阿那曲唑和他莫昔芬作为早期乳腺癌辅助治疗的效果:ATAC试验的10年分析。

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Cuzick J, Sestak I, Baum M, Buzdar A, Howell A, Dowsett M, Forbes JF

阿那曲唑和他莫昔芬作为早期乳腺癌辅助治疗的效果:ATAC试验的10年分析。

《柳叶刀》2010年12月11日(12):1135-41。doi: 10.1016 / s1470 - 2045(10) 70257 - 6。Epub 2010 11月17日。

PubMed ID
21087898 (PubMed视图
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摘要

背景:ariimidex，他莫昔芬，单独或联合(ATAC)试验的目的是比较阿那曲唑(1mg)和他莫昔芬(20mg)作为绝经后早期乳腺癌的辅助治疗，每天口服，持续5年的疗效和安全性。在本分析中，我们评估了中位随访120个月后的长期结果。方法:我们使用比例风险模型来评估所有随机患者(阿那曲唑n=3125，他莫昔芬n=3116)和激素受体阳性患者(阿那曲唑n=2618，他莫昔芬n=2598)的无病生存的主要终点、复发时间、远端复发时间、新发对侧乳腺癌的发生率、总生存期和有无复发的死亡。治疗结束后，我们继续以蒙面方式收集骨折和严重不良事件的数据(安全人群:阿那曲唑n=3092，他莫昔芬n=3094)。本研究注册为国际标准随机对照试验，编号为ISRCTN18233230。结果:患者中位随访120个月(范围0-145);阿那曲唑组随访24,522女性年，他莫昔芬组随访23,950女性年。在全部研究人群中，阿那曲唑组与他莫昔芬组相比无病生存有显著改善(危险比[HR] 0.91, 95% CI 0.83-0.99;P =0.04)，复发时间(0.84,0.75-0.93;P =0.001)、远端复发时间(0.87,0.77-0.99; p=0.03). For hormone-receptor-positive patients, the results were also significantly in favour of the anastrozole group for disease-free survival (HR 0.86, 95% CI 0.78-0.95; p=0.003), time to recurrence (0.79, 0.70-0.89; p=0.0002), and time to distant recurrence (0.85, 0.73-0.98; p=0.02). In hormone-receptor-positive patients, absolute differences in time to recurrence between anastrozole and tamoxifen increased over time (2.7% at 5 years and 4.3% at 10 years) and recurrence rates remained significantly lower on anastrozole than tamoxifen after treatment completion (HR 0.81, 95% CI 0.67-0.98; p=0.03), although the carryover benefit was smaller after 8 years. There was weak evidence of fewer deaths after recurrence with anastrozole compared with tamoxifen treatment in the hormone-receptor-positive subgroup (HR 0.87, 95% CI 0.74-1.02; p=0.09), but there was little difference in overall mortality (0.95, 95% CI 0.84-1.06; p=0.4). Fractures were more frequent during active treatment in patients receiving anastrozole than those receiving tamoxifen (451 vs 351; OR 1.33, 95% CI 1.15-1.55; p<0.0001), but were similar in the post-treatment follow-up period (110 vs 112; OR 0.98, 95% CI 0.74-1.30; p=0.9). Treatment-related serious adverse events were less common in the anastrozole group than the tamoxifen group (223 anastrozole vs 369 tamoxifen; OR 0.57, 95% CI 0.48-0.69; p<0.0001), but were similar after treatment completion (66 vs 78; OR 0.84, 95% CI 0.60-1.19; p=0.3). No differences in non-breast cancer causes of death were apparent and the incidence of other cancers was similar between groups (425 vs 431) and continue to be higher with anastrozole for colorectal (66 vs 44) and lung cancer (51 vs 34), and lower for endometrial cancer (six vs 24), melanoma (eight vs 19), and ovarian cancer (17 vs 28). No new safety concerns were reported. INTERPRETATION: These data confirm the long-term superior efficacy and safety of anastrozole over tamoxifen as initial adjuvant therapy for postmenopausal women with hormone-sensitive early breast cancer.

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