DATA研究评估了两种不同的阿那替珠单药应用时间在经过2-3年的他莫昔芬治疗后患有激素受体阳性乳腺癌且无病的患者中的应用效果。我们在此呈现随访分析，该分析在所有患者治疗分离后的跟踪期达到至少10年后进行。这个开放标签、随机、3期的DATA研究在荷兰的79家医院进行（ClinicalTrials.gov，编号NCT00301457）。绝经后的激素受体阳性乳腺癌患者在经过2-3年辅助性他莫昔芬治疗后被指定为接受3年或6年的阿那替珠（口服1 mg/天）。随机分配（1:1）是按照激素受体状态、淋巴结状态、HER2状态和先前的他莫昔芬疗程分层的。主要结局是调整后的无病生存期，定义为从随机分配后3年开始的无病生存期。调整后的总生存期被评估为次要结局。分析是根据意向治疗设计进行的。在2006年6月28日至2009年8月10日期间，有1912名患者随机分配为3年（n=955）或6年（n=957）的阿那替珠。其中，1660名患者在随机分配后3年是符合资格且无病的。6年组（n=827）的10年调整后无病生存率为69.2%（95% CI 55.8-72.3），3年组（n=833）的为66.0%（95% CI 62.5-69.2）（风险比（HR）0.86; 95% CI 0.72-1.01; p=0.073）。6年组的10年调整后总生存率为80.9%（95% CI 77.9-83.5），3年组的为79.2%（95% CI 76.2-81.9）（HR 0.93; 95% CI 0.75-1.16; p=0.53）。在顺序内分泌治疗超过5年的情况下延长芳香酶抑制剂治疗并未改善激素受体阳性乳腺癌绝经后妇女的调整后无病生存和调整后总生存。AstraZeneca.© 2023 作者。

The DATA study evaluated the use of two different durations of anastrozole in patients with hormone receptor-positive breast cancer who were disease-free after 2-3 years of tamoxifen. We hereby present the follow-up analysis, which was performed after all patients reached a minimum follow-up of 10 years beyond treatment divergence.The open-label, randomised, phase 3 DATA study was performed in 79 hospitals in the Netherlands (ClinicalTrials.gov, number NCT00301457). Postmenopausal women with hormone receptor-positive breast cancer who were disease-free after 2-3 years of adjuvant tamoxifen treatment were assigned to either 3 or 6 years of anastrozole (1 mg orally once a day). Randomisation (1:1) was stratified by hormone receptor status, nodal status, HER2 status, and prior tamoxifen duration. The primary outcome was adapted disease-free survival, defined as disease-free survival from 3 years after randomisation onwards. Adapted overall survival was assessed as a secondary outcome. Analyses were performed according to the intention-to-treat design.Between June 28, 2006, and August 10, 2009, 1912 patients were randomly assigned to 3 years (n = 955) or 6 years (n = 957) of anastrozole. Of these, 1660 patients were eligible and disease-free at 3 years after randomisation. The 10-year adapted disease-free survival was 69.2% (95% CI 55.8-72.3) in the 6-year group (n = 827) and 66.0% (95% CI 62.5-69.2) in the 3-year group (n = 833) (hazard ratio (HR) 0.86; 95% CI 0.72-1.01; p = 0.073). The 10-year adapted overall survival was 80.9% (95% CI 77.9-83.5) in the 6-year group and 79.2% (95% CI 76.2-81.9) in the 3-year group (HR 0.93; 95% CI 0.75-1.16; p = 0.53).Extended aromatase inhibition beyond 5 years of sequential endocrine therapy did not improve the adapted disease-free survival and adapted overall survival of postmenopausal women with hormone receptor-positive breast cancer.AstraZeneca.© 2023 The Authors.