed to access the efficacy and safety of 500 mg fulvestrant in estrogen receptor （ER） positive postmenopausal patients who had previous AI treatments with locally advanced and metastatic breast cancer. Methods： This study retrospectively analyzed the clinical data from 188 post-AI ER positive and （or） progesterone receptor （PR）-positive locally advanced and metastatic breast cancer patients treated with 500 mg fulvestrant in Fudan University Shanghai Cancer Center from Jul. 2011 to Dec. 2015. Primary end point was progression-free survival （PFS）. Secondary end points were objective response rate （ORR）, clinical benefit rate （CBR） and safety profile. Results： After the median follow-up of 11.3 months, median PFS was 5.9 months （95%CI： 4.2-7.5）, CBR was 40.0% and ORR was 3.4%. COX proportional hazards regression analysis indicated that PFS was correlated with the number of metastatic sites （HR=1.92, 95% CI： 1.2-2.9, P =0.002） and previous lines of chemotherapy （HR=1.52, 95%CI：1.0-2.1, P=0.022）. Six patients stopped the treatment for intolerable adverse events. Conclusion： The treatment of 500 mg fulvestrant has a favorable efficacy and safety in treatment of post-AI ER positive postmenopausal patients with metastatic breast cancer.

关 键 词：氟维司群 转移性乳腺癌 雌激素阳性 芳香化酶抑制剂 

分 类 号：R737.9[医药卫生—肿瘤]