FDA药物批准总结:fulvestrant。
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布罗斯PF,科恩MH,威廉姆斯,Pazdur R
FDA药物批准总结:fulvestrant。
肿瘤学家。2002;7 (6):477 - 80。
- PubMed ID
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12490735 (在PubMed]
- 文摘
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荷尔蒙乳腺癌患者回应它莫西芬可能获得额外受益于第二个内分泌代理后进展或他莫昔芬治疗后复发。Fulvestrant (Faslodex ((R)),在182780年,阿斯利康制药;特拉华州威尔明顿)是一种选择性雌激素拮抗剂设计没有雌激素的影响。缺乏水溶解度导致肠胃外的发展制定每月肌内管理。Fulvestrant已表现出抑制雌激素敏感组织的增殖作用在体外和体内,并没有明显的可测量的雌激素活性。的数据营销批准fulvestrant为基础总结如下。八百五十一绝经后妇女晚期乳腺癌参加两个III期研究中,400年和451年欧洲北美双盲研究开放研究,比较fulvestrant与阿那曲唑的疗效和安全性。四百二十八名患者被随机分配接受fulvestrant 250毫克每月由肌内注射,423名患者接受阿那曲唑每日1毫克。患者认为激素敏感受体状态或之前应对内分泌治疗。超过96%的患者曾收到他莫昔芬,在辅助设置或治疗转移性疾病。 The primary study end points were response rate and time to progression. Response rates for patients treated with fulvestrant were 17% and 20% in the North American and European trials, respectively, compared with 17% and 15% in the anastrozole treatment arms. There were no statistically significant differences in response rates, time to progression, or survival between treatment arms in either study. The most common adverse events attributed to the treatment (>10%) were injection-site reactions and hot flashes. Common events (1%-10%) included asthenia, headache, and gastrointestinal disturbances (nausea, vomiting, and diarrhea), as well as rash and urinary tract infections. A small increase in joint disorders was reported in the anastrozole-treated patients. On April 25, 2002, fulvestrant 250 mg by monthly intramuscular injection was approved by the U.S. Food and Drug Administration for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women with disease progression following antiestrogen therapy. Approval was based on similarity of response rates and time to progression between fulvestrant and anastrozole.
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