Department of Medical Oncology, GROW - School for Oncology and Developmental Biology, Maastricht University Medical Centre, Maastricht, The Netherlands.
Department of Internal Medicine, Medical Centre Alkmaar, Alkmaar, The Netherlands.
Breast Cancer Res Treat. 2020 Apr;180(3):675-685. doi: 10.1007/s10549-020-05567-9. Epub 2020 Mar 2.
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.
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.
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.
No association was observed between a reduced BMD and DRFS. Neither did we observe an impact of bisphosphonates on DRFS.
III 期 DATA 研究比较了绝经后乳腺癌患者在接受 2-3 年他莫昔芬辅助治疗后，分别接受 6 年和 3 年阿那曲唑辅助治疗的效果。本预先计划的辅助研究评估了骨密度（BMD）降低与远处无复发生存率（DRFS）之间的关系，并评估了双膦酸盐对 DRFS 的影响。
我们选择了所有在随机分组后 3 年内进行了 BMD 测量（标志）且无任何 DRFS 事件的患者。采用 Kaplan-Meier 方法和 Cox 比例风险模型进行分析。
在 1860 名符合条件的患者中，有 1142 名在标志前进行了 DEXA 扫描。436 名（38.2%）患者的 BMD 正常，565 名（49.5%）患者存在骨质减少，141 名（12.3%）患者存在骨质疏松症。从标志开始后中位随访 5.0 年，骨质减少或骨质疏松症（与正常 BMD 相比）均与 6 年组[骨质减少 HR 0.82（95% CI 0.45-1.49），骨质疏松症 HR 1.10（95% CI 0.26-4.67）]和 3 年组[骨质减少 HR 0.75（95% CI 0.40-1.42），骨质疏松症 HR 1.86（95% CI 0.43-8.01）]的 DRFS 无相关性。此外，双膦酸盐的使用并未影响 DRFS。
BMD 降低与 DRFS 之间未观察到相关性。双膦酸盐对 DRFS 也没有影响。
