PURPOSE The phase III DATA study compared 6 and 3 years of adjuvant anastrozole following 2-3 years of tamoxifen in postmenopausal breast cancer patients. This pre-planned side-study assessed the relationship between a reduced bone mineral density (BMD) and distant recurrence-free survival (DRFS), and evaluated the effect of bisphosphonates on DRFS. METHODS We selected all patients with a BMD measurement within 3 years after randomisation (landmark) without any DRFS events. Kaplan-Meier methods and Cox proportional hazards models were used for analyses. RESULTS Of 1860 eligible patients, 1142 had a DEXA scan before the landmark. The BMD was normal in 436 (38.2%) and showed osteopenia in 565 (49.5%) and osteoporosis in 141 (12.3%) patients. After a median follow-up of 5.0 years from the landmark, neither osteopenia nor osteoporosis (compared with normal BMD) were associated with DRFS in both the 6-year [osteopenia HR 0.82 (95% CI 0.45-1.49), osteoporosis HR 1.10 (95% CI 0.26-4.67)] and the 3-year arm [osteopenia HR 0.75 (95% CI 0.40-1.42), osteoporosis HR 1.86 (95% CI 0.43-8.01)]. Moreover, bisphosphonate use did not impact DRFS. CONCLUSION No association was observed between a reduced BMD and DRFS. Neither did we observe an impact of bisphosphonates on DRFS.

中文翻译：

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与骨矿物质密度和双膦酸盐使用有关的乳腺癌结果：DATA试验的子研究。

目的III期数据研究比较了更年期后乳腺癌患者他莫昔芬2-3年后6年和3年佐剂阿那曲唑的辅助作用。这项预先计划的附带研究评估了骨矿物质密度（BMD）降低与远距离无复发生存（DRFS）之间的关系，并评估了双膦酸盐对DRFS的影响。方法我们选择了在随机分配后3年内（具有里程碑意义）无任何DRFS事件的所有BMD测量患者。使用Kaplan-Meier方法和Cox比例风险模型进行分析。结果在1860名符合条件的患者中，有1142名在地标之前进行了DEXA扫描。BMD 436例（38.2％）正常，565例（​​49.5％）出现骨质减少，141例（12.3％）出现骨质疏松。在对标志性建筑进行了5.0年的平均随访之后，在6年[骨质疏松HR 0.82（95％CI 0.45-1.49），骨质疏松HR 1.10（95％CI 0.26-4.67）]和3年中，骨质疏松症和骨质疏松症（与正常BMD相比）均与DRFS无关。手臂[骨质疏松症HR 0.75（95％CI 0.40-1.42），骨质疏松症HR 1.86（95％CI 0.43-8.01）]。而且，双膦酸盐的使用不会影响DRFS。结论在降低的BMD和DRFS之间未发现相关性。我们也没有观察到双膦酸盐对DRFS的影响。