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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 fulvestrant 500 mg in postmenopausal women with hormone receptor-positive metastatic breast cancer. Methods The clinical data of 61 patients with postmenopausal ER-positive metastatic breast cancer treated with 500 mg fulvestrant admitted from February 2012 to August 2014 in Cancer Hospital of Fudan University were retrospectively analyzed. The clinical efficacy, influencing factors and adverse reactions of fulvestrant were evaluated. Kaplan-Meire survival analysis, log-rank test and COX proportional hazards regression model were used to analyze the survival. Results The median progression-free survival (PFS) was 6.4 months at the median follow-up of 17.2 months (range, 2.0 to 32.7 months), with a clinical benefit of 37.7% (23/61) and objective response rate 8.2% (5/61), median OS was 27.0 months. Univariate analysis (Log-rank test) showed that after treatment with fulvestrant 500 mg, PFS and endocrine therapy after cancer metastasis, previous use of tamoxifen, only bone metastasis and visceral metastasis was significantly related (χ2 = 5.197, 5.179, 5.479, P = 0.047, 0.024, 0.023, 0.019). COX proportional hazard regression analysis showed that PFS was related to endocrine therapy and visceral metastasis after cancer metastasis (HR = 3.1, 95% CI: 1.1-8.8, P = 0.036; HR = 2.3, 95% CI: 4.3, P = 0.013). The risk of disease progression in endocrine-treated patients after cancer metastasis was 3.1 times that in non-recipients, and the risk of visceral metastasis was 2.3 times that in non-responders. This group of patients with fulvestrant 500mg did not appear after Ⅲ degrees and above adverse reactions, and no treatment-related deaths. Conclusion The efficacy and safety of fulvestrant 500 mg in the treatment of postmenopausal women with ER-positive metastatic breast cancer are worthy of recognition.