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首页> 外文期刊>The oncologist >Approval summary: Letrozole (Femara? Tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: Conversion of accelerated to full approval
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Approval summary: Letrozole (Femara? Tablets) for adjuvant and extended adjuvant postmenopausal breast cancer treatment: Conversion of accelerated to full approval

机译：批准摘要：来曲唑（Femara？片剂）用于绝经后乳腺癌的辅助和扩展辅助治疗：从加速批准转换为完全批准

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On April 30, 2010, the U.S. Food and Drug Administration onverted letrozole (Femara? Novartis Pharmaceuticals Corporation, East Hanover, NJ) from accelerated to full approval for adjuvant and extended adjuvant (following 5 years of tamoxifen) treatment of postmenopausal womenwith hormone receptor-positive early breast cancer. The initial accelerated approvals of letrozole for adjuvant and extended adjuvant treatment on December 28, 2005 and October 29, 2004, respectively, were based on an analysis of the disease-free survival (DFS) outcome of patients followed for medians of 26 months and 28 months, respectively. Both trials were double-blind, multicenter studies. Both trials were unblinded early when an interim analysis showed a favorable letrozole effect on DFS. In updated intention-to-treat analyses of both trials, the risk for a DFS event was lower with letrozole than with tamoxifen (hazard ratio [HR], 0.87; 95% confidence interval [CI], 0.77-0. 99; p =.03) in the adjuvant trial and was lower than with placebo (HR, 0.89; 95% CI, 0.76-1. 03; p=12) in the extended adjuvant trial. The latter analysis ignores the interim switch of 60% of placebo-treated patients to letrozole. Bone fractures and osteoporosis were reported more frequently following treatment with letrozole whereas tamoxifen was associated with a higher risk for endometrial proliferation and endometrial cancer. Myocardial infarction was more frequently reported with letrozole than with tamoxifen, but the incidence of thromboembolic events was higher with tamoxifen than with letrozole. Lipid-lowering medications were required for 25% of patients on letrozole and 16% of patients on tamoxifen.
机译：2010年4月30日，美国食品药品监督管理局（FDA）宣布将来曲唑（Femara？Novartis Pharmaceuticals Corporation，新泽西州东汉诺威）从加速批准转为全面批准佐洛芬治疗5年后使用激素受体治疗的绝经后妇女的佐剂。早期乳腺癌阳性。来曲唑分别于2005年12月28日和2004年10月29日获得初步加速批准，用于辅助和扩展辅助治疗，其依据是对患者的无病生存期（DFS）结果进行了分析，其中位数为26个月和28个月。两项试验均为双盲，多中心研究。当一项中期分析显示来曲唑对DFS有良好的作用时，这两项试验都是早期的。在两项试验的意向治疗分析中，来曲唑引起的DFS事件风险均低于他莫昔芬（危险比[HR]为0.87; 95％置信区间[CI]为0.77-0。99; p = .03）在辅助试验中低于安慰剂组（HR，0.89; 95％CI，0.76-1。03; p = 12）。后者的分析忽略了60％接受安慰剂治疗的患者向来曲唑的过渡。用来曲唑治疗后，骨折和骨质疏松症的报道更为频繁，而他莫昔芬与子宫内膜增生和子宫内膜癌的风险更高。与他莫昔芬相比，来曲唑对心肌梗塞的报道更为频繁，但他莫昔芬的血栓栓塞事件的发生率高于来曲唑。 25％的来曲唑患者和16％的他莫昔芬患者需要降脂药物。

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