FACE临床研究最终分析出来了:两种芳香化酶抑制剂“势均力敌”
  • 总计4136 例绝经后激素受体(HR)阳性、淋巴结阳性早期乳腺癌(eBC)受试者随机分为每日口服来曲唑(2.5 mg) 或阿那曲唑 (1 mg)辅助治疗5年或直到疾病复发;
  • 来曲唑组2061例,阿那曲唑组2075例;分层因素为淋巴结数、表皮生长因子受体2状态;
  • 来曲唑和阿那曲唑组,估算的5年DFS率分别为84.9%和82.9%;所有不良事件及3-4度不良事件的发生率均无差异。
  • 来曲唑辅助治疗绝经后HR阳性、淋巴结阳性eBC,在疗效和安全性方面未显明优于阿那曲唑。
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Comparative Efficacy and Safety of Adjuvant Letrozole Versus Anastrozole in Postmenopausal Patients With Hormone Receptor-Positive, Node-Positive Early Breast Cancer: Final Results of the Randomized Phase III Femara Versus Anastrozole Clinical Evaluation (FACE) Trial

比较来曲唑对照阿那曲唑辅助治疗绝经后激素受体阳性、淋巴结阳性早期乳腺癌的疗效和安全性:弗隆对照阿那曲唑III期(FACE)临床研究的最终结果

10.1200/JCO.2016.69.2871

2017-04-01, Article

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Purpose The Letrozole (Femara) Versus Anastrozole Clinical Evaluation (FACE) study compared the efficacy and safety of adjuvant letrozole versus anastrozole in postmenopausal patients with hormone receptor (HR) -positive and node-positive early breast cancer (eBC). Methods Postmenopausal women with HR-positive and node-positive eBC were randomly assigned to receive adjuvant therapy with either letrozole (2.5 mg) or anastrozole (1 mg) once per day for 5 years or until recurrence of disease. Patients were stratified on the basis of the number of lymph nodes and human epidermal growth factor receptor 2 status. The primary end point was 5-year disease-free survival (DFS), and the key secondary end points were overall survival and safety. Results A total of 4,136 patients were randomly assigned to receive either letrozole (n = 2,061) or anastrozole (n = 2,075). The final analysis was done at 709 DFS events (letrozole, 341 [16.5%]; anastrozole, 368 [17.7%]). The 5-year estimated DFS rate was 84.9% for letrozole versus 82.9% for anastrozole arm (hazard ratio, 0.93; 95% CI, 0.80 to 1.07; P = .3150). Exploratory analysis showed similar DFS with letrozole and anastrozole in all evaluated subgroups. The 5-year estimated overall survival rate was 89.9% for letrozole versus 89.2% for anastrozole arm (hazard ratio, 0.98; 95% CI, 0.82 to 1.17; P = .7916). Most common grade 3 to 4 adverse events (> 5% of patients) reported for letrozole versus anastrozole were arthralgia (3.9% v 3.3%, and 48.2% v 47.9% for all adverse events), hypertension (1.2% v 1.0%), hot flushes (0.8% v 0.4%), myalgia (0.8% v 0.7%), dyspnea (0.8% v 0.5%), and depression (0.8% v 0.6%). Conclusion Letrozole did not demonstrate significantly superior efficacy or safety compared with anastrozole in postmenopausal patients with HR-positive, node-positive eBC.

First Authors:
Ian Smith

Correspondence Authors:
Ian Smith

All Authors:
Ian Smith,Denise Yardley,Howard Burris,Richard De Boer,Dino Amadori,Kristi McIntyre,Bent Ejlertsen,Michael Gnant,Walter Jonat,Kathleen I Pritchard,Mitch Dowsett,Lowell Hart,Susan Poggio,Lisa Comarella,Herve Salomon,Barbara Wamil,Joyce O'Shaughnessy

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