Ian Smith and Mitch Dowsett, Royal Marsden Hospital; Institute of Cancer Research, London, United Kingdom; Denise Yardley and Howard Burris, Sarah Cannon Research Institute; Tennessee Oncology, Nashville, TN; Richard De Boer, Royal Melbourne and Western Hospitals, Melbourne, Australia; Dino Amadori, Istituto Scientifico Romagnolo per lo Studio e la Cura del Tumori Istituto di Ricovero eCura a Carattere Scientifico, Meldola; Lisa Comarella, CROS NT, Verona, Italy; Kristi McIntyre and Joyce O'Shaughnessy, Texas Oncology, US Oncology; Joyce O'Shaughnessy, Baylor University Medical Center; Baylor Charles A. Sammons Cancer Center; The US Oncology Network, Dallas, TX; Bent Ejlertsen, Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen, Denmark; Michael Gnant, Medical University of Vienna, Vienna, Austria; Walter Jonat, Universitätsklinikum Schleswig-Holstein, Kiel, Germany; Kathleen I. Pritchard, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada; Lowell Hart, Florida Cancer Specialists, Fort Myers, FL; Susan Poggio and Barbara Wamil, Novartis Pharmaceuticals Corporation, East Hanover, NJ; and Herve Salomon, Novartis Pharma, Rueil-Malmaison, France.
J Clin Oncol. 2017 Apr 1;35(10):1041-1048. doi: 10.1200/JCO.2016.69.2871. Epub 2017 Jan 23.
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.
Letrozole（Femara）与 Anastrozole 临床评估（FACE）研究比较了辅助性 letrozole 与 anastrozole 在激素受体（HR）阳性和淋巴结阳性早期乳腺癌（eBC）绝经后患者中的疗效和安全性。
HR 阳性和淋巴结阳性 eBC 的绝经后妇女被随机分配接受辅助治疗，每日一次分别接受 letrozole（2.5mg）或 anastrozole（1mg）治疗，为期 5 年或直至疾病复发。患者根据淋巴结数量和人表皮生长因子受体 2 状态进行分层。主要终点是 5 年无病生存率（DFS），关键次要终点是总生存率和安全性。
共有 4136 名患者被随机分配接受 letrozole（n=2061）或 anastrozole（n=2075）治疗。最终分析在 709 例 DFS 事件时进行（letrozole，341[16.5%]；anastrozole，368[17.7%]）。letrozole 组的 5 年估计 DFS 率为 84.9%，anastrozole 组为 82.9%（风险比，0.93；95%CI，0.80 至 1.07；P=0.3150）。探索性分析显示，letrozole 和 anastrozole 在所有评估的亚组中均具有相似的 DFS。letrozole 组的 5 年估计总生存率为 89.9%，anastrozole 组为 89.2%（风险比，0.98；95%CI，0.82 至 1.17；P=0.7916）。letrozole 组比 anastrozole 组报告的最常见 3 级至 4 级不良事件（>5%的患者）为关节痛（3.9%对 3.3%，所有不良事件为 48.2%对 47.9%）、高血压（1.2%对 1.0%）、热潮红（0.8%对 0.4%）、肌痛（0.8%对 0.7%）、呼吸困难（0.8%对 0.5%）和抑郁（0.8%对 0.6%）。
在 HR 阳性、淋巴结阳性 eBC 的绝经后患者中，letrozole 与 anastrozole 相比，疗效或安全性并未显著提高。
