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目的探讨氟维司群(FUL)对受体阳性转移性乳腺癌(MBC)患者的疗效及安全性。方法 24例患者接受氟维司群治疗,0、14及28 d各肌内注射250 mg,随后每28天肌内注射250 mg,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)及临床获益率(CBR)。结果本组24例患者中位TTP为4.4个月,ORR为8.3%(2/24),CBR为25.0%,其中部分缓解(PR)2例,疾病稳定(SD)超过24周4例。氟维司群的疗效与患者术后无病生存期(DFS)及解救治疗线数等因素相关。全组不良反应较轻微。结论氟维司群是治疗MBC患者的有效内分泌治疗药物,安全性较好。
Objective To investigate the efficacy and safety of fulvestrant (FUL) in patients with receptor-positive metastatic breast cancer (MBC). Methods Twenty-four patients received fulvestrant treatment and received intramuscular injections of 250 mg on days 0, 14 and 28 followed by intramuscular injections of 250 mg every 28 days until tumor progression. The primary end point was time to disease progression (TTP), secondary endpoints were objective response rate (ORR) and clinical benefit rate (CBR). Results The median TTP of the 24 patients was 4.4 months. The ORR was 8.3% (2/24) and the CBR was 25.0%. There were 2 cases of partial remission (PR) and 4 cases of stable disease (SD) over 24 weeks. The efficacy of fulvestrant and patients with disease-free survival (DFS) and the number of rescue treatment lines and other factors. The whole group of minor adverse reactions. Conclusion Fulvestrant is an effective endocrine therapy for patients with MBC, and it is safe.