Background and purpose: Fulvestrant, an estrogen receptor (ER) antagonist with no known agonist effects, has shown activity in patients with recurrent ER-positive advanced breast cancer or those patients who have disease progression after endocrine therapy of TAM. This prospective study was designed to evaluate the efficacy and safety of fulvestrant in advanced breast cancer of Chinese women who failed to previous TAM treatment. Methods: Twenty-one patients were enrolled and treated with 250 mg/month of fulvestrant every four weeks via an intramuscular injection. The primary endpoint was to find the time to progression (TTP), secondary endpoints included objective response rate (ORR), duration of response (DoR) and clinical benefit rate (CBR). Results: The median TTP was 4 months with an overall response rate of 19%. One-year survival rate was 42.8%. Two-year survival rate was 32.8%. Median DoR from response to disease progression was 8 months. CBR was 33.3%, including 4 patients who showed a partial response(PR) and 3 patients who achieved stable disease(SD)>24 weeks. Patients with high ER expression had higher CBR than patients with ER lower expression(100% vs 17.6%, P=0.002). Patients with longer postoperative DFS had higher CBR than patients with shorter DFS (46.7% vs 0, P=0.040). Patients treated with fulvestrant as first line got more benefit than those as second line(CBR: 80.0% vs 18.8%, P=0.01). Patients with lung metastasis had higher CBR than those without lung metastasis (CBR: 55.6% vs 16.7%, P=0.06l). The treatment was well tolerated. The main side effects were fatigue, hot flushes, rash and anorexia, etc. Four patients, who receivedfulvestrant for more than 8 months, had adverse events (AE) in peripheral neuropathy. Conclusion: This data demonstrates that 250 mg of fulvestrant is effective and tolerable in the treatment of postmenopausal women with advanced breast cancer whose disease has progressed or recurred after prior endocrine treatment.%背景与目的:氟维司群是一种雌激素受体(estrogen receptor,ER)拮抗剂,该药对既往经内分泌治疗后进展的转移性乳腺癌(MBC)仍有较好疗效.本研究观察氟维司群对他莫昔芬(TAM)治疗后进展的绝经后MBC患者的疗效及安全性.方法:氟维司群250 mg,肌肉注射,每月1次,直至肿瘤进展.主要研究终点为至疾病进展时间(TTP),次要终点为客观有效率(ORR),缓解期(DoR)及临床获益率(CBR).结果:本组21例患者中位TTP为4个月,ORR为19.0％,CBR为33.3％,其中部分缓解(PR)4例,疾病稳定(SD)超过24周3例,有效患者的中位DoR为8个月,1年生存率为42.8％,2年生存率为23.8％,中位总生存时间(OS)为11个月.氟维司群的疗效与患者ER状态、术后无病生存期(DFS)及是否为初始治疗等因素相关:ER高表达者较ER低表达者更易从氟维司群治疗中获益(CBR分别为100％和17.6％,P=0.002),DFS超过2年者的CBR明显较DFS小于2年者高(分别为46.7％和0,P=0.040),氟维司群为MBC初始治疗者的CBR较非初始治疗者明显增高(分别为80.0％和18.8％,P=0.01).有肺转移者氟维司群的疗效较无转移者好(CBR分别为55.6％和16.7％,P=0.061).全组不良反应较轻微,主要表现为乏力、潮热、关节疼痛、皮疹及食欲减退等.在接受氟维司群长时间(8～16个月)治疗的MBC患者中有4例(28.5％)出现上肢麻木等外周神经症状,且进行性加重.结论:氟维司群250 mg是治疗TAM失败后的绝经后MBC患者的有效内分泌治疗药物,且耐受性较好.
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