阿那曲唑和三苯氧胺作为早期乳腺癌的辅助治疗:10年期ATAC试验分析。

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Cuzick J,斯塔克我,Baum M, Buzdar,豪厄尔,Dowsett M,福布斯摩根富林明

阿那曲唑和三苯氧胺作为早期乳腺癌的辅助治疗:10年期ATAC试验分析。

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

PubMed ID
21087898 (在PubMed
]
文摘

背景:瑞宁德,它莫西芬,单独或组合(ATAC)试验设计比较阿那曲唑的疗效和安全性(1毫克)与三苯氧胺(20毫克),每天口服5年来,作为辅助治疗绝经后妇女早期乳腺癌。在这个分析中,我们评估后,平均120个月的随访,长期的结果。方法:我们使用比例风险模型来评估无病生存的主要终点和次要终点的时间复发时间遥远的复发,新侧乳腺癌发病率总体生存和死亡有或没有在所有随机患者复发(阿那曲唑n = 3125,三苯氧胺n = 3116)和激素受体阳性患者(阿那曲唑n = 2618,三苯氧胺n = 2598)。治疗完成后,我们继续对骨折和严重不良事件收集数据蒙面的方式(安全人口:阿那曲唑n = 3092,三苯氧胺n = 3094)。这项研究被注册为一个国际标准的随机对照试验,ISRCTN18233230数量。结果:随访平均120个月(范围0 - 145);有24522的后续woman-years阿那曲唑组和23950 woman-years三苯氧胺组。在完整的研究人群,有显著改善阿那曲唑组与三苯氧胺组的无病生存期(危险比[HR] 0.91, 95%可信区间0.83 - -0.99;p = 0.04),复发时间(0.84,0.75 - -0.93;p = 0.001),和遥远的复发时间(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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